natural medicine law newsletter - dietary … 2012/mar2012nml-28.pdfcopies of all documents...

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In This Issue: CSPI Threatens Almay over Twist Label..............1 Sentenced for Misbranding Products ....................1 FTC Stops Fake New Cites re Acai Products........1 FTC Budget Down................................................2 New Dietary Ingredients........................................3 Section 403 Letters...............................................4 Health Claim for Vit D and Risk of Falling............5 EU Commission Approves and Rejects Claims...5 EFSA Opinion of Slowly Digestible Starch...........5 Update to Herbal Ingredient Names.....................6 FY2013 FDA Budget............................................9 In Re Vitamin C Antitrust Litigation......................12 Lloyd Library Photo Credits................................14 Axis Labs Sentenced in Colorado......................21 FDA Approves Two Enzyme Products................23 MHRA Upholds Complaints................................24 Trademarks for Capsicum Annuum.....................26 CSPI Says Less Salt; Salt Institute Says Salt Needed................................................................26 CRN Says FDA Data Outdated........................27 Interesting Meetings & Programs.......................28 Harvesting Health Through The Law...................28 Special Supplement to Vol. 15, No.5, Supp.5. Diet May Help Prevent Cognitive Decline; Magnesium May Prevent Stroke; Vit. D Reduces Stress Fractures; Retinal May Reduce Melanoma; Vit. D Use Must Account for Weight; Vit. D Associated with Less Risk of Pancreatic Cancer; Italian Researchers Find 300,000 IU Vit. D Re- duces Dysmenorrhea Pain and Use of NSAIDs.

See CSPI THREATENS -- Cont’d on p. 14... See SENTENCING -- Cont’d on p.17...

See NEWS SITES STOPPED - on p.18...

CSPI THREATENS CLASS ACTION SUIT

UNLESS AMWAY CHANGESLABEL OF TWIST TUBES

CSPI announced February 28,

2012 that Amway, the multi-levelmarketing company, will face theprospect of a class action lawsuitover its Nutrilite line of liquiddietary supplements.

Labels for Nutrilite’s “fruits &vegetables 2GO Twist Tubes”claim in big print that the productrepresents two servings of fruitsand vegetables. The fine printclarifies that a dose “contains theantioxidant equivalent of 2servings.” Either way, thenonprofit Center for Science in thePublic Interest says that thecompany’s 10-milliliter tubes donot come close to conveying thesame health benefits as real fruitor vegetables. Similarly, Amwayclaims that Nutrilite’s ImmunityTwist Tubes are an “immunesystem booster” that will “protectyour cells.” (The Strawberry Kiwiflavor has neither strawberry norkiwi, despite the attractive picturesof those fruits on the box.) Theimmunity claim is unlawful,according to CSPI, because itimplies the product will preventdisease. It won’t, says the group.

The watchdog group will sue theAda, Michigan-based companyunless it stops advertisingunsubstantiated nutrition andhealth benefits in connection with“fruits and vegetables 2GO” and

MANUFACTURERSSENTENCED FOR

MISBRANDINGPRODUCTS AS DIETARY

SUPPLEMENTS

Food and Drug Administration,

Office of Criminal Investigations

Emphasizing that punishment was

necessary to deter others and toprotect consumers, Chief U.S.District Judge B. Lynn Winmill inIdaho, on January 17, 2012,imposed probation and fines ontwo companies that earlier had pledguilty to causing purported dietarysupplements to be unlawfullymanufactured and distributed ininterstate commerce, U.S. AttorneyWendy J. Olson announced.

DCD, LLC was fined $125,000and R&D Holdings $21,000,approximately equivalent to therevenue associated with the salesof the violating products. As acondition of probation, DCD, LLCand its subsidiary, AdvancedMuscle Science must implement atesting protocol for its products toensure future products sold asdietary supplements do not containsynthetic steroids. R&D Holdings

FTC STOPS FAKENEWS SITES IN

ACAI BERRY SCAM

FTC said on January 25, 2012 that

six online marketers agreed tosettlements with the Federal TradeCommission that will permanentlyhalt their allegedly deceptivepractice of using fake newswebsites to market acai berrysupplements and other weight-lossproducts.

As part of its ongoing crackdownon bogus health claims, theproposed settlements will requirethat the six operations make clearwhen their commercial messagesare advertisements rather thanobjective journalism, and will barthe defendants from furtherdeceptive claims about health-related products such as the acai

Vol. 15 No. 5 March 2012

Natural Medicine LawTM Newsletter

March 2012 Natural Medicine LawTM

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Natural Medicine LawTM

Newsletter

Muscatatuck Publishers, Inc.P.O. Box 741261

Boynton Beach, FL 33474-1261William J. Skinner

Editor and PublisherRegistered Pharmacist and Attorney

Copyright 2012 by Muscatatuck Publishers, Inc.Exclusive of U.S. Government document excerpts,photocopying, faxing, and electronic transfer is pro-hibited without permission. Copies of all documentsmentioned in this publication, except copyrightedmaterials, are available on request for a fee. Tele-phone (561) 641-2900 or E-mail at:<[email protected]> for permission.

Published six times a year. Subscription price is

US$249.00 per year in U.S., Canada, and Mexico.Subscriptions to other countries are an additionalUS$25.00 per year for postage and handling. Ad-ditional copy in same envelope for US$130.00.Natural Medicine Law (ISSN 1095-6336) reportson legal issues. Readers should discuss legal issueswith legal counsel before taking action based oninformation in this publication. Subscribers regis-tered with the Copyright Clearance Center may re-produce parts or all of Natural Medicine Law foreducational classes, provided that a base fee is paiddirectly to Copyright Clearance Center, 222 Rose-wood Drive, Danvers, MA 09123, telephone (508)750-8400. www.copyright.com Violation of copy-right will result in legal action, including civil andcriminal penalties and suspension of service.

Advertisements

Editorial CorrespondenceFlorida address above

Toll-Free Telephone: (561) 433-1170E-mail: [email protected]

Check rates on website.

See FTC BUDGET DOWN - Cont’d page 19...

FTC BUDGET DOWN

Federal Trade Commission’s

budget request for FY 2013 isdown about $11 million from thecurrent FY to a round figure of$300 million that includes 1183full-time equivalent workers.

Relying on the latest comparabledata available in FY 2011, FTCdoes not say why they do not haveFY 2012 data ready, the agencyactivities are summarized as “InFY 2011, the FTC filed 83 newcomplaints in federal district courtand obtained 90 permanentinjunctions and orders requiringdefendants to pay more than $218million in consumer redress ordisgorgement of ill-gotten gains, aswell as 3 civil contempt orders ofmore than $5 million. In addition,cases referred to DOJ resulted in 6court judgments for civil penaltiesof more than $9.5 million.Furthermore, the FTC filed 22 newadministrative actions andobtained 18 administrative ordersin past and new cases.”

“During the same timeframe, theCommission completed 6rulemakings, issued 9 reports,released 60 new consumer andbusiness education publications,released 26 consumer and businesseducation videos and audio PSAs,and launched 7 consumer andbusiness education websites andmicrosites.” FY 2011 was a busyyear.

The budget request states that:

“Health Claims — TheFTC places a high priority onpreventing and stopping deceptiveor unfair health claims.

“ Prevention and TreatmentClaims: As part of its ongoingefforts to stop bogus diseasetreatment claims, the FTC filed suitin October 2010 against WellnessSupport Network Inc., an onlinemarketer that allegedly deceivedconsumers with baseless claimsthat its supplements would treatand prevent diabetes. Also inOctober 2010, the Court of Appealsfor the First Circuit upheld adecision in favor of the FTC thatorders Direct Marketing Concepts,Inc. and ITV Direct, Inc. to pay$48.2 million for deceptivelyadvertising dietary supplements.These supplements, ‘SupremeGreens’ and ‘Coral Calcium,’ wereportrayed as being effective intreating and preventing seriousdiseases, including cancer. TheFTC finalized an order in January2011 settling charges that TheDannon Company, Inc. ex-aggerated the health benefits of itsActivia yogurt and DanActivedairy drink, two popular productsthat contain beneficial bacteriaknown as probiotics. In May 2011,Oreck Corporation agreed to pay$750,000 to settle charges that itfalsely claimed that its vacuum andair cleaner can reduce the risk offlu and other illnesses, andeliminate virtually all commongerms and allergens. In August2011, the FTC brought its firstcases targeting health claims in themobile application marketplace.The FTC alleged that the marketersfalsely claimed that theirsmartphone apps ‘AcneApp’ and‘Acne Pwner’ could treat acne. Thetwo settlements resolving theseallegations bar the marketers frommaking certain health relatedclaims without scientificevidence.”

“Weight Loss and ToningClaims: In April 2011, theCommission requested that federalcourts temporarily halt theallegedly deceptive tactics of 10operations using fake newswebsites to market acai berryweight-loss products. According tothe FTC, the Internet Marketersfalsely claimed endorsement fromABC, Fox News, CBS, CNN, USAToday, and Consumer Reports. In

Natural Medicine LawTM March 2012

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www.NatMedLaw.comfor

Natural Medicine TiesTM

See NEW INGREDIENTS -- Cont’d on p. 7...

NEW DIETARYINGREDIENTS

NML brings readers more

summaries of new dietaryingredient notices, also known as75-day notices, than any otherpublication. Unfortunately, despiteCongressional instructions thatthese be placed in public files, theagency takes pleasure in dribblingthe reports out in a confusing orderthat makes it impractical forinterested persons to find them.Nevertheless, NML will continueto keep readers informed byrepeatedly asking FDA to disclosethese documents.

Arcadia Biosciences, Inc. ofDavis, California, sent an NDInotice to FDA on August 27, 2009for the NDI Sonova 400™. Theoriginal notice is not in the publicfile. There are amendment lettersof November 13, 2009 andNovember 26, 2009 transmittingrequested information. TheNovember 13 letter offered labelstatements concerning servingsizes and recommended dailyintake of one gram capsules ofSonova 400 containing 400 mgGLA: Take one to two capsulesdaily, preferably with meals; 0.5gram capsules of Sonova 400containing 200 mg GLA: Take twoto four capsules daily, preferablywith meals; and Liquid Sonova400: Take one-quarter teaspoonfulonce or twice a day, with or withoutmeals. Also the same letterdescribed certain Omega 3-6-9blends (liquids and capsules)containing Sonova 400. Otheringredients used to mix withSonova 400 are GRAS includingtocophenols (182.3890), ascorbylpalmitate (182.3149), rosemaryextract (182.20), and citric acid

(182.1033). Finally the November13 letter offered a warningstatement: “Warning: If you arepregnant, nursing or taking andmedications, consult your doctorbefore use.” A letter of November16 listed reprints referenced in theoriginal notice. FDA’s Dan D.Levy, PhD., Microbiologist,Supervisor, New DietaryIngredient Review Team,responded to Don Emlay by letterof November 25, 2009, stating thatacceptance of the NDI for filing isa procedural matter and does notconstitute a finding by FDA that theNDI or supplement that containsthe NDI are safe or are notadulterated. FDA is not precludedfrom taking action in the futureagainst any dietary supplementcontaining the NDI if these arefound to be unsafe, adulterated ormisbranded. This letter addressesonly Sonova 400 and does notaddress any of the other issuesincluding the proposed label or useof seed oil or other materialsderived from GLA-producingsafflower plant you use to produceSonova 400™. The company mayconsult with FDA’s staffconcerning other uses to ensurethat human and animal feed safetyissues are resolved prior tocommercial distribution. The NDIwas received at the FDA DocketManagement Branch on January28, 2010, having been forwardedon December 21, 2009 by FredHines, DVM. The file wasassigned to Docket No. FDA-1995-S-0039-0271, RPT 609. Thisfile was posted onwww.regulations.gov on January23, 2012 and accessed February 20,2012. Note the FDA’s two yeardelay in making this file availableto the public.

