murphy’s law · 4 if you have difficulty accessing any of these files, please contact elise perry...
TRANSCRIPT
Kirkpatrick amp Lockhart LLP
reg
MURPHYrsquoS LAW
DECEMBER 2003
FOOD amp DRUG PRACTICEwwwklcom
KampL Regulatory Update
Contents
GENERAL NEWS 1
COSMETICS 3
DIETARY SUPPLEMENTSFOOD 4
OTC DRUGS 6
MEDICAL DEVICES 7
INTERNATIONAL UPDATE 8
MEETINGS AND CONFERENCES 10
1
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
GENERAL NEWS FDA issues transitional compliance policy guide on food import compliance
httpwwwfdagovbbstopicsNEWS2003NEW00995html
FDA Booklets lsquoWhat You Need to Know About Food Facility Registrationrsquo and lsquoWhat You Needto Know About Prior Notice of Imported Food Shipmentsrsquohttpwwwcfsanfdagov~dmsfsbtbookhtml
Guidance for Industry Prior Notice of Imported Food ndash Questions and Answershttpwwwcfsanfdagov~pnpnqaguidhtml
Guidance for Industry Questions and Answers Regarding Registration of Food Facilitieshttpwwwcfsanfdagov~dmsffreguidhtml
Compliance Policy Guide Guidance for FDA Staff on Registration of Food Facilitieshttpwwwcfsanfdagov~furlscpgreghtml
Compliance Policy Guide Guidance for FDA Staff on Notice of Imported Foodhttpwwwcfsanfdagov~pncpgpnhtml
Interim Final Rule on Food Facilities Registrationhttpa257gakamaitechnet7257242214mar20010800edocketaccessgpogov2003pdf03-25849pdf
Interim Final Rule on Notice of Imported Foodhttpa257gakamaitechnet7257242210oct20030800edocketaccessgpogov2003pdf03-25877pdf
FDA Resource Page FDA Actions on New Bioterrorism Legislationhttpwwwcfsanfdagov~dmsfsbtacthtml
US Department of Homeland Security announces cargo security initiativeRelease httpwwwcustomsustreasgovxpcgovnewsroompress_releases11202003xmlPress conference httpwwwdhsgovdhspublicdisplaycontent=2344
Food Security continues to be a Bush administration priorityhttpwwwfoodnavigatorcomnewsnews-NGaspid=47938
The US Court of Appeals for the Federal Circuit modifies the Festo decision by clarifying theuse of intellectual property protectionhttpwwwdevicelinkcommddiarchive0312015html
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
The Association of Analytical Communities (AOAC) publishes ldquoTop 10 List of What to Ask Your(Contract) Labrdquohttpwwwaoacorgproficiencytestingtop_ten_queshtm
The California Air Resources Board (CARB) held a meeting to discuss new amendments to CARBconsumer products regulation scheduled to take effect in mid-2004httpwwwwaiborgregulatoryprinthtm
FDA to revise civil money penalties announces hearingshttpa257gakamaitechnet7257242214mar20010800edocketaccessgpogov2003pdf03-29741pdf
Federal team to examine adverse event reportshttpwwwthompsoncomhp_newsbriefs031211e_fooddrughtml
FTC releases guidance to media on false weight loss claimshttpwwwftcgovopa200312weightlossrpthtm
Harmonization International Conference guidelines availability
Stability data package for registration applications in climatic zones III and IV and stability testing ofnew drug substances and productshttpa257gakamaitechnet7257242214mar20010800edocketaccessgpogov2003pdf03-29103pdf
US state and city governments are pressing ahead with plans to re-import US made drugs from Canadahttpwwwsltribcom2003Nov11272003nation_w114839asp
Meanwhile FDA and Health Canada have signed a Memorandum of Understanding to shareenforcement related information including specifically cross-border issues such as Internetpharmacies and counterfeit drugshttpwwwglobeandmailcomservletstoryRTGAM20031118wdrug1118BNStoryNational
First chewable birth control pill approved by FDAhttpmsnbcmsncomDefaultaspxid=3475869ampp1=0
FDA proposes an incentive to remove illegal Rx drugshttpwwwfdagovcderpikenov2003htmIllegalRxs
In October FDA issued the draft guidance Marketed Unapproved Drugs Compliance Policy GuidehttpwwwfdagovOHRMSDOCKETS98fr2003D-0478-gdl0001pdf
Medical Devicelink examines whether FDArsquos enforcement policy is really more aggressivehttpwwwdevicelinkcommddiarchive0312018html
At CHPA conference speaker says retailers manufacturers of OTC prescription and natural healthcareremedies must seek new ways to market to the total wellness needs of consumershttpwwwmronscomdrnonews2262htm
Healthcare spending has slowed to the lowest level in three years because it is believed of cost increaseshttpwwwpost-gazettecompg03346250297stm
Top Court refuses to hear drug makerrsquos patent dispute casehttpwwwdetnewscom2003business031202c04-339686htm
Many health problems begin with gum disease studies findhttpwwwtheledgercomappspbcsdllarticleAID=20031216NEWS3121603011021
2
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
3
COSMETICS
Regulatory Update
Technical amendment to Skin Protectant Drugs for Over the Counter Use Monographhttpa257gakamaitechnet7257242214mar20010800edocketaccessgpogov2003pdf03-30394pdf
See recent international regulatory news items at Beauty-on-Linehttpwwwbeauty-on-linecombrd01-00asp
Safety and Effectiveness Update
The first head-to-head trial of Botox versus three over-the-counter cosmetic creams is now enrollingsubjectshttpbizyahoocomprnews031124nym012_1html
Moisturizing tights are introduced by CSP International Industria Calze This and other new productnews can be found in Mintelrsquos November press releasehttpwwwin-cosmeticscompagecfmlink=82
Cosmetic ingredient makers win awards for UV-absorber and thickenerhttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=331
Japanrsquos textile company Omikenshi develops a rayon fiber with a fresh grapefruit fragrancehttpwwwbharattextilecomnewsitems1986336
Rate of home fires caused by candles has recently surgedhttpwwwnfpaorgPressRoomNewsReleasesCandlescandlesasp
Study finds that sunscreen does not increase risk of melanomahttpwwwreuterscomnewsArticlejhtmltype=healthNewsampstoryID=3996984
Business and Industry Update
US Congressmen write letter accusing Mary Kay of abetting religious persecution in ChinahttpwwwcnsnewscomViewCultureaspPage=5CCulture5Carchive5C2003115CCUL20031120ahtml
Del Laboratories named Most Innovative Marketer by Womenrsquos Wear Daily honored for itscontinuous flow of innovation across cosmetic categorieshttpbizyahoocomprnews031210nyw082_1html
The UKrsquos Boots retailer is opening 32 stores on the US east coast and in Denver in spring 2004httpwwwcosmeticsbusinesscomnewsstoryaspstoryid=322
Mintel issues its 2004 product predictions covering cosmetics scents foods and packaging trendshttpwwwwebdeskcomnew-product-predictions
Mintel also examines the makeup market finding that lipstick reigns and Asian and Hispanic womenare the most avid consumershttpwwwin-cosmeticscompagecfmlink=74
Black hair care products are set to become less race-specifichttpwwwin-cosmeticscompagecfmlink=83
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
4
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
The menrsquos toiletries market in the UShttpwwwin-cosmeticscompagecfmlink=79
German company Henkel to acquire Dialhttpwwwcbccacpbusiness031215b121524html
Legislative Update
The House has passed a bill that would regulate non-corrective contact lenses as medical deviceshttpwwwguardiancoukuslateststory01282-340854000html
DIETARY SUPPLEMENTSFOOD
Regulatory Update
FTC submits comments to FDA on food labels and obesityhttpwwwftcgovopa200312fdaobesityhtm
Advisory panel recommends big changes to recommended daily value calculations for vitamins andmineralshttpmagazinesivillagecomgoodhousekeepinghbnewsarticle0krt_2003_12_12_knigt_2734-0109-NTR-FDA~TB~ew~xml00html
Advanced notice of proposed rulemaking published for comment on regulating qualified health claimshttpa257gakamaitechnet7257242214mar20010800edocketaccessgpogov2003pdf03-29448pdf
Food labels face overhaul to reflect latest information on nutritionhttpwwwhealthcentralcomnewsNewsFullTextcfmid=516512
USDA issues new food safety guidelines for consumershttpwwwusdagovnewsreleases2003110386htm
FDA approves whole grain health claimhttpwwwthompsoncomhp_newsbriefs031211c_fooddrughtml
Consumerlabcom reports improvement in the quality of SAMehttpwwwconsumerlabcomresultssameasp
US health insurers ponder whether to make obesity treatments reimbursablehttpstorynewsyahoocomnewstmpl=storyampcid=1506ampncid=751ampe=6ampu=afp20031212ts_alt_afpyear_us_obesity
Some say DSHEA opened the door to the current steroids doping scandalshttpwwwbayareacommldmercurynewssports7503489htm
Enforcement Update
Contaminated food seized at Washington DC distributorhttpwwwfdagovbbstopicsnews2003doj112803html
$27 million worth of Royal Tongan Limu destroyed because of persistent unsubstantiated health claimshttpwwwfdagovbbstopicsNEWS2003NEW00976html
American Nutraceuticals receives warning letter for drug claims on behalf of its supplement productshttpwwwfdagovfoiwarning_lettersg4406dhtm
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Food importer Golden Luck Inc receives a warning letter for distributing adulterated products andfor failing to bring misbranded products into compliance even after submitting certificates ofcompletion for reconditioning to FDAhttpwwwfdagovfoiwarning_lettersg4394dhtm
Genesis Juice Cooperative receives warning letter for deviations from Juice Hazard Analysis CriticalControl Pointhttpwwwfdagovfoiwarning_lettersg4402dhtm
Superior Nut Company receives a warning letter for insanitary conditionshttpwwwfdagovfoiwarning_lettersg4362dhtm
Safety and Effectiveness Update
Research seems to indicate that water can lsquorememberrsquo compounds even after the compounds havebeen removedhttpwwwnewsscotsmancomindexcfmid=1093712003
And homeopathy reduces arsenic poisoning in micehttpwwwnewscientistcomnewsnewsjspid=ns99994305
Kraft has agreed to get the trans fats out of Oreos but figuring out how is a challenge for their research teamhttpwwwmetroactivecompaperscruz120303fats-0349html
Study finds black elderberry extract seems to ameliorate flu symptoms and shorten its durationhttpwwwfoodnavigatorcomnewsnews-NGaspid=48460
Wheat grain may be beneficial to diabeticshttpnewsbbccouk2hihealth3279591stm
Some US children show early signs of heart diseasehttpwwwnewscientistcomnewsnewsjspid=ns99994364
Cocoa has even more cancer preventing compounds than red wine or green tea say scientistshttpwwwnewscornelledureleasesNov03HotCocoa-Leebpfhtml
Cinnamon is found to improve blood sugar levelshttpwwwnewscientistcomnewsnewsjspid=ns99994413
Business and Industry Update
Nutraquest seeks to sue sports team over player deathhttpwwwwjlacomnewsstories1203112405html
Masterfoods USA introduces CocoaVia its new functional chocolate product containing phytosterolsand flavonols believed to protect the hearthttpwwwnutraingredients-usacomnewsnews-NGaspid=48471
Mintel issues its 2004 product predictions covering cosmetics scents foods and packaging trendshttpwwwwebdeskcomnew-product-predictions
An international survey finds mothers the world over worry over their childrenrsquos weight will pay morefor healthier food and rely on multiple information sources in making purchasing decisionshttphomebusinesswirecomportalsitegoogleindexjspndmViewId=news_viewampnewsId=20031210005453ampnewsLang=en
5
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Legislative Update
American Herbal Products Association press release on the bill entitled Dietary Supplement Accessand Awareness Act (HR 3377)httpwwwalliance-natural-healthorgindexcfmaction=newsampID=42
The Senate Governmental Affairs Committee heard about the USrsquos pressing need for an agriculturalanti-terror plan in last monthrsquos hearingshttpwwwzwirecomsitenewscfmBRD=1829ampdept_id=112755ampnewsid=10635153ampPAG=461amprfi=9
OTC DRUGS
Regulatory Update
FDA advisory committee votes to allow OTC sales of emergency contraceptive pillhttpwwwdocguidecomnewscontentnsfnews8525697700573E1885256DFF004D2D50OpenDocumentampc=Contraceptionampcount=10
Joint meeting of FDArsquos Nonprescription Drugs Advisory Committee and the Reproductive HealthDrugs Advisory Committee on December 16httpwwwfdagovocadvisoryaccalendarcder12541d121603html
Claritin approved for OTC use on hiveshttpwwwdocguidecomnewscontentnsfnews8525697700573E1885256DE4004D67B1OpenDocumentampc=Allergy20Otherampcount=10
FDA Advisory Committee considers broader professional labeling of aspirin to include an indicationfor use in prevention of a first heart attack in patients at risk for coronary heart diseasehttpwwwpressicomintrelease81538html
Enforcement Update
Nutra Med receives warning letter for deviations from cGMP regulationshttpwwwfdagovfoiwarning_lettersg4357dhtm
Product Safety and Effectiveness Update
Researchers find that an aspirin a day can stave off disease in elderlyhttpwwwiolcozaindexphpclick_id=31ampart_id=qw1071548463830B252ampset_id=1
Doctors warn of dangers of combining medications for fluhttpwwwwralcomhealth2705344detailhtml
AMA publishes list of drugs that are potentially hazardous to the elderlyhttparchinteama-assnorgcgicontentfull163222716Article with interview of principal drafter of AMA reporthttpwashingtontimescomnational20031214-114551-1067rhtm
This cold and flu season many new remedies are on the shelveshttpwwwsun-sentinelcomsportssfl-coldremedydec1401933986storycoll=sfla-sports-headlines
Homeopathic flu remedies receive attentionhttpwwwreformercomStories01413102~8862~183588800html
Interview with a naturapathhttpwwworegonlivecommetrosouthwestoregonianindexssfbasemetro_southwest_news1070629282241150xml
6
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
7
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Business and Industry Update
ACNielson begins tracking sales of OTC remedies in convenience storeshttpwwwmronscomdrnonews1942htm
Procter amp Gamble is teaming with Fleetwood RV in a marketing ploy to have a large purple RVfeatured in ads for OTC Prilosechttpbizyahoocomprnews031215lam040_1html
Baby boomers boost tooth whitener saleshttpwwwdelawareonlinecomnewsjournalbusiness20031215boomersboosttoohtml
OTC flu remedies are facing shortages during this flu seasonhttpwwwnbc5comhealth2701177detailhtmlz=dpampdpswid=1167317ampdppid=65195
An overview of some of the many new flu remedies on the market this yearhttpwwwdetnewscom2003health031217h05-10909htm
MEDICAL DEVICES
Regulatory Update
Proposed rule on the effective date on requirement for premarket approval for three Class IIIpreamendments deviceshttpa257gakamaitechnet7257242214mar20010800edocketaccessgpogov2003pdf03-28741pdf
FDA Commissioner McClellan challenges industry to improve development processhttpwwwdevicelinkcommddiarchive0312014html
FDA approves injectable gel to treat facial wrinkleshttpwwwfdagovbbstopicsANSWERS2003ANS01271html
Devicelink editorial on FDArsquos voluntary third-party inspection initiativehttpwwwdevicelinkcommddiarchive0312017html
FDA approves laser treatment for acnehttpbizyahoocomprnews031124nym152_1html
Enforcement Update
Device maker Applied Laboratories Inc receives warning letter for violation of Quality System Regulationhttpwwwfdagovfoiwarning_lettersg4408dhtm
Medical kit maker American Medical Devices Inc receives cGMP warning letterhttpwwwfdagovfoiwarning_lettersg4410dhtm
Plus Orthepedics receives a warning letter for failing to meet requirements for an Investigative DeviceExemption and for failing to be specific enough with regard to the companyrsquos corrective action planhttpwwwfdagovfoiwarning_lettersg4331dhtm
Drug Free Enterprises maker of drug test kits receives a warning letter for cGMP violations andviolations in its conduct of a consumer surveyhttpwwwfdagovfoiwarning_lettersg4363dhtm
Wood Hygienic Institute receives a cGMP warning letter for its colonic irrigation deviceshttpwwwfdagovfoiwarning_lettersg4399dhtm
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
8
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Safety and Effectiveness Update
New allograft technique allows surgeons to save limbshttpwwwchroncomcsCDAssistorymplmetropolitan2232953
Biolectrical Impedence Analysis may be best measure of childhood weight problemshttpwwwsciencedailycomreleases200310031009065701htm
Electrical stimulation procedure may aid stroke recoveryhttpwwwdevicelinkcommddiarchive0312020html
Virtual colonoscopy is found to be as effective as traditional optical colonoscopyhttpwwwama-assnorgamednews20031222hlbf1222htm
Business and Industry Update
Medical ethics and financial interests clash in referrals to imaging centershttpwwwcourier-journalcomlocalnews20031201kywir-front-mri1201-17507html
INTERNATIONAL UPDATE
Europe
EU Court okays online sales for over-the-counter drugshttpwwweubusinesscomafp031211145511hmn3w13q
COLIPA publishes its lsquoFirst observations of the European Cosmetics Industry on the Commissionproposal for a European chemicals legislationrsquohttpwwwcolipacomdocpress_statement_071103pdf
Monaco agrees to introduce EU rules on cosmetics production into the principality to assist localmanufacturers in selling their brands across Europehttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=334
Steroids found in herbal eczema creamshttpnewsbbccouk2hihealth3301481stm
European Commission proposes new regulations for food contact substanceshttpwwwfoodnavigatorcomnewsnews-NGaspid=47870
Member states failed to support an initiative to approve the first GM foodstuffhttpwwwfoodnavigatorcomnewsnews-NGaspid=48319
EU issues report on presence of persistent chemicals in the human body and the blood test resultson a commissionerhttpeuropaeuintrapidstartcgiguestenkshp_actiongettxt=gtampdoc=MEMO03219|0|RAPIDamplg=ENampdisplay=
Outlook is favorable for easier marketing of cholesterol lowering foods in Europehttpwwwnutraingredientscomnewsnews-NGaspid=48480
The UK is a growth market for functional foodshttpwwwnutraingredientscomnewsnews-NGaspid=48485
Businesses and advertisers take notice of the huge purchasing power in the swelling ranks ofEuropean seniorshttpstraitstimesasia1comsgworldstory0438622511500html
EU counterfeit cosmetics and perfumes seizures up 300 over 2001 and 2002 EC reportshttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=328
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
9
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Avon builds manufacturing plant in RussiahttpwwwindustryweekcomCurrentArticlesAsparticlesaspArticleId=1533
Swedish cosmetic company Oriflame is also building a factory in Russiahttpwwwgateway2russiacomstart_150361php
AsiaPacific
Therapeutic tourism is booming in Karnataka India where clinics offer ayurveda homeopathyyoga naturopathy acupuncture and morehttpwwwrediffcommoney2003dec09tourhtm
The Asian cosmetics market boom in China stagnation in Japan local competition in South Koreahttpwwwbeauty-on-linecomebnnewsletteraspeid=80
In South Korea the makers of a cosmetics refrigerator are eyeing the overseas markethttpwwwkoreaheraldcokrSITEdatahtml_dir20031213200312130014asp
Australian food manufacturers and retailers must meet new labeling standards as of December 20httpwwwfoodnavigatorcomnewsnews-NGaspid=48488
Revlon debuts in BruneihttpwwwbrudirectcomDailyInfoNewsArchiveDec03121203bb17htm
Indian cosmetics company Emami has filed a criminal complaint against Bollywood filmmakersHrithik and Rakesh Roshan for failing to honor product placement agreements in their latest filmhttpwwwapunkachoicecomhappenings20031211-0html
LVMH plans to expand its Christian Dior line in China and Japanhttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=332
Kanebo and Kao have joined forces to challenge Shiseidohttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=319
The Pacific Bridge Asian Medical December Newsletter features a story on ASEAN plans to reducenon-tariff barriers for cosmetics and pharmaceuticalshttpwwwpacificbridgemedicalcomnewsletterv3n9pdf
The Americas
MexRegscom is an Internet source for Mexican regulationshttpwwwmexregscom
Health Canada advises against the use of the herb comfrey or products that contain comfreyhttpwwwhc-scgccaenglishmediareleases20032003_101htm
Researcher finds high mercury levels in Mexican women and border states traced to Mexican madeskin whitening creamhttpwwwbostoncomnewsglobehealth_sciencearticles20031216whitening_skin_can_be_deadly
Waxing manicures for men are becoming popular in traditionally macho Mexico Puerto Rico andArgentinahttpbusiness-timesasia1comsgstory0456710046200html
10
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
011904 ndash 012204 Informex Venetian Hotel Sands Expo CenterLas Vegas Nevada USAMore info httpwwwinformexcom
012704 ndash 013104 Soap and Detergent Association (SDA) Boca Raton Resort amp ClubAnnual Meeting and Industry Convention Boca Raton Florida USA
More info (202) 347-2900
020904 ndash 021204 ICE Expo The Hyatt RegencyMiami Florida USAMore info (630) 653-2155Email icealluredcomhttpwwwice-expocom
022604 ndash 022904 Cosmetic Toiletry and Fragrance Association (CTFA) Boca Raton Resort amp ClubAnnual Meeting and Industry Convention Boca Raton Florida USA
More info (202) 331-1770
030904 ndash 031104 Personal Care Ingredients Asia JinHan Exhibition CenterGuangzhou ChinaMore info Step Exhibitions(44) 1892-518877httpwwwstepexcom
032204 ndash 032304 Society of Cosmetic Scientists Spring Symposium Kettering Park Hotel KetteringldquoPerfumemdashthe Constant Elementrdquo Northants UK
Tel 44-1582-726661Email ifsccscsconnectcomwwwscsorguk
032404 SCC Teamworks 2004 Midwest Chapter More info httpwwwmidwestsccorgSupplierrsquos Day
032404 ndash 032604 Institute of Packaging Professionals Marriott MarquisFlexible Packaging Conference 2004 Atlanta Georgia USA
More info Stan Zelesnik IOPP(630) 544-5050 ext 108Email szelesnikiopporghttpwwwiopporg
041304 ndash 041404 Personal Care Ingredients and Technology Sheraton Hotel NYCExhibition 2004 High Function Naturals Contact PCITXHigh Performance Ingredients and Tel 949-487-9970High Impact Color E-mail bobgraysonassociatescom
041404 ndash 041804 Intercharm Professional 2004 Moscow RussiaE-mail mointercharmruwwwintercharmneteng
042004 ndash 042204 The Color Pigments Manufacturing Association Inc Chicago Illinois USAInternational Color Pigments Conference More info (703) 684-4044
Email cpmacpmacom
042704 042904 In-Cosmetics Milan ItalyContact patricialefevrereedexpocouk
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
MEETINGS AND CONFERENCES
050604 ndash 050704 Society of Cosmetic Chemists (SCC) Mohegan SunAnnual Scientific Seminar Uncansville Connecticut USA
More info (212) 668-1500
052404 ndash 052804 Aromatherapy and Perfumery Seminar Grasse FranceProperties of natural raw materials used Tel 33-4-92-42-34-90in perfumery and aromatherapy E-mail gipprodaromfr
060104 ndash 060504 World Perfumery Congress The Future of Perfumery Palais des FestivalsCannes FranceMore info (33) 55-96-21-32Email infoworldperfumerycongresscomhttpwwwworldperfumerycongresscom
062004 ndash 062304 6th World Surfactants Congress Berlin GermanyMore info (49) 30-300-66-90Email berlincpo-hanserdehttpwwwcesio2004de