Nuliv Science USA, Inc. ofWalnut, California, wrote to FDAon two unknown dates and letterswere filed September 9, 2009 andOctober 13, 2009 concerning anNDI containing Astragalus(Astragalus membranaceus) andNotoginseng extract (Notoginseng)in a variety of products rangingfrom dietary supplements, drinksand protein shakes. The NDI isnamed AstraGin and will be servedup at levels of 10 mg to 150 mg.“The exact details have yet to befinalized but are underdevelopment with variouscompanies likely interested inincluding AstraGin into theirproducts. The safety was discussedas relying on Chinese medicinaluse in Traditional ChineseMedicine. “Since these two herbshave been used safely individually,in combination with each other andother herbs, it is safe to assume thattheir application in a dietarysupplement, drink, or shake withother known ingredients would beentirely safe based on therecommended dosage of 10-150mg.” The signers, Michael Wangand Jason Wang requested that allinformation be kept confidential.FDA’s Dan D. Levy, PhD.,Microbiologist, Supervisor, NewDietary Ingredient Review Team,responded to Jason Wang by letterof November 24, 2009 stating thatFDA completed a review of thenotification and advises that thenotification does not meet therequirements of 21 CFR 190.6 andis incomplete. The serving quant-ity do not give the portions of thetwo ingredients. Also, the noticedoes not provide information aboutthe parts of the plants used in theproduct or the methods used,


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Colchicum autumnalePhoto Courtesy of Lloyd Library and Museum

See SECTION 403 LETTERS -- Cont’d p. 10...

SECTION 403(r)(6) LETTERS

In this issue, NML will provide

some of the Courtesy Letters thatFDA has provided throughFreedom of Information Actrequests. These are fill-in letterthat were left blank in previousissues because FDA did not postthese on the agency website priorto 2008 or has not yet posted themon the www.regulations.govwebsite.

Enzymatic Therapy, Inc. ofGreen Bay, Wisconsin sent a letterto FDA on November 12, 2001 togive notice of claims it would useon 85 different products. Thecompany filed a table listing brandname, product name, dietaryingredients, and statement ofclaims. FDA’s John B. Foret,Director, Division of Complianceand Enforcement, Office ofNutritional Products, Labeling andDietary Supplements, wrote onDecember 27, 2001 to JeaneneMoenckmeier to state that thenames of products EzymaticTherapy Candida Formula andPhytoPharmica Candimyacinuse the claims “… fulfill the needsof a yeast-controlled program” and“Research suggests a link betweenthese natural compounds and thebalance of yeast in the body.” FDAwrote that these claims, includingthe names of the products in andof themselves (i.e., CandidaFormula and Candimyacin), aredisease claims because theysuggest that the products areintended to treat, prevent, ormitigate diseases, namely Candidayeast infections. FDA wrote thatthe products PhytoPharmicaClinical Nutrients for 50-PlusMen and Enzymatic TherapyDoctor’s Choice for 50-Plus Men

use the claim “…important tohealthy blood cholesterol levels.”FDA explained that it did notnecessarily believe that all claimsabout the maintenance of normalcholesterol levels constitutedimplied disease claims. However,FDA wrote in its preamble to thestructure/function claims finalregulation (65 FR 1000 at 1018)that to avoid implying that theproduct treats or prevents disease,a cholesterol maintenance claimwould have to clarify the productis only for maintenance ofcholesterol levels that are alreadyin the normal range. FDA wrotethat the products PhytoPharmicaClinical Nutrients for Diabetesand Enzymatic Therapy Doctor’sChoice for Diabetes uses theclaims “…to provide nutritionalsupport for diabetics,” “providestargeted nutrition support forindividuals with diabetes,”“Clinical Nutrients for Diabeticsis a nutritional supplementspecifically formulated to providevitamins, minerals, and herbs forindividuals with elevated bloodsugar levels,” and “ClinicalNutrients for Diabetics includes …Gymnema sylvestre, an herb longrecommended for diabetics.”These claims, including the namesof the products because they usethe term “diabetics” (i.e., ClinicalNutrients for Diabetics andDoctor’s Choice for Diabetics), aredisease claims. The productsPhytoPharmica Clinical Nut-rients to Retain HealthyCholesterol Levels, EnzymaticTherapy Doctor’s Choice toRetain Healthy CholesterolLevels, Enzymatic TherapyFlush-Free HexaNiacin, Enzy-matic Therapy GugulPlex,PhytoPharmica Flush-FreeHexaNiacin, and PhytoPharmica

GugulPlex use the claim “…retainhealthy cholesterol levels.” FDAexplained that it did not necessarilybelieve that all claims about themaintenance of normal cholesterollevels constituted implied diseaseclaims. However, FDA wrote inits preamble to the structure/function claims final regulation (65FR 1000 at 1018) that to avoidimplying that the product treats orprevents disease, a cholesterolmaintenance claim would have toclarify the product is only formaintenance of cholesterol levelsthat are already in the normalrange. FDA also considers theproduct names PhytoPharmicaClinical Nutrients to RetainHealthy Cholesterol Levels andEnzymatic Therapy Doctor’sChoice to Retain HealthyCholesterol Levels to be implieddisease claims in and ofthemselves. The products Enzy-matic Therapy, Inc. DMG-B15-Plus and PhytoPharmica Pro-


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Natural Medicine Law Natural Medicine Law Natural Medicine Law Natural Medicine Law Natural Medicine Law Around the WAround the WAround the WAround the WAround the Worldorldorldorldorld

Berlaymont Building in BrusselsHome of the European Commission

See RISK OF FALLING -- Cont’d on p. 13...

See EC REGULATION -- Cont’d on page 6... Big Ben and Parliament Building in London

HEALTH CLAIM FORVITAMIN D

AND RISK OF FALLING

EU’s EFSA Panel on Dietetic

Products, Nutrition and Allergies(NDA) has issued a ScientificOpinion concerning the use ofVitamin D for reducing the risk offalling. Here is the Abstractprovided by the NDA.

Following an application fromDSM Nutritional Products EuropeAG, submitted pursuant to Article14 of Regulation (EC) No. 1924/2006 via the Competent Authorityof the United Kingdom, the Panelon Dietetic Products, Nutrition andAllergies was asked to deliver anopinion of the scientificsubstantiation of a health claimrelated to vitamin D and risk offalling. Vitamin D (D

2 and D

3) is

sufficiently characterized. Areduction in the risk of fallingamong men and women 60 year ofage and older is beneficial tohuman health by reducing the riskof bone fractures. Daily vitaminD supplementation (800 – 1000I.U.; 20-25 mcg) in combinationwith calcium, when compared tocalcium alone, significantlyreduced the risk of falling (.i.e. riskof falls, risk of falling at least once,or both) in elderly subjects in thefive human intervention studiesprovided by the applicant whichhad falls as the primary outcome.

EFSA OPINION ON HEALTHCLAIMS REGARDINGSLOWLY DIGESTIBLE

STARCH, ETC.

EU’s EFSA Panel on Dietetic

Products, Nutrition and Allergies(NDA) has issued a ScientificOpinion concerning the use ofhealth claim related to “slowlydigestible starch in starch-containing foods” and “reductionof post-prandial glycaemicresponses.” Here is the Abstractprovided by the NDA.

Following an application fromKraft Foods Europe, submittedpursuant to Article 13(5) ofRegulation (EC) No. 1924/2006via the Competent Authority ofBelgium, the EFSA Panel onDietetic Products, Nutrition andAllergies was asked to deliver anopinion of the scientificsubstantiation of a health claimrelated to “slowly digestible starchin starch-containing foods” and“reduction of post-prandialglycaemic responses.” The foodconstituent, “slowly digestiblestarch (SDS)”, as defined by theapplicant in applying anappropriate method (such as themethod developed by Englyst etal. (1996; 1999)), which is thesubject of the health claim, and thecomparator food constituent,“rapidly digestible starch (RDS)”,

See STARCH IN CEREALS -- Cont’d on p. 6...

EU COMMISSIONAPPROVES/REJECTSHEALTH CLAIMS ON

THREE FOODS

The European Commission voted

to approve one health claim forfood and reject two other claimsback in November 2011. Theseactions are now public.

A claim that oat beta-glucan canlower blood cholesterol wassubmitted by CreaNutrition, AGunder Article 14(1)(1) ofRegulation (EC) No. 1924/2006that was worded as follows: Theinclusion of oat beta-glucan aspart of a balanced diet can activelylower/reduce blood LDL (low-density lipoprotein) and totalcholesterol.) The EFSA providedan opinion that this claim shouldbe considered as complying withthe regulations and should bepermitted. The EC regulation setsforth the particulars for the use ofthe claim.

A claim that soy protein has aneffect of reducing blood cholesterolconcentrations was proposed byHarlandHall Ltd on behalf of theSoya Protein Association, theEuropean Vegetable ProteinAssociation and the EuropeanNatural Soyfood ManufacturersAssociation that was worded asfollows: Soy protein has beenshown to lower/reduce bloodcholesterol; blood cholesterollowering may reduce the risk of(coronary) heart disease. TheEFSA provided an opinion that acause and effect relationship hadnot been established and the claimsshould not be considered as


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STARCH IN CEREALS -- Cont’d from p. 5...

See HERBAL NAMES -- Cont’d on p.24...

as defined by applicant, aresufficiently characterized inrelation to the claimed effect. Theclaimed effect, reduction of post-prandial glycaemic responses (aslong as post-prandial responsesare not increased), may be abeneficial physiological effect.The studies provided consistentlyshowed that consumption of 40-50% of digestible starch as “SDS”in cereal products containingabout 55-70% of availablecarbohydrates as starch and 30-45% as sugars in the context of ameal providing at least 60E% ofavailable carbohydrates inducessignificantly lower post-prandialglycaemic responses (withoutleading to disproportionallyincreased post-prandial insulin-aemic responses) than theconsumption of all digestiblestarch as “RDS” in cereal productswith a similar content of availablecarbohydrates, starch and sugars.Cereal products, however,providing around 30% as sugarsdid not show such as effect. Acause and effect relationship hasbeen established between theconsumption of “SDS”, ascompared to the consumption of“RDS”, in cereal products andreduced post-prandial glycaemicresponses (without dispro-portionally increased post-prandial insulinaemic responses).© European Food SafetyAuthority, 2011

According to the NDA theapplicant submitted five humanintervention studies of which fourare considered proprietary. “ThePanel could have reached theconclusion that the rate of starchdigestibility assessed in vitro incereal products has an effect onpost-prandial glycaemic responsesin vivo in humans without the datamarked as proprietary by theapplicant. However, the fourunpublished studies claimed asproprietary by the applicant wererequired to establish conditions for

use for this specific claim.” ThePanel considers that the followingwording reflects the scientificevidence: “Consumption of cerealproducts high in slowly digestiblestarch raises blood glucoseconcentrations less after a mealthan cereal products low in slowlydigestible starch.” The ScientificOpinion can be found in EFSAJournal 2011; 9(7): 2292.

complying with the regulations.The EC regulation sets forth theparticulars for rejecting the use ofthe claim.

A claim that Actomel®, afermented milk product containingLactobacillus casei (DN114-001),and yogurt symbiosis on thereduction of the presence ofClostridium difficile toxins in thegut was submitted bay DanoneFrance. The submitted claim wasworded as follows: Fermented milkcontaining Lactobacillus casei(DN114-001) and yogurt symbiosisdecreases the presence ofClostridium difficile toxins in thegut (of susceptible ageing people).Presence of Clostridium difficiletoxins is associated with theincidence of acute diarrheoa. TheEFSA provided an opinion that acause and effect relationship hadnot been established and the claimsshould not be considered ascomplying with the regulations.The EC regulation sets forth theparticulars for rejecting the use ofthe claim.

This Regulation may be found inthe Official Journal of theEuropean Union, 15.11.2011.

EC REGULATION -- Cont’d from p. 5...

UPDATE TO HERBALINGREDIENT NAMES

On March 1, 2012 Australia

updated the names for herbalingredients used forcomplementary medicines on theAustralian Register of TherapeuticGoods (ARTG). During thedevelopment of the 2009Therapeutic Goods amendments, areview was undertaken of thenames of all herbal ingredientseligible for use in medicines toensure they are identified by theircorrect authenticated names andare defined by correct requirementsand references. Various resourceshave been utilized to verifybotanical names such as The PlantList and the Germplasm ResourcesInformation Network.

The next phase of the project willinvolve updating the names ofingredients that are currentlyincluded in medicines on theARTG. The OCM will write tosponsors seeking theirauthorization (as a request undersubsection 9D(1) of theTherapeutic Goods Act 1989) forthe TGA to correct the names ofherbal ingredients used in theirmedicines. Sponsors will be askedto provide this authorization to theOCM in writing by 12 April 2012.

The required name changes willbe made during the week starting12 March 2012.

Sponsors are reminded that ifrequests are not received by thespecified date any subsequentvariation made to an entry thatincludes a superseded name in theformulation will not validate andrequests to update to the correct


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.See NEW INGREDIENTS -- Cont’d on p. 8...

NEW INGREDIENTS -- Cont’d from page 3...

including solvents, to produce theproducts. For these reasons, theinformation is incomplete and doesnot provide an adequate basis toconclude that AstraGin, when usedas recommended, will reasonablybe expected to be safe. Therefore,the product may be adulterated andis prohibited from being enteredinto interstate commerce. The NDIwas received at the FDA DocketManagement Branch on January28, 2010, having been forwardedon December 22, 2009 by FredHines, DVM. The file wasassigned to Docket No. FDA-1995-S-0039-0272, RPT 610. Thisfile was posted onwww.regulations.gov on January23, 2012 and accessed February 20,2012. Note the FDA’s two yeardelay in making this file availableto the public.

Reports 611, 612, and 613 are notavailable under those identificationnumbers on www.regulations.govand were not provided under aprevious Freedom of InformationRequest. NML will file a Freedomof Information request to obtainthem.

SanRx Pharmaceuticals, Inc.of La Jolla, California, sent an NDInotice to FDA dated August 26,2009 concerning a product named,CaPterin. Although the public fileis missing a large number ofdocuments that were redacted,there is a label diagram providedthat describes that product as beinga naturally occurring substance inplants and animals that is used inthe biosynthesis of folates and mayhelp in the synthesis of DNA andRNA, formation of red blood cellsand in metabolic regulation. Thelabel states the product is

manufactured for SanRx. Theproduct is packaged as a powderin 200 mg pouches forreconstitution. The proposed labelsuggests that a pouch be mixed in200 mml or 7 oz of water or dilutejuice and taken daily one half hourbefore a meal. A caution suggestedfor the label is to consult with aphysician if you have vasculardisease, diabetes, or metabolicdisorders. Also take with cautionif you are pregnant or nursing,taking medication, facing surgery,have bleeding problems, orundergoing treatment which mayaffect the ability of the blood toclot. Page 15 of the noticediscloses that some pharmacologicstudies have been undertaken bythe National Cancer Institute.Also, the notice states that thenormal diet of humans and otherfactors results in a dose of 200 mgbeing safe for maintaining normalcellular functions and improve-ment of health. The notice statesthat 200 mg of CaPterin isequivalent to 150 mg of BH4 thatis commonly prescribed forphenylalanemia. The noticecontains a discussion of using theproduct for DOPA-responsivedystonia. Safety data wasdiscussed. FDA asked forsupplemental materials reflectedby a letter of September 22, 2009describing items that had beenprovided, including copies of 46reference articles. FDA’s Dan D.Levy, PhD., Microbiologist,Supervisor, New DietaryIngredient Review Team,responded to Richard Lowenthal,MS at Pacific-Link ConsultingServices in San Diego, Californiaby letter of December 4, 2009stating that FDA had carefullyconsidered the informationprovided and has significant

concerns about the evidence onwhich the company relies tosupport its conclusion that the NDIwill reasonably be expected to besafe under the conditions of usedescribed in the notification. Someof the examples given by FDAinclude that the agency was unableto identify CaPterin from theinformation provided. It is unclearhow calcium and pterin for acomplex that is different from asimple mixture of calcium andpterin and whether thephysiological properties of calciumpterin are different from theproperties of calcium chloride andpterin. There was only cursoryinformation about the manu-facturing process and it is unclearhow calcium pterin is qualitativelyand quantitatively related to theinformation on which the companybases its claims of safety.Therefore the product may beadulterated and may not beintroduced into interstatecommerce. FDA also advised thatthe product may be subject toSection 301(11) that prohibits theintroduction into interstatecommerce any food, includingdietary supplements, for whichsubstantial clinical investigationshave been instituted and theirexistence made public. FDA statedthe agency did not considerwhether Section 301(11) or itsexemptions applied to this NDI.The NDI was received at the FDADocket Management Branch onJanuary 28, 2010, having beenforwarded on December 24, 2009by Fred Hines, DVM. The file wasassigned to Docket No. FDA-1995-S-0039-draft 7379, RPT 614.This file was provided to NMLunder a Freedom of Information


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NEW INGREDIENTS -- Cont’d from p. 7...

GoldensealPhoto Courtesy of Lloyd Library & Museum

See NEW INGREDIENTS -- Cont’d p. 16 ...

request and the RPT 614 was noton www.regulations.gov onFebruary 20, 2012.

Nephro-Tech 1, LLC ofShawnee, Kansas wrote FDA onSeptember 24, 2009 to file a 75-day notice for calcium formate foruse as a dietary supplement. Citinga U.S. Patent #6,528,542, thesponsor claimed a dosage range of0.5 gm to 3.0 gms of calciumformate per day (~154 to 924 mgelemental calcium). Summaries ofthree research papers werementioned as being enclosed.These discussed the bioavailabilityof calcium from calcium formate,the absorption and elimination offormate following oraladministration of calcium formate,and the ocular and systemic safetyevaluation of calcium formate as adietary supplement. FDA’s Dan D.Levy, PhD., Microbiologist,Supervisor, New DietaryIngredient Review Team,responded to G. P. Georges by letterof December 9, 2009 stating theagency had carefully reviewed theinformation provided and hassignificant concerns about theevidence on which the conclusionwas made that the NDI wouldreasonably be expected to be safewhen used as suggested in thelabeling. FDA said the agency wasunable to establish the identity ofthe NDI because the notice doesnot contain information about themanufacturing process or thespecifications of the product.While indicating the product is100% calcium formate, there is noinformation about analyticalmethods used to determine thepurity. FDA was unable toestablish the safety of the NDI, asthe clinical safety study described

was a limited 14 day study and waslimited to ocular end points.Moreover, the study was limited insize to 12 persons. Therefor thestudy does not address chronic useof calcium formate in adults or theregular use of the ingredient bychildren. FDA conducted aliterature review of the NDIingredient and was unable to findserving levels and did not findevidence of food use at the servinglevels proposed in the notification.The maximum amount for anacceptable daily intake by the FAO/WHO Joint Committee on FoodAdditives for formic acid as apreservative and as a flavoringagent is 0-3 mg/Kg BW, whichcorresponded to 210 mg/day for a70 Kg adult. For these reasons, theinformation cited as evidence doesnot provide an adequate basis toconclude that when used assuggested, the NDI will reasonablybe expected to be safe. Such aproduct may be adulterated and isprohibited from entry intointerstate commerce. The NDI wasreceived at the FDA DocketManagement Branch on January28, 2010, having been forwardedon December 29, 2009 by FredHines, DVM. The file wasassigned to Docket No. FDA-1995-S-0039-draft 7383, RPT 615.This file was provided to NMLunder a Freedom of Informationrequest and the RPT 615 was noton www.regulations.gov onFebruary 20, 2012. The nextavailable RPT is No. 623.

Max International, LLC ofSalt Lake City, Utah, throughBentley Biomedical Consultingof Laguna Niguel, California,submitted an NDI on December 4,2009 to FDA concerningRiboCeine™ (D-Ribose-L-

Cysteine), a combination of twodietary supplements , amino acidL-Cysteine and the sugar Ribose.The conditions of use are to use onetablet or capsule daily to promotethe production of glutathione. It isdesigned for healthy, non-pregnant,non-lactating adults and notintended for use by children,pregnant women or lactatingmothers. Safety information aboutboth ingredients was discussed. L-Cysteine is GRAS under twosections of CFR and approved as adirect food additive under 21CFR172.320. D-Ribose has FDAGRAS status as a food additive.Used at a daily level of 250 mg thisis expected to provide 121 mg ofcysteine, for a 60 Kg man, or 2 mg/Kg per day and 150 mg of ribose,for a 60 kg body weight person,approximately 2.5 mg ribose perday. Safety studies were describedin rats and Zebrafish, as well as inother studies. FDA’s Dan D. Levy,PhD., Microbiologist, Supervisor,


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See FDA BUDGET - - Continued on page 13...

FY 2013 U.S. FDA BUDGET

Since President Johnson proposed the first unified

budget for the country in 1969, your editor has beenlooking at U.S. budget documents. A person used tobe able to hold these in one hand, now it takes a boxand two strong arms to handle these books. Thebooks have grown more complicated with 10-yearprojections, inflation prediction tables, and other sidecharts. So it is a chore to digest and understand whatis being proposed in many cases. It is no wonder theHouse and Senate Members vote on the bills withoutunderstanding them. Here are some quotes from theBudget and the Appendix, only two of nine separatecategories of information released with the package.

First, the President’s Message about the President’sBudget simply summarizes the FDA budget withthese words:

“We are supporting research at the NationalInstitutes of Health that will accelerate thetranslation of new discoveries in biomedicalscience into new therapies and cures, alongwith initiatives at the Food and DrugAdministration that will speed the approval ofnew medicines. We make importantinvestments in the science and research neededto tackle the most important environmentalchallenges of our time, and we are investing infields as varied as cyber-security, nano-technology, and advanced manufacturing. ThisBudget also puts an emphasis on the basicresearch that leads to the breakthroughs oftomorrow, which increasingly is no longerbeing conducted by the private sector, as wellas helping inventors bring their innovationsfrom laboratory to market.”

FY 2013 Budget of the United States, page 5

Next the Budget book of 256 pages contains theFunding Highlights for the Department of Health andHuman Services on only two pages.

Funding Highlights

Page 108 — Bolsters food and medical productsafety activities by increasing the Food and DrugAdministration’s total resources by $654 million

above the 2012 level and supports a new effort toimprove food and drug import safety.

Page 110 — Strengthens the Safety of U.S. Foodand Medicines. The Budget includes $2.5 billion inbudget authority and $4.5 billion in total programresources for the Food and Drug Administration(FDA). This includes $10 million in new resources toimprove food safety and medical product imports tothe United States through a greater FDA presence inforeign countries such as China. The Budget alsoincludes new user fee programs to supportimplementation of key elements of the Food SafetyModernization Act, and to bring more safe, effective,and affordable generic drugs and generic biologics,also known as biosimilars, to the American public. Tobetter protect public health in response to natural orintentional threats, the Administration also invests inFDA’s efforts to advance regulatory science andsupport the review of new medical countermeasuresfor chemical, radiological, biomedical, and nuclearthreats.

SpendingDiscretionary Budget Authority:Food and Drug Administration 1

Actual Estimate Estimate 2011 2012 2013

$2,403 $2,506 $2,517Program Level (non-add)

$3,636 $3,832 $4,486

1 FDA budget authority reported to Treasury for 2011is $54 million lower than actual available budgetauthority due to the timing of FDA user fee collections.

Source: www.whitehouse.gov/sites/default/files/omb/budget/fy2013/assets/budget.pdf

More details are given in the Appendix to the Budget.This is the bigger book with legislative languagedescribing where the President wants the money to bespent. There are four pages about the Food and DrugAdministration. This language also covers themanufacturer’s fees that FDA has been charging forseveral years. There are 59 mentions of fees you should


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See SECTION 403 LETTERS -- Continued on page 11...