091004 ndash 091204 Pathways to Beauty and Wellness Jacob K Javitz Convention CenterNew York New York USAMore info Grayson Associates(949) 487-9970Email suzannegraysonassociatescom
101004 ndash 101304 RAPS 2004 Annual Conference and Exhibition Washington Hilton and TowersWashington DC USAhttpwwwrapsorg
102004 ndash 102204 Centifolia International Congress of Perfumery Grasse Franceand Natural Ingredients Contact le Club des Entrepreneurs
Tel 33-4-97-05-57-60clubdesentrepreneursville-grassefr
102404 ndash 102704 ISFCC International Congress Dolphin Hotel Walt Disney World ResortOrlando Florida USAMore info (212) 668-1500
102404 ndash 102804 International Federation of Essential Oils Lisbon Portugaland Aroma Trades International Conference 2004 More info +44-20-7836-2460
Email ifeatadministratorfdforgukhttpwwwifeatorgIFEAT20Lisbon20flyer2004pdf
102804 ndash 110104 11th Perfumery amp Cosmetics Exhibitionmdash Sokolniki Exhibition Center MoscowInterCharm E-mail mointercharmru
wwwintercharmneteng
111004 ndash 111204 Cosmoprof Asia and The Natural Health Fair Hong Kong Convention and Exhibit CenterhttpwwwnaturalhealthfaircomNHFupdate_enhtml
111604 ndash 111804 Health Ingredients Europe The Netherlandswwwhi-eventscom
10
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Kirkpatrick amp Lockhart LLP
Challenge us
Kirkpatrick amp Lockhartrsquos Food and Drug Practice offers comprehensive legal and
regulatory counseling to companies and other organizations regulated by FDA
under the Federal Food Drug and Cosmetic Act We represent manufacturers
and distributors of food dietary supplements pharmaceuticals medical devices
biologicals and personal care and cosmetic products Areas of experience include
enforcement approvals and clearance labeling and advertising clinical research
inspections and importexport
P A R T N E R S
Gary L Yingling 2027789124 gyinglingklcom
Suzan Onel 2027789134 sonelklcom
O F C O U N S E L
Emalee G Murphy 2027789428 emaleemurphyklcom
A S S O C I A T E S
Ann M Begley 2027789365 abegleyklcom
Rebecca L Dandeker 2027789409 rdandekerklcom
Joshua S Kim 2027789039 jkimklcom
FOOD amp DRUG PRACTICE
copy 2003 KIRKPATRICK amp LOCKHART LLP ALL RIGHTS RESERVED
This publicationnewsletter is for informational purposes and does not contain or convey legal advice The information hereinshould not be used or relied upon in regard to any particular facts or circumstances without first consulting a lawyer
BOSTONDALLASHARRISBURGLOS ANGELESMIAMINEWARKNEW YORKPITTSBURGHSAN FRANCISCOWASHINGTON
16
KampL Regulatory Update
Contents
GENERAL NEWS 1
COSMETICS 3
DIETARY SUPPLEMENTSFOOD 4
OTC DRUGS 6
MEDICAL DEVICES 7
INTERNATIONAL UPDATE 8
MEETINGS AND CONFERENCES 10
1
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
GENERAL NEWS FDA issues transitional compliance policy guide on food import compliance
httpwwwfdagovbbstopicsNEWS2003NEW00995html
FDA Booklets lsquoWhat You Need to Know About Food Facility Registrationrsquo and lsquoWhat You Needto Know About Prior Notice of Imported Food Shipmentsrsquohttpwwwcfsanfdagov~dmsfsbtbookhtml
Guidance for Industry Prior Notice of Imported Food ndash Questions and Answershttpwwwcfsanfdagov~pnpnqaguidhtml
Guidance for Industry Questions and Answers Regarding Registration of Food Facilitieshttpwwwcfsanfdagov~dmsffreguidhtml
Compliance Policy Guide Guidance for FDA Staff on Registration of Food Facilitieshttpwwwcfsanfdagov~furlscpgreghtml
Compliance Policy Guide Guidance for FDA Staff on Notice of Imported Foodhttpwwwcfsanfdagov~pncpgpnhtml
Interim Final Rule on Food Facilities Registrationhttpa257gakamaitechnet7257242214mar20010800edocketaccessgpogov2003pdf03-25849pdf
Interim Final Rule on Notice of Imported Foodhttpa257gakamaitechnet7257242210oct20030800edocketaccessgpogov2003pdf03-25877pdf
FDA Resource Page FDA Actions on New Bioterrorism Legislationhttpwwwcfsanfdagov~dmsfsbtacthtml
US Department of Homeland Security announces cargo security initiativeRelease httpwwwcustomsustreasgovxpcgovnewsroompress_releases11202003xmlPress conference httpwwwdhsgovdhspublicdisplaycontent=2344
Food Security continues to be a Bush administration priorityhttpwwwfoodnavigatorcomnewsnews-NGaspid=47938
The US Court of Appeals for the Federal Circuit modifies the Festo decision by clarifying theuse of intellectual property protectionhttpwwwdevicelinkcommddiarchive0312015html
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
The Association of Analytical Communities (AOAC) publishes ldquoTop 10 List of What to Ask Your(Contract) Labrdquohttpwwwaoacorgproficiencytestingtop_ten_queshtm
The California Air Resources Board (CARB) held a meeting to discuss new amendments to CARBconsumer products regulation scheduled to take effect in mid-2004httpwwwwaiborgregulatoryprinthtm
FDA to revise civil money penalties announces hearingshttpa257gakamaitechnet7257242214mar20010800edocketaccessgpogov2003pdf03-29741pdf
Federal team to examine adverse event reportshttpwwwthompsoncomhp_newsbriefs031211e_fooddrughtml
FTC releases guidance to media on false weight loss claimshttpwwwftcgovopa200312weightlossrpthtm
Harmonization International Conference guidelines availability
Stability data package for registration applications in climatic zones III and IV and stability testing ofnew drug substances and productshttpa257gakamaitechnet7257242214mar20010800edocketaccessgpogov2003pdf03-29103pdf
US state and city governments are pressing ahead with plans to re-import US made drugs from Canadahttpwwwsltribcom2003Nov11272003nation_w114839asp
Meanwhile FDA and Health Canada have signed a Memorandum of Understanding to shareenforcement related information including specifically cross-border issues such as Internetpharmacies and counterfeit drugshttpwwwglobeandmailcomservletstoryRTGAM20031118wdrug1118BNStoryNational
First chewable birth control pill approved by FDAhttpmsnbcmsncomDefaultaspxid=3475869ampp1=0
FDA proposes an incentive to remove illegal Rx drugshttpwwwfdagovcderpikenov2003htmIllegalRxs
In October FDA issued the draft guidance Marketed Unapproved Drugs Compliance Policy GuidehttpwwwfdagovOHRMSDOCKETS98fr2003D-0478-gdl0001pdf
Medical Devicelink examines whether FDArsquos enforcement policy is really more aggressivehttpwwwdevicelinkcommddiarchive0312018html
At CHPA conference speaker says retailers manufacturers of OTC prescription and natural healthcareremedies must seek new ways to market to the total wellness needs of consumershttpwwwmronscomdrnonews2262htm
Healthcare spending has slowed to the lowest level in three years because it is believed of cost increaseshttpwwwpost-gazettecompg03346250297stm
Top Court refuses to hear drug makerrsquos patent dispute casehttpwwwdetnewscom2003business031202c04-339686htm
Many health problems begin with gum disease studies findhttpwwwtheledgercomappspbcsdllarticleAID=20031216NEWS3121603011021
2
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
3
COSMETICS
Regulatory Update
Technical amendment to Skin Protectant Drugs for Over the Counter Use Monographhttpa257gakamaitechnet7257242214mar20010800edocketaccessgpogov2003pdf03-30394pdf
See recent international regulatory news items at Beauty-on-Linehttpwwwbeauty-on-linecombrd01-00asp
Safety and Effectiveness Update
The first head-to-head trial of Botox versus three over-the-counter cosmetic creams is now enrollingsubjectshttpbizyahoocomprnews031124nym012_1html
Moisturizing tights are introduced by CSP International Industria Calze This and other new productnews can be found in Mintelrsquos November press releasehttpwwwin-cosmeticscompagecfmlink=82
Cosmetic ingredient makers win awards for UV-absorber and thickenerhttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=331
Japanrsquos textile company Omikenshi develops a rayon fiber with a fresh grapefruit fragrancehttpwwwbharattextilecomnewsitems1986336
Rate of home fires caused by candles has recently surgedhttpwwwnfpaorgPressRoomNewsReleasesCandlescandlesasp
Study finds that sunscreen does not increase risk of melanomahttpwwwreuterscomnewsArticlejhtmltype=healthNewsampstoryID=3996984
Business and Industry Update
US Congressmen write letter accusing Mary Kay of abetting religious persecution in ChinahttpwwwcnsnewscomViewCultureaspPage=5CCulture5Carchive5C2003115CCUL20031120ahtml
Del Laboratories named Most Innovative Marketer by Womenrsquos Wear Daily honored for itscontinuous flow of innovation across cosmetic categorieshttpbizyahoocomprnews031210nyw082_1html
The UKrsquos Boots retailer is opening 32 stores on the US east coast and in Denver in spring 2004httpwwwcosmeticsbusinesscomnewsstoryaspstoryid=322
Mintel issues its 2004 product predictions covering cosmetics scents foods and packaging trendshttpwwwwebdeskcomnew-product-predictions
Mintel also examines the makeup market finding that lipstick reigns and Asian and Hispanic womenare the most avid consumershttpwwwin-cosmeticscompagecfmlink=74
Black hair care products are set to become less race-specifichttpwwwin-cosmeticscompagecfmlink=83
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
4
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
The menrsquos toiletries market in the UShttpwwwin-cosmeticscompagecfmlink=79
German company Henkel to acquire Dialhttpwwwcbccacpbusiness031215b121524html
Legislative Update
The House has passed a bill that would regulate non-corrective contact lenses as medical deviceshttpwwwguardiancoukuslateststory01282-340854000html
DIETARY SUPPLEMENTSFOOD
Regulatory Update
FTC submits comments to FDA on food labels and obesityhttpwwwftcgovopa200312fdaobesityhtm
Advisory panel recommends big changes to recommended daily value calculations for vitamins andmineralshttpmagazinesivillagecomgoodhousekeepinghbnewsarticle0krt_2003_12_12_knigt_2734-0109-NTR-FDA~TB~ew~xml00html
Advanced notice of proposed rulemaking published for comment on regulating qualified health claimshttpa257gakamaitechnet7257242214mar20010800edocketaccessgpogov2003pdf03-29448pdf
Food labels face overhaul to reflect latest information on nutritionhttpwwwhealthcentralcomnewsNewsFullTextcfmid=516512
USDA issues new food safety guidelines for consumershttpwwwusdagovnewsreleases2003110386htm
FDA approves whole grain health claimhttpwwwthompsoncomhp_newsbriefs031211c_fooddrughtml
Consumerlabcom reports improvement in the quality of SAMehttpwwwconsumerlabcomresultssameasp
US health insurers ponder whether to make obesity treatments reimbursablehttpstorynewsyahoocomnewstmpl=storyampcid=1506ampncid=751ampe=6ampu=afp20031212ts_alt_afpyear_us_obesity
Some say DSHEA opened the door to the current steroids doping scandalshttpwwwbayareacommldmercurynewssports7503489htm
Enforcement Update
Contaminated food seized at Washington DC distributorhttpwwwfdagovbbstopicsnews2003doj112803html
$27 million worth of Royal Tongan Limu destroyed because of persistent unsubstantiated health claimshttpwwwfdagovbbstopicsNEWS2003NEW00976html
American Nutraceuticals receives warning letter for drug claims on behalf of its supplement productshttpwwwfdagovfoiwarning_lettersg4406dhtm
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Food importer Golden Luck Inc receives a warning letter for distributing adulterated products andfor failing to bring misbranded products into compliance even after submitting certificates ofcompletion for reconditioning to FDAhttpwwwfdagovfoiwarning_lettersg4394dhtm
Genesis Juice Cooperative receives warning letter for deviations from Juice Hazard Analysis CriticalControl Pointhttpwwwfdagovfoiwarning_lettersg4402dhtm
Superior Nut Company receives a warning letter for insanitary conditionshttpwwwfdagovfoiwarning_lettersg4362dhtm
Safety and Effectiveness Update
Research seems to indicate that water can lsquorememberrsquo compounds even after the compounds havebeen removedhttpwwwnewsscotsmancomindexcfmid=1093712003
And homeopathy reduces arsenic poisoning in micehttpwwwnewscientistcomnewsnewsjspid=ns99994305
Kraft has agreed to get the trans fats out of Oreos but figuring out how is a challenge for their research teamhttpwwwmetroactivecompaperscruz120303fats-0349html
Study finds black elderberry extract seems to ameliorate flu symptoms and shorten its durationhttpwwwfoodnavigatorcomnewsnews-NGaspid=48460
Wheat grain may be beneficial to diabeticshttpnewsbbccouk2hihealth3279591stm
Some US children show early signs of heart diseasehttpwwwnewscientistcomnewsnewsjspid=ns99994364
Cocoa has even more cancer preventing compounds than red wine or green tea say scientistshttpwwwnewscornelledureleasesNov03HotCocoa-Leebpfhtml
Cinnamon is found to improve blood sugar levelshttpwwwnewscientistcomnewsnewsjspid=ns99994413
Business and Industry Update
Nutraquest seeks to sue sports team over player deathhttpwwwwjlacomnewsstories1203112405html
Masterfoods USA introduces CocoaVia its new functional chocolate product containing phytosterolsand flavonols believed to protect the hearthttpwwwnutraingredients-usacomnewsnews-NGaspid=48471
Mintel issues its 2004 product predictions covering cosmetics scents foods and packaging trendshttpwwwwebdeskcomnew-product-predictions
An international survey finds mothers the world over worry over their childrenrsquos weight will pay morefor healthier food and rely on multiple information sources in making purchasing decisionshttphomebusinesswirecomportalsitegoogleindexjspndmViewId=news_viewampnewsId=20031210005453ampnewsLang=en
5
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Legislative Update
American Herbal Products Association press release on the bill entitled Dietary Supplement Accessand Awareness Act (HR 3377)httpwwwalliance-natural-healthorgindexcfmaction=newsampID=42
The Senate Governmental Affairs Committee heard about the USrsquos pressing need for an agriculturalanti-terror plan in last monthrsquos hearingshttpwwwzwirecomsitenewscfmBRD=1829ampdept_id=112755ampnewsid=10635153ampPAG=461amprfi=9
OTC DRUGS
Regulatory Update
FDA advisory committee votes to allow OTC sales of emergency contraceptive pillhttpwwwdocguidecomnewscontentnsfnews8525697700573E1885256DFF004D2D50OpenDocumentampc=Contraceptionampcount=10
Joint meeting of FDArsquos Nonprescription Drugs Advisory Committee and the Reproductive HealthDrugs Advisory Committee on December 16httpwwwfdagovocadvisoryaccalendarcder12541d121603html
Claritin approved for OTC use on hiveshttpwwwdocguidecomnewscontentnsfnews8525697700573E1885256DE4004D67B1OpenDocumentampc=Allergy20Otherampcount=10
FDA Advisory Committee considers broader professional labeling of aspirin to include an indicationfor use in prevention of a first heart attack in patients at risk for coronary heart diseasehttpwwwpressicomintrelease81538html
Enforcement Update
Nutra Med receives warning letter for deviations from cGMP regulationshttpwwwfdagovfoiwarning_lettersg4357dhtm
Product Safety and Effectiveness Update
Researchers find that an aspirin a day can stave off disease in elderlyhttpwwwiolcozaindexphpclick_id=31ampart_id=qw1071548463830B252ampset_id=1
Doctors warn of dangers of combining medications for fluhttpwwwwralcomhealth2705344detailhtml
AMA publishes list of drugs that are potentially hazardous to the elderlyhttparchinteama-assnorgcgicontentfull163222716Article with interview of principal drafter of AMA reporthttpwashingtontimescomnational20031214-114551-1067rhtm
This cold and flu season many new remedies are on the shelveshttpwwwsun-sentinelcomsportssfl-coldremedydec1401933986storycoll=sfla-sports-headlines
Homeopathic flu remedies receive attentionhttpwwwreformercomStories01413102~8862~183588800html
Interview with a naturapathhttpwwworegonlivecommetrosouthwestoregonianindexssfbasemetro_southwest_news1070629282241150xml
6
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
7
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Business and Industry Update
ACNielson begins tracking sales of OTC remedies in convenience storeshttpwwwmronscomdrnonews1942htm
Procter amp Gamble is teaming with Fleetwood RV in a marketing ploy to have a large purple RVfeatured in ads for OTC Prilosechttpbizyahoocomprnews031215lam040_1html
Baby boomers boost tooth whitener saleshttpwwwdelawareonlinecomnewsjournalbusiness20031215boomersboosttoohtml
OTC flu remedies are facing shortages during this flu seasonhttpwwwnbc5comhealth2701177detailhtmlz=dpampdpswid=1167317ampdppid=65195
An overview of some of the many new flu remedies on the market this yearhttpwwwdetnewscom2003health031217h05-10909htm
MEDICAL DEVICES
Regulatory Update
Proposed rule on the effective date on requirement for premarket approval for three Class IIIpreamendments deviceshttpa257gakamaitechnet7257242214mar20010800edocketaccessgpogov2003pdf03-28741pdf
FDA Commissioner McClellan challenges industry to improve development processhttpwwwdevicelinkcommddiarchive0312014html
FDA approves injectable gel to treat facial wrinkleshttpwwwfdagovbbstopicsANSWERS2003ANS01271html
Devicelink editorial on FDArsquos voluntary third-party inspection initiativehttpwwwdevicelinkcommddiarchive0312017html
FDA approves laser treatment for acnehttpbizyahoocomprnews031124nym152_1html
Enforcement Update
Device maker Applied Laboratories Inc receives warning letter for violation of Quality System Regulationhttpwwwfdagovfoiwarning_lettersg4408dhtm
Medical kit maker American Medical Devices Inc receives cGMP warning letterhttpwwwfdagovfoiwarning_lettersg4410dhtm
Plus Orthepedics receives a warning letter for failing to meet requirements for an Investigative DeviceExemption and for failing to be specific enough with regard to the companyrsquos corrective action planhttpwwwfdagovfoiwarning_lettersg4331dhtm
Drug Free Enterprises maker of drug test kits receives a warning letter for cGMP violations andviolations in its conduct of a consumer surveyhttpwwwfdagovfoiwarning_lettersg4363dhtm
Wood Hygienic Institute receives a cGMP warning letter for its colonic irrigation deviceshttpwwwfdagovfoiwarning_lettersg4399dhtm
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
8
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Safety and Effectiveness Update
New allograft technique allows surgeons to save limbshttpwwwchroncomcsCDAssistorymplmetropolitan2232953
Biolectrical Impedence Analysis may be best measure of childhood weight problemshttpwwwsciencedailycomreleases200310031009065701htm
Electrical stimulation procedure may aid stroke recoveryhttpwwwdevicelinkcommddiarchive0312020html
Virtual colonoscopy is found to be as effective as traditional optical colonoscopyhttpwwwama-assnorgamednews20031222hlbf1222htm
Business and Industry Update
Medical ethics and financial interests clash in referrals to imaging centershttpwwwcourier-journalcomlocalnews20031201kywir-front-mri1201-17507html
INTERNATIONAL UPDATE
Europe
EU Court okays online sales for over-the-counter drugshttpwwweubusinesscomafp031211145511hmn3w13q
COLIPA publishes its lsquoFirst observations of the European Cosmetics Industry on the Commissionproposal for a European chemicals legislationrsquohttpwwwcolipacomdocpress_statement_071103pdf
Monaco agrees to introduce EU rules on cosmetics production into the principality to assist localmanufacturers in selling their brands across Europehttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=334
Steroids found in herbal eczema creamshttpnewsbbccouk2hihealth3301481stm
European Commission proposes new regulations for food contact substanceshttpwwwfoodnavigatorcomnewsnews-NGaspid=47870
Member states failed to support an initiative to approve the first GM foodstuffhttpwwwfoodnavigatorcomnewsnews-NGaspid=48319
EU issues report on presence of persistent chemicals in the human body and the blood test resultson a commissionerhttpeuropaeuintrapidstartcgiguestenkshp_actiongettxt=gtampdoc=MEMO03219|0|RAPIDamplg=ENampdisplay=
Outlook is favorable for easier marketing of cholesterol lowering foods in Europehttpwwwnutraingredientscomnewsnews-NGaspid=48480
The UK is a growth market for functional foodshttpwwwnutraingredientscomnewsnews-NGaspid=48485
Businesses and advertisers take notice of the huge purchasing power in the swelling ranks ofEuropean seniorshttpstraitstimesasia1comsgworldstory0438622511500html
EU counterfeit cosmetics and perfumes seizures up 300 over 2001 and 2002 EC reportshttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=328
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
9
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Avon builds manufacturing plant in RussiahttpwwwindustryweekcomCurrentArticlesAsparticlesaspArticleId=1533
Swedish cosmetic company Oriflame is also building a factory in Russiahttpwwwgateway2russiacomstart_150361php
AsiaPacific
Therapeutic tourism is booming in Karnataka India where clinics offer ayurveda homeopathyyoga naturopathy acupuncture and morehttpwwwrediffcommoney2003dec09tourhtm
The Asian cosmetics market boom in China stagnation in Japan local competition in South Koreahttpwwwbeauty-on-linecomebnnewsletteraspeid=80
In South Korea the makers of a cosmetics refrigerator are eyeing the overseas markethttpwwwkoreaheraldcokrSITEdatahtml_dir20031213200312130014asp
Australian food manufacturers and retailers must meet new labeling standards as of December 20httpwwwfoodnavigatorcomnewsnews-NGaspid=48488
Revlon debuts in BruneihttpwwwbrudirectcomDailyInfoNewsArchiveDec03121203bb17htm
Indian cosmetics company Emami has filed a criminal complaint against Bollywood filmmakersHrithik and Rakesh Roshan for failing to honor product placement agreements in their latest filmhttpwwwapunkachoicecomhappenings20031211-0html
LVMH plans to expand its Christian Dior line in China and Japanhttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=332
Kanebo and Kao have joined forces to challenge Shiseidohttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=319
The Pacific Bridge Asian Medical December Newsletter features a story on ASEAN plans to reducenon-tariff barriers for cosmetics and pharmaceuticalshttpwwwpacificbridgemedicalcomnewsletterv3n9pdf
The Americas
MexRegscom is an Internet source for Mexican regulationshttpwwwmexregscom
Health Canada advises against the use of the herb comfrey or products that contain comfreyhttpwwwhc-scgccaenglishmediareleases20032003_101htm
Researcher finds high mercury levels in Mexican women and border states traced to Mexican madeskin whitening creamhttpwwwbostoncomnewsglobehealth_sciencearticles20031216whitening_skin_can_be_deadly
Waxing manicures for men are becoming popular in traditionally macho Mexico Puerto Rico andArgentinahttpbusiness-timesasia1comsgstory0456710046200html
10
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
011904 ndash 012204 Informex Venetian Hotel Sands Expo CenterLas Vegas Nevada USAMore info httpwwwinformexcom
012704 ndash 013104 Soap and Detergent Association (SDA) Boca Raton Resort amp ClubAnnual Meeting and Industry Convention Boca Raton Florida USA
More info (202) 347-2900