SECTION 403 LETTERS -- Continued from page 4...

DMG-B15 use the claims “Potassium is well-knownfor the role it plays in regulating blood pressure…role it plays in blood pressure,” and “Researcherscontinue to explore the connection between calciumand cholesterol levels.” FDA explained that it didnot necessarily believe that all claims about themaintenance of normal cholesterol levels constitutedimplied disease claims. However, FDA wrote in itspreamble to the structure/function claims finalregulation (65 FR 1000 at 1018) that to avoid implyingthat the product treats or prevents disease, acholesterol maintenance claim would have to clarifythe product is only for maintenance of cholesterollevels that are already in the normal range. Becauseyour claims have no such clarification, FDA considersthe claims to be implied disease claims for treatmentof elevated blood pressure or hypertension, which isa disease. The products Enzymatic TherapyGarlinase 4000 and PhytoPharmica Garlinase 4000use the claims “…retain healthy cholesterol levels”and “support retention of healthy cholesterol levels.”FDA explained that for the reasons set forth in thepreamble to the final structure/function regulation (65FR 1000 at 1018) these claims standing alone areimplied disease claims for preventing coronary heartdisease by preventing the development of elevatedcholesterol levels or reducing elevated cholesterol.The product Phytopharmica Glucoril uses the claim“…an herb long recommended for diabetics.” Thisis a disease claim that implies that because the productis intended for use by people with diabetes, it isintended to treat that these people have. The productsEnzymatic Therapy St. John’s Wort Extract andPhytopharmica Hyperimed used the claims “…relieving occasional anxiety, apathy, sleeplessness,and feelings of worthlessness.” The claims are implieddisease claims that describe a group of signs andsymptoms that, when considered together imply thatthe product is intended to treat, prevent, or mitigatediseases, namely, anxiety disorders and depression.The products Enzymatic Therapy Olive LeafExtract with Hawthorne and Phytopharmica OliveLeaf Extract with Hawthorne use the claim “Usefulin dilating coronary blood vessels and increasingblood flow to the heart.” A claim about coronaryblood vessels and increasing blood flow to the heartis an implied disease claim. The products EnzymaticTherapy Potassium Plus and PhytopharmicaPotassium Plus use the claims “Supports retention

of healthy blood pressure levels,” “…benefits bloodpressure,” and “… helps regulate blood pressure.”A claims about blood pressure that do not make clearthat the product is only for people with blood pressurethat is already within normal limits implies that theproduct is intended to treat elevated blood pressureor hypertension, which is a disease. These claimsare therefore, disease claims. The product EnzymaticTherapy Quercezyme-Plus uses the claim “…support enzyme functions that break down fibrin, ablood-clotting agent.” FDA explained that thepreamble to the final regulation on structure/functionclaims issued at 65 FR 1016 stated that plateletaggregation is a normal function needed to maintainhomeostasis, inhibiting or decreasing plateletaggregation is a well-recognized therapy for theprevention of stroke and recurrent heart attack.Consequently any claim that affects plateletaggregation or other aspects of blood clotting impliesthat the product is intended to correct some deviationin platelet function from the normal. Therefore, theseclaims are disease claims. FDA stated that if theseclaims are used, the products will be regulated underthe drug provisions under the Act. This notice andFDA response were received by FDA’s DocketsManagement Branch on January 7, 2002 and placedin Docket No. 97S-0163 as LET 562. This file wastransferred to a new Docket No. FDA-1997-S-0006-0873 and posted to the www.regulations.gov web onDecember 2, 2008.

Vita Cube Systems, Inc. of Denver, Colorado,wrote FDA on December 5, 2001, to give notice forsix of its products – Ginkgo Clear, Visual Eyes,Muscle MR3, Enduro Max, Balanced Mood, and PureHeat. Each product had a paragraph of statementsfor the bottle and box. FDA responded by letter ofDecember 21, 2001 to William E. Wheeler, Ph.D.,R.D. from John B. Foret, Director, Division ofCompliance and Enforcement, Office of NutritionalProducts, Labeling and Dietary Supplements, whereinhe stated that the claims made for: Visual Eyes –Vision Health, namely, “…help stop the progressionof macular degeneration,” “ … help stop theprogression of Macular Degeneration, the leadingcause of blindness…,” and “… treat a wide array ofeye disorders such as cataracts and retinopathy” andfor Pure Heat – Soft Tissue Support, namely,


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SECTION 403 LETTERS - Cont’d from p. 10...

See SECTION 403 LETTERS Cont’d on p. 12...

“…sport injuries and chronic jointpain,” “… alleviate pain andenhance healing,” “… containsnatural COX-2 inhibitor likeactions, which may have pain-relieving characteristics,” and“why millions of individuals sufferfrom joint pain and arthritis.” TheFDA letter explained that the aboveitalicized claims are claims to treat,prevent, cure, or mitigate disease.These claims do not meet therequirements of 21 USC Section343(r)( 6), but suggest the productsare drugs. These claims are subjectto regulation under the drugprovisions of the Act. This noticeand FDA response were receivedby FDA’s Dockets ManagementBranch on January 7, 2002 andplaced in Docket No. 97S-0163 asLET 563. This file was transferredto a new Docket No. FDA-1997-S-0006-0874 and posted to thewww.regulations.gov web onDecember 2, 2008.

Solstice Medicine Company ofLos Angeles, California, wrote toFDA on November 26, 2001,concerning claims for its productRyukakusan Herbal Candy,namely, “Supports the health of therespiratory systems and refreshesat the same time. This statementhas not been evaluated by the Foodand Drug Administration. Thisproduct is not intended todiagnose, treat, cure, or preventany disease.” FDA responded byletter of December 21, 2001 toWina Tran from John B. Foret,Director, Division of Complianceand Enforcement, Office ofNutritional Products, Labeling andDietary Supplements, wherein hestated that the product is not adietary supplement within the

meaning of the statute at Section201(ff), but it is a conventionalfood that has its own labeling andother requirements outside ofSection 343(r)( 6). This notice andFDA response were received byFDA’s Dockets ManagementBranch on March 7, 2002 andplaced in Docket No. 97S-0163 asLET 564. This file was transferredto a new Docket No. FDA-1997-S-0006-0875 and posted to thewww.regulations.gov web onDecember 2, 2008.

Indiana Botanical Gardens,Inc. of Hobart, Indiana, wrote toFDA on June 20, 2002 concerningstatements of claims it would makefor its product, Gingko Biloba 30mg Extract and 60 mg ExtractCapsules. The statements are:“Research and clinical studiesdemonstrate that Gingko Biloba: dilates the blood vessels, allowingimproved circulation. supportsand improves mental clarity inpeople of all ages. is an effectiveantioxidant that inhibits freeradicals. increases the oxygencontent of the blood. increasescirculation to the retina. increases oxygen and the bloodflow to the brain and extremities. supplies nutritional support tothe entire body. inhibits theclumping of blood platelets. helps the body adapt to stress.FDA’s John B. Foret, Director,Division of Compliance andEnforcement, Office of NutritionalProducts, Labeling and DietarySupplements, over an non legiblesignature of another person, wroteto Tim Cleland on July 22, 2002 tostate that the claim “inhibits theclumping of blood platelets” is adisease claim and not a Section403(r)(6) claim. If the companyintends to use that claim the

product will be regulated under thedrug provisions of the Act. Thisnotice and FDA response werereceived by FDA’s DocketsManagement Branch and placed inDocket No. 97S-0163 as LET 621.This file was transferred to a newDocket No. FDA-1997-S-0006-0950 and posted to thewww.regulations.gov web onDecember 2, 2008.

Nature’s Answer of Hauppauge,New York, wrote to FDA on June17, 2002 to give notice that itwould used the claim “May reducerisk of osteoporosis” for its productCalcium Crystals Plus™. FDA’sJohn B. Foret, Director, Divisionof Compliance and Enforcement,Office of Nutritional Products,Labeling and Dietary Supplements,over an non legible signature ofanother person, wrote to FrankD’Amelio to state that this is notan authorized health claim for therelationship of calcium andosteoporosis under 21 CFR 101.72.If the regulation is not followed theproduct would be misbranded andfailure to make a claim within theregulation cited subjects theproduct to regulation as a drug.This notice and FDA responsewere received by FDA’s DocketsManagement Branch and placed inDocket No. 97S-0163 as LET 622.This file was transferred to a newDocket No. FDA-1997-S-0006-0951 and posted to thewww.regulations.gov web onDecember 2, 2008.

Enzymatic Therapy® NaturalMedicines™ of Green Bay,Wisconsin, wrote FDA on June 25,2002 that it would make the claim“10 pills, 20 days, Heartburn


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Coltsfoot (Tussilago Farfara)

Photo Courtesy of Lloyd Library and Museum

SECTION 403 LETTERS - Cont’d from p.11...

Free™.” The product name isHeartburn Free™. FDA’s John B.Foret, Director, Division ofCompliance and Enforcement,Office of Nutritional Products,Labeling and Dietary Supplements,over an non legible signature ofanother person, wrote to Robert C.Doster, to state that the claimincluding the name of the productsuggests that it intended to be usedto treat heartburn and therefore thatthe product is a drug. If this claimis used the product will beregulated as a drug under the Act.This notice and FDA responsewere received by FDA’s DocketsManagement Branch and placed inDocket No. 97S-0163 as LET 623.This file was transferred to a newDocket No. FDA-1997-S-0006-0952 and posted to thewww.regulations.gov web onDecember 2, 2008.

Pharmavite of Mission Hills,California, wrote to FDA on June18, 2001 to submit a notice forstatements of claim for its productJoint Action. The claims givenwere: “Joint Repair and PainRelief,” “Joint Action wasdesigned combining two of today’smost popular choices for jointhealth. SAM-e and Glucosaminehave each been extensively studiedand recommended in Europe andthe U.S.,” “In Joint Action, thesetwo ingredients have beenclinically shown to: Relieve JointPain, Repair Damage,” and“Cartilage rebuilding andregeneration are normal functionsof the body. During your lifetime,joint cartilage begins to breakdown due to physical stress andaging, causing joint pain andmaking even everyday activitieslike walking difficult to perform.

That’s why it’s essential tomaintain healthy levels of nutrientsthat promote joint health andmobility. Through supplement-ation, Joint Action helps repairjoint damage which relieves jointpain.” FDA’s John B. Foret,Director, Division of Complianceand Enforcement, Office ofNutritional Products, Labeling andDietary Supplements, over an nonlegible signature of another person,wrote to David Kropp on July 22,2002 to state that “Joint Repairand Pain Relief,” “… jointcartilage begins to break down dueto physical stress and aging,causing joint pain…,” and “…Joint Action … relieves joint pain.”were claims to mitigate disease,namely, joint disorders such asarthritis. [Note, however, the thirdclaim does not appear to be one ofthe claims forbidden by FDA. –Ed.] But the agency stated theseare disease claims and thensuggested that an acceptable claimwould be “for pain associated withnon-disease states, such as musclepain following exercise.” FDA’sletter stated that some of the othernon-forbidden claims would not beexpected from aging and physicalstress which are not diseases. Painwould not be expected unless therewas an underlying disease. If theclaims are used, FDA told thecompany to expect the products tobe regulated as drugs under the Act.This notice and FDA responsewere received by FDA’s DocketsManagement Branch and placed inDocket No. 97S-0163 as LET 624.This file was transferred to a newDocket No. FDA-1997-S-0006-0953 and posted to thewww.regulations.gov web onDecember 2, 2008.

IN RE VITAMIN CANTITRUST LITIGATION

This case is proceeding to a March

16, 2012 telephone conference ona Motion to Compel production ofdocuments. The case is now beforeMagistrate Judge James Orenstein.The case is In Re Vitamin CAntitrust Litigation, 1:06-md-01738, U.S. District Court for NewYork, Eastern District. Judge BrainM. Cogan, presiding. The trialschedule was set forth in theJanuary 2012 issue of NML. Thecase citation was omitted inJanuary.

RESEARCH CLAIMS

If you have a claim you want to

check, go to the Index and Searchpage on www.natmedlaw.com andtype in the claim phrase. Checkthe product on which the claim isbeing made to see if FDA has com-mented on the claim before. Thismay help you determine what FDAwill do with your similar claim.


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See PURPOSE FOR REJECTION - Continued on page 20...

FDA BUDGET -- Continued from page 9...

understand how much that sellers of products arepaying to get the agency to approve products fasterthan taxpayer appropriations would allow them todo. There are four pages of information on the FDAportion of this tome of 1,478 pages.

Source: www.whitehouse.gov/sites/default/files/omb/budget/fy2013/assets/hhs.pdf

FDA Commissioner Margaret Hamburg issued a32-page statement about the President’s FDA Budgeton February 29, 2012 before the Committee onAppropriations, Subcommittee on Agriculture, RuralDevelopment, Food and Drug Administration, andRelated Agencies, U.S. House of Representatives. Inthis the Commissioner mentioned fees for variousFDA approval reviews. These fees are for: a bio-similar biological review fee; a new generic drug userreview fee; a drug user review fee; a first cos-metic review fee; and a Food Safety ModernizationAct user fee.

Hamburg’s statement to Congress said: “The FY2013 increase for user fees, including increases forcurrent law user fees and amounts for seven new userfee programs, accounts for 98 percent of the FDAbudget increase. FDA user fee programs supportsafety and effectiveness reviews of human and animaldrugs, biological products, medical devices, and otherFDA-regulated products. Fees also allow FDAprograms to achieve timely and enhanced premarketreview performance. Finally, fees support theprograms and operations of the FDA Center forTobacco Products.” At least a third of the Statementdescribes what FDA does with the user fees. Formore on the user fees, see the Commissioner’s fullStatement.

Source: www.fda.gov/NewsEvents/Testimony/ucm293842.htm

Here are some of the things analysts have beenreporting. The President requested only $11.5 millionover FY 2012 levels (less than 0.5% increase). Thisis better than many agencies that experienced actualcuts in their budget. [See article in this issue on theFTC budget cuts.- Ed.]

The six Centers at FDA will get $24.5 million lessnext year despite Congress asking them to do moreand more. And $3.5 million less will be spent onbuildings and facilities. The Commissioner’s Officegets an increase of $9.3 million and the “White OakConsolidation” gets $17.7 million to equip the newbiological sciences building there. This White Oakcampus is in Prince George’s County in a formermilitary facility that Congress was persuaded toconvert, rather than buy a new area in northernMontgomery County a few years ago. There was nowater or sewer on the FDA proposed new cite thatwould have cost taxpayers gazillions, so the retrofittingof FDA onto White Oak may really save taxpayerssome money. Rental costs elsewhere are increasedby $12.5 million.

Looking at budget lines, the increases are $39.5million and the offsets are $28 million, netting anincrease of $11.5 million.

The Alliance to Strengthen the FDA says “the FDA’smission, responsibilities and tasks are growing eachyear.” For more see: http://strengthentheFDA.org.

Statistical pooling of the data from these randomizedcontrolled trials consistently shows a significant reductionin the risk of falling. The available data do not provideinformation about the lowest effective dose of vitamin Dneeded to obtain the claimed effect. On the basis of thedata presented, the Panel concludes that a cause and effectrelationship has been established between the intake ofvitamin D and a reduction of risk of falling. In order toobtain the claimed effect, 800 I.U. (20 mcg) of vitaminD from all sources should be consumed daily. The targetpopulation is men and women 60 years of age and older.© European Food Safety Authority, 2011.

Seven randomized, controlled clinical trials (RCTs),five observational studies and four meta-analyses werementioned as being submitted to the NDA Panel.RCTs mentioned were those by Bischoff-Ferrari et al2006), Pfeifer et al (2000), Bischoff et al (2003, Flickeret al (2005), Prince et al (2008), Pfeifer et al (2009)and Broe et al (2007).

In the end, the Panel said that the language for aclaim that the evidence supported was: “Vitamin D

RISK OF FALLING -- Continued from page 5...


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PHOTOGRAPHS FROM LLOYD LIBRARY AND MUSEUM

Page 8 - Goldenseal (Hydrastis canadensis) from AMERICANMEDICINAL PLANTS by Charles Frederick Millspaugh (1887)Page 12 - Coltsfoot (Tussilago farfara) from MEDICAL BOTANYby William Woodville (1810)Page 16 - Ginger (Zingiber Officinale) from MEDICAL BOTANYby Stephenson & Churchill (1810)

Page 4 - (Colchicum autumnales) from FLORA HOMOEOPATHICA

by Edward Hamilton, London. (1852-1853)

www.natmedlaw.com

Back Cover -- Panax Ginseng (Panas quinequefolius) from FAMILYFLORA and MATERIA MEDICA BOTANICA by Peter P. Good, 1847

Back Cover --Nutmeg Tree (Myristica Moshata) from MEDICALBOTANY by Stephenson & Churchill (1834)

Page 22 -- Poke Weed (Phytolacca Decandra) from VEGETABLEMATERIA MEDICA by William P. C. Barton (1817-1818)

CSPI THREATENS -- Continued from page 1...

“Immunity” Twist Tubes. Also, both product linescontain the artificial sweetener sucralose, despite aprint advertisement for “fruits & vegetables 2GO”that claims the product has no artificial ingredients.Twist Tubes are meant to be diluted in 16 ounces ofwater before consuming.

“Amway is sending a horrible health message toAmerican consumers when it holds out its Twist Tubesas a short cut to getting the health benefits of realfood,” said CSPI staff litigator Seema Rattan. “Peoplewho want the health benefits of two servings of fruitsand vegetables are far better off eating two servingsof fruits and vegetables. And no one should bedeceived into thinking that these pricey little tubeswill prevent them from getting sick.”

A 20-dose pack of Nutrilite “fruits & vegetables2GO Twist Tubes” costs $19.99 plus $7.95 shippingand handling if purchased at www.amway.com;Immunity Twist Tubes cost $12.35 plus $7.95shipping and handling. Otherwise, the products arenot available in stores but are sold by Amwaydistributors.

“Fruits & vegetables 2GO” has “the antioxidantequivalent of two of the 9–13 daily servings of fruitsand vegetables your body needs,” according toAmway. But there’s far more to fruits and vegetablesthan just antioxidants, according to CSPI. Neither“fruits & vegetables 2GO” nor Immunity Twist Tubeshas any fiber, for instance. Real fruits and vegetableshave up to 8,000 phytochemicals that may providehealth benefits—something that supplements simplycannot mimic, according to CSPI. Vitamins, like theA, B, and C vitamins in Twist Tubes, account for onlya small fraction of the antioxidant activity in wholefruits and vegetables. While the Immunity Twist Tubecontains 1,000 mg of vitamin C, human tissues aregenerally saturated with vitamin C at 400 mg per day,and any excess is typically excreted.

In an eight-page demand letter to Amway ChairmanSteve Van Andel, CSPI says that Amway’s labelingand advertising for Nutrilite products violates federal

regulations and consumer protection laws in theDistrict of Columbia, Massachusetts, Texas, NewJersey, and California.

“Should Amway choose not to respond toCSPI’s findings, CSPI will pursue litigation toseek the following:

Entry of a permanent injunction that prohibitsAmway from representing that its dietarySupplement products provide any number ofservings of fruits and vegetables or theantioxidant equivalent of any number of fruitsand vegetables.

Entry of a permanent injunction that prohibitsAmway from representing that any of itsdietary supplement products can be used in thediagnosis, cure, mitigation, treatment, orprevention of disease.

Entry of a permanent injunction that mandatesa series of corrective advertisements tocorrect Amway’s prior consumer deception withrespect to the benefits of its “fruits &vegetables 2GO” Twist Tubes and its ImmunityTwist Tubes.

Disgorgement of Amway’s profits from thesale of its “fruits & vegetables 2GO” TwistTubes and its Immunity Twist Tubes.”

See CSPI THREATENS ... Continued on page 16...


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See CSPI THREATENS- - Cont’d p. 17...

NEW INGREDIENTS -- Cont’d from p.8 ...

New Dietary Ingredient ReviewTeam, responded to Robert Seipleat Bentley Biometical Consultingby letter of February 22, 2010stating the notification was about20(1’,2’ ,3’ ,4’-tetrahydroxy-butyl)thiazolidine-4-carboxylicacid (CAS# 17087-36-4) that wascalled D-Ribose-L-Cysteine. Fromthe notification, it appears that thisNDI is not a dietary supplementwithin the meaning of DSHEA.The combination product appearsto have pharmacological propertiesdistinct from the properties of theoriginal ingredients. The notifi-cation does not contain enoughinformation to determine if theseproperties are attributed to theclaimed slow hydrolysis into theoriginal ingredients as opposed topharmacological properties relatedto the combination. Because theNDI does not appear to be a dietarysupplement, FDA did not evaluatethe safety data. The NDI wasreceived at the FDA DocketManagement Branch on May 3,2010, having been forwarded onMarch 29, 2010 by Fred Hines,DVM. The file was assigned toDocket No. FDA-1995-S-0039-draft 7499, RPT 623. This file wasprovided to NML under a Freedomof Information request and the RPT623 was not onwww.regulations.gov on February20, 2012. The next available RPTis No. 632.

Yamaha Motor Co, Ltd. ofFukuroi, Shizuoka, Japan onNovember 2, 2009 filed an NDIwith FDA for its product PurestaOil which is a mixture ofastaxanthin-rich oil extract from thealgae Haematococcus pluvialls andpalm oil which contains medium-

chain triglycerides. The productwill be used for incorporating intoa variety of final products.Amendment letters were filedDecember 1, 2009 and January 20,2010. FDA’s Dan D. Levy, PhD.,Microbiologist, Supervisor, NewDietary Ingredient Review Team,responded to Keisuke Nakagawaon January 22, 2010 to state thematerial received on January 20was a substantive amendment thatwill reset the 75-day date toJanuary 20. On February 17, 2010the sponsor filed additionalinformation in response to requeststhat are not in the public file. Theinformation included the methodof manufacture of the tea extract,the conditions of use of the PurestaOil. FDA’s Levy sent a final letteron March 3, 2010 stating thatacceptance of the NDI for filing isa procedural matter and does notconstitute a finding by FDA thatthe NDI or supplement thatcontains the NDI are safe or arenot adulterated. FDA is notprecluded from taking action in thefuture against any dietarysupplement containing the NDI ifthese are found to be unsafe,adulterated or misbranded. TheNDI was received at the FDADocket Management Branch onJune 17, 2010, having beenforwarded on May 3, 2010 by FredHines, DVM. The file wasassigned to Docket No. FDA-1995-S-0039-draft 7389, RPT632. This file was provided toNML under a Freedom ofInformation request and the RPT632 was not on www.regu-lations.gov on February 20, 2012.The next available RPT is No. 634.This will be presented in the Mayissue of NML.

Zingiber Officianale (1810)Photo Courtesy of Lloyd Library and Museum

CSPI’s litigation unit hassuccessfully prompted severalmajor food companies, includingQuaker, Frito-Lay, Procter &Gamble, Tropicana, and PinnacleFoods, to halt a variety ofmisleading labeling or marketingpractices. In 2008, CSPI joinedlitigation that returned approx-imately $12 million in refunds toconsumers who purchased thedietary supplement Airborne;labels and ads falsely claimed theproduct would cure and preventcolds. To learn more at CSPIcontact in Washington, D.C. – JeffCronin, 202-777-8370 or AngelaMorris, 202-777-8316.