020904 ndash 021204 ICE Expo The Hyatt RegencyMiami Florida USAMore info (630) 653-2155Email icealluredcomhttpwwwice-expocom
022604 ndash 022904 Cosmetic Toiletry and Fragrance Association (CTFA) Boca Raton Resort amp ClubAnnual Meeting and Industry Convention Boca Raton Florida USA
More info (202) 331-1770
030904 ndash 031104 Personal Care Ingredients Asia JinHan Exhibition CenterGuangzhou ChinaMore info Step Exhibitions(44) 1892-518877httpwwwstepexcom
032204 ndash 032304 Society of Cosmetic Scientists Spring Symposium Kettering Park Hotel KetteringldquoPerfumemdashthe Constant Elementrdquo Northants UK
Tel 44-1582-726661Email ifsccscsconnectcomwwwscsorguk
032404 SCC Teamworks 2004 Midwest Chapter More info httpwwwmidwestsccorgSupplierrsquos Day
032404 ndash 032604 Institute of Packaging Professionals Marriott MarquisFlexible Packaging Conference 2004 Atlanta Georgia USA
More info Stan Zelesnik IOPP(630) 544-5050 ext 108Email szelesnikiopporghttpwwwiopporg
041304 ndash 041404 Personal Care Ingredients and Technology Sheraton Hotel NYCExhibition 2004 High Function Naturals Contact PCITXHigh Performance Ingredients and Tel 949-487-9970High Impact Color E-mail bobgraysonassociatescom
041404 ndash 041804 Intercharm Professional 2004 Moscow RussiaE-mail mointercharmruwwwintercharmneteng
042004 ndash 042204 The Color Pigments Manufacturing Association Inc Chicago Illinois USAInternational Color Pigments Conference More info (703) 684-4044
Email cpmacpmacom
042704 042904 In-Cosmetics Milan ItalyContact patricialefevrereedexpocouk
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
MEETINGS AND CONFERENCES
050604 ndash 050704 Society of Cosmetic Chemists (SCC) Mohegan SunAnnual Scientific Seminar Uncansville Connecticut USA
More info (212) 668-1500
052404 ndash 052804 Aromatherapy and Perfumery Seminar Grasse FranceProperties of natural raw materials used Tel 33-4-92-42-34-90in perfumery and aromatherapy E-mail gipprodaromfr
060104 ndash 060504 World Perfumery Congress The Future of Perfumery Palais des FestivalsCannes FranceMore info (33) 55-96-21-32Email infoworldperfumerycongresscomhttpwwwworldperfumerycongresscom
062004 ndash 062304 6th World Surfactants Congress Berlin GermanyMore info (49) 30-300-66-90Email berlincpo-hanserdehttpwwwcesio2004de
091004 ndash 091204 Pathways to Beauty and Wellness Jacob K Javitz Convention CenterNew York New York USAMore info Grayson Associates(949) 487-9970Email suzannegraysonassociatescom
101004 ndash 101304 RAPS 2004 Annual Conference and Exhibition Washington Hilton and TowersWashington DC USAhttpwwwrapsorg
102004 ndash 102204 Centifolia International Congress of Perfumery Grasse Franceand Natural Ingredients Contact le Club des Entrepreneurs
Tel 33-4-97-05-57-60clubdesentrepreneursville-grassefr
102404 ndash 102704 ISFCC International Congress Dolphin Hotel Walt Disney World ResortOrlando Florida USAMore info (212) 668-1500
102404 ndash 102804 International Federation of Essential Oils Lisbon Portugaland Aroma Trades International Conference 2004 More info +44-20-7836-2460
Email ifeatadministratorfdforgukhttpwwwifeatorgIFEAT20Lisbon20flyer2004pdf
102804 ndash 110104 11th Perfumery amp Cosmetics Exhibitionmdash Sokolniki Exhibition Center MoscowInterCharm E-mail mointercharmru
wwwintercharmneteng
111004 ndash 111204 Cosmoprof Asia and The Natural Health Fair Hong Kong Convention and Exhibit CenterhttpwwwnaturalhealthfaircomNHFupdate_enhtml
111604 ndash 111804 Health Ingredients Europe The Netherlandswwwhi-eventscom
10
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Kirkpatrick amp Lockhart LLP
Challenge us
Kirkpatrick amp Lockhartrsquos Food and Drug Practice offers comprehensive legal and
regulatory counseling to companies and other organizations regulated by FDA
under the Federal Food Drug and Cosmetic Act We represent manufacturers
and distributors of food dietary supplements pharmaceuticals medical devices
biologicals and personal care and cosmetic products Areas of experience include
enforcement approvals and clearance labeling and advertising clinical research
inspections and importexport
P A R T N E R S
Gary L Yingling 2027789124 gyinglingklcom
Suzan Onel 2027789134 sonelklcom
O F C O U N S E L
Emalee G Murphy 2027789428 emaleemurphyklcom
A S S O C I A T E S
Ann M Begley 2027789365 abegleyklcom
Rebecca L Dandeker 2027789409 rdandekerklcom
Joshua S Kim 2027789039 jkimklcom
FOOD amp DRUG PRACTICE
copy 2003 KIRKPATRICK amp LOCKHART LLP ALL RIGHTS RESERVED
This publicationnewsletter is for informational purposes and does not contain or convey legal advice The information hereinshould not be used or relied upon in regard to any particular facts or circumstances without first consulting a lawyer
BOSTONDALLASHARRISBURGLOS ANGELESMIAMINEWARKNEW YORKPITTSBURGHSAN FRANCISCOWASHINGTON
16
The Association of Analytical Communities (AOAC) publishes ldquoTop 10 List of What to Ask Your(Contract) Labrdquohttpwwwaoacorgproficiencytestingtop_ten_queshtm
The California Air Resources Board (CARB) held a meeting to discuss new amendments to CARBconsumer products regulation scheduled to take effect in mid-2004httpwwwwaiborgregulatoryprinthtm
FDA to revise civil money penalties announces hearingshttpa257gakamaitechnet7257242214mar20010800edocketaccessgpogov2003pdf03-29741pdf
Federal team to examine adverse event reportshttpwwwthompsoncomhp_newsbriefs031211e_fooddrughtml
FTC releases guidance to media on false weight loss claimshttpwwwftcgovopa200312weightlossrpthtm
Harmonization International Conference guidelines availability
Stability data package for registration applications in climatic zones III and IV and stability testing ofnew drug substances and productshttpa257gakamaitechnet7257242214mar20010800edocketaccessgpogov2003pdf03-29103pdf
US state and city governments are pressing ahead with plans to re-import US made drugs from Canadahttpwwwsltribcom2003Nov11272003nation_w114839asp
Meanwhile FDA and Health Canada have signed a Memorandum of Understanding to shareenforcement related information including specifically cross-border issues such as Internetpharmacies and counterfeit drugshttpwwwglobeandmailcomservletstoryRTGAM20031118wdrug1118BNStoryNational
First chewable birth control pill approved by FDAhttpmsnbcmsncomDefaultaspxid=3475869ampp1=0
FDA proposes an incentive to remove illegal Rx drugshttpwwwfdagovcderpikenov2003htmIllegalRxs
In October FDA issued the draft guidance Marketed Unapproved Drugs Compliance Policy GuidehttpwwwfdagovOHRMSDOCKETS98fr2003D-0478-gdl0001pdf
Medical Devicelink examines whether FDArsquos enforcement policy is really more aggressivehttpwwwdevicelinkcommddiarchive0312018html
At CHPA conference speaker says retailers manufacturers of OTC prescription and natural healthcareremedies must seek new ways to market to the total wellness needs of consumershttpwwwmronscomdrnonews2262htm
Healthcare spending has slowed to the lowest level in three years because it is believed of cost increaseshttpwwwpost-gazettecompg03346250297stm
Top Court refuses to hear drug makerrsquos patent dispute casehttpwwwdetnewscom2003business031202c04-339686htm
Many health problems begin with gum disease studies findhttpwwwtheledgercomappspbcsdllarticleAID=20031216NEWS3121603011021
2
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
3
COSMETICS
Regulatory Update
Technical amendment to Skin Protectant Drugs for Over the Counter Use Monographhttpa257gakamaitechnet7257242214mar20010800edocketaccessgpogov2003pdf03-30394pdf
See recent international regulatory news items at Beauty-on-Linehttpwwwbeauty-on-linecombrd01-00asp
Safety and Effectiveness Update
The first head-to-head trial of Botox versus three over-the-counter cosmetic creams is now enrollingsubjectshttpbizyahoocomprnews031124nym012_1html
Moisturizing tights are introduced by CSP International Industria Calze This and other new productnews can be found in Mintelrsquos November press releasehttpwwwin-cosmeticscompagecfmlink=82
Cosmetic ingredient makers win awards for UV-absorber and thickenerhttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=331
Japanrsquos textile company Omikenshi develops a rayon fiber with a fresh grapefruit fragrancehttpwwwbharattextilecomnewsitems1986336
Rate of home fires caused by candles has recently surgedhttpwwwnfpaorgPressRoomNewsReleasesCandlescandlesasp
Study finds that sunscreen does not increase risk of melanomahttpwwwreuterscomnewsArticlejhtmltype=healthNewsampstoryID=3996984
Business and Industry Update
US Congressmen write letter accusing Mary Kay of abetting religious persecution in ChinahttpwwwcnsnewscomViewCultureaspPage=5CCulture5Carchive5C2003115CCUL20031120ahtml
Del Laboratories named Most Innovative Marketer by Womenrsquos Wear Daily honored for itscontinuous flow of innovation across cosmetic categorieshttpbizyahoocomprnews031210nyw082_1html
The UKrsquos Boots retailer is opening 32 stores on the US east coast and in Denver in spring 2004httpwwwcosmeticsbusinesscomnewsstoryaspstoryid=322
Mintel issues its 2004 product predictions covering cosmetics scents foods and packaging trendshttpwwwwebdeskcomnew-product-predictions
Mintel also examines the makeup market finding that lipstick reigns and Asian and Hispanic womenare the most avid consumershttpwwwin-cosmeticscompagecfmlink=74
Black hair care products are set to become less race-specifichttpwwwin-cosmeticscompagecfmlink=83
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
4
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
The menrsquos toiletries market in the UShttpwwwin-cosmeticscompagecfmlink=79
German company Henkel to acquire Dialhttpwwwcbccacpbusiness031215b121524html
Legislative Update
The House has passed a bill that would regulate non-corrective contact lenses as medical deviceshttpwwwguardiancoukuslateststory01282-340854000html
DIETARY SUPPLEMENTSFOOD
Regulatory Update
FTC submits comments to FDA on food labels and obesityhttpwwwftcgovopa200312fdaobesityhtm
Advisory panel recommends big changes to recommended daily value calculations for vitamins andmineralshttpmagazinesivillagecomgoodhousekeepinghbnewsarticle0krt_2003_12_12_knigt_2734-0109-NTR-FDA~TB~ew~xml00html
Advanced notice of proposed rulemaking published for comment on regulating qualified health claimshttpa257gakamaitechnet7257242214mar20010800edocketaccessgpogov2003pdf03-29448pdf
Food labels face overhaul to reflect latest information on nutritionhttpwwwhealthcentralcomnewsNewsFullTextcfmid=516512
USDA issues new food safety guidelines for consumershttpwwwusdagovnewsreleases2003110386htm
FDA approves whole grain health claimhttpwwwthompsoncomhp_newsbriefs031211c_fooddrughtml
Consumerlabcom reports improvement in the quality of SAMehttpwwwconsumerlabcomresultssameasp
US health insurers ponder whether to make obesity treatments reimbursablehttpstorynewsyahoocomnewstmpl=storyampcid=1506ampncid=751ampe=6ampu=afp20031212ts_alt_afpyear_us_obesity
Some say DSHEA opened the door to the current steroids doping scandalshttpwwwbayareacommldmercurynewssports7503489htm
Enforcement Update
Contaminated food seized at Washington DC distributorhttpwwwfdagovbbstopicsnews2003doj112803html
$27 million worth of Royal Tongan Limu destroyed because of persistent unsubstantiated health claimshttpwwwfdagovbbstopicsNEWS2003NEW00976html
American Nutraceuticals receives warning letter for drug claims on behalf of its supplement productshttpwwwfdagovfoiwarning_lettersg4406dhtm
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Food importer Golden Luck Inc receives a warning letter for distributing adulterated products andfor failing to bring misbranded products into compliance even after submitting certificates ofcompletion for reconditioning to FDAhttpwwwfdagovfoiwarning_lettersg4394dhtm
Genesis Juice Cooperative receives warning letter for deviations from Juice Hazard Analysis CriticalControl Pointhttpwwwfdagovfoiwarning_lettersg4402dhtm
Superior Nut Company receives a warning letter for insanitary conditionshttpwwwfdagovfoiwarning_lettersg4362dhtm
Safety and Effectiveness Update
Research seems to indicate that water can lsquorememberrsquo compounds even after the compounds havebeen removedhttpwwwnewsscotsmancomindexcfmid=1093712003
And homeopathy reduces arsenic poisoning in micehttpwwwnewscientistcomnewsnewsjspid=ns99994305
Kraft has agreed to get the trans fats out of Oreos but figuring out how is a challenge for their research teamhttpwwwmetroactivecompaperscruz120303fats-0349html
Study finds black elderberry extract seems to ameliorate flu symptoms and shorten its durationhttpwwwfoodnavigatorcomnewsnews-NGaspid=48460
Wheat grain may be beneficial to diabeticshttpnewsbbccouk2hihealth3279591stm
Some US children show early signs of heart diseasehttpwwwnewscientistcomnewsnewsjspid=ns99994364
Cocoa has even more cancer preventing compounds than red wine or green tea say scientistshttpwwwnewscornelledureleasesNov03HotCocoa-Leebpfhtml
Cinnamon is found to improve blood sugar levelshttpwwwnewscientistcomnewsnewsjspid=ns99994413
Business and Industry Update
Nutraquest seeks to sue sports team over player deathhttpwwwwjlacomnewsstories1203112405html
Masterfoods USA introduces CocoaVia its new functional chocolate product containing phytosterolsand flavonols believed to protect the hearthttpwwwnutraingredients-usacomnewsnews-NGaspid=48471
Mintel issues its 2004 product predictions covering cosmetics scents foods and packaging trendshttpwwwwebdeskcomnew-product-predictions
An international survey finds mothers the world over worry over their childrenrsquos weight will pay morefor healthier food and rely on multiple information sources in making purchasing decisionshttphomebusinesswirecomportalsitegoogleindexjspndmViewId=news_viewampnewsId=20031210005453ampnewsLang=en
5
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Legislative Update
American Herbal Products Association press release on the bill entitled Dietary Supplement Accessand Awareness Act (HR 3377)httpwwwalliance-natural-healthorgindexcfmaction=newsampID=42
The Senate Governmental Affairs Committee heard about the USrsquos pressing need for an agriculturalanti-terror plan in last monthrsquos hearingshttpwwwzwirecomsitenewscfmBRD=1829ampdept_id=112755ampnewsid=10635153ampPAG=461amprfi=9
OTC DRUGS
Regulatory Update
FDA advisory committee votes to allow OTC sales of emergency contraceptive pillhttpwwwdocguidecomnewscontentnsfnews8525697700573E1885256DFF004D2D50OpenDocumentampc=Contraceptionampcount=10
Joint meeting of FDArsquos Nonprescription Drugs Advisory Committee and the Reproductive HealthDrugs Advisory Committee on December 16httpwwwfdagovocadvisoryaccalendarcder12541d121603html
Claritin approved for OTC use on hiveshttpwwwdocguidecomnewscontentnsfnews8525697700573E1885256DE4004D67B1OpenDocumentampc=Allergy20Otherampcount=10
FDA Advisory Committee considers broader professional labeling of aspirin to include an indicationfor use in prevention of a first heart attack in patients at risk for coronary heart diseasehttpwwwpressicomintrelease81538html
Enforcement Update
Nutra Med receives warning letter for deviations from cGMP regulationshttpwwwfdagovfoiwarning_lettersg4357dhtm
Product Safety and Effectiveness Update
Researchers find that an aspirin a day can stave off disease in elderlyhttpwwwiolcozaindexphpclick_id=31ampart_id=qw1071548463830B252ampset_id=1
Doctors warn of dangers of combining medications for fluhttpwwwwralcomhealth2705344detailhtml
AMA publishes list of drugs that are potentially hazardous to the elderlyhttparchinteama-assnorgcgicontentfull163222716Article with interview of principal drafter of AMA reporthttpwashingtontimescomnational20031214-114551-1067rhtm
This cold and flu season many new remedies are on the shelveshttpwwwsun-sentinelcomsportssfl-coldremedydec1401933986storycoll=sfla-sports-headlines
Homeopathic flu remedies receive attentionhttpwwwreformercomStories01413102~8862~183588800html
Interview with a naturapathhttpwwworegonlivecommetrosouthwestoregonianindexssfbasemetro_southwest_news1070629282241150xml
6
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
7
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Business and Industry Update
ACNielson begins tracking sales of OTC remedies in convenience storeshttpwwwmronscomdrnonews1942htm
Procter amp Gamble is teaming with Fleetwood RV in a marketing ploy to have a large purple RVfeatured in ads for OTC Prilosechttpbizyahoocomprnews031215lam040_1html
Baby boomers boost tooth whitener saleshttpwwwdelawareonlinecomnewsjournalbusiness20031215boomersboosttoohtml
OTC flu remedies are facing shortages during this flu seasonhttpwwwnbc5comhealth2701177detailhtmlz=dpampdpswid=1167317ampdppid=65195
An overview of some of the many new flu remedies on the market this yearhttpwwwdetnewscom2003health031217h05-10909htm
MEDICAL DEVICES
Regulatory Update
Proposed rule on the effective date on requirement for premarket approval for three Class IIIpreamendments deviceshttpa257gakamaitechnet7257242214mar20010800edocketaccessgpogov2003pdf03-28741pdf
FDA Commissioner McClellan challenges industry to improve development processhttpwwwdevicelinkcommddiarchive0312014html
FDA approves injectable gel to treat facial wrinkleshttpwwwfdagovbbstopicsANSWERS2003ANS01271html
Devicelink editorial on FDArsquos voluntary third-party inspection initiativehttpwwwdevicelinkcommddiarchive0312017html
FDA approves laser treatment for acnehttpbizyahoocomprnews031124nym152_1html
Enforcement Update
Device maker Applied Laboratories Inc receives warning letter for violation of Quality System Regulationhttpwwwfdagovfoiwarning_lettersg4408dhtm
Medical kit maker American Medical Devices Inc receives cGMP warning letterhttpwwwfdagovfoiwarning_lettersg4410dhtm
Plus Orthepedics receives a warning letter for failing to meet requirements for an Investigative DeviceExemption and for failing to be specific enough with regard to the companyrsquos corrective action planhttpwwwfdagovfoiwarning_lettersg4331dhtm
Drug Free Enterprises maker of drug test kits receives a warning letter for cGMP violations andviolations in its conduct of a consumer surveyhttpwwwfdagovfoiwarning_lettersg4363dhtm
Wood Hygienic Institute receives a cGMP warning letter for its colonic irrigation deviceshttpwwwfdagovfoiwarning_lettersg4399dhtm
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
8
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Safety and Effectiveness Update
New allograft technique allows surgeons to save limbshttpwwwchroncomcsCDAssistorymplmetropolitan2232953
Biolectrical Impedence Analysis may be best measure of childhood weight problemshttpwwwsciencedailycomreleases200310031009065701htm
Electrical stimulation procedure may aid stroke recoveryhttpwwwdevicelinkcommddiarchive0312020html
Virtual colonoscopy is found to be as effective as traditional optical colonoscopyhttpwwwama-assnorgamednews20031222hlbf1222htm
Business and Industry Update
Medical ethics and financial interests clash in referrals to imaging centershttpwwwcourier-journalcomlocalnews20031201kywir-front-mri1201-17507html
INTERNATIONAL UPDATE
Europe
EU Court okays online sales for over-the-counter drugshttpwwweubusinesscomafp031211145511hmn3w13q
COLIPA publishes its lsquoFirst observations of the European Cosmetics Industry on the Commissionproposal for a European chemicals legislationrsquohttpwwwcolipacomdocpress_statement_071103pdf
Monaco agrees to introduce EU rules on cosmetics production into the principality to assist localmanufacturers in selling their brands across Europehttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=334
Steroids found in herbal eczema creamshttpnewsbbccouk2hihealth3301481stm
European Commission proposes new regulations for food contact substanceshttpwwwfoodnavigatorcomnewsnews-NGaspid=47870
Member states failed to support an initiative to approve the first GM foodstuffhttpwwwfoodnavigatorcomnewsnews-NGaspid=48319
EU issues report on presence of persistent chemicals in the human body and the blood test resultson a commissionerhttpeuropaeuintrapidstartcgiguestenkshp_actiongettxt=gtampdoc=MEMO03219|0|RAPIDamplg=ENampdisplay=
Outlook is favorable for easier marketing of cholesterol lowering foods in Europehttpwwwnutraingredientscomnewsnews-NGaspid=48480
The UK is a growth market for functional foodshttpwwwnutraingredientscomnewsnews-NGaspid=48485
Businesses and advertisers take notice of the huge purchasing power in the swelling ranks ofEuropean seniorshttpstraitstimesasia1comsgworldstory0438622511500html
EU counterfeit cosmetics and perfumes seizures up 300 over 2001 and 2002 EC reportshttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=328
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
9
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Avon builds manufacturing plant in RussiahttpwwwindustryweekcomCurrentArticlesAsparticlesaspArticleId=1533
Swedish cosmetic company Oriflame is also building a factory in Russiahttpwwwgateway2russiacomstart_150361php
AsiaPacific
Therapeutic tourism is booming in Karnataka India where clinics offer ayurveda homeopathyyoga naturopathy acupuncture and morehttpwwwrediffcommoney2003dec09tourhtm
The Asian cosmetics market boom in China stagnation in Japan local competition in South Koreahttpwwwbeauty-on-linecomebnnewsletteraspeid=80
In South Korea the makers of a cosmetics refrigerator are eyeing the overseas markethttpwwwkoreaheraldcokrSITEdatahtml_dir20031213200312130014asp
Australian food manufacturers and retailers must meet new labeling standards as of December 20httpwwwfoodnavigatorcomnewsnews-NGaspid=48488
Revlon debuts in BruneihttpwwwbrudirectcomDailyInfoNewsArchiveDec03121203bb17htm
Indian cosmetics company Emami has filed a criminal complaint against Bollywood filmmakersHrithik and Rakesh Roshan for failing to honor product placement agreements in their latest filmhttpwwwapunkachoicecomhappenings20031211-0html
LVMH plans to expand its Christian Dior line in China and Japanhttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=332
Kanebo and Kao have joined forces to challenge Shiseidohttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=319
The Pacific Bridge Asian Medical December Newsletter features a story on ASEAN plans to reducenon-tariff barriers for cosmetics and pharmaceuticalshttpwwwpacificbridgemedicalcomnewsletterv3n9pdf
The Americas
MexRegscom is an Internet source for Mexican regulationshttpwwwmexregscom
Health Canada advises against the use of the herb comfrey or products that contain comfreyhttpwwwhc-scgccaenglishmediareleases20032003_101htm
Researcher finds high mercury levels in Mexican women and border states traced to Mexican madeskin whitening creamhttpwwwbostoncomnewsglobehealth_sciencearticles20031216whitening_skin_can_be_deadly