The Center for Science in thePublic Interest is a nonprofit healthadvocacy group based inWashington, DC, that focuses onnutrition and food safety policies. CSPI is supported by the 900,000U.S. and Canadian subscribers toits Nutrition Action Healthletter

CSPI THREATENS ... from p. 14...


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CSPI THREATENS -- Continued from page 16...

and by foundation grants. The CSPI lists its attorneysat: Litigation Office, The Meadows Building, 5646Milton Street, Suite 211, Dallas, Texas 75206.Telephone: (214) 827-2774. Signers of the letter toAmway are Stephen Gardner, Litigation Director, andSeema Rattan, Litigation Staff Attorney. Gardner hasexperience with the Attorney Generals’ offices in NewYork and Texas, as well as adjunct teaching at anumber of law schools.

no longer manufactures or distributes supplements ordrugs and the Court ordered it not to do so for twoyears from the date of sentencing as a condition of itsprobation.

The companies pled guilty in November 2011.According to the plea agreements, DCD, LLC dbaAdvanced Muscle Science (DCD), and R&DHoldings, LLC dba Culver Concepts, Bradley Asgard,and Bjorklund (R&D Holdings), misbranded productsas dietary supplements, when the products wereactually drugs, as defined under the Food, Drug andCosmetic Act (FDCA) and the Dietary SupplementHealth and Education Act (DSHEA). The chargeswere brought in federal court in Idaho because thecompanies delivered their products to a retail companylocated in Idaho for further distribution throughoutthe United States.

According to the plea agreements, DCD distributedthe products “Dienedrone” and “Liquidrone,” andR&D distributed “Orafinadrol 50,”“Microdrol” and“Methyldrostanolone,” as dietary supplements. TheFDA found that the active ingredients in the productswere synthetic anabolic steroids, or synthetic chemicalclones of anabolic steroids, which were not dietaryingredients, but rather unapproved drugs under theFDCA. The products did not meet the DSHEA legaldefinition of a dietary supplement, nor did they meetany other definition of food.

DCD, LLC dba Advanced Muscle Science wasorganized as a Nevada LLC, with offices in Californiaand Michigan. R&D Holdings is located in Irvine,California. Both companies distributed their productsto a large Internet-based retailer that has its

SENTENCING -- Continued from page 1...

headquarters in Meridian, Idaho, and maintainswarehouses in Boise and elsewhere.

“These prosecutions and sentencings are necessaryto protect the public from synthetic steroidsmasquerading as dietary supplements,” said Olson.“DCD, LLC’s testing protocol and R&D’s agreementnot to manufacture these products are positive stepsfor the dietary supplement industry as it strugglesthroughout the country to ensure that consumers areusing only safe products.”

NML reviewed the court docket of the DCD caseto learn more about this “sentencing” of corporateentities by the Sentencing Reform Act of 1984. Thecourt order placed DCD, LLC, dba Advanced MuscleScience on probation for five years and imposed thestandard conditions of supervision. In addition,special conditions of probation were added thatrequired the payment of fines monthly through March5, 2014. The fines start at $1,000 per month for eightmonths beginning January 17, 2012, through August5, 2012, then $3,000 per month for six monthsSeptember 5, 2012 through February 5, 2013, then$4,000 per month for six months March 5, 2013through August 5, 2013, then a $50,000 lumps sumby September 5, 2013 and a final payment of $25,000by March 5, 2014.

The financial penalties are subject to review onchange of defendant’s financial circumstances. Alsothere are orders to not violate another Federal criminalstatute, submit to searches on demand by the probationofficer, allow access to all requested financialinformation, make quarterly reports on theorganization’s financial status, follow the testprocedures enumerated in the plea agreement, complywith DSHEA, and notify the probation officer or courtimmediately in changes of financial condition. Thecourt waived interest on the fines.

The Rule 11 Plea Agreement is 15 pages long andhad been discussed and signed between thegovernment and defendant before it was filed in theU.S. District Court in Boise, Idaho on October 5,2011. The Plea Agreement is signed by U. S. AttorneyWendy J. Olson (208)334-1211, and Assistant U.S.Attorney Kevin T. Maloney for the government and

See SENTENCING -- Continued on page 18...


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SENTENCING -- Continued from p. 17...

Use WWW.NATMEDLAW.COM to research claims

by DCD, LLC Managing Member David Cannoy andRichard D. Collins, Esq., (according to the Applicationfor Admission Pro Hac Vice) of Mineola, New York(516) 2940-0300. Local (Boise, Idaho) counsel fordefendant was Charles F. Peterson, Esq. (208) 342-4633.

In May 2011, Tribravus Enterprises dba IForceNutrition, headquartered in Vista, California, wassentenced in U.S. District Court in Idaho fordistributing the products “17aPheraFLEX,”“Dymethazine” and “Methadrol,” as dietarysupplements.

The DCD case was investigated by the Food andDrug Administration, Office of CriminalInvestigations. List on the Criminal Cover Sheet asInvestigative Agent is Rob Blienkinsop from FDA(208) 433-3557. This article was compiled by NMLfrom a U.S. Department of Justice Press Release,United States Attorney, District of Idaho, as well ascourt files (some files have been sealed from publicview by the Clerk) by NML. Contact: Pamela Bearg,Public Information Officer (208) 334-1211 if you donot have access to court files.

The case is USA v. DCD LLC, dba Advanced MuscleScience, Case No. CR 11-0234. Presiding Chief JudgeB. Lynn Winmill was born in Idaho, educated at IdahoState University and Harvard Law School and wasnominated to the Federal bench in 1995 by PresidentWilliam J. Clinton. Judge Winmill has served as chiefjudge since 1999.

berry weight-loss supplements and colon cleansersthat they marketed.

The defendants also are required to disclose anymaterial connections they have with merchants, andwill be barred from making deceptive claims aboutother products, such as the work-at-home schemes orpenny auctions that most of them promoted. The

NEWS SITES STOPPED -- Continued from page 1...

settlements also require that these defendantscollectively pay roughly $500,000 to the Commissionbecause their advertisements violated federal law.This money amounts to most of their assets.

At the request of the FTC, federal courts temporarilyhalted these operations and four others. In its sweeplast year against marketers who allegedly used fakenews sites to promote weight-loss products, the FTCalleged that their websites were designed to falselyappear as if they were part of legitimate newsorganizations, but were actually nothing more thanadvertisements deceptively enticing consumers to buythe featured acai berry weight-loss products fromonline merchants. With titles such as “News 6 NewsAlerts,” “Health News Health Alerts,” or “Health 5Beat Health News,” the sites often falsely representedthat the reports they carried had been seen on majormedia outlets such as ABC, Fox News, CBS, CNN,USA Today, and Consumer Reports. Investigative-sounding headlines presented stories that purportedto document a reporter’s first-hand experience withacai berry supplements – typically claiming to havelost 25 pounds in four weeks, according to the FTCcomplaints.

The proposed settlements impose monetaryjudgments in the full amount of the monetarycommissions the defendants received for deceptivemarketing through their fake news sites. Due to thedefendants’ financial condition, the judgments willbe suspended if the FTC receives specified assetsfrom them. In all cases, if it is later determined thatthe financial information the defendants provided theFTC was false, the full amount of their judgmentswould become due:

Ricardo Jose Labra’s $2.5 million judgment willbe suspended when he pays $280,000 and records a$39,500 lien on his home.

Zachary S. Graham, Ambervine Marketing, LLCand Encastle, Inc. Graham’s $953,000 judgment willbe suspended when he pays $110,000 plus most ofthe proceeds from the sale of a truck.

Tanner Garrett Vaughn’s $203,000 judgment willbe suspended when he pays close to $80,000 over athree-year period.


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NEWS SITES STOPPED -- Continued from page 18...

Thou Lee’s $204,000 judgment will be suspendedwhen he pays $13,000 plus the proceeds from the saleof a BMW.

Charles Dunlevy’s $143,000 judgment will besuspended when he pays an estimated $2,000 fromfrozen assets and the sale of a boat.

DLXM, LLC and Michael Volozin The $594,000judgment will be suspended because of thedefendants’ inability to pay.

According to the FTC complaints, in pitching theacai weight-loss products, the defendants postedattention-grabbing ads on search engines and highvolume websites, such as “Acai Berry EXPOSED –Health Reporter Discovers the Shocking Truth,”driving traffic to the fake news sites and ultimately tothe sites where merchants sell the products. The FTCreceived numerous complaints from consumers whopaid between $70 and $100 for weight-loss productsafter having been deceived by fake news sites.

Derived from acai palm trees that are native toCentral and South America, acai berry supplementsoften are marketed to consumers who hope to loseweight. In another recent settlement with online acaiberry marketers, defendants in the Central CoastNutraceuticals case were required to pay $1.5 million.In 2011, the Commission brought suit against twoother online acai berry marketers: LeanSpa, LLC,which the Commission sued in conjunction with theState of Connecticut, and Jesse Willms. In both cases,the FTC obtained preliminary injunctions barring thedefendants from engaging in the charged deceptivepractices.

The FTC helps consumers recognize and avoiddeceptive claims made by fake news sites that marketacai berries for weight loss. To learn more, see theconsumer alert THIS JUST IN: Fake News SitesPromote Bogus Weight Loss Benefits of Acai BerrySupplements, and the video Free Trial Offers, whichexplains how free trials are often used to market acaiberry supplements and other products.

The Commission votes authorizing the staff to filethe proposed settlement orders against Ricardo Labraand Tanner Vaughn were 4-0. The votes authorizing

the staff to file the proposed settlement orders againstZachary Graham, Ambervine Marketing, LLC andEncastle, Inc.; Thou Lee, DLXM, LLC and MichaelVolozin; and Charles Dunlevy were 3-1, withCommissioner J. Thomas Rosch voting no. Thefollowing courts have approved the settlement orders:

U.S. District Court for the Northern District ofIllinois, Eastern Division, on January 11 and 12, 2012.(Zachary S. Graham, Ambervine Marketing LLC, andEncastle, Inc.; Ricardo Jose Labra; and Thou Lee, alsodoing business as TL Advertising.); U.S. District Court for the Northern District ofGeorgia on January 12, 2012. (Charles Dunlevy.); U.S. District Court for the Western District ofWashington on January 12, 2012. (Tanner GarrettVaughn, also doing business as Lead Expose, Inc.,and Uptown Media, Inc.); and U.S. District Court for the Eastern District ofNew York on January 19, 2012. (DLXM, LLC, alsodoing business as DLX Marketing, and MichaelVolozin, also known as Mikhail Volozin.)

NOTE: A settlement order is for settlement purposesonly and does not constitute an admission by thedefendant that the law has been violated. Settlementorders have the force of law when approved andsigned by the District Court judge.

August 2011, the Commission finalized a settlementrequiring Nivea skin cream maker Beiersdorf, Inc. tostop claiming that regular use of its Nivea MySilhouette! skin cream can significantly reduceconsumers’ body size. The company also agreed topay $900,000 as part of the settlement. Also in August2011, the Second Circuit upheld summary judgmentin the FTC’s favor in Bronson Partners, whichinvolved deceptive weight loss claims for its teas. TheCommission announced in September 2011 thatReebok International Ltd. had agreed to pay $25million to resolve charges that the companydeceptively advertised “toning shoes,” which itclaimed would provide extra tone and strength to legand buttock muscles.”

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“ Children’s Immunity and Brain Boosters: In June2011, the FTC finalized an order with NBTY, Inc., amajor marketer of vitamins, for making false andunsupported claims that its Disney and Marvel Heroesline of children’s multivitamins contained a significantamount of DHA (docosahexaenoic acid, an Omega-3fatty acid) and promoted healthy brain and eyedevelopment in children. As part of the settlement,NBTY, Inc. and its two subsidiaries agreed to pay $2.1million to provide refunds to consumers whopurchased these multivitamins.”