Waxing manicures for men are becoming popular in traditionally macho Mexico Puerto Rico andArgentinahttpbusiness-timesasia1comsgstory0456710046200html
10
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
011904 ndash 012204 Informex Venetian Hotel Sands Expo CenterLas Vegas Nevada USAMore info httpwwwinformexcom
012704 ndash 013104 Soap and Detergent Association (SDA) Boca Raton Resort amp ClubAnnual Meeting and Industry Convention Boca Raton Florida USA
More info (202) 347-2900
020904 ndash 021204 ICE Expo The Hyatt RegencyMiami Florida USAMore info (630) 653-2155Email icealluredcomhttpwwwice-expocom
022604 ndash 022904 Cosmetic Toiletry and Fragrance Association (CTFA) Boca Raton Resort amp ClubAnnual Meeting and Industry Convention Boca Raton Florida USA
More info (202) 331-1770
030904 ndash 031104 Personal Care Ingredients Asia JinHan Exhibition CenterGuangzhou ChinaMore info Step Exhibitions(44) 1892-518877httpwwwstepexcom
032204 ndash 032304 Society of Cosmetic Scientists Spring Symposium Kettering Park Hotel KetteringldquoPerfumemdashthe Constant Elementrdquo Northants UK
Tel 44-1582-726661Email ifsccscsconnectcomwwwscsorguk
032404 SCC Teamworks 2004 Midwest Chapter More info httpwwwmidwestsccorgSupplierrsquos Day
032404 ndash 032604 Institute of Packaging Professionals Marriott MarquisFlexible Packaging Conference 2004 Atlanta Georgia USA
More info Stan Zelesnik IOPP(630) 544-5050 ext 108Email szelesnikiopporghttpwwwiopporg
041304 ndash 041404 Personal Care Ingredients and Technology Sheraton Hotel NYCExhibition 2004 High Function Naturals Contact PCITXHigh Performance Ingredients and Tel 949-487-9970High Impact Color E-mail bobgraysonassociatescom
041404 ndash 041804 Intercharm Professional 2004 Moscow RussiaE-mail mointercharmruwwwintercharmneteng
042004 ndash 042204 The Color Pigments Manufacturing Association Inc Chicago Illinois USAInternational Color Pigments Conference More info (703) 684-4044
Email cpmacpmacom
042704 042904 In-Cosmetics Milan ItalyContact patricialefevrereedexpocouk
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
MEETINGS AND CONFERENCES
050604 ndash 050704 Society of Cosmetic Chemists (SCC) Mohegan SunAnnual Scientific Seminar Uncansville Connecticut USA
More info (212) 668-1500
052404 ndash 052804 Aromatherapy and Perfumery Seminar Grasse FranceProperties of natural raw materials used Tel 33-4-92-42-34-90in perfumery and aromatherapy E-mail gipprodaromfr
060104 ndash 060504 World Perfumery Congress The Future of Perfumery Palais des FestivalsCannes FranceMore info (33) 55-96-21-32Email infoworldperfumerycongresscomhttpwwwworldperfumerycongresscom
062004 ndash 062304 6th World Surfactants Congress Berlin GermanyMore info (49) 30-300-66-90Email berlincpo-hanserdehttpwwwcesio2004de
091004 ndash 091204 Pathways to Beauty and Wellness Jacob K Javitz Convention CenterNew York New York USAMore info Grayson Associates(949) 487-9970Email suzannegraysonassociatescom
101004 ndash 101304 RAPS 2004 Annual Conference and Exhibition Washington Hilton and TowersWashington DC USAhttpwwwrapsorg
102004 ndash 102204 Centifolia International Congress of Perfumery Grasse Franceand Natural Ingredients Contact le Club des Entrepreneurs
Tel 33-4-97-05-57-60clubdesentrepreneursville-grassefr
102404 ndash 102704 ISFCC International Congress Dolphin Hotel Walt Disney World ResortOrlando Florida USAMore info (212) 668-1500
102404 ndash 102804 International Federation of Essential Oils Lisbon Portugaland Aroma Trades International Conference 2004 More info +44-20-7836-2460
Email ifeatadministratorfdforgukhttpwwwifeatorgIFEAT20Lisbon20flyer2004pdf
102804 ndash 110104 11th Perfumery amp Cosmetics Exhibitionmdash Sokolniki Exhibition Center MoscowInterCharm E-mail mointercharmru
wwwintercharmneteng
111004 ndash 111204 Cosmoprof Asia and The Natural Health Fair Hong Kong Convention and Exhibit CenterhttpwwwnaturalhealthfaircomNHFupdate_enhtml
111604 ndash 111804 Health Ingredients Europe The Netherlandswwwhi-eventscom
10
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Kirkpatrick amp Lockhart LLP
Challenge us
Kirkpatrick amp Lockhartrsquos Food and Drug Practice offers comprehensive legal and
regulatory counseling to companies and other organizations regulated by FDA
under the Federal Food Drug and Cosmetic Act We represent manufacturers
and distributors of food dietary supplements pharmaceuticals medical devices
biologicals and personal care and cosmetic products Areas of experience include
enforcement approvals and clearance labeling and advertising clinical research
inspections and importexport
P A R T N E R S
Gary L Yingling 2027789124 gyinglingklcom
Suzan Onel 2027789134 sonelklcom
O F C O U N S E L
Emalee G Murphy 2027789428 emaleemurphyklcom
A S S O C I A T E S
Ann M Begley 2027789365 abegleyklcom
Rebecca L Dandeker 2027789409 rdandekerklcom
Joshua S Kim 2027789039 jkimklcom
FOOD amp DRUG PRACTICE
copy 2003 KIRKPATRICK amp LOCKHART LLP ALL RIGHTS RESERVED
This publicationnewsletter is for informational purposes and does not contain or convey legal advice The information hereinshould not be used or relied upon in regard to any particular facts or circumstances without first consulting a lawyer
BOSTONDALLASHARRISBURGLOS ANGELESMIAMINEWARKNEW YORKPITTSBURGHSAN FRANCISCOWASHINGTON
16
3
COSMETICS
Regulatory Update
Technical amendment to Skin Protectant Drugs for Over the Counter Use Monographhttpa257gakamaitechnet7257242214mar20010800edocketaccessgpogov2003pdf03-30394pdf
See recent international regulatory news items at Beauty-on-Linehttpwwwbeauty-on-linecombrd01-00asp
Safety and Effectiveness Update
The first head-to-head trial of Botox versus three over-the-counter cosmetic creams is now enrollingsubjectshttpbizyahoocomprnews031124nym012_1html
Moisturizing tights are introduced by CSP International Industria Calze This and other new productnews can be found in Mintelrsquos November press releasehttpwwwin-cosmeticscompagecfmlink=82
Cosmetic ingredient makers win awards for UV-absorber and thickenerhttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=331
Japanrsquos textile company Omikenshi develops a rayon fiber with a fresh grapefruit fragrancehttpwwwbharattextilecomnewsitems1986336
Rate of home fires caused by candles has recently surgedhttpwwwnfpaorgPressRoomNewsReleasesCandlescandlesasp
Study finds that sunscreen does not increase risk of melanomahttpwwwreuterscomnewsArticlejhtmltype=healthNewsampstoryID=3996984
Business and Industry Update
US Congressmen write letter accusing Mary Kay of abetting religious persecution in ChinahttpwwwcnsnewscomViewCultureaspPage=5CCulture5Carchive5C2003115CCUL20031120ahtml
Del Laboratories named Most Innovative Marketer by Womenrsquos Wear Daily honored for itscontinuous flow of innovation across cosmetic categorieshttpbizyahoocomprnews031210nyw082_1html
The UKrsquos Boots retailer is opening 32 stores on the US east coast and in Denver in spring 2004httpwwwcosmeticsbusinesscomnewsstoryaspstoryid=322
Mintel issues its 2004 product predictions covering cosmetics scents foods and packaging trendshttpwwwwebdeskcomnew-product-predictions
Mintel also examines the makeup market finding that lipstick reigns and Asian and Hispanic womenare the most avid consumershttpwwwin-cosmeticscompagecfmlink=74
Black hair care products are set to become less race-specifichttpwwwin-cosmeticscompagecfmlink=83
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
4
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
The menrsquos toiletries market in the UShttpwwwin-cosmeticscompagecfmlink=79
German company Henkel to acquire Dialhttpwwwcbccacpbusiness031215b121524html
Legislative Update
The House has passed a bill that would regulate non-corrective contact lenses as medical deviceshttpwwwguardiancoukuslateststory01282-340854000html
DIETARY SUPPLEMENTSFOOD
Regulatory Update
FTC submits comments to FDA on food labels and obesityhttpwwwftcgovopa200312fdaobesityhtm
Advisory panel recommends big changes to recommended daily value calculations for vitamins andmineralshttpmagazinesivillagecomgoodhousekeepinghbnewsarticle0krt_2003_12_12_knigt_2734-0109-NTR-FDA~TB~ew~xml00html
Advanced notice of proposed rulemaking published for comment on regulating qualified health claimshttpa257gakamaitechnet7257242214mar20010800edocketaccessgpogov2003pdf03-29448pdf
Food labels face overhaul to reflect latest information on nutritionhttpwwwhealthcentralcomnewsNewsFullTextcfmid=516512
USDA issues new food safety guidelines for consumershttpwwwusdagovnewsreleases2003110386htm
FDA approves whole grain health claimhttpwwwthompsoncomhp_newsbriefs031211c_fooddrughtml
Consumerlabcom reports improvement in the quality of SAMehttpwwwconsumerlabcomresultssameasp
US health insurers ponder whether to make obesity treatments reimbursablehttpstorynewsyahoocomnewstmpl=storyampcid=1506ampncid=751ampe=6ampu=afp20031212ts_alt_afpyear_us_obesity
Some say DSHEA opened the door to the current steroids doping scandalshttpwwwbayareacommldmercurynewssports7503489htm
Enforcement Update
Contaminated food seized at Washington DC distributorhttpwwwfdagovbbstopicsnews2003doj112803html
$27 million worth of Royal Tongan Limu destroyed because of persistent unsubstantiated health claimshttpwwwfdagovbbstopicsNEWS2003NEW00976html
American Nutraceuticals receives warning letter for drug claims on behalf of its supplement productshttpwwwfdagovfoiwarning_lettersg4406dhtm
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Food importer Golden Luck Inc receives a warning letter for distributing adulterated products andfor failing to bring misbranded products into compliance even after submitting certificates ofcompletion for reconditioning to FDAhttpwwwfdagovfoiwarning_lettersg4394dhtm
Genesis Juice Cooperative receives warning letter for deviations from Juice Hazard Analysis CriticalControl Pointhttpwwwfdagovfoiwarning_lettersg4402dhtm
Superior Nut Company receives a warning letter for insanitary conditionshttpwwwfdagovfoiwarning_lettersg4362dhtm
Safety and Effectiveness Update
Research seems to indicate that water can lsquorememberrsquo compounds even after the compounds havebeen removedhttpwwwnewsscotsmancomindexcfmid=1093712003
And homeopathy reduces arsenic poisoning in micehttpwwwnewscientistcomnewsnewsjspid=ns99994305
Kraft has agreed to get the trans fats out of Oreos but figuring out how is a challenge for their research teamhttpwwwmetroactivecompaperscruz120303fats-0349html
Study finds black elderberry extract seems to ameliorate flu symptoms and shorten its durationhttpwwwfoodnavigatorcomnewsnews-NGaspid=48460
Wheat grain may be beneficial to diabeticshttpnewsbbccouk2hihealth3279591stm
Some US children show early signs of heart diseasehttpwwwnewscientistcomnewsnewsjspid=ns99994364
Cocoa has even more cancer preventing compounds than red wine or green tea say scientistshttpwwwnewscornelledureleasesNov03HotCocoa-Leebpfhtml
Cinnamon is found to improve blood sugar levelshttpwwwnewscientistcomnewsnewsjspid=ns99994413
Business and Industry Update
Nutraquest seeks to sue sports team over player deathhttpwwwwjlacomnewsstories1203112405html
Masterfoods USA introduces CocoaVia its new functional chocolate product containing phytosterolsand flavonols believed to protect the hearthttpwwwnutraingredients-usacomnewsnews-NGaspid=48471
Mintel issues its 2004 product predictions covering cosmetics scents foods and packaging trendshttpwwwwebdeskcomnew-product-predictions
An international survey finds mothers the world over worry over their childrenrsquos weight will pay morefor healthier food and rely on multiple information sources in making purchasing decisionshttphomebusinesswirecomportalsitegoogleindexjspndmViewId=news_viewampnewsId=20031210005453ampnewsLang=en
5
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Legislative Update
American Herbal Products Association press release on the bill entitled Dietary Supplement Accessand Awareness Act (HR 3377)httpwwwalliance-natural-healthorgindexcfmaction=newsampID=42
The Senate Governmental Affairs Committee heard about the USrsquos pressing need for an agriculturalanti-terror plan in last monthrsquos hearingshttpwwwzwirecomsitenewscfmBRD=1829ampdept_id=112755ampnewsid=10635153ampPAG=461amprfi=9
OTC DRUGS
Regulatory Update
FDA advisory committee votes to allow OTC sales of emergency contraceptive pillhttpwwwdocguidecomnewscontentnsfnews8525697700573E1885256DFF004D2D50OpenDocumentampc=Contraceptionampcount=10
Joint meeting of FDArsquos Nonprescription Drugs Advisory Committee and the Reproductive HealthDrugs Advisory Committee on December 16httpwwwfdagovocadvisoryaccalendarcder12541d121603html
Claritin approved for OTC use on hiveshttpwwwdocguidecomnewscontentnsfnews8525697700573E1885256DE4004D67B1OpenDocumentampc=Allergy20Otherampcount=10
FDA Advisory Committee considers broader professional labeling of aspirin to include an indicationfor use in prevention of a first heart attack in patients at risk for coronary heart diseasehttpwwwpressicomintrelease81538html
Enforcement Update
Nutra Med receives warning letter for deviations from cGMP regulationshttpwwwfdagovfoiwarning_lettersg4357dhtm
Product Safety and Effectiveness Update
Researchers find that an aspirin a day can stave off disease in elderlyhttpwwwiolcozaindexphpclick_id=31ampart_id=qw1071548463830B252ampset_id=1
Doctors warn of dangers of combining medications for fluhttpwwwwralcomhealth2705344detailhtml
AMA publishes list of drugs that are potentially hazardous to the elderlyhttparchinteama-assnorgcgicontentfull163222716Article with interview of principal drafter of AMA reporthttpwashingtontimescomnational20031214-114551-1067rhtm
This cold and flu season many new remedies are on the shelveshttpwwwsun-sentinelcomsportssfl-coldremedydec1401933986storycoll=sfla-sports-headlines
Homeopathic flu remedies receive attentionhttpwwwreformercomStories01413102~8862~183588800html
Interview with a naturapathhttpwwworegonlivecommetrosouthwestoregonianindexssfbasemetro_southwest_news1070629282241150xml
6
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
7
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Business and Industry Update
ACNielson begins tracking sales of OTC remedies in convenience storeshttpwwwmronscomdrnonews1942htm
Procter amp Gamble is teaming with Fleetwood RV in a marketing ploy to have a large purple RVfeatured in ads for OTC Prilosechttpbizyahoocomprnews031215lam040_1html
Baby boomers boost tooth whitener saleshttpwwwdelawareonlinecomnewsjournalbusiness20031215boomersboosttoohtml
OTC flu remedies are facing shortages during this flu seasonhttpwwwnbc5comhealth2701177detailhtmlz=dpampdpswid=1167317ampdppid=65195
An overview of some of the many new flu remedies on the market this yearhttpwwwdetnewscom2003health031217h05-10909htm
MEDICAL DEVICES
Regulatory Update
Proposed rule on the effective date on requirement for premarket approval for three Class IIIpreamendments deviceshttpa257gakamaitechnet7257242214mar20010800edocketaccessgpogov2003pdf03-28741pdf
FDA Commissioner McClellan challenges industry to improve development processhttpwwwdevicelinkcommddiarchive0312014html
FDA approves injectable gel to treat facial wrinkleshttpwwwfdagovbbstopicsANSWERS2003ANS01271html
Devicelink editorial on FDArsquos voluntary third-party inspection initiativehttpwwwdevicelinkcommddiarchive0312017html
FDA approves laser treatment for acnehttpbizyahoocomprnews031124nym152_1html
Enforcement Update
Device maker Applied Laboratories Inc receives warning letter for violation of Quality System Regulationhttpwwwfdagovfoiwarning_lettersg4408dhtm
Medical kit maker American Medical Devices Inc receives cGMP warning letterhttpwwwfdagovfoiwarning_lettersg4410dhtm
Plus Orthepedics receives a warning letter for failing to meet requirements for an Investigative DeviceExemption and for failing to be specific enough with regard to the companyrsquos corrective action planhttpwwwfdagovfoiwarning_lettersg4331dhtm
Drug Free Enterprises maker of drug test kits receives a warning letter for cGMP violations andviolations in its conduct of a consumer surveyhttpwwwfdagovfoiwarning_lettersg4363dhtm
Wood Hygienic Institute receives a cGMP warning letter for its colonic irrigation deviceshttpwwwfdagovfoiwarning_lettersg4399dhtm
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
8
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Safety and Effectiveness Update
New allograft technique allows surgeons to save limbshttpwwwchroncomcsCDAssistorymplmetropolitan2232953
Biolectrical Impedence Analysis may be best measure of childhood weight problemshttpwwwsciencedailycomreleases200310031009065701htm
Electrical stimulation procedure may aid stroke recoveryhttpwwwdevicelinkcommddiarchive0312020html
Virtual colonoscopy is found to be as effective as traditional optical colonoscopyhttpwwwama-assnorgamednews20031222hlbf1222htm
Business and Industry Update
Medical ethics and financial interests clash in referrals to imaging centershttpwwwcourier-journalcomlocalnews20031201kywir-front-mri1201-17507html
INTERNATIONAL UPDATE
Europe
EU Court okays online sales for over-the-counter drugshttpwwweubusinesscomafp031211145511hmn3w13q
COLIPA publishes its lsquoFirst observations of the European Cosmetics Industry on the Commissionproposal for a European chemicals legislationrsquohttpwwwcolipacomdocpress_statement_071103pdf
Monaco agrees to introduce EU rules on cosmetics production into the principality to assist localmanufacturers in selling their brands across Europehttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=334
Steroids found in herbal eczema creamshttpnewsbbccouk2hihealth3301481stm
European Commission proposes new regulations for food contact substanceshttpwwwfoodnavigatorcomnewsnews-NGaspid=47870
Member states failed to support an initiative to approve the first GM foodstuffhttpwwwfoodnavigatorcomnewsnews-NGaspid=48319
EU issues report on presence of persistent chemicals in the human body and the blood test resultson a commissionerhttpeuropaeuintrapidstartcgiguestenkshp_actiongettxt=gtampdoc=MEMO03219|0|RAPIDamplg=ENampdisplay=
Outlook is favorable for easier marketing of cholesterol lowering foods in Europehttpwwwnutraingredientscomnewsnews-NGaspid=48480
The UK is a growth market for functional foodshttpwwwnutraingredientscomnewsnews-NGaspid=48485
Businesses and advertisers take notice of the huge purchasing power in the swelling ranks ofEuropean seniorshttpstraitstimesasia1comsgworldstory0438622511500html
EU counterfeit cosmetics and perfumes seizures up 300 over 2001 and 2002 EC reportshttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=328
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
9
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Avon builds manufacturing plant in RussiahttpwwwindustryweekcomCurrentArticlesAsparticlesaspArticleId=1533
Swedish cosmetic company Oriflame is also building a factory in Russiahttpwwwgateway2russiacomstart_150361php
AsiaPacific
Therapeutic tourism is booming in Karnataka India where clinics offer ayurveda homeopathyyoga naturopathy acupuncture and morehttpwwwrediffcommoney2003dec09tourhtm
The Asian cosmetics market boom in China stagnation in Japan local competition in South Koreahttpwwwbeauty-on-linecomebnnewsletteraspeid=80
In South Korea the makers of a cosmetics refrigerator are eyeing the overseas markethttpwwwkoreaheraldcokrSITEdatahtml_dir20031213200312130014asp
Australian food manufacturers and retailers must meet new labeling standards as of December 20httpwwwfoodnavigatorcomnewsnews-NGaspid=48488
Revlon debuts in BruneihttpwwwbrudirectcomDailyInfoNewsArchiveDec03121203bb17htm
Indian cosmetics company Emami has filed a criminal complaint against Bollywood filmmakersHrithik and Rakesh Roshan for failing to honor product placement agreements in their latest filmhttpwwwapunkachoicecomhappenings20031211-0html
LVMH plans to expand its Christian Dior line in China and Japanhttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=332
Kanebo and Kao have joined forces to challenge Shiseidohttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=319
The Pacific Bridge Asian Medical December Newsletter features a story on ASEAN plans to reducenon-tariff barriers for cosmetics and pharmaceuticalshttpwwwpacificbridgemedicalcomnewsletterv3n9pdf
The Americas
MexRegscom is an Internet source for Mexican regulationshttpwwwmexregscom
Health Canada advises against the use of the herb comfrey or products that contain comfreyhttpwwwhc-scgccaenglishmediareleases20032003_101htm
Researcher finds high mercury levels in Mexican women and border states traced to Mexican madeskin whitening creamhttpwwwbostoncomnewsglobehealth_sciencearticles20031216whitening_skin_can_be_deadly
Waxing manicures for men are becoming popular in traditionally macho Mexico Puerto Rico andArgentinahttpbusiness-timesasia1comsgstory0456710046200html
10
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
011904 ndash 012204 Informex Venetian Hotel Sands Expo CenterLas Vegas Nevada USAMore info httpwwwinformexcom
012704 ndash 013104 Soap and Detergent Association (SDA) Boca Raton Resort amp ClubAnnual Meeting and Industry Convention Boca Raton Florida USA
More info (202) 347-2900
020904 ndash 021204 ICE Expo The Hyatt RegencyMiami Florida USAMore info (630) 653-2155Email icealluredcomhttpwwwice-expocom
022604 ndash 022904 Cosmetic Toiletry and Fragrance Association (CTFA) Boca Raton Resort amp ClubAnnual Meeting and Industry Convention Boca Raton Florida USA
More info (202) 331-1770
030904 ndash 031104 Personal Care Ingredients Asia JinHan Exhibition CenterGuangzhou ChinaMore info Step Exhibitions(44) 1892-518877httpwwwstepexcom
032204 ndash 032304 Society of Cosmetic Scientists Spring Symposium Kettering Park Hotel KetteringldquoPerfumemdashthe Constant Elementrdquo Northants UK
Tel 44-1582-726661Email ifsccscsconnectcomwwwscsorguk
032404 SCC Teamworks 2004 Midwest Chapter More info httpwwwmidwestsccorgSupplierrsquos Day
032404 ndash 032604 Institute of Packaging Professionals Marriott MarquisFlexible Packaging Conference 2004 Atlanta Georgia USA
More info Stan Zelesnik IOPP(630) 544-5050 ext 108Email szelesnikiopporghttpwwwiopporg
041304 ndash 041404 Personal Care Ingredients and Technology Sheraton Hotel NYCExhibition 2004 High Function Naturals Contact PCITXHigh Performance Ingredients and Tel 949-487-9970High Impact Color E-mail bobgraysonassociatescom
041404 ndash 041804 Intercharm Professional 2004 Moscow RussiaE-mail mointercharmruwwwintercharmneteng
042004 ndash 042204 The Color Pigments Manufacturing Association Inc Chicago Illinois USAInternational Color Pigments Conference More info (703) 684-4044
Email cpmacpmacom
042704 042904 In-Cosmetics Milan ItalyContact patricialefevrereedexpocouk
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
MEETINGS AND CONFERENCES
050604 ndash 050704 Society of Cosmetic Chemists (SCC) Mohegan SunAnnual Scientific Seminar Uncansville Connecticut USA
More info (212) 668-1500
052404 ndash 052804 Aromatherapy and Perfumery Seminar Grasse FranceProperties of natural raw materials used Tel 33-4-92-42-34-90in perfumery and aromatherapy E-mail gipprodaromfr
060104 ndash 060504 World Perfumery Congress The Future of Perfumery Palais des FestivalsCannes FranceMore info (33) 55-96-21-32Email infoworldperfumerycongresscomhttpwwwworldperfumerycongresscom
062004 ndash 062304 6th World Surfactants Congress Berlin GermanyMore info (49) 30-300-66-90Email berlincpo-hanserdehttpwwwcesio2004de
091004 ndash 091204 Pathways to Beauty and Wellness Jacob K Javitz Convention CenterNew York New York USAMore info Grayson Associates(949) 487-9970Email suzannegraysonassociatescom
101004 ndash 101304 RAPS 2004 Annual Conference and Exhibition Washington Hilton and TowersWashington DC USAhttpwwwrapsorg
102004 ndash 102204 Centifolia International Congress of Perfumery Grasse Franceand Natural Ingredients Contact le Club des Entrepreneurs
Tel 33-4-97-05-57-60clubdesentrepreneursville-grassefr
102404 ndash 102704 ISFCC International Congress Dolphin Hotel Walt Disney World ResortOrlando Florida USAMore info (212) 668-1500
102404 ndash 102804 International Federation of Essential Oils Lisbon Portugaland Aroma Trades International Conference 2004 More info +44-20-7836-2460
Email ifeatadministratorfdforgukhttpwwwifeatorgIFEAT20Lisbon20flyer2004pdf
102804 ndash 110104 11th Perfumery amp Cosmetics Exhibitionmdash Sokolniki Exhibition Center MoscowInterCharm E-mail mointercharmru
wwwintercharmneteng
111004 ndash 111204 Cosmoprof Asia and The Natural Health Fair Hong Kong Convention and Exhibit CenterhttpwwwnaturalhealthfaircomNHFupdate_enhtml
111604 ndash 111804 Health Ingredients Europe The Netherlandswwwhi-eventscom
10
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Kirkpatrick amp Lockhart LLP
Challenge us
Kirkpatrick amp Lockhartrsquos Food and Drug Practice offers comprehensive legal and
regulatory counseling to companies and other organizations regulated by FDA
under the Federal Food Drug and Cosmetic Act We represent manufacturers
and distributors of food dietary supplements pharmaceuticals medical devices
biologicals and personal care and cosmetic products Areas of experience include
enforcement approvals and clearance labeling and advertising clinical research
inspections and importexport
P A R T N E R S
Gary L Yingling 2027789124 gyinglingklcom
Suzan Onel 2027789134 sonelklcom
O F C O U N S E L
Emalee G Murphy 2027789428 emaleemurphyklcom
A S S O C I A T E S
Ann M Begley 2027789365 abegleyklcom
Rebecca L Dandeker 2027789409 rdandekerklcom
Joshua S Kim 2027789039 jkimklcom
FOOD amp DRUG PRACTICE
copy 2003 KIRKPATRICK amp LOCKHART LLP ALL RIGHTS RESERVED
This publicationnewsletter is for informational purposes and does not contain or convey legal advice The information hereinshould not be used or relied upon in regard to any particular facts or circumstances without first consulting a lawyer
BOSTONDALLASHARRISBURGLOS ANGELESMIAMINEWARKNEW YORKPITTSBURGHSAN FRANCISCOWASHINGTON
16
4
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
The menrsquos toiletries market in the UShttpwwwin-cosmeticscompagecfmlink=79
German company Henkel to acquire Dialhttpwwwcbccacpbusiness031215b121524html
Legislative Update
The House has passed a bill that would regulate non-corrective contact lenses as medical deviceshttpwwwguardiancoukuslateststory01282-340854000html
DIETARY SUPPLEMENTSFOOD
Regulatory Update
FTC submits comments to FDA on food labels and obesityhttpwwwftcgovopa200312fdaobesityhtm
Advisory panel recommends big changes to recommended daily value calculations for vitamins andmineralshttpmagazinesivillagecomgoodhousekeepinghbnewsarticle0krt_2003_12_12_knigt_2734-0109-NTR-FDA~TB~ew~xml00html
Advanced notice of proposed rulemaking published for comment on regulating qualified health claimshttpa257gakamaitechnet7257242214mar20010800edocketaccessgpogov2003pdf03-29448pdf
Food labels face overhaul to reflect latest information on nutritionhttpwwwhealthcentralcomnewsNewsFullTextcfmid=516512
USDA issues new food safety guidelines for consumershttpwwwusdagovnewsreleases2003110386htm
FDA approves whole grain health claimhttpwwwthompsoncomhp_newsbriefs031211c_fooddrughtml
Consumerlabcom reports improvement in the quality of SAMehttpwwwconsumerlabcomresultssameasp
US health insurers ponder whether to make obesity treatments reimbursablehttpstorynewsyahoocomnewstmpl=storyampcid=1506ampncid=751ampe=6ampu=afp20031212ts_alt_afpyear_us_obesity
Some say DSHEA opened the door to the current steroids doping scandalshttpwwwbayareacommldmercurynewssports7503489htm
Enforcement Update
Contaminated food seized at Washington DC distributorhttpwwwfdagovbbstopicsnews2003doj112803html
$27 million worth of Royal Tongan Limu destroyed because of persistent unsubstantiated health claimshttpwwwfdagovbbstopicsNEWS2003NEW00976html
American Nutraceuticals receives warning letter for drug claims on behalf of its supplement productshttpwwwfdagovfoiwarning_lettersg4406dhtm
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Food importer Golden Luck Inc receives a warning letter for distributing adulterated products andfor failing to bring misbranded products into compliance even after submitting certificates ofcompletion for reconditioning to FDAhttpwwwfdagovfoiwarning_lettersg4394dhtm
Genesis Juice Cooperative receives warning letter for deviations from Juice Hazard Analysis CriticalControl Pointhttpwwwfdagovfoiwarning_lettersg4402dhtm
Superior Nut Company receives a warning letter for insanitary conditionshttpwwwfdagovfoiwarning_lettersg4362dhtm
Safety and Effectiveness Update
Research seems to indicate that water can lsquorememberrsquo compounds even after the compounds havebeen removedhttpwwwnewsscotsmancomindexcfmid=1093712003
And homeopathy reduces arsenic poisoning in micehttpwwwnewscientistcomnewsnewsjspid=ns99994305
Kraft has agreed to get the trans fats out of Oreos but figuring out how is a challenge for their research teamhttpwwwmetroactivecompaperscruz120303fats-0349html
Study finds black elderberry extract seems to ameliorate flu symptoms and shorten its durationhttpwwwfoodnavigatorcomnewsnews-NGaspid=48460
Wheat grain may be beneficial to diabeticshttpnewsbbccouk2hihealth3279591stm
Some US children show early signs of heart diseasehttpwwwnewscientistcomnewsnewsjspid=ns99994364
Cocoa has even more cancer preventing compounds than red wine or green tea say scientistshttpwwwnewscornelledureleasesNov03HotCocoa-Leebpfhtml
Cinnamon is found to improve blood sugar levelshttpwwwnewscientistcomnewsnewsjspid=ns99994413
Business and Industry Update
Nutraquest seeks to sue sports team over player deathhttpwwwwjlacomnewsstories1203112405html
Masterfoods USA introduces CocoaVia its new functional chocolate product containing phytosterolsand flavonols believed to protect the hearthttpwwwnutraingredients-usacomnewsnews-NGaspid=48471
Mintel issues its 2004 product predictions covering cosmetics scents foods and packaging trendshttpwwwwebdeskcomnew-product-predictions
An international survey finds mothers the world over worry over their childrenrsquos weight will pay morefor healthier food and rely on multiple information sources in making purchasing decisionshttphomebusinesswirecomportalsitegoogleindexjspndmViewId=news_viewampnewsId=20031210005453ampnewsLang=en
5
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Legislative Update
American Herbal Products Association press release on the bill entitled Dietary Supplement Accessand Awareness Act (HR 3377)httpwwwalliance-natural-healthorgindexcfmaction=newsampID=42
The Senate Governmental Affairs Committee heard about the USrsquos pressing need for an agriculturalanti-terror plan in last monthrsquos hearingshttpwwwzwirecomsitenewscfmBRD=1829ampdept_id=112755ampnewsid=10635153ampPAG=461amprfi=9
OTC DRUGS
Regulatory Update
FDA advisory committee votes to allow OTC sales of emergency contraceptive pillhttpwwwdocguidecomnewscontentnsfnews8525697700573E1885256DFF004D2D50OpenDocumentampc=Contraceptionampcount=10
Joint meeting of FDArsquos Nonprescription Drugs Advisory Committee and the Reproductive HealthDrugs Advisory Committee on December 16httpwwwfdagovocadvisoryaccalendarcder12541d121603html
Claritin approved for OTC use on hiveshttpwwwdocguidecomnewscontentnsfnews8525697700573E1885256DE4004D67B1OpenDocumentampc=Allergy20Otherampcount=10
FDA Advisory Committee considers broader professional labeling of aspirin to include an indicationfor use in prevention of a first heart attack in patients at risk for coronary heart diseasehttpwwwpressicomintrelease81538html
Enforcement Update
Nutra Med receives warning letter for deviations from cGMP regulationshttpwwwfdagovfoiwarning_lettersg4357dhtm
Product Safety and Effectiveness Update
Researchers find that an aspirin a day can stave off disease in elderlyhttpwwwiolcozaindexphpclick_id=31ampart_id=qw1071548463830B252ampset_id=1
Doctors warn of dangers of combining medications for fluhttpwwwwralcomhealth2705344detailhtml
AMA publishes list of drugs that are potentially hazardous to the elderlyhttparchinteama-assnorgcgicontentfull163222716Article with interview of principal drafter of AMA reporthttpwashingtontimescomnational20031214-114551-1067rhtm
This cold and flu season many new remedies are on the shelveshttpwwwsun-sentinelcomsportssfl-coldremedydec1401933986storycoll=sfla-sports-headlines
Homeopathic flu remedies receive attentionhttpwwwreformercomStories01413102~8862~183588800html
Interview with a naturapathhttpwwworegonlivecommetrosouthwestoregonianindexssfbasemetro_southwest_news1070629282241150xml
6
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
7
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Business and Industry Update
ACNielson begins tracking sales of OTC remedies in convenience storeshttpwwwmronscomdrnonews1942htm
Procter amp Gamble is teaming with Fleetwood RV in a marketing ploy to have a large purple RVfeatured in ads for OTC Prilosechttpbizyahoocomprnews031215lam040_1html
Baby boomers boost tooth whitener saleshttpwwwdelawareonlinecomnewsjournalbusiness20031215boomersboosttoohtml
OTC flu remedies are facing shortages during this flu seasonhttpwwwnbc5comhealth2701177detailhtmlz=dpampdpswid=1167317ampdppid=65195
An overview of some of the many new flu remedies on the market this yearhttpwwwdetnewscom2003health031217h05-10909htm
MEDICAL DEVICES
Regulatory Update
Proposed rule on the effective date on requirement for premarket approval for three Class IIIpreamendments deviceshttpa257gakamaitechnet7257242214mar20010800edocketaccessgpogov2003pdf03-28741pdf
FDA Commissioner McClellan challenges industry to improve development processhttpwwwdevicelinkcommddiarchive0312014html
FDA approves injectable gel to treat facial wrinkleshttpwwwfdagovbbstopicsANSWERS2003ANS01271html
Devicelink editorial on FDArsquos voluntary third-party inspection initiativehttpwwwdevicelinkcommddiarchive0312017html
FDA approves laser treatment for acnehttpbizyahoocomprnews031124nym152_1html
Enforcement Update
Device maker Applied Laboratories Inc receives warning letter for violation of Quality System Regulationhttpwwwfdagovfoiwarning_lettersg4408dhtm
Medical kit maker American Medical Devices Inc receives cGMP warning letterhttpwwwfdagovfoiwarning_lettersg4410dhtm
Plus Orthepedics receives a warning letter for failing to meet requirements for an Investigative DeviceExemption and for failing to be specific enough with regard to the companyrsquos corrective action planhttpwwwfdagovfoiwarning_lettersg4331dhtm
Drug Free Enterprises maker of drug test kits receives a warning letter for cGMP violations andviolations in its conduct of a consumer surveyhttpwwwfdagovfoiwarning_lettersg4363dhtm
Wood Hygienic Institute receives a cGMP warning letter for its colonic irrigation deviceshttpwwwfdagovfoiwarning_lettersg4399dhtm
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
8
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Safety and Effectiveness Update
New allograft technique allows surgeons to save limbshttpwwwchroncomcsCDAssistorymplmetropolitan2232953
Biolectrical Impedence Analysis may be best measure of childhood weight problemshttpwwwsciencedailycomreleases200310031009065701htm
Electrical stimulation procedure may aid stroke recoveryhttpwwwdevicelinkcommddiarchive0312020html
Virtual colonoscopy is found to be as effective as traditional optical colonoscopyhttpwwwama-assnorgamednews20031222hlbf1222htm
Business and Industry Update
Medical ethics and financial interests clash in referrals to imaging centershttpwwwcourier-journalcomlocalnews20031201kywir-front-mri1201-17507html
INTERNATIONAL UPDATE
Europe
EU Court okays online sales for over-the-counter drugshttpwwweubusinesscomafp031211145511hmn3w13q
COLIPA publishes its lsquoFirst observations of the European Cosmetics Industry on the Commissionproposal for a European chemicals legislationrsquohttpwwwcolipacomdocpress_statement_071103pdf
Monaco agrees to introduce EU rules on cosmetics production into the principality to assist localmanufacturers in selling their brands across Europehttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=334
Steroids found in herbal eczema creamshttpnewsbbccouk2hihealth3301481stm
European Commission proposes new regulations for food contact substanceshttpwwwfoodnavigatorcomnewsnews-NGaspid=47870
Member states failed to support an initiative to approve the first GM foodstuffhttpwwwfoodnavigatorcomnewsnews-NGaspid=48319
EU issues report on presence of persistent chemicals in the human body and the blood test resultson a commissionerhttpeuropaeuintrapidstartcgiguestenkshp_actiongettxt=gtampdoc=MEMO03219|0|RAPIDamplg=ENampdisplay=
Outlook is favorable for easier marketing of cholesterol lowering foods in Europehttpwwwnutraingredientscomnewsnews-NGaspid=48480
The UK is a growth market for functional foodshttpwwwnutraingredientscomnewsnews-NGaspid=48485
Businesses and advertisers take notice of the huge purchasing power in the swelling ranks ofEuropean seniorshttpstraitstimesasia1comsgworldstory0438622511500html
EU counterfeit cosmetics and perfumes seizures up 300 over 2001 and 2002 EC reportshttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=328
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
9
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Avon builds manufacturing plant in RussiahttpwwwindustryweekcomCurrentArticlesAsparticlesaspArticleId=1533
Swedish cosmetic company Oriflame is also building a factory in Russiahttpwwwgateway2russiacomstart_150361php
AsiaPacific
Therapeutic tourism is booming in Karnataka India where clinics offer ayurveda homeopathyyoga naturopathy acupuncture and morehttpwwwrediffcommoney2003dec09tourhtm
The Asian cosmetics market boom in China stagnation in Japan local competition in South Koreahttpwwwbeauty-on-linecomebnnewsletteraspeid=80
In South Korea the makers of a cosmetics refrigerator are eyeing the overseas markethttpwwwkoreaheraldcokrSITEdatahtml_dir20031213200312130014asp
Australian food manufacturers and retailers must meet new labeling standards as of December 20httpwwwfoodnavigatorcomnewsnews-NGaspid=48488
Revlon debuts in BruneihttpwwwbrudirectcomDailyInfoNewsArchiveDec03121203bb17htm
Indian cosmetics company Emami has filed a criminal complaint against Bollywood filmmakersHrithik and Rakesh Roshan for failing to honor product placement agreements in their latest filmhttpwwwapunkachoicecomhappenings20031211-0html
LVMH plans to expand its Christian Dior line in China and Japanhttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=332
Kanebo and Kao have joined forces to challenge Shiseidohttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=319
The Pacific Bridge Asian Medical December Newsletter features a story on ASEAN plans to reducenon-tariff barriers for cosmetics and pharmaceuticalshttpwwwpacificbridgemedicalcomnewsletterv3n9pdf
The Americas
MexRegscom is an Internet source for Mexican regulationshttpwwwmexregscom
Health Canada advises against the use of the herb comfrey or products that contain comfreyhttpwwwhc-scgccaenglishmediareleases20032003_101htm
Researcher finds high mercury levels in Mexican women and border states traced to Mexican madeskin whitening creamhttpwwwbostoncomnewsglobehealth_sciencearticles20031216whitening_skin_can_be_deadly
Waxing manicures for men are becoming popular in traditionally macho Mexico Puerto Rico andArgentinahttpbusiness-timesasia1comsgstory0456710046200html
10
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
011904 ndash 012204 Informex Venetian Hotel Sands Expo CenterLas Vegas Nevada USAMore info httpwwwinformexcom
012704 ndash 013104 Soap and Detergent Association (SDA) Boca Raton Resort amp ClubAnnual Meeting and Industry Convention Boca Raton Florida USA
More info (202) 347-2900
020904 ndash 021204 ICE Expo The Hyatt RegencyMiami Florida USAMore info (630) 653-2155Email icealluredcomhttpwwwice-expocom
022604 ndash 022904 Cosmetic Toiletry and Fragrance Association (CTFA) Boca Raton Resort amp ClubAnnual Meeting and Industry Convention Boca Raton Florida USA
More info (202) 331-1770
030904 ndash 031104 Personal Care Ingredients Asia JinHan Exhibition CenterGuangzhou ChinaMore info Step Exhibitions(44) 1892-518877httpwwwstepexcom
032204 ndash 032304 Society of Cosmetic Scientists Spring Symposium Kettering Park Hotel KetteringldquoPerfumemdashthe Constant Elementrdquo Northants UK
Tel 44-1582-726661Email ifsccscsconnectcomwwwscsorguk
032404 SCC Teamworks 2004 Midwest Chapter More info httpwwwmidwestsccorgSupplierrsquos Day
032404 ndash 032604 Institute of Packaging Professionals Marriott MarquisFlexible Packaging Conference 2004 Atlanta Georgia USA
More info Stan Zelesnik IOPP(630) 544-5050 ext 108Email szelesnikiopporghttpwwwiopporg
041304 ndash 041404 Personal Care Ingredients and Technology Sheraton Hotel NYCExhibition 2004 High Function Naturals Contact PCITXHigh Performance Ingredients and Tel 949-487-9970High Impact Color E-mail bobgraysonassociatescom
041404 ndash 041804 Intercharm Professional 2004 Moscow RussiaE-mail mointercharmruwwwintercharmneteng
042004 ndash 042204 The Color Pigments Manufacturing Association Inc Chicago Illinois USAInternational Color Pigments Conference More info (703) 684-4044
Email cpmacpmacom
042704 042904 In-Cosmetics Milan ItalyContact patricialefevrereedexpocouk
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
MEETINGS AND CONFERENCES
050604 ndash 050704 Society of Cosmetic Chemists (SCC) Mohegan SunAnnual Scientific Seminar Uncansville Connecticut USA
More info (212) 668-1500
052404 ndash 052804 Aromatherapy and Perfumery Seminar Grasse FranceProperties of natural raw materials used Tel 33-4-92-42-34-90in perfumery and aromatherapy E-mail gipprodaromfr
060104 ndash 060504 World Perfumery Congress The Future of Perfumery Palais des FestivalsCannes FranceMore info (33) 55-96-21-32Email infoworldperfumerycongresscomhttpwwwworldperfumerycongresscom
062004 ndash 062304 6th World Surfactants Congress Berlin GermanyMore info (49) 30-300-66-90Email berlincpo-hanserdehttpwwwcesio2004de
091004 ndash 091204 Pathways to Beauty and Wellness Jacob K Javitz Convention CenterNew York New York USAMore info Grayson Associates(949) 487-9970Email suzannegraysonassociatescom
101004 ndash 101304 RAPS 2004 Annual Conference and Exhibition Washington Hilton and TowersWashington DC USAhttpwwwrapsorg
102004 ndash 102204 Centifolia International Congress of Perfumery Grasse Franceand Natural Ingredients Contact le Club des Entrepreneurs
Tel 33-4-97-05-57-60clubdesentrepreneursville-grassefr
102404 ndash 102704 ISFCC International Congress Dolphin Hotel Walt Disney World ResortOrlando Florida USAMore info (212) 668-1500
102404 ndash 102804 International Federation of Essential Oils Lisbon Portugaland Aroma Trades International Conference 2004 More info +44-20-7836-2460
Email ifeatadministratorfdforgukhttpwwwifeatorgIFEAT20Lisbon20flyer2004pdf
102804 ndash 110104 11th Perfumery amp Cosmetics Exhibitionmdash Sokolniki Exhibition Center MoscowInterCharm E-mail mointercharmru
wwwintercharmneteng
111004 ndash 111204 Cosmoprof Asia and The Natural Health Fair Hong Kong Convention and Exhibit CenterhttpwwwnaturalhealthfaircomNHFupdate_enhtml
111604 ndash 111804 Health Ingredients Europe The Netherlandswwwhi-eventscom
10
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Kirkpatrick amp Lockhart LLP
Challenge us
Kirkpatrick amp Lockhartrsquos Food and Drug Practice offers comprehensive legal and
regulatory counseling to companies and other organizations regulated by FDA
under the Federal Food Drug and Cosmetic Act We represent manufacturers
and distributors of food dietary supplements pharmaceuticals medical devices
biologicals and personal care and cosmetic products Areas of experience include
enforcement approvals and clearance labeling and advertising clinical research
inspections and importexport
P A R T N E R S
Gary L Yingling 2027789124 gyinglingklcom
Suzan Onel 2027789134 sonelklcom
O F C O U N S E L
Emalee G Murphy 2027789428 emaleemurphyklcom
A S S O C I A T E S
Ann M Begley 2027789365 abegleyklcom
Rebecca L Dandeker 2027789409 rdandekerklcom
Joshua S Kim 2027789039 jkimklcom
FOOD amp DRUG PRACTICE
copy 2003 KIRKPATRICK amp LOCKHART LLP ALL RIGHTS RESERVED
This publicationnewsletter is for informational purposes and does not contain or convey legal advice The information hereinshould not be used or relied upon in regard to any particular facts or circumstances without first consulting a lawyer
BOSTONDALLASHARRISBURGLOS ANGELESMIAMINEWARKNEW YORKPITTSBURGHSAN FRANCISCOWASHINGTON
16
Food importer Golden Luck Inc receives a warning letter for distributing adulterated products andfor failing to bring misbranded products into compliance even after submitting certificates ofcompletion for reconditioning to FDAhttpwwwfdagovfoiwarning_lettersg4394dhtm
Genesis Juice Cooperative receives warning letter for deviations from Juice Hazard Analysis CriticalControl Pointhttpwwwfdagovfoiwarning_lettersg4402dhtm
Superior Nut Company receives a warning letter for insanitary conditionshttpwwwfdagovfoiwarning_lettersg4362dhtm
Safety and Effectiveness Update
Research seems to indicate that water can lsquorememberrsquo compounds even after the compounds havebeen removedhttpwwwnewsscotsmancomindexcfmid=1093712003
And homeopathy reduces arsenic poisoning in micehttpwwwnewscientistcomnewsnewsjspid=ns99994305
Kraft has agreed to get the trans fats out of Oreos but figuring out how is a challenge for their research teamhttpwwwmetroactivecompaperscruz120303fats-0349html