“Caffeinated Alcohol Beverages: In November2010, the FTC sent warning letters to the promotersof Four Loko, Joose, Core Spiked, and othercaffeinated alcohol drinks. Citing incidents“suggesting that alcohol containing added caffeinepresents unusual risks to health and safety,” the FTCletters warned that marketing of such beverages mayconstitute an unfair or deceptive practice that violatesthe FTC Act. In September 2011, Phusion Projects,LLC, the marketer of Four Loko, agreed to re-labeland repackage the supersized, high alcohol, fruit-flavored, carbonated malt beverage, to resolveCommission charges of deceptive advertising.”

“ Contact Lenses: The FTC reached a settlementwith an Internet marketer Gothic Lens LLC and itsmanager in February 2011 that will put a stop to theiralleged illegal practice of selling cosmetic contactlenses to consumers without prescriptions. TheCommission reached a similar settlement in July 2011with an Internet marketer and his company, JokeshopUSA, LLC, that put a stop to their alleged illegalpractice of selling cosmetic contact lenses toconsumers without prescriptions.”

In the back of the Budget Request, FTC mentionsdietary supplements two more times.

First, in the context of advertising practices. “Advertising for Foods, Over-the-Counter Drugs,Dietary Supplements, and Medical Devices:Advertising Practices devotes substantial resourcesto ensuring the accuracy of health claims inadvertising and takes action against companiesmaking deceptive representations. In addition totraditional law enforcement actions, the FTC createseducation materials to help companies understand the

need for adequate substantiation and information tohelp consumers spot deceptive claims.”

And second, in the context of Advertising Research,where FTC says:

“ Advertising Research and Data Development: Toadvance the development of sound advertising policy,Economic and Consumer Policy Analysis supportsdata and research projects analyzing how advertisingclaims and policies affect consumers’ and firms’decisions. Past studies examined the effects ofdifferent types of disclosures on consumerunderstanding of advertising claims for foods anddietary supplements and the nature of food advertisingto children.”

With regard to efforts to reduce obesity, the FTCrequest has this to say:

“ Childhood Obesity and Food Marketing toChildren: Advertising Practices has been leading theFTC’s efforts to support self-regulation in the area offood marketing to children. In 2008, the FTC issueda report on the expenditures of 44 major food andbeverage companies for food marketing to childrenages 2 to 17 during 2006. In 2010, AdvertisingPractices initiated a follow-up study. In addition, inresponse to a Congressional directive, AdvertisingPractices is coordinating a working group with FDA,CDC, and USDA to develop voluntary nutritionprinciples to guide self-regulatory efforts to addressfood marketing to children.”

The FTC is active in enforcing many other statutesincluding those concerning maintaining competitionand tracking down and stopping fraud and abuse inmany industries. For a complete copy of the FTCBudget Request, go to: www.ftc.gov/ftc/oed/fmo/2013_CBJ.pdf.

may reduce the risk of falling. Falling is a risk factorfor bone fracture.” The Scientific Opinion can befound in EFSA Journal 2011; 9(9): 2382.

RISK OF FALLING -- Continued from page 13...


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Poke Weed (Phytolacca decandra)(1817-1818)Photo Courtesy of Lloyd Library & Museum

WWW.NATMEDLAW.COM

See AXIS LABS - Cont’d on p.23...

AXIS LABS SENTENCEDFOR DISTRIBUTION OFPRODUCT CONTAININGSYNTHETIC ANABOLIC

STEROIDS

The U.S. Attorney’s Office for the

District of Colorado announcedJanuary 18, 2012 that Axis Labs,LLC, a company based inCentennial, Colorado, wassentenced by Chief U.S. DistrictCourt Judge Wiley Y. Daniel toserve one year probation and pay$107,000 to the U.S. AssetForfeiture Fund as well as pay afine of $50,000 in connection withthe illegal distribution of productcontaining synthetic anabolicsteroids.

On September 7, 2011 Axis Labswas charged by Information withmail fraud. On October 13, 2011the company pled guilty to mailfraud. They were sentencedJanuary 18, 2012.

According to court documents,Axis Labs was involved in theillegal distribution of a productcalled “Monster Caps” whichcontained synthetic anabolicsteroids, United States AttorneyJohn Walsh and FDA Office ofCriminal Investigations SpecialAgent in Charge Patrick Hollandannounced.

Axis Labs engaged in the businessof manufacturing, labeling,shipping and selling certain foodproducts. The business was activein and responsible for thedistribution and marketing of aproduct called “Monster Caps.” The intended use of the productwas to enable weight loss and theproduction of muscle mass. Theproduct falsely purported pursuant

to its label to be a “dietarysupplement” and therefore couldbe distributed and dispensedwithout prior approval from theFDA and without a prescriptionfrom a duly authorized physician. “Monster Caps” containedanabolic steroids, or similarsynthetic compounds. BecauseAxis Labs intended these productsto affect the structure and functionof the human body, they wereactually drugs regulated by law. Moreover, they were also newdrugs and lacked the approvedNew Drug Application as requiredby law.

Between June 2008 and May2009, Axis Labs sold “MonsterCaps” on the Internet, to customersthroughout the United Stateswithout the required FDA approvalfor a new drug and withoutrequiring a prescription. Thecompany distributed the product bydelivering it, or causing it to bedelivered to customers via theUnited States Mail, or UPS.

“Consumers need to haveconfidence that products claimingto be ‘dietary supplements’ are not,in fact, unapproved new drugs,”said Patrick J. Holland, SpecialAgent in Charge of the FDA Officeof Criminal Investigations. “Wewill aggressively investigate thosewho place profits over publichealth by marketing purporteddietary supplements that containdrug substances such as syntheticanabolic steroids.”

There was an information filedcontaining one count of mail fraudand Aiding and Abetting, 18 USC1341 and 2. During the SentencingHearing the LLC spokesperson

was a Mr. Gatchis who spoke onhis own behalf.

This case was investigated byFood and Drug Administration –Office of Criminal Investigations.The FDA Office of CriminalInvestigations listed on theInformation Form is Dan Burke,Special Agent.

This case was prosecuted byAssistant U.S. Attorneys JaimePena, with the Health Care FraudTask Force. Tele: 303-454-0100 orEmail: [email protected] Tonya Andrews, same Tele.and Email:[email protected] attorneys were DavidLindsey, Esq. of Englewood,Colorado, Tele:303-228-2270 andRichard D. Collins, Esq. of the firmCollins, McDonald & Gann, P.C.,in Mineola, New York, Tele.: 516-294-0300, or Email:[email protected].


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See HERBAL MEDICINE REGISTRATION.-- on page 23...


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HERBAL MEDICINE REGISTRATION - Continued from page 22...

Source of more web information: http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedicinesregulation/RegisteredTraditionalHerbalMedicines/LIstofproductsgrantedaTraditionalHerbalRegistrationTHR/index.htm

The case was USA v. Axis Labs, LLC, Case No. 1:11-cr-00363. Presiding was U.S. District Judge WileyY. Daniel who was nominated in 1995 by PresidentWilliam J. Clinton and assumed the bench in the sameyear. Judge Daniel has been chief Judge since 2008.This article was prepared using a release by the U.S.Attorney’s Office in Denver and a review of the courtdocket by NML.

AXIS LABS -- Continued from page 19...FDA APPROVES TWO NEW

PANCREATIC ENZYME PRODUCTS

Two new pancreatic enzyme products used to help

aid food digestion, Ultresa (pancrelipase) and Viokace(pancrelipase), were approved March 1, 2012 by theU.S. Food and Drug Administration.

Ultresa is a delayed-release capsule used to treatchildren and adults with cystic fibrosis, a seriousgenetic disorder affecting the lungs and other organs,

See ENZYME PRODUCTS -- Cont’d on p. 24...


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ENZYME PRODUCTS -- Continued from page 23...

or other conditions who cannot digest food normallybecause their pancreas does not make enoughpancreatic enzymes.

Viokace, in combination with a proton pumpinhibitor, is used to treat adults who cannot digestfood normally. Adults with chronic pancreatitis, acontinuing, chronic inflammatory process of thepancreas, or those who have had some or all of theirpancreases removed (pancreatectomy) may not digestfood normally because they lack needed enzymes orbecause their enzymes are not released into the bowel(intestine). Viokace’s safety and efficacy in childrenhas not been established.

“The approvals of Ultresa and Viokace, along withthe other approved pancreatic enzyme products, allowhealth care providers to prescribe the product that ismost appropriate for the estimated 200,000 patientsin the United States who have pancreaticinsufficiency,” said Julie Beitz, M.D., director of theOffice of Drug Evaluation III in FDA’s Center forDrug Evaluation and Research.

Ultresa and Viokace are the fourth and fifthpancreatic enzyme products approved by FDA. OtherFDA-approved pancreatic enzyme products includeCreon (2009), Zenpep (2009) and Pancreaze (2010).Approved pancreatic enzyme products meet FDAstandards for safety, efficacy and product quality.

Unapproved pancreatic enzyme products had beenavailable for many years. FDA established a date ofApril 28, 2010 for the makers of pancreatic enzymeproducts to stop manufacturing and distributingunapproved products.

Ultresa and Viokace are marketed by Bridgewater,N.J.-based Aptalis Pharma U.S. Inc.

name will attract the appropriate fee.

Although the superseded ingredient names will berecorded in the ingredient code tables as synonyms,these names will no longer be able to be used in anARTG listing or on the label of a medicine.

HERBAL NAMES UPDATE -- Continued from page 7...

Sponsors are also reminded that they are required toupdate the labels of any medicines containingingredients subject to name change at the next printrun, or within two years of the names being updatedby the TGA.

For further information please contact the TGA byemail on [email protected] or by phone on 02 62328634.

List of herbal ingredient names used in medicineson the ARTG requiring correction may be found at:http://tga.gov.au/industry/cm-notices-herbalnames-120301.htm.

MHRA UPHOLDS COMPLAINT ABOUTPOINT OF SALE ADVERTISING OF

NELSON’S HOMEOPATHIC PRODUCTS

Back on November 9, 2011, the Nightingale

Collaboration (NC) complained to the Medicines andHealthcare products Regulatory Agency in the U.K.about certain point of sale advertising found inHolland and Barrett Stores and on their website.Earlier in 2011 the NC complained about similar pointof sale advertising found in Boots Pharmacy Storesfor homeopathic products.

In the case of Boots the offending advertising wasa book of flip cards next to a rack of homeopathicproducts. The flip cards listed indications, symptomsand homeopathic products. MHRA ruled theindications were not licensed because they were notregistered under the Simplified Rules Scheme forhomeopathic products.

NC soon released an advertisement to chastise theSuperintendent Pharmacist or Manager present indrug stores or pharmacies in the UK, telling themabout the Boots case saying further that “You will beaware that the professionalism of pharmacies andpharmacists is vital to maintain public confidence andthat abiding by the MHRA’s rules and the law is anecessary part of professionalism. You may be usingpoint of sale information similar to that of used byBoots and would suggest that you review it to ensurethat you are not in breach of the MHRA’s


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NIGHTINGALE -- Continued from page 24...

See CAPSICUM TRADEMARKS -- Continued on page 26...

requirements, whether under the Simplified Schemeor other MHRA rules.”

Boots and Holland and Barrett agreed to removethe point of sale advertising and review their websites.These cases may be looked up at: www.mhra.gov.uk/Howweregulate/Medicines/Advertisingofmedicines/Advertisinginvestigations.

The control of advertising of medicines in the UKis explained in The Blue Guide. The Blue Guide maybe downloaded at: www.mhra.gov.uk/home/groups/pl-a/documents/publication/con2022589.pdf.

The NC is a private company limited by guaranteewith a registered office at 7 St. John’s Road, Harrow,HA1 2EY.

TRADEMARKS FOR CAPSICUM ANNUUM

Surprise, there is no trademark for Capsicum

Annuum on the USPTO web site; there is no Annuumtrademark on the web site as well; but there are ninemarks for Capsicum: three dead and six alive. Hereis a brief review.