Study finds black elderberry extract seems to ameliorate flu symptoms and shorten its durationhttpwwwfoodnavigatorcomnewsnews-NGaspid=48460
Wheat grain may be beneficial to diabeticshttpnewsbbccouk2hihealth3279591stm
Some US children show early signs of heart diseasehttpwwwnewscientistcomnewsnewsjspid=ns99994364
Cocoa has even more cancer preventing compounds than red wine or green tea say scientistshttpwwwnewscornelledureleasesNov03HotCocoa-Leebpfhtml
Cinnamon is found to improve blood sugar levelshttpwwwnewscientistcomnewsnewsjspid=ns99994413
Business and Industry Update
Nutraquest seeks to sue sports team over player deathhttpwwwwjlacomnewsstories1203112405html
Masterfoods USA introduces CocoaVia its new functional chocolate product containing phytosterolsand flavonols believed to protect the hearthttpwwwnutraingredients-usacomnewsnews-NGaspid=48471
Mintel issues its 2004 product predictions covering cosmetics scents foods and packaging trendshttpwwwwebdeskcomnew-product-predictions
An international survey finds mothers the world over worry over their childrenrsquos weight will pay morefor healthier food and rely on multiple information sources in making purchasing decisionshttphomebusinesswirecomportalsitegoogleindexjspndmViewId=news_viewampnewsId=20031210005453ampnewsLang=en
5
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Legislative Update
American Herbal Products Association press release on the bill entitled Dietary Supplement Accessand Awareness Act (HR 3377)httpwwwalliance-natural-healthorgindexcfmaction=newsampID=42
The Senate Governmental Affairs Committee heard about the USrsquos pressing need for an agriculturalanti-terror plan in last monthrsquos hearingshttpwwwzwirecomsitenewscfmBRD=1829ampdept_id=112755ampnewsid=10635153ampPAG=461amprfi=9
OTC DRUGS
Regulatory Update
FDA advisory committee votes to allow OTC sales of emergency contraceptive pillhttpwwwdocguidecomnewscontentnsfnews8525697700573E1885256DFF004D2D50OpenDocumentampc=Contraceptionampcount=10
Joint meeting of FDArsquos Nonprescription Drugs Advisory Committee and the Reproductive HealthDrugs Advisory Committee on December 16httpwwwfdagovocadvisoryaccalendarcder12541d121603html
Claritin approved for OTC use on hiveshttpwwwdocguidecomnewscontentnsfnews8525697700573E1885256DE4004D67B1OpenDocumentampc=Allergy20Otherampcount=10
FDA Advisory Committee considers broader professional labeling of aspirin to include an indicationfor use in prevention of a first heart attack in patients at risk for coronary heart diseasehttpwwwpressicomintrelease81538html
Enforcement Update
Nutra Med receives warning letter for deviations from cGMP regulationshttpwwwfdagovfoiwarning_lettersg4357dhtm
Product Safety and Effectiveness Update
Researchers find that an aspirin a day can stave off disease in elderlyhttpwwwiolcozaindexphpclick_id=31ampart_id=qw1071548463830B252ampset_id=1
Doctors warn of dangers of combining medications for fluhttpwwwwralcomhealth2705344detailhtml
AMA publishes list of drugs that are potentially hazardous to the elderlyhttparchinteama-assnorgcgicontentfull163222716Article with interview of principal drafter of AMA reporthttpwashingtontimescomnational20031214-114551-1067rhtm
This cold and flu season many new remedies are on the shelveshttpwwwsun-sentinelcomsportssfl-coldremedydec1401933986storycoll=sfla-sports-headlines
Homeopathic flu remedies receive attentionhttpwwwreformercomStories01413102~8862~183588800html
Interview with a naturapathhttpwwworegonlivecommetrosouthwestoregonianindexssfbasemetro_southwest_news1070629282241150xml
6
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
7
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Business and Industry Update
ACNielson begins tracking sales of OTC remedies in convenience storeshttpwwwmronscomdrnonews1942htm
Procter amp Gamble is teaming with Fleetwood RV in a marketing ploy to have a large purple RVfeatured in ads for OTC Prilosechttpbizyahoocomprnews031215lam040_1html
Baby boomers boost tooth whitener saleshttpwwwdelawareonlinecomnewsjournalbusiness20031215boomersboosttoohtml
OTC flu remedies are facing shortages during this flu seasonhttpwwwnbc5comhealth2701177detailhtmlz=dpampdpswid=1167317ampdppid=65195
An overview of some of the many new flu remedies on the market this yearhttpwwwdetnewscom2003health031217h05-10909htm
MEDICAL DEVICES
Regulatory Update
Proposed rule on the effective date on requirement for premarket approval for three Class IIIpreamendments deviceshttpa257gakamaitechnet7257242214mar20010800edocketaccessgpogov2003pdf03-28741pdf
FDA Commissioner McClellan challenges industry to improve development processhttpwwwdevicelinkcommddiarchive0312014html
FDA approves injectable gel to treat facial wrinkleshttpwwwfdagovbbstopicsANSWERS2003ANS01271html
Devicelink editorial on FDArsquos voluntary third-party inspection initiativehttpwwwdevicelinkcommddiarchive0312017html
FDA approves laser treatment for acnehttpbizyahoocomprnews031124nym152_1html
Enforcement Update
Device maker Applied Laboratories Inc receives warning letter for violation of Quality System Regulationhttpwwwfdagovfoiwarning_lettersg4408dhtm
Medical kit maker American Medical Devices Inc receives cGMP warning letterhttpwwwfdagovfoiwarning_lettersg4410dhtm
Plus Orthepedics receives a warning letter for failing to meet requirements for an Investigative DeviceExemption and for failing to be specific enough with regard to the companyrsquos corrective action planhttpwwwfdagovfoiwarning_lettersg4331dhtm
Drug Free Enterprises maker of drug test kits receives a warning letter for cGMP violations andviolations in its conduct of a consumer surveyhttpwwwfdagovfoiwarning_lettersg4363dhtm
Wood Hygienic Institute receives a cGMP warning letter for its colonic irrigation deviceshttpwwwfdagovfoiwarning_lettersg4399dhtm
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
8
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Safety and Effectiveness Update
New allograft technique allows surgeons to save limbshttpwwwchroncomcsCDAssistorymplmetropolitan2232953
Biolectrical Impedence Analysis may be best measure of childhood weight problemshttpwwwsciencedailycomreleases200310031009065701htm
Electrical stimulation procedure may aid stroke recoveryhttpwwwdevicelinkcommddiarchive0312020html
Virtual colonoscopy is found to be as effective as traditional optical colonoscopyhttpwwwama-assnorgamednews20031222hlbf1222htm
Business and Industry Update
Medical ethics and financial interests clash in referrals to imaging centershttpwwwcourier-journalcomlocalnews20031201kywir-front-mri1201-17507html
INTERNATIONAL UPDATE
Europe
EU Court okays online sales for over-the-counter drugshttpwwweubusinesscomafp031211145511hmn3w13q
COLIPA publishes its lsquoFirst observations of the European Cosmetics Industry on the Commissionproposal for a European chemicals legislationrsquohttpwwwcolipacomdocpress_statement_071103pdf
Monaco agrees to introduce EU rules on cosmetics production into the principality to assist localmanufacturers in selling their brands across Europehttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=334
Steroids found in herbal eczema creamshttpnewsbbccouk2hihealth3301481stm
European Commission proposes new regulations for food contact substanceshttpwwwfoodnavigatorcomnewsnews-NGaspid=47870
Member states failed to support an initiative to approve the first GM foodstuffhttpwwwfoodnavigatorcomnewsnews-NGaspid=48319
EU issues report on presence of persistent chemicals in the human body and the blood test resultson a commissionerhttpeuropaeuintrapidstartcgiguestenkshp_actiongettxt=gtampdoc=MEMO03219|0|RAPIDamplg=ENampdisplay=
Outlook is favorable for easier marketing of cholesterol lowering foods in Europehttpwwwnutraingredientscomnewsnews-NGaspid=48480
The UK is a growth market for functional foodshttpwwwnutraingredientscomnewsnews-NGaspid=48485
Businesses and advertisers take notice of the huge purchasing power in the swelling ranks ofEuropean seniorshttpstraitstimesasia1comsgworldstory0438622511500html
EU counterfeit cosmetics and perfumes seizures up 300 over 2001 and 2002 EC reportshttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=328
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
9
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Avon builds manufacturing plant in RussiahttpwwwindustryweekcomCurrentArticlesAsparticlesaspArticleId=1533
Swedish cosmetic company Oriflame is also building a factory in Russiahttpwwwgateway2russiacomstart_150361php
AsiaPacific
Therapeutic tourism is booming in Karnataka India where clinics offer ayurveda homeopathyyoga naturopathy acupuncture and morehttpwwwrediffcommoney2003dec09tourhtm
The Asian cosmetics market boom in China stagnation in Japan local competition in South Koreahttpwwwbeauty-on-linecomebnnewsletteraspeid=80
In South Korea the makers of a cosmetics refrigerator are eyeing the overseas markethttpwwwkoreaheraldcokrSITEdatahtml_dir20031213200312130014asp
Australian food manufacturers and retailers must meet new labeling standards as of December 20httpwwwfoodnavigatorcomnewsnews-NGaspid=48488
Revlon debuts in BruneihttpwwwbrudirectcomDailyInfoNewsArchiveDec03121203bb17htm
Indian cosmetics company Emami has filed a criminal complaint against Bollywood filmmakersHrithik and Rakesh Roshan for failing to honor product placement agreements in their latest filmhttpwwwapunkachoicecomhappenings20031211-0html
LVMH plans to expand its Christian Dior line in China and Japanhttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=332
Kanebo and Kao have joined forces to challenge Shiseidohttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=319
The Pacific Bridge Asian Medical December Newsletter features a story on ASEAN plans to reducenon-tariff barriers for cosmetics and pharmaceuticalshttpwwwpacificbridgemedicalcomnewsletterv3n9pdf
The Americas
MexRegscom is an Internet source for Mexican regulationshttpwwwmexregscom
Health Canada advises against the use of the herb comfrey or products that contain comfreyhttpwwwhc-scgccaenglishmediareleases20032003_101htm
Researcher finds high mercury levels in Mexican women and border states traced to Mexican madeskin whitening creamhttpwwwbostoncomnewsglobehealth_sciencearticles20031216whitening_skin_can_be_deadly
Waxing manicures for men are becoming popular in traditionally macho Mexico Puerto Rico andArgentinahttpbusiness-timesasia1comsgstory0456710046200html
10
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
011904 ndash 012204 Informex Venetian Hotel Sands Expo CenterLas Vegas Nevada USAMore info httpwwwinformexcom
012704 ndash 013104 Soap and Detergent Association (SDA) Boca Raton Resort amp ClubAnnual Meeting and Industry Convention Boca Raton Florida USA
More info (202) 347-2900
020904 ndash 021204 ICE Expo The Hyatt RegencyMiami Florida USAMore info (630) 653-2155Email icealluredcomhttpwwwice-expocom
022604 ndash 022904 Cosmetic Toiletry and Fragrance Association (CTFA) Boca Raton Resort amp ClubAnnual Meeting and Industry Convention Boca Raton Florida USA
More info (202) 331-1770
030904 ndash 031104 Personal Care Ingredients Asia JinHan Exhibition CenterGuangzhou ChinaMore info Step Exhibitions(44) 1892-518877httpwwwstepexcom
032204 ndash 032304 Society of Cosmetic Scientists Spring Symposium Kettering Park Hotel KetteringldquoPerfumemdashthe Constant Elementrdquo Northants UK
Tel 44-1582-726661Email ifsccscsconnectcomwwwscsorguk
032404 SCC Teamworks 2004 Midwest Chapter More info httpwwwmidwestsccorgSupplierrsquos Day
032404 ndash 032604 Institute of Packaging Professionals Marriott MarquisFlexible Packaging Conference 2004 Atlanta Georgia USA
More info Stan Zelesnik IOPP(630) 544-5050 ext 108Email szelesnikiopporghttpwwwiopporg
041304 ndash 041404 Personal Care Ingredients and Technology Sheraton Hotel NYCExhibition 2004 High Function Naturals Contact PCITXHigh Performance Ingredients and Tel 949-487-9970High Impact Color E-mail bobgraysonassociatescom
041404 ndash 041804 Intercharm Professional 2004 Moscow RussiaE-mail mointercharmruwwwintercharmneteng
042004 ndash 042204 The Color Pigments Manufacturing Association Inc Chicago Illinois USAInternational Color Pigments Conference More info (703) 684-4044
Email cpmacpmacom
042704 042904 In-Cosmetics Milan ItalyContact patricialefevrereedexpocouk
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
MEETINGS AND CONFERENCES
050604 ndash 050704 Society of Cosmetic Chemists (SCC) Mohegan SunAnnual Scientific Seminar Uncansville Connecticut USA
More info (212) 668-1500
052404 ndash 052804 Aromatherapy and Perfumery Seminar Grasse FranceProperties of natural raw materials used Tel 33-4-92-42-34-90in perfumery and aromatherapy E-mail gipprodaromfr
060104 ndash 060504 World Perfumery Congress The Future of Perfumery Palais des FestivalsCannes FranceMore info (33) 55-96-21-32Email infoworldperfumerycongresscomhttpwwwworldperfumerycongresscom
062004 ndash 062304 6th World Surfactants Congress Berlin GermanyMore info (49) 30-300-66-90Email berlincpo-hanserdehttpwwwcesio2004de
091004 ndash 091204 Pathways to Beauty and Wellness Jacob K Javitz Convention CenterNew York New York USAMore info Grayson Associates(949) 487-9970Email suzannegraysonassociatescom
101004 ndash 101304 RAPS 2004 Annual Conference and Exhibition Washington Hilton and TowersWashington DC USAhttpwwwrapsorg
102004 ndash 102204 Centifolia International Congress of Perfumery Grasse Franceand Natural Ingredients Contact le Club des Entrepreneurs
Tel 33-4-97-05-57-60clubdesentrepreneursville-grassefr
102404 ndash 102704 ISFCC International Congress Dolphin Hotel Walt Disney World ResortOrlando Florida USAMore info (212) 668-1500
102404 ndash 102804 International Federation of Essential Oils Lisbon Portugaland Aroma Trades International Conference 2004 More info +44-20-7836-2460
Email ifeatadministratorfdforgukhttpwwwifeatorgIFEAT20Lisbon20flyer2004pdf
102804 ndash 110104 11th Perfumery amp Cosmetics Exhibitionmdash Sokolniki Exhibition Center MoscowInterCharm E-mail mointercharmru
wwwintercharmneteng
111004 ndash 111204 Cosmoprof Asia and The Natural Health Fair Hong Kong Convention and Exhibit CenterhttpwwwnaturalhealthfaircomNHFupdate_enhtml
111604 ndash 111804 Health Ingredients Europe The Netherlandswwwhi-eventscom
10
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Kirkpatrick amp Lockhart LLP
Challenge us
Kirkpatrick amp Lockhartrsquos Food and Drug Practice offers comprehensive legal and
regulatory counseling to companies and other organizations regulated by FDA
under the Federal Food Drug and Cosmetic Act We represent manufacturers
and distributors of food dietary supplements pharmaceuticals medical devices
biologicals and personal care and cosmetic products Areas of experience include
enforcement approvals and clearance labeling and advertising clinical research
inspections and importexport
P A R T N E R S
Gary L Yingling 2027789124 gyinglingklcom
Suzan Onel 2027789134 sonelklcom
O F C O U N S E L
Emalee G Murphy 2027789428 emaleemurphyklcom
A S S O C I A T E S
Ann M Begley 2027789365 abegleyklcom
Rebecca L Dandeker 2027789409 rdandekerklcom
Joshua S Kim 2027789039 jkimklcom
FOOD amp DRUG PRACTICE
copy 2003 KIRKPATRICK amp LOCKHART LLP ALL RIGHTS RESERVED
This publicationnewsletter is for informational purposes and does not contain or convey legal advice The information hereinshould not be used or relied upon in regard to any particular facts or circumstances without first consulting a lawyer
BOSTONDALLASHARRISBURGLOS ANGELESMIAMINEWARKNEW YORKPITTSBURGHSAN FRANCISCOWASHINGTON
16
Legislative Update
American Herbal Products Association press release on the bill entitled Dietary Supplement Accessand Awareness Act (HR 3377)httpwwwalliance-natural-healthorgindexcfmaction=newsampID=42
The Senate Governmental Affairs Committee heard about the USrsquos pressing need for an agriculturalanti-terror plan in last monthrsquos hearingshttpwwwzwirecomsitenewscfmBRD=1829ampdept_id=112755ampnewsid=10635153ampPAG=461amprfi=9
OTC DRUGS
Regulatory Update
FDA advisory committee votes to allow OTC sales of emergency contraceptive pillhttpwwwdocguidecomnewscontentnsfnews8525697700573E1885256DFF004D2D50OpenDocumentampc=Contraceptionampcount=10
Joint meeting of FDArsquos Nonprescription Drugs Advisory Committee and the Reproductive HealthDrugs Advisory Committee on December 16httpwwwfdagovocadvisoryaccalendarcder12541d121603html
Claritin approved for OTC use on hiveshttpwwwdocguidecomnewscontentnsfnews8525697700573E1885256DE4004D67B1OpenDocumentampc=Allergy20Otherampcount=10
FDA Advisory Committee considers broader professional labeling of aspirin to include an indicationfor use in prevention of a first heart attack in patients at risk for coronary heart diseasehttpwwwpressicomintrelease81538html
Enforcement Update
Nutra Med receives warning letter for deviations from cGMP regulationshttpwwwfdagovfoiwarning_lettersg4357dhtm
Product Safety and Effectiveness Update
Researchers find that an aspirin a day can stave off disease in elderlyhttpwwwiolcozaindexphpclick_id=31ampart_id=qw1071548463830B252ampset_id=1
Doctors warn of dangers of combining medications for fluhttpwwwwralcomhealth2705344detailhtml
AMA publishes list of drugs that are potentially hazardous to the elderlyhttparchinteama-assnorgcgicontentfull163222716Article with interview of principal drafter of AMA reporthttpwashingtontimescomnational20031214-114551-1067rhtm
This cold and flu season many new remedies are on the shelveshttpwwwsun-sentinelcomsportssfl-coldremedydec1401933986storycoll=sfla-sports-headlines
Homeopathic flu remedies receive attentionhttpwwwreformercomStories01413102~8862~183588800html
Interview with a naturapathhttpwwworegonlivecommetrosouthwestoregonianindexssfbasemetro_southwest_news1070629282241150xml
6
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
7
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Business and Industry Update
ACNielson begins tracking sales of OTC remedies in convenience storeshttpwwwmronscomdrnonews1942htm
Procter amp Gamble is teaming with Fleetwood RV in a marketing ploy to have a large purple RVfeatured in ads for OTC Prilosechttpbizyahoocomprnews031215lam040_1html
Baby boomers boost tooth whitener saleshttpwwwdelawareonlinecomnewsjournalbusiness20031215boomersboosttoohtml
OTC flu remedies are facing shortages during this flu seasonhttpwwwnbc5comhealth2701177detailhtmlz=dpampdpswid=1167317ampdppid=65195
An overview of some of the many new flu remedies on the market this yearhttpwwwdetnewscom2003health031217h05-10909htm
MEDICAL DEVICES
Regulatory Update
Proposed rule on the effective date on requirement for premarket approval for three Class IIIpreamendments deviceshttpa257gakamaitechnet7257242214mar20010800edocketaccessgpogov2003pdf03-28741pdf
FDA Commissioner McClellan challenges industry to improve development processhttpwwwdevicelinkcommddiarchive0312014html
FDA approves injectable gel to treat facial wrinkleshttpwwwfdagovbbstopicsANSWERS2003ANS01271html
Devicelink editorial on FDArsquos voluntary third-party inspection initiativehttpwwwdevicelinkcommddiarchive0312017html
FDA approves laser treatment for acnehttpbizyahoocomprnews031124nym152_1html
Enforcement Update
Device maker Applied Laboratories Inc receives warning letter for violation of Quality System Regulationhttpwwwfdagovfoiwarning_lettersg4408dhtm
Medical kit maker American Medical Devices Inc receives cGMP warning letterhttpwwwfdagovfoiwarning_lettersg4410dhtm
Plus Orthepedics receives a warning letter for failing to meet requirements for an Investigative DeviceExemption and for failing to be specific enough with regard to the companyrsquos corrective action planhttpwwwfdagovfoiwarning_lettersg4331dhtm
Drug Free Enterprises maker of drug test kits receives a warning letter for cGMP violations andviolations in its conduct of a consumer surveyhttpwwwfdagovfoiwarning_lettersg4363dhtm
Wood Hygienic Institute receives a cGMP warning letter for its colonic irrigation deviceshttpwwwfdagovfoiwarning_lettersg4399dhtm
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
8
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Safety and Effectiveness Update
New allograft technique allows surgeons to save limbshttpwwwchroncomcsCDAssistorymplmetropolitan2232953
Biolectrical Impedence Analysis may be best measure of childhood weight problemshttpwwwsciencedailycomreleases200310031009065701htm
Electrical stimulation procedure may aid stroke recoveryhttpwwwdevicelinkcommddiarchive0312020html
Virtual colonoscopy is found to be as effective as traditional optical colonoscopyhttpwwwama-assnorgamednews20031222hlbf1222htm
Business and Industry Update
Medical ethics and financial interests clash in referrals to imaging centershttpwwwcourier-journalcomlocalnews20031201kywir-front-mri1201-17507html
INTERNATIONAL UPDATE
Europe
EU Court okays online sales for over-the-counter drugshttpwwweubusinesscomafp031211145511hmn3w13q
COLIPA publishes its lsquoFirst observations of the European Cosmetics Industry on the Commissionproposal for a European chemicals legislationrsquohttpwwwcolipacomdocpress_statement_071103pdf
Monaco agrees to introduce EU rules on cosmetics production into the principality to assist localmanufacturers in selling their brands across Europehttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=334
Steroids found in herbal eczema creamshttpnewsbbccouk2hihealth3301481stm
European Commission proposes new regulations for food contact substanceshttpwwwfoodnavigatorcomnewsnews-NGaspid=47870
Member states failed to support an initiative to approve the first GM foodstuffhttpwwwfoodnavigatorcomnewsnews-NGaspid=48319
EU issues report on presence of persistent chemicals in the human body and the blood test resultson a commissionerhttpeuropaeuintrapidstartcgiguestenkshp_actiongettxt=gtampdoc=MEMO03219|0|RAPIDamplg=ENampdisplay=
Outlook is favorable for easier marketing of cholesterol lowering foods in Europehttpwwwnutraingredientscomnewsnews-NGaspid=48480
The UK is a growth market for functional foodshttpwwwnutraingredientscomnewsnews-NGaspid=48485
Businesses and advertisers take notice of the huge purchasing power in the swelling ranks ofEuropean seniorshttpstraitstimesasia1comsgworldstory0438622511500html
EU counterfeit cosmetics and perfumes seizures up 300 over 2001 and 2002 EC reportshttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=328
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
9
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Avon builds manufacturing plant in RussiahttpwwwindustryweekcomCurrentArticlesAsparticlesaspArticleId=1533
Swedish cosmetic company Oriflame is also building a factory in Russiahttpwwwgateway2russiacomstart_150361php
AsiaPacific
Therapeutic tourism is booming in Karnataka India where clinics offer ayurveda homeopathyyoga naturopathy acupuncture and morehttpwwwrediffcommoney2003dec09tourhtm
The Asian cosmetics market boom in China stagnation in Japan local competition in South Koreahttpwwwbeauty-on-linecomebnnewsletteraspeid=80
In South Korea the makers of a cosmetics refrigerator are eyeing the overseas markethttpwwwkoreaheraldcokrSITEdatahtml_dir20031213200312130014asp
Australian food manufacturers and retailers must meet new labeling standards as of December 20httpwwwfoodnavigatorcomnewsnews-NGaspid=48488
Revlon debuts in BruneihttpwwwbrudirectcomDailyInfoNewsArchiveDec03121203bb17htm
Indian cosmetics company Emami has filed a criminal complaint against Bollywood filmmakersHrithik and Rakesh Roshan for failing to honor product placement agreements in their latest filmhttpwwwapunkachoicecomhappenings20031211-0html
LVMH plans to expand its Christian Dior line in China and Japanhttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=332
Kanebo and Kao have joined forces to challenge Shiseidohttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=319
The Pacific Bridge Asian Medical December Newsletter features a story on ASEAN plans to reducenon-tariff barriers for cosmetics and pharmaceuticalshttpwwwpacificbridgemedicalcomnewsletterv3n9pdf
The Americas
MexRegscom is an Internet source for Mexican regulationshttpwwwmexregscom
Health Canada advises against the use of the herb comfrey or products that contain comfreyhttpwwwhc-scgccaenglishmediareleases20032003_101htm
Researcher finds high mercury levels in Mexican women and border states traced to Mexican madeskin whitening creamhttpwwwbostoncomnewsglobehealth_sciencearticles20031216whitening_skin_can_be_deadly
Waxing manicures for men are becoming popular in traditionally macho Mexico Puerto Rico andArgentinahttpbusiness-timesasia1comsgstory0456710046200html
10
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
011904 ndash 012204 Informex Venetian Hotel Sands Expo CenterLas Vegas Nevada USAMore info httpwwwinformexcom
012704 ndash 013104 Soap and Detergent Association (SDA) Boca Raton Resort amp ClubAnnual Meeting and Industry Convention Boca Raton Florida USA
More info (202) 347-2900
020904 ndash 021204 ICE Expo The Hyatt RegencyMiami Florida USAMore info (630) 653-2155Email icealluredcomhttpwwwice-expocom
022604 ndash 022904 Cosmetic Toiletry and Fragrance Association (CTFA) Boca Raton Resort amp ClubAnnual Meeting and Industry Convention Boca Raton Florida USA
More info (202) 331-1770
030904 ndash 031104 Personal Care Ingredients Asia JinHan Exhibition CenterGuangzhou ChinaMore info Step Exhibitions(44) 1892-518877httpwwwstepexcom
032204 ndash 032304 Society of Cosmetic Scientists Spring Symposium Kettering Park Hotel KetteringldquoPerfumemdashthe Constant Elementrdquo Northants UK
Tel 44-1582-726661Email ifsccscsconnectcomwwwscsorguk
032404 SCC Teamworks 2004 Midwest Chapter More info httpwwwmidwestsccorgSupplierrsquos Day
032404 ndash 032604 Institute of Packaging Professionals Marriott MarquisFlexible Packaging Conference 2004 Atlanta Georgia USA
More info Stan Zelesnik IOPP(630) 544-5050 ext 108Email szelesnikiopporghttpwwwiopporg
041304 ndash 041404 Personal Care Ingredients and Technology Sheraton Hotel NYCExhibition 2004 High Function Naturals Contact PCITXHigh Performance Ingredients and Tel 949-487-9970High Impact Color E-mail bobgraysonassociatescom
041404 ndash 041804 Intercharm Professional 2004 Moscow RussiaE-mail mointercharmruwwwintercharmneteng
042004 ndash 042204 The Color Pigments Manufacturing Association Inc Chicago Illinois USAInternational Color Pigments Conference More info (703) 684-4044
Email cpmacpmacom
042704 042904 In-Cosmetics Milan ItalyContact patricialefevrereedexpocouk
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
MEETINGS AND CONFERENCES
050604 ndash 050704 Society of Cosmetic Chemists (SCC) Mohegan SunAnnual Scientific Seminar Uncansville Connecticut USA
More info (212) 668-1500
052404 ndash 052804 Aromatherapy and Perfumery Seminar Grasse FranceProperties of natural raw materials used Tel 33-4-92-42-34-90in perfumery and aromatherapy E-mail gipprodaromfr
060104 ndash 060504 World Perfumery Congress The Future of Perfumery Palais des FestivalsCannes FranceMore info (33) 55-96-21-32Email infoworldperfumerycongresscomhttpwwwworldperfumerycongresscom
062004 ndash 062304 6th World Surfactants Congress Berlin GermanyMore info (49) 30-300-66-90Email berlincpo-hanserdehttpwwwcesio2004de
091004 ndash 091204 Pathways to Beauty and Wellness Jacob K Javitz Convention CenterNew York New York USAMore info Grayson Associates(949) 487-9970Email suzannegraysonassociatescom
101004 ndash 101304 RAPS 2004 Annual Conference and Exhibition Washington Hilton and TowersWashington DC USAhttpwwwrapsorg
102004 ndash 102204 Centifolia International Congress of Perfumery Grasse Franceand Natural Ingredients Contact le Club des Entrepreneurs
Tel 33-4-97-05-57-60clubdesentrepreneursville-grassefr
102404 ndash 102704 ISFCC International Congress Dolphin Hotel Walt Disney World ResortOrlando Florida USAMore info (212) 668-1500
102404 ndash 102804 International Federation of Essential Oils Lisbon Portugaland Aroma Trades International Conference 2004 More info +44-20-7836-2460
Email ifeatadministratorfdforgukhttpwwwifeatorgIFEAT20Lisbon20flyer2004pdf
102804 ndash 110104 11th Perfumery amp Cosmetics Exhibitionmdash Sokolniki Exhibition Center MoscowInterCharm E-mail mointercharmru
wwwintercharmneteng
111004 ndash 111204 Cosmoprof Asia and The Natural Health Fair Hong Kong Convention and Exhibit CenterhttpwwwnaturalhealthfaircomNHFupdate_enhtml
111604 ndash 111804 Health Ingredients Europe The Netherlandswwwhi-eventscom
10
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Kirkpatrick amp Lockhart LLP
Challenge us
Kirkpatrick amp Lockhartrsquos Food and Drug Practice offers comprehensive legal and
regulatory counseling to companies and other organizations regulated by FDA
under the Federal Food Drug and Cosmetic Act We represent manufacturers
and distributors of food dietary supplements pharmaceuticals medical devices
biologicals and personal care and cosmetic products Areas of experience include
enforcement approvals and clearance labeling and advertising clinical research
inspections and importexport
P A R T N E R S
Gary L Yingling 2027789124 gyinglingklcom
Suzan Onel 2027789134 sonelklcom
O F C O U N S E L
Emalee G Murphy 2027789428 emaleemurphyklcom
A S S O C I A T E S
Ann M Begley 2027789365 abegleyklcom
Rebecca L Dandeker 2027789409 rdandekerklcom
Joshua S Kim 2027789039 jkimklcom
FOOD amp DRUG PRACTICE
copy 2003 KIRKPATRICK amp LOCKHART LLP ALL RIGHTS RESERVED
This publicationnewsletter is for informational purposes and does not contain or convey legal advice The information hereinshould not be used or relied upon in regard to any particular facts or circumstances without first consulting a lawyer
BOSTONDALLASHARRISBURGLOS ANGELESMIAMINEWARKNEW YORKPITTSBURGHSAN FRANCISCOWASHINGTON
16
7
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Business and Industry Update
ACNielson begins tracking sales of OTC remedies in convenience storeshttpwwwmronscomdrnonews1942htm
Procter amp Gamble is teaming with Fleetwood RV in a marketing ploy to have a large purple RVfeatured in ads for OTC Prilosechttpbizyahoocomprnews031215lam040_1html
Baby boomers boost tooth whitener saleshttpwwwdelawareonlinecomnewsjournalbusiness20031215boomersboosttoohtml
OTC flu remedies are facing shortages during this flu seasonhttpwwwnbc5comhealth2701177detailhtmlz=dpampdpswid=1167317ampdppid=65195
An overview of some of the many new flu remedies on the market this yearhttpwwwdetnewscom2003health031217h05-10909htm
MEDICAL DEVICES
Regulatory Update
Proposed rule on the effective date on requirement for premarket approval for three Class IIIpreamendments deviceshttpa257gakamaitechnet7257242214mar20010800edocketaccessgpogov2003pdf03-28741pdf
FDA Commissioner McClellan challenges industry to improve development processhttpwwwdevicelinkcommddiarchive0312014html
FDA approves injectable gel to treat facial wrinkleshttpwwwfdagovbbstopicsANSWERS2003ANS01271html
Devicelink editorial on FDArsquos voluntary third-party inspection initiativehttpwwwdevicelinkcommddiarchive0312017html
FDA approves laser treatment for acnehttpbizyahoocomprnews031124nym152_1html
Enforcement Update
Device maker Applied Laboratories Inc receives warning letter for violation of Quality System Regulationhttpwwwfdagovfoiwarning_lettersg4408dhtm
Medical kit maker American Medical Devices Inc receives cGMP warning letterhttpwwwfdagovfoiwarning_lettersg4410dhtm
Plus Orthepedics receives a warning letter for failing to meet requirements for an Investigative DeviceExemption and for failing to be specific enough with regard to the companyrsquos corrective action planhttpwwwfdagovfoiwarning_lettersg4331dhtm
Drug Free Enterprises maker of drug test kits receives a warning letter for cGMP violations andviolations in its conduct of a consumer surveyhttpwwwfdagovfoiwarning_lettersg4363dhtm
Wood Hygienic Institute receives a cGMP warning letter for its colonic irrigation deviceshttpwwwfdagovfoiwarning_lettersg4399dhtm
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
8
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Safety and Effectiveness Update
New allograft technique allows surgeons to save limbshttpwwwchroncomcsCDAssistorymplmetropolitan2232953
Biolectrical Impedence Analysis may be best measure of childhood weight problemshttpwwwsciencedailycomreleases200310031009065701htm
Electrical stimulation procedure may aid stroke recoveryhttpwwwdevicelinkcommddiarchive0312020html
Virtual colonoscopy is found to be as effective as traditional optical colonoscopyhttpwwwama-assnorgamednews20031222hlbf1222htm
Business and Industry Update
Medical ethics and financial interests clash in referrals to imaging centershttpwwwcourier-journalcomlocalnews20031201kywir-front-mri1201-17507html
INTERNATIONAL UPDATE
Europe
EU Court okays online sales for over-the-counter drugshttpwwweubusinesscomafp031211145511hmn3w13q
COLIPA publishes its lsquoFirst observations of the European Cosmetics Industry on the Commissionproposal for a European chemicals legislationrsquohttpwwwcolipacomdocpress_statement_071103pdf
Monaco agrees to introduce EU rules on cosmetics production into the principality to assist localmanufacturers in selling their brands across Europehttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=334
Steroids found in herbal eczema creamshttpnewsbbccouk2hihealth3301481stm
European Commission proposes new regulations for food contact substanceshttpwwwfoodnavigatorcomnewsnews-NGaspid=47870
Member states failed to support an initiative to approve the first GM foodstuffhttpwwwfoodnavigatorcomnewsnews-NGaspid=48319
EU issues report on presence of persistent chemicals in the human body and the blood test resultson a commissionerhttpeuropaeuintrapidstartcgiguestenkshp_actiongettxt=gtampdoc=MEMO03219|0|RAPIDamplg=ENampdisplay=
Outlook is favorable for easier marketing of cholesterol lowering foods in Europehttpwwwnutraingredientscomnewsnews-NGaspid=48480
The UK is a growth market for functional foodshttpwwwnutraingredientscomnewsnews-NGaspid=48485
Businesses and advertisers take notice of the huge purchasing power in the swelling ranks ofEuropean seniorshttpstraitstimesasia1comsgworldstory0438622511500html
EU counterfeit cosmetics and perfumes seizures up 300 over 2001 and 2002 EC reportshttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=328
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
9
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Avon builds manufacturing plant in RussiahttpwwwindustryweekcomCurrentArticlesAsparticlesaspArticleId=1533
Swedish cosmetic company Oriflame is also building a factory in Russiahttpwwwgateway2russiacomstart_150361php
AsiaPacific
Therapeutic tourism is booming in Karnataka India where clinics offer ayurveda homeopathyyoga naturopathy acupuncture and morehttpwwwrediffcommoney2003dec09tourhtm
The Asian cosmetics market boom in China stagnation in Japan local competition in South Koreahttpwwwbeauty-on-linecomebnnewsletteraspeid=80
In South Korea the makers of a cosmetics refrigerator are eyeing the overseas markethttpwwwkoreaheraldcokrSITEdatahtml_dir20031213200312130014asp
Australian food manufacturers and retailers must meet new labeling standards as of December 20httpwwwfoodnavigatorcomnewsnews-NGaspid=48488
Revlon debuts in BruneihttpwwwbrudirectcomDailyInfoNewsArchiveDec03121203bb17htm
Indian cosmetics company Emami has filed a criminal complaint against Bollywood filmmakersHrithik and Rakesh Roshan for failing to honor product placement agreements in their latest filmhttpwwwapunkachoicecomhappenings20031211-0html
LVMH plans to expand its Christian Dior line in China and Japanhttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=332
Kanebo and Kao have joined forces to challenge Shiseidohttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=319
The Pacific Bridge Asian Medical December Newsletter features a story on ASEAN plans to reducenon-tariff barriers for cosmetics and pharmaceuticalshttpwwwpacificbridgemedicalcomnewsletterv3n9pdf
The Americas
MexRegscom is an Internet source for Mexican regulationshttpwwwmexregscom
Health Canada advises against the use of the herb comfrey or products that contain comfreyhttpwwwhc-scgccaenglishmediareleases20032003_101htm
Researcher finds high mercury levels in Mexican women and border states traced to Mexican madeskin whitening creamhttpwwwbostoncomnewsglobehealth_sciencearticles20031216whitening_skin_can_be_deadly
Waxing manicures for men are becoming popular in traditionally macho Mexico Puerto Rico andArgentinahttpbusiness-timesasia1comsgstory0456710046200html
10
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
011904 ndash 012204 Informex Venetian Hotel Sands Expo CenterLas Vegas Nevada USAMore info httpwwwinformexcom
012704 ndash 013104 Soap and Detergent Association (SDA) Boca Raton Resort amp ClubAnnual Meeting and Industry Convention Boca Raton Florida USA
More info (202) 347-2900
020904 ndash 021204 ICE Expo The Hyatt RegencyMiami Florida USAMore info (630) 653-2155Email icealluredcomhttpwwwice-expocom
022604 ndash 022904 Cosmetic Toiletry and Fragrance Association (CTFA) Boca Raton Resort amp ClubAnnual Meeting and Industry Convention Boca Raton Florida USA
More info (202) 331-1770
030904 ndash 031104 Personal Care Ingredients Asia JinHan Exhibition CenterGuangzhou ChinaMore info Step Exhibitions(44) 1892-518877httpwwwstepexcom
032204 ndash 032304 Society of Cosmetic Scientists Spring Symposium Kettering Park Hotel KetteringldquoPerfumemdashthe Constant Elementrdquo Northants UK
Tel 44-1582-726661Email ifsccscsconnectcomwwwscsorguk
032404 SCC Teamworks 2004 Midwest Chapter More info httpwwwmidwestsccorgSupplierrsquos Day
032404 ndash 032604 Institute of Packaging Professionals Marriott MarquisFlexible Packaging Conference 2004 Atlanta Georgia USA
More info Stan Zelesnik IOPP(630) 544-5050 ext 108Email szelesnikiopporghttpwwwiopporg
041304 ndash 041404 Personal Care Ingredients and Technology Sheraton Hotel NYCExhibition 2004 High Function Naturals Contact PCITXHigh Performance Ingredients and Tel 949-487-9970High Impact Color E-mail bobgraysonassociatescom
041404 ndash 041804 Intercharm Professional 2004 Moscow RussiaE-mail mointercharmruwwwintercharmneteng
042004 ndash 042204 The Color Pigments Manufacturing Association Inc Chicago Illinois USAInternational Color Pigments Conference More info (703) 684-4044
Email cpmacpmacom
042704 042904 In-Cosmetics Milan ItalyContact patricialefevrereedexpocouk
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
MEETINGS AND CONFERENCES
050604 ndash 050704 Society of Cosmetic Chemists (SCC) Mohegan SunAnnual Scientific Seminar Uncansville Connecticut USA
More info (212) 668-1500
052404 ndash 052804 Aromatherapy and Perfumery Seminar Grasse FranceProperties of natural raw materials used Tel 33-4-92-42-34-90in perfumery and aromatherapy E-mail gipprodaromfr
060104 ndash 060504 World Perfumery Congress The Future of Perfumery Palais des FestivalsCannes FranceMore info (33) 55-96-21-32Email infoworldperfumerycongresscomhttpwwwworldperfumerycongresscom
062004 ndash 062304 6th World Surfactants Congress Berlin GermanyMore info (49) 30-300-66-90Email berlincpo-hanserdehttpwwwcesio2004de
091004 ndash 091204 Pathways to Beauty and Wellness Jacob K Javitz Convention CenterNew York New York USAMore info Grayson Associates(949) 487-9970Email suzannegraysonassociatescom
101004 ndash 101304 RAPS 2004 Annual Conference and Exhibition Washington Hilton and TowersWashington DC USAhttpwwwrapsorg
102004 ndash 102204 Centifolia International Congress of Perfumery Grasse Franceand Natural Ingredients Contact le Club des Entrepreneurs
Tel 33-4-97-05-57-60clubdesentrepreneursville-grassefr
102404 ndash 102704 ISFCC International Congress Dolphin Hotel Walt Disney World ResortOrlando Florida USAMore info (212) 668-1500
102404 ndash 102804 International Federation of Essential Oils Lisbon Portugaland Aroma Trades International Conference 2004 More info +44-20-7836-2460
Email ifeatadministratorfdforgukhttpwwwifeatorgIFEAT20Lisbon20flyer2004pdf
102804 ndash 110104 11th Perfumery amp Cosmetics Exhibitionmdash Sokolniki Exhibition Center MoscowInterCharm E-mail mointercharmru
wwwintercharmneteng
111004 ndash 111204 Cosmoprof Asia and The Natural Health Fair Hong Kong Convention and Exhibit CenterhttpwwwnaturalhealthfaircomNHFupdate_enhtml
111604 ndash 111804 Health Ingredients Europe The Netherlandswwwhi-eventscom
10
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Kirkpatrick amp Lockhart LLP
Challenge us
Kirkpatrick amp Lockhartrsquos Food and Drug Practice offers comprehensive legal and
regulatory counseling to companies and other organizations regulated by FDA
under the Federal Food Drug and Cosmetic Act We represent manufacturers
and distributors of food dietary supplements pharmaceuticals medical devices
biologicals and personal care and cosmetic products Areas of experience include
enforcement approvals and clearance labeling and advertising clinical research
inspections and importexport
P A R T N E R S
Gary L Yingling 2027789124 gyinglingklcom
Suzan Onel 2027789134 sonelklcom
O F C O U N S E L
Emalee G Murphy 2027789428 emaleemurphyklcom
A S S O C I A T E S
Ann M Begley 2027789365 abegleyklcom
Rebecca L Dandeker 2027789409 rdandekerklcom
Joshua S Kim 2027789039 jkimklcom
FOOD amp DRUG PRACTICE
copy 2003 KIRKPATRICK amp LOCKHART LLP ALL RIGHTS RESERVED
This publicationnewsletter is for informational purposes and does not contain or convey legal advice The information hereinshould not be used or relied upon in regard to any particular facts or circumstances without first consulting a lawyer
BOSTONDALLASHARRISBURGLOS ANGELESMIAMINEWARKNEW YORKPITTSBURGHSAN FRANCISCOWASHINGTON
16
8
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Safety and Effectiveness Update
New allograft technique allows surgeons to save limbshttpwwwchroncomcsCDAssistorymplmetropolitan2232953
Biolectrical Impedence Analysis may be best measure of childhood weight problemshttpwwwsciencedailycomreleases200310031009065701htm
Electrical stimulation procedure may aid stroke recoveryhttpwwwdevicelinkcommddiarchive0312020html
Virtual colonoscopy is found to be as effective as traditional optical colonoscopyhttpwwwama-assnorgamednews20031222hlbf1222htm
Business and Industry Update
Medical ethics and financial interests clash in referrals to imaging centershttpwwwcourier-journalcomlocalnews20031201kywir-front-mri1201-17507html
INTERNATIONAL UPDATE
Europe
EU Court okays online sales for over-the-counter drugshttpwwweubusinesscomafp031211145511hmn3w13q
COLIPA publishes its lsquoFirst observations of the European Cosmetics Industry on the Commissionproposal for a European chemicals legislationrsquohttpwwwcolipacomdocpress_statement_071103pdf
Monaco agrees to introduce EU rules on cosmetics production into the principality to assist localmanufacturers in selling their brands across Europehttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=334
Steroids found in herbal eczema creamshttpnewsbbccouk2hihealth3301481stm
European Commission proposes new regulations for food contact substanceshttpwwwfoodnavigatorcomnewsnews-NGaspid=47870
Member states failed to support an initiative to approve the first GM foodstuffhttpwwwfoodnavigatorcomnewsnews-NGaspid=48319
EU issues report on presence of persistent chemicals in the human body and the blood test resultson a commissionerhttpeuropaeuintrapidstartcgiguestenkshp_actiongettxt=gtampdoc=MEMO03219|0|RAPIDamplg=ENampdisplay=
Outlook is favorable for easier marketing of cholesterol lowering foods in Europehttpwwwnutraingredientscomnewsnews-NGaspid=48480
The UK is a growth market for functional foodshttpwwwnutraingredientscomnewsnews-NGaspid=48485
Businesses and advertisers take notice of the huge purchasing power in the swelling ranks ofEuropean seniorshttpstraitstimesasia1comsgworldstory0438622511500html
EU counterfeit cosmetics and perfumes seizures up 300 over 2001 and 2002 EC reportshttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=328
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
9
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Avon builds manufacturing plant in RussiahttpwwwindustryweekcomCurrentArticlesAsparticlesaspArticleId=1533
Swedish cosmetic company Oriflame is also building a factory in Russiahttpwwwgateway2russiacomstart_150361php
AsiaPacific
Therapeutic tourism is booming in Karnataka India where clinics offer ayurveda homeopathyyoga naturopathy acupuncture and morehttpwwwrediffcommoney2003dec09tourhtm
The Asian cosmetics market boom in China stagnation in Japan local competition in South Koreahttpwwwbeauty-on-linecomebnnewsletteraspeid=80
In South Korea the makers of a cosmetics refrigerator are eyeing the overseas markethttpwwwkoreaheraldcokrSITEdatahtml_dir20031213200312130014asp
Australian food manufacturers and retailers must meet new labeling standards as of December 20httpwwwfoodnavigatorcomnewsnews-NGaspid=48488
Revlon debuts in BruneihttpwwwbrudirectcomDailyInfoNewsArchiveDec03121203bb17htm
Indian cosmetics company Emami has filed a criminal complaint against Bollywood filmmakersHrithik and Rakesh Roshan for failing to honor product placement agreements in their latest filmhttpwwwapunkachoicecomhappenings20031211-0html
LVMH plans to expand its Christian Dior line in China and Japanhttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=332
Kanebo and Kao have joined forces to challenge Shiseidohttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=319
The Pacific Bridge Asian Medical December Newsletter features a story on ASEAN plans to reducenon-tariff barriers for cosmetics and pharmaceuticalshttpwwwpacificbridgemedicalcomnewsletterv3n9pdf
The Americas
MexRegscom is an Internet source for Mexican regulationshttpwwwmexregscom
Health Canada advises against the use of the herb comfrey or products that contain comfreyhttpwwwhc-scgccaenglishmediareleases20032003_101htm
Researcher finds high mercury levels in Mexican women and border states traced to Mexican madeskin whitening creamhttpwwwbostoncomnewsglobehealth_sciencearticles20031216whitening_skin_can_be_deadly
Waxing manicures for men are becoming popular in traditionally macho Mexico Puerto Rico andArgentinahttpbusiness-timesasia1comsgstory0456710046200html
10
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
011904 ndash 012204 Informex Venetian Hotel Sands Expo CenterLas Vegas Nevada USAMore info httpwwwinformexcom
012704 ndash 013104 Soap and Detergent Association (SDA) Boca Raton Resort amp ClubAnnual Meeting and Industry Convention Boca Raton Florida USA
More info (202) 347-2900
020904 ndash 021204 ICE Expo The Hyatt RegencyMiami Florida USAMore info (630) 653-2155Email icealluredcomhttpwwwice-expocom
022604 ndash 022904 Cosmetic Toiletry and Fragrance Association (CTFA) Boca Raton Resort amp ClubAnnual Meeting and Industry Convention Boca Raton Florida USA
More info (202) 331-1770
030904 ndash 031104 Personal Care Ingredients Asia JinHan Exhibition CenterGuangzhou ChinaMore info Step Exhibitions(44) 1892-518877httpwwwstepexcom
032204 ndash 032304 Society of Cosmetic Scientists Spring Symposium Kettering Park Hotel KetteringldquoPerfumemdashthe Constant Elementrdquo Northants UK
Tel 44-1582-726661Email ifsccscsconnectcomwwwscsorguk
032404 SCC Teamworks 2004 Midwest Chapter More info httpwwwmidwestsccorgSupplierrsquos Day
032404 ndash 032604 Institute of Packaging Professionals Marriott MarquisFlexible Packaging Conference 2004 Atlanta Georgia USA
More info Stan Zelesnik IOPP(630) 544-5050 ext 108Email szelesnikiopporghttpwwwiopporg
041304 ndash 041404 Personal Care Ingredients and Technology Sheraton Hotel NYCExhibition 2004 High Function Naturals Contact PCITXHigh Performance Ingredients and Tel 949-487-9970High Impact Color E-mail bobgraysonassociatescom
041404 ndash 041804 Intercharm Professional 2004 Moscow RussiaE-mail mointercharmruwwwintercharmneteng
042004 ndash 042204 The Color Pigments Manufacturing Association Inc Chicago Illinois USAInternational Color Pigments Conference More info (703) 684-4044
Email cpmacpmacom
042704 042904 In-Cosmetics Milan ItalyContact patricialefevrereedexpocouk
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
MEETINGS AND CONFERENCES
050604 ndash 050704 Society of Cosmetic Chemists (SCC) Mohegan SunAnnual Scientific Seminar Uncansville Connecticut USA
More info (212) 668-1500
052404 ndash 052804 Aromatherapy and Perfumery Seminar Grasse FranceProperties of natural raw materials used Tel 33-4-92-42-34-90in perfumery and aromatherapy E-mail gipprodaromfr
060104 ndash 060504 World Perfumery Congress The Future of Perfumery Palais des FestivalsCannes FranceMore info (33) 55-96-21-32Email infoworldperfumerycongresscomhttpwwwworldperfumerycongresscom
062004 ndash 062304 6th World Surfactants Congress Berlin GermanyMore info (49) 30-300-66-90Email berlincpo-hanserdehttpwwwcesio2004de
091004 ndash 091204 Pathways to Beauty and Wellness Jacob K Javitz Convention CenterNew York New York USAMore info Grayson Associates(949) 487-9970Email suzannegraysonassociatescom
101004 ndash 101304 RAPS 2004 Annual Conference and Exhibition Washington Hilton and TowersWashington DC USAhttpwwwrapsorg
102004 ndash 102204 Centifolia International Congress of Perfumery Grasse Franceand Natural Ingredients Contact le Club des Entrepreneurs
Tel 33-4-97-05-57-60clubdesentrepreneursville-grassefr
102404 ndash 102704 ISFCC International Congress Dolphin Hotel Walt Disney World ResortOrlando Florida USAMore info (212) 668-1500
102404 ndash 102804 International Federation of Essential Oils Lisbon Portugaland Aroma Trades International Conference 2004 More info +44-20-7836-2460
Email ifeatadministratorfdforgukhttpwwwifeatorgIFEAT20Lisbon20flyer2004pdf
102804 ndash 110104 11th Perfumery amp Cosmetics Exhibitionmdash Sokolniki Exhibition Center MoscowInterCharm E-mail mointercharmru
wwwintercharmneteng
111004 ndash 111204 Cosmoprof Asia and The Natural Health Fair Hong Kong Convention and Exhibit CenterhttpwwwnaturalhealthfaircomNHFupdate_enhtml
111604 ndash 111804 Health Ingredients Europe The Netherlandswwwhi-eventscom
10
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Kirkpatrick amp Lockhart LLP
Challenge us
Kirkpatrick amp Lockhartrsquos Food and Drug Practice offers comprehensive legal and
regulatory counseling to companies and other organizations regulated by FDA
under the Federal Food Drug and Cosmetic Act We represent manufacturers
and distributors of food dietary supplements pharmaceuticals medical devices
biologicals and personal care and cosmetic products Areas of experience include
enforcement approvals and clearance labeling and advertising clinical research
inspections and importexport
P A R T N E R S
Gary L Yingling 2027789124 gyinglingklcom
Suzan Onel 2027789134 sonelklcom
O F C O U N S E L
Emalee G Murphy 2027789428 emaleemurphyklcom
A S S O C I A T E S
Ann M Begley 2027789365 abegleyklcom
Rebecca L Dandeker 2027789409 rdandekerklcom
Joshua S Kim 2027789039 jkimklcom
FOOD amp DRUG PRACTICE
copy 2003 KIRKPATRICK amp LOCKHART LLP ALL RIGHTS RESERVED
This publicationnewsletter is for informational purposes and does not contain or convey legal advice The information hereinshould not be used or relied upon in regard to any particular facts or circumstances without first consulting a lawyer
BOSTONDALLASHARRISBURGLOS ANGELESMIAMINEWARKNEW YORKPITTSBURGHSAN FRANCISCOWASHINGTON
16
9
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Avon builds manufacturing plant in RussiahttpwwwindustryweekcomCurrentArticlesAsparticlesaspArticleId=1533
Swedish cosmetic company Oriflame is also building a factory in Russiahttpwwwgateway2russiacomstart_150361php
AsiaPacific
Therapeutic tourism is booming in Karnataka India where clinics offer ayurveda homeopathyyoga naturopathy acupuncture and morehttpwwwrediffcommoney2003dec09tourhtm
The Asian cosmetics market boom in China stagnation in Japan local competition in South Koreahttpwwwbeauty-on-linecomebnnewsletteraspeid=80
In South Korea the makers of a cosmetics refrigerator are eyeing the overseas markethttpwwwkoreaheraldcokrSITEdatahtml_dir20031213200312130014asp
Australian food manufacturers and retailers must meet new labeling standards as of December 20httpwwwfoodnavigatorcomnewsnews-NGaspid=48488
Revlon debuts in BruneihttpwwwbrudirectcomDailyInfoNewsArchiveDec03121203bb17htm
Indian cosmetics company Emami has filed a criminal complaint against Bollywood filmmakersHrithik and Rakesh Roshan for failing to honor product placement agreements in their latest filmhttpwwwapunkachoicecomhappenings20031211-0html
LVMH plans to expand its Christian Dior line in China and Japanhttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=332
Kanebo and Kao have joined forces to challenge Shiseidohttpwwwcosmeticsbusinesscomnewsstoryaspstoryid=319
The Pacific Bridge Asian Medical December Newsletter features a story on ASEAN plans to reducenon-tariff barriers for cosmetics and pharmaceuticalshttpwwwpacificbridgemedicalcomnewsletterv3n9pdf
The Americas
MexRegscom is an Internet source for Mexican regulationshttpwwwmexregscom
Health Canada advises against the use of the herb comfrey or products that contain comfreyhttpwwwhc-scgccaenglishmediareleases20032003_101htm
Researcher finds high mercury levels in Mexican women and border states traced to Mexican madeskin whitening creamhttpwwwbostoncomnewsglobehealth_sciencearticles20031216whitening_skin_can_be_deadly
Waxing manicures for men are becoming popular in traditionally macho Mexico Puerto Rico andArgentinahttpbusiness-timesasia1comsgstory0456710046200html
10
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
011904 ndash 012204 Informex Venetian Hotel Sands Expo CenterLas Vegas Nevada USAMore info httpwwwinformexcom
012704 ndash 013104 Soap and Detergent Association (SDA) Boca Raton Resort amp ClubAnnual Meeting and Industry Convention Boca Raton Florida USA
More info (202) 347-2900
020904 ndash 021204 ICE Expo The Hyatt RegencyMiami Florida USAMore info (630) 653-2155Email icealluredcomhttpwwwice-expocom
022604 ndash 022904 Cosmetic Toiletry and Fragrance Association (CTFA) Boca Raton Resort amp ClubAnnual Meeting and Industry Convention Boca Raton Florida USA
More info (202) 331-1770
030904 ndash 031104 Personal Care Ingredients Asia JinHan Exhibition CenterGuangzhou ChinaMore info Step Exhibitions(44) 1892-518877httpwwwstepexcom
032204 ndash 032304 Society of Cosmetic Scientists Spring Symposium Kettering Park Hotel KetteringldquoPerfumemdashthe Constant Elementrdquo Northants UK
Tel 44-1582-726661Email ifsccscsconnectcomwwwscsorguk
032404 SCC Teamworks 2004 Midwest Chapter More info httpwwwmidwestsccorgSupplierrsquos Day
032404 ndash 032604 Institute of Packaging Professionals Marriott MarquisFlexible Packaging Conference 2004 Atlanta Georgia USA
More info Stan Zelesnik IOPP(630) 544-5050 ext 108Email szelesnikiopporghttpwwwiopporg
041304 ndash 041404 Personal Care Ingredients and Technology Sheraton Hotel NYCExhibition 2004 High Function Naturals Contact PCITXHigh Performance Ingredients and Tel 949-487-9970High Impact Color E-mail bobgraysonassociatescom
041404 ndash 041804 Intercharm Professional 2004 Moscow RussiaE-mail mointercharmruwwwintercharmneteng
042004 ndash 042204 The Color Pigments Manufacturing Association Inc Chicago Illinois USAInternational Color Pigments Conference More info (703) 684-4044
Email cpmacpmacom
042704 042904 In-Cosmetics Milan ItalyContact patricialefevrereedexpocouk
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
MEETINGS AND CONFERENCES
050604 ndash 050704 Society of Cosmetic Chemists (SCC) Mohegan SunAnnual Scientific Seminar Uncansville Connecticut USA
More info (212) 668-1500
052404 ndash 052804 Aromatherapy and Perfumery Seminar Grasse FranceProperties of natural raw materials used Tel 33-4-92-42-34-90in perfumery and aromatherapy E-mail gipprodaromfr
060104 ndash 060504 World Perfumery Congress The Future of Perfumery Palais des FestivalsCannes FranceMore info (33) 55-96-21-32Email infoworldperfumerycongresscomhttpwwwworldperfumerycongresscom
062004 ndash 062304 6th World Surfactants Congress Berlin GermanyMore info (49) 30-300-66-90Email berlincpo-hanserdehttpwwwcesio2004de
091004 ndash 091204 Pathways to Beauty and Wellness Jacob K Javitz Convention CenterNew York New York USAMore info Grayson Associates(949) 487-9970Email suzannegraysonassociatescom
101004 ndash 101304 RAPS 2004 Annual Conference and Exhibition Washington Hilton and TowersWashington DC USAhttpwwwrapsorg
102004 ndash 102204 Centifolia International Congress of Perfumery Grasse Franceand Natural Ingredients Contact le Club des Entrepreneurs
Tel 33-4-97-05-57-60clubdesentrepreneursville-grassefr
102404 ndash 102704 ISFCC International Congress Dolphin Hotel Walt Disney World ResortOrlando Florida USAMore info (212) 668-1500
102404 ndash 102804 International Federation of Essential Oils Lisbon Portugaland Aroma Trades International Conference 2004 More info +44-20-7836-2460
Email ifeatadministratorfdforgukhttpwwwifeatorgIFEAT20Lisbon20flyer2004pdf
102804 ndash 110104 11th Perfumery amp Cosmetics Exhibitionmdash Sokolniki Exhibition Center MoscowInterCharm E-mail mointercharmru
wwwintercharmneteng
111004 ndash 111204 Cosmoprof Asia and The Natural Health Fair Hong Kong Convention and Exhibit CenterhttpwwwnaturalhealthfaircomNHFupdate_enhtml
111604 ndash 111804 Health Ingredients Europe The Netherlandswwwhi-eventscom
10
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Kirkpatrick amp Lockhart LLP
Challenge us
Kirkpatrick amp Lockhartrsquos Food and Drug Practice offers comprehensive legal and
regulatory counseling to companies and other organizations regulated by FDA
under the Federal Food Drug and Cosmetic Act We represent manufacturers
and distributors of food dietary supplements pharmaceuticals medical devices
biologicals and personal care and cosmetic products Areas of experience include
enforcement approvals and clearance labeling and advertising clinical research
inspections and importexport
P A R T N E R S
Gary L Yingling 2027789124 gyinglingklcom
Suzan Onel 2027789134 sonelklcom
O F C O U N S E L
Emalee G Murphy 2027789428 emaleemurphyklcom
A S S O C I A T E S
Ann M Begley 2027789365 abegleyklcom
Rebecca L Dandeker 2027789409 rdandekerklcom
Joshua S Kim 2027789039 jkimklcom
FOOD amp DRUG PRACTICE
copy 2003 KIRKPATRICK amp LOCKHART LLP ALL RIGHTS RESERVED
This publicationnewsletter is for informational purposes and does not contain or convey legal advice The information hereinshould not be used or relied upon in regard to any particular facts or circumstances without first consulting a lawyer
BOSTONDALLASHARRISBURGLOS ANGELESMIAMINEWARKNEW YORKPITTSBURGHSAN FRANCISCOWASHINGTON
16
10
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
011904 ndash 012204 Informex Venetian Hotel Sands Expo CenterLas Vegas Nevada USAMore info httpwwwinformexcom
012704 ndash 013104 Soap and Detergent Association (SDA) Boca Raton Resort amp ClubAnnual Meeting and Industry Convention Boca Raton Florida USA
More info (202) 347-2900
020904 ndash 021204 ICE Expo The Hyatt RegencyMiami Florida USAMore info (630) 653-2155Email icealluredcomhttpwwwice-expocom
022604 ndash 022904 Cosmetic Toiletry and Fragrance Association (CTFA) Boca Raton Resort amp ClubAnnual Meeting and Industry Convention Boca Raton Florida USA
More info (202) 331-1770
030904 ndash 031104 Personal Care Ingredients Asia JinHan Exhibition CenterGuangzhou ChinaMore info Step Exhibitions(44) 1892-518877httpwwwstepexcom
032204 ndash 032304 Society of Cosmetic Scientists Spring Symposium Kettering Park Hotel KetteringldquoPerfumemdashthe Constant Elementrdquo Northants UK
Tel 44-1582-726661Email ifsccscsconnectcomwwwscsorguk
032404 SCC Teamworks 2004 Midwest Chapter More info httpwwwmidwestsccorgSupplierrsquos Day
032404 ndash 032604 Institute of Packaging Professionals Marriott MarquisFlexible Packaging Conference 2004 Atlanta Georgia USA
More info Stan Zelesnik IOPP(630) 544-5050 ext 108Email szelesnikiopporghttpwwwiopporg
041304 ndash 041404 Personal Care Ingredients and Technology Sheraton Hotel NYCExhibition 2004 High Function Naturals Contact PCITXHigh Performance Ingredients and Tel 949-487-9970High Impact Color E-mail bobgraysonassociatescom
041404 ndash 041804 Intercharm Professional 2004 Moscow RussiaE-mail mointercharmruwwwintercharmneteng
042004 ndash 042204 The Color Pigments Manufacturing Association Inc Chicago Illinois USAInternational Color Pigments Conference More info (703) 684-4044
Email cpmacpmacom
042704 042904 In-Cosmetics Milan ItalyContact patricialefevrereedexpocouk
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
MEETINGS AND CONFERENCES
050604 ndash 050704 Society of Cosmetic Chemists (SCC) Mohegan SunAnnual Scientific Seminar Uncansville Connecticut USA
More info (212) 668-1500
052404 ndash 052804 Aromatherapy and Perfumery Seminar Grasse FranceProperties of natural raw materials used Tel 33-4-92-42-34-90in perfumery and aromatherapy E-mail gipprodaromfr
060104 ndash 060504 World Perfumery Congress The Future of Perfumery Palais des FestivalsCannes FranceMore info (33) 55-96-21-32Email infoworldperfumerycongresscomhttpwwwworldperfumerycongresscom
062004 ndash 062304 6th World Surfactants Congress Berlin GermanyMore info (49) 30-300-66-90Email berlincpo-hanserdehttpwwwcesio2004de
091004 ndash 091204 Pathways to Beauty and Wellness Jacob K Javitz Convention CenterNew York New York USAMore info Grayson Associates(949) 487-9970Email suzannegraysonassociatescom
101004 ndash 101304 RAPS 2004 Annual Conference and Exhibition Washington Hilton and TowersWashington DC USAhttpwwwrapsorg
102004 ndash 102204 Centifolia International Congress of Perfumery Grasse Franceand Natural Ingredients Contact le Club des Entrepreneurs
Tel 33-4-97-05-57-60clubdesentrepreneursville-grassefr
102404 ndash 102704 ISFCC International Congress Dolphin Hotel Walt Disney World ResortOrlando Florida USAMore info (212) 668-1500
102404 ndash 102804 International Federation of Essential Oils Lisbon Portugaland Aroma Trades International Conference 2004 More info +44-20-7836-2460
Email ifeatadministratorfdforgukhttpwwwifeatorgIFEAT20Lisbon20flyer2004pdf
102804 ndash 110104 11th Perfumery amp Cosmetics Exhibitionmdash Sokolniki Exhibition Center MoscowInterCharm E-mail mointercharmru
wwwintercharmneteng
111004 ndash 111204 Cosmoprof Asia and The Natural Health Fair Hong Kong Convention and Exhibit CenterhttpwwwnaturalhealthfaircomNHFupdate_enhtml
111604 ndash 111804 Health Ingredients Europe The Netherlandswwwhi-eventscom
10
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Kirkpatrick amp Lockhart LLP
Challenge us
Kirkpatrick amp Lockhartrsquos Food and Drug Practice offers comprehensive legal and
regulatory counseling to companies and other organizations regulated by FDA
under the Federal Food Drug and Cosmetic Act We represent manufacturers
and distributors of food dietary supplements pharmaceuticals medical devices
biologicals and personal care and cosmetic products Areas of experience include
enforcement approvals and clearance labeling and advertising clinical research
inspections and importexport
P A R T N E R S
Gary L Yingling 2027789124 gyinglingklcom
Suzan Onel 2027789134 sonelklcom
O F C O U N S E L
Emalee G Murphy 2027789428 emaleemurphyklcom
A S S O C I A T E S
Ann M Begley 2027789365 abegleyklcom
Rebecca L Dandeker 2027789409 rdandekerklcom
Joshua S Kim 2027789039 jkimklcom
FOOD amp DRUG PRACTICE
copy 2003 KIRKPATRICK amp LOCKHART LLP ALL RIGHTS RESERVED
This publicationnewsletter is for informational purposes and does not contain or convey legal advice The information hereinshould not be used or relied upon in regard to any particular facts or circumstances without first consulting a lawyer
BOSTONDALLASHARRISBURGLOS ANGELESMIAMINEWARKNEW YORKPITTSBURGHSAN FRANCISCOWASHINGTON
16
050604 ndash 050704 Society of Cosmetic Chemists (SCC) Mohegan SunAnnual Scientific Seminar Uncansville Connecticut USA
More info (212) 668-1500
052404 ndash 052804 Aromatherapy and Perfumery Seminar Grasse FranceProperties of natural raw materials used Tel 33-4-92-42-34-90in perfumery and aromatherapy E-mail gipprodaromfr
060104 ndash 060504 World Perfumery Congress The Future of Perfumery Palais des FestivalsCannes FranceMore info (33) 55-96-21-32Email infoworldperfumerycongresscomhttpwwwworldperfumerycongresscom
062004 ndash 062304 6th World Surfactants Congress Berlin GermanyMore info (49) 30-300-66-90Email berlincpo-hanserdehttpwwwcesio2004de
091004 ndash 091204 Pathways to Beauty and Wellness Jacob K Javitz Convention CenterNew York New York USAMore info Grayson Associates(949) 487-9970Email suzannegraysonassociatescom
101004 ndash 101304 RAPS 2004 Annual Conference and Exhibition Washington Hilton and TowersWashington DC USAhttpwwwrapsorg
102004 ndash 102204 Centifolia International Congress of Perfumery Grasse Franceand Natural Ingredients Contact le Club des Entrepreneurs
Tel 33-4-97-05-57-60clubdesentrepreneursville-grassefr
102404 ndash 102704 ISFCC International Congress Dolphin Hotel Walt Disney World ResortOrlando Florida USAMore info (212) 668-1500
102404 ndash 102804 International Federation of Essential Oils Lisbon Portugaland Aroma Trades International Conference 2004 More info +44-20-7836-2460
Email ifeatadministratorfdforgukhttpwwwifeatorgIFEAT20Lisbon20flyer2004pdf
102804 ndash 110104 11th Perfumery amp Cosmetics Exhibitionmdash Sokolniki Exhibition Center MoscowInterCharm E-mail mointercharmru
wwwintercharmneteng
111004 ndash 111204 Cosmoprof Asia and The Natural Health Fair Hong Kong Convention and Exhibit CenterhttpwwwnaturalhealthfaircomNHFupdate_enhtml
111604 ndash 111804 Health Ingredients Europe The Netherlandswwwhi-eventscom
10
If you have difficulty
accessing any of
these files please
contact Elise Perry
(eperryklcom)
for hard copies
Kirkpatrick amp Lockhart LLP
wwwklcomFOOD amp DRUG PRACTICE
Kirkpatrick amp Lockhart LLP
Challenge us
Kirkpatrick amp Lockhartrsquos Food and Drug Practice offers comprehensive legal and
regulatory counseling to companies and other organizations regulated by FDA
under the Federal Food Drug and Cosmetic Act We represent manufacturers
and distributors of food dietary supplements pharmaceuticals medical devices
biologicals and personal care and cosmetic products Areas of experience include
enforcement approvals and clearance labeling and advertising clinical research
inspections and importexport
P A R T N E R S
Gary L Yingling 2027789124 gyinglingklcom
Suzan Onel 2027789134 sonelklcom
O F C O U N S E L
Emalee G Murphy 2027789428 emaleemurphyklcom
A S S O C I A T E S
Ann M Begley 2027789365 abegleyklcom
Rebecca L Dandeker 2027789409 rdandekerklcom
Joshua S Kim 2027789039 jkimklcom
FOOD amp DRUG PRACTICE
copy 2003 KIRKPATRICK amp LOCKHART LLP ALL RIGHTS RESERVED
This publicationnewsletter is for informational purposes and does not contain or convey legal advice The information hereinshould not be used or relied upon in regard to any particular facts or circumstances without first consulting a lawyer
BOSTONDALLASHARRISBURGLOS ANGELESMIAMINEWARKNEW YORKPITTSBURGHSAN FRANCISCOWASHINGTON
16
Kirkpatrick amp Lockhart LLP
Challenge us
Kirkpatrick amp Lockhartrsquos Food and Drug Practice offers comprehensive legal and
regulatory counseling to companies and other organizations regulated by FDA
under the Federal Food Drug and Cosmetic Act We represent manufacturers
and distributors of food dietary supplements pharmaceuticals medical devices
biologicals and personal care and cosmetic products Areas of experience include
enforcement approvals and clearance labeling and advertising clinical research
inspections and importexport
P A R T N E R S
Gary L Yingling 2027789124 gyinglingklcom
Suzan Onel 2027789134 sonelklcom
O F C O U N S E L
Emalee G Murphy 2027789428 emaleemurphyklcom
A S S O C I A T E S
Ann M Begley 2027789365 abegleyklcom
Rebecca L Dandeker 2027789409 rdandekerklcom
Joshua S Kim 2027789039 jkimklcom
FOOD amp DRUG PRACTICE
copy 2003 KIRKPATRICK amp LOCKHART LLP ALL RIGHTS RESERVED
This publicationnewsletter is for informational purposes and does not contain or convey legal advice The information hereinshould not be used or relied upon in regard to any particular facts or circumstances without first consulting a lawyer
BOSTONDALLASHARRISBURGLOS ANGELESMIAMINEWARKNEW YORKPITTSBURGHSAN FRANCISCOWASHINGTON
16