OCAT with a large cat head protruding from the Ois a word and design service mark for use inInternational Class 041 for educational services,namely, conducting training classes in the field ofusing oleoresin capsicum aerosol for individualsinvolved in human services work, law enforcementofficers, security guards and public safety personnelwas first used August 3, 2011 The application is aservice mark filed at Serial No. 85/436302 onSeptember 30, 2011 by Personal ProtectionConsultants, Inc. of Spring Mount, Pennsylvania. Theexaminer has issued a letter requesting informationor stating an initial refusal and a response is due 6months from January 1, 2012.

OCAT with a large O containing a side view of acat is a word and design mark for use in InternationalClass 041 for educational services, namely,conducting training classes in the field of usingoleoresin capsicum aerosol for individuals involvedin human services work, law enforcement officers,security guards and public safety personnel was first

used June 1, 2006. The application is for a servicemark filed at Serial No. 76/654572 on February 3,2006 by Personal Protection Consultants, Inc. ofSpring Mount, Pennsylvania. The mark wasregistered on December 12, 2006 as Registration No.3182427. On February 9, 2009 the USPTO Emailedan acceptance of Section 8 & 15 Affidavit.

OCAT is a word mark for use in International Class041 for educational services, namely, conductingtraining classes in the field of using oleoresincapsicum aerosol for individuals involved in humanservices work, law enforcement officers, securityguards and public safety personnel. The mark isRegistration No. 3118804 granted on July 25, 2006to Personal Protection Consultants, Inc. of SpringMount, Pennsylvania. On October 22, 2010 theUSPTO Emailed an acceptance of Section 8 & 15Affidavit.

CAPSICUM is a word and design mark in IC 035for business and management consultant servicesrelation to several business purposes. Above the “i”in the word has a reverse “s” indicating smoke, steamor vapor. The mark was first used March 1, 2002.This mark was approved September 17, 2002 asRegistration No. 2762624 to Capsicum Group, Inc.of Berwyn, Pennsylvania. An assignment has beenrecorded to the Capsicum Group, LLC, Ltd ofPhiladelphia, Pennsylvania.

CAPSICUM is a word mark in IC 035 for businessand management consultant services relation toseveral business purposes. The mark was first usedMarch 1, 2002. This mark was approved September16, 2002 as Registration No. 2765339 to CapsicumGroup, Inc. of Berwyn, Pennsylvania. An assignmenthas been recorded to the Capsicum Group, LLC, Ltdof Philadelphia, Pennsylvania.

POROUS-CAPSICUM-PLASTER is a word anddesign mark in IC 005 for pharmaceuticalpreparations; namely, medicated plasters of thetreatment of minor aches and pains of the musclesand joints. The design has the look of a cigar wrapperband with the three words set one over the other. Itwas first used in August 5, 1988. The mark was issuedRegistration No. 1923244 on October 3, 1995 to


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See CSPI vs SALT INSTITUTE -- Continued on page 27...

Anglo-Swiss Trading Co., PTC. LTD of Singapore.The mark was assigned to Astrabon (S) PTE, LTD ofSingapore on February 13, 1996.

WILD WILLY’S CAPSICUM COWBOYS is nowa cancelled mark that was filed May 26, 2000 byWilliam C. Mill, II of West Littleton, Colorado andregistered on December 17, 2002 for bottles salsas inIC 030. The mark was cancelled for failure to file aSection 8 (6 year) affidavit of use. This mark wasfirst used June 1, 1999.

POROUS-CAPSICUM-PLASTER is a mark offoreign characters (Chinese) that translate to theEnglish words given here. The mark was first usedOctober 24, 1961 and first used in commerce onAugust 5, 1980 by So’s U.S.A., Inc of Los Angeles,California in IC 005 for pharmaceutical preparationto comfort complaints of Rheumatism, Lumbago,Sciatic, Chest and Lung complaints. The mark wasissued a final refusal on April 17, 1992 and abandonedNovember 25, 1992 for failure to respond or lateresponse to an Office Action.

POROUS-CAPSICUM-PLASTER is anabandoned mark in the form of a design of pepperfruits surrounding the three words, one over the other.The mark was first used October 24, 1961 and firstused in commerce on August 5, 1988 by So’s U.S.A.,Inc of Los Angeles, California in IC 005 forpharmaceutical preparation to comfort complaints ofRheumatism, Lumbago, Sciatic, Chest and Lungcomplaints. The mark was issued a final refusal onApril 17, 1992 and abandoned November 25, 1992for failure to respond or late response to an OfficeAction.

CSPI AGAIN CALLS FORLESS SALT; THE SALT INSTITUTE

PROVIDES MORE STUDIES

In a January 30, 2012 news release the Center for

Science in the Public Interest released the results of apublic survey that claimed “71 percent of Americansindicated that the food industry had a responsibilityto reduce the sodium content of their foods, and 58percent support a government requirement to reducethe sodium in processed and restaurant foods.” About

the same time CSPI says it wrote to FDA to demanda “strong, but realistic, mandatory regulations toreduce sodium levels in restaurant and packagedfoods.”

The CSPI release did not say how many people werequizzed, when the survey was taken, or what surveyfirm did the work in either its news release or in thenine-page letter it sent to FDA. CSPI did say theJanuary 2012 national survey was taken by telephone.But CPSI did mention sources for other surveys takenyears earlier in the footnotes of its letter to FDA. Theletter to FDA can be viewed at: http://cspinet.org/new/pdf/fda-comments-sodium-reduction2012.pdf.

The Salt Institute provides the manufacturers pointof view and announced on February 1, 2012 with aPRWeb announcement stating, among many otherthings, that comments published onwww.regulations.gov website concerning FDA’s saltideas were 9 to 1 against FDA taking any actions onsalt. The Salt Institute cited “Graudal and Jürgensdid a 2011 meta-analysis of 167 previous studies onsalt, one of the most exhaustive reviews to date. Theirfindings were published in the American Journal ofHypertension and the prestigious Cochrane LibraryJournal. In all, six 2011 medical studies vindicatedsalt’s impact on health while pointing out the risks oflow-salt diets, including:

Type 1 Diabetes risk: In a study on patients with type 1diabetes, low sodium intake was independentlyassociated with all cause mortality and ESRD (end-stagerenal disease).

Type 2 Diabetes risk: In an Australian study with type 2diabetes patients, lower sodium was associated withincreased all-cause and cardiovascular mortality.

No benefit to salt reduction: A study published in theAmerican Journal of Hypertension showed eating lesssalt will not prevent heart attacks, strokes or early death.On the contrary, low-sodium diets increase likelihoodof premature death.

Risk of death: A multi-year study on a very large cohortconcluded that lower salt intakes resulted in highermorbidity and mortality.

Negative effects of low-salt intakes: An analysis of 167studies showed individuals placed on the U.S. DietaryGuidelines-recommended salt levels experienced


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CSPI vs SALT INSTITUTE -- Continued from page 26...

significant increases in plasma renin, aldosterone,adrenaline, and noradrenalin, cholesterol andtriglycerides – all risk factors for diabetes andcardiovascular disease.

Risk of current U.S. Dietary Guidelines: An analysis ofalmost 29,000 adults published in the Journal of theAmerican Medical Association, examining theassociation between estimated sodium intakes andcardiovascular events, showed that CV risk was increasedamong those with the lowest levels equivalent to thecurrent recommendations in the Dietary Guidelines.

According to the Salt Institute the comments postedon the government’s website, Graudal and Jürgenstold the FDA “that the `science’ on which the FDApolicy on sodium reduction is based is dubious. Thistruth is already unmistakable now for most interestedscientists and sooner or later it will be clear also tolaymen. When this happens there will be responsiblepersons who would have a problem as the presentrecommendations may kill people instead of savingthem. We therefore suggest that FDA, instead ofconsidering how to reduce the sodium intake in thepopulation, reconsiders the policy.”

The title of the Salt Institute’s PRWeb release wasa question, “Is the U.S. Government’s SodiumReduction Policy Based Upon ‘The Biggest Delusionin the History of Preventive Medicine?’” This canbe viewed at: www.prweb.com/printer/9155620.htm.

CRN SAYS FDA DATA OUTDATED

The Council for Responsible Nutrition has issued a

Backgrounder piece that appears under “What’s New”on the home page of its website at www.crnusa.orgthat states FDA’s data about the “often-cited statisticthat the Food and Drug Administration (FDA)receives ‘less than one percent of all adverse eventsassociated with dietary supplements’ is based onoutdated, irrelevant data.”

CRN says what is missing is that the FDA does notaccount for the fact that dietary supplements have beensafe for a long time. And there are other problemswith FDA’s thinking on this that CRN has footnotedcarefully. For example,

• The “less than one percent” statistic originated froman FDA-commissioned study released in 2000. It pre-dates the 2006 law that requires dietary supplementmanufacturers to report serious adverse events to FDAand is therefore outdated.

• Even more troubling, it’s not about dietarysupplements. The author of that study bases this “lessthan one percent” finding on prescription drug andvaccine related adverse event data – NOT dietarysupplement related data. It is a “best estimate,”following a conclusion that the reporting rate of drugand vaccine adverse events “is very low” and thatsupplements are likely to be similarly under-reported.

• Despite this flawed assumption, the “one percent”statistic has taken on a life of its own, appearing inthe media; cited in conferences and scientific journals;referenced by the HHS Inspector General and theGAO; and reiterated by FDA itself.

• In 2006, Congress passed a law requiringmanufacturers to report all serious adverse events theyreceive to FDA. The dietary supplement industrysupported this law, which has been in effect sinceDecember 2007.

• FDA has the authority to take action againstsupplement companies that violate the law by failingto report. The agency has used that authority to issuewarning letters, products recalls, and even bring anenforcement action against a firm that failed to fileits adverse event reports. The numbers show thatdietary supplements are among the safest FDA-regulated products.

• Between 2007 and 2010, FDA received a total of4,194 serious adverse events reports associated withdietary supplements over that four-year period.

• In 2010 alone, FDA received over 471,000 reportsof serious adverse events related to drugs or biologicproducts—of this number, nearly 83,000 were deaths.

• These numbers demonstrate the wide margins ofsafety that dietary supplements enjoy as billions ofdosage units were sold during that same timeframe.

William J. Skinner, R.Ph., Attorney at Law, Editor

HARVESTING HEALTHTHROUGH THE LAW

International Congress on

Natural Products Research

2012

New York, New York

July 28-August 1, 2012

www.pharmacognosy.us

www.icnpr2012.org

Natural Anticancer DrugsOlomouc, Czech Republic

June 30 - July 4, 2012

www.nad2012.com

Int’l Symposium onEssential Oils

Lisbon, PortugalSeptember 5 - 8, 2012www.iseo2012.fc.ut.pt

American Herbalist Guild

Symposium

October 18-21, 2012

Seven Springs Mountain Resort

Seven Springs, PA.

More details soon at:

www.americanherbalistsguild.com

NML sorts through important

developments every day so thatyou do not miss them every othermonth. Some readers say they areglad to learn about or to bereminded of the issues NMLreports on because there are toomany events, decisions,developments, and court cases tocover them all. It is like havinganother person on the staff, onesaid, and the cost is tiny comparedto the health care costs for anotheremployee.

In the U.S., corporations arereceiving criminal sentences forviolating the FDCA. Fines,probation, reports, meetings, andbanned production are included inthese sentences. Probation did notalways apply to corporations, butit does now. Persons involved inthese kinds of cases who violate theFDCA in the future are likelyasking for time in prison for thenext conviction.

CSPI is another example of aprivate attorney general, withoutall of the statutory authority of an

officer of the government,conducting law suits to getsettlements from companies whoare claimed to be misleading thepublic. CSPI has successfullypressured for changes in productlabeling in the past and they tell youabout some of that in their letter toAmway. We do not know yet howAmway will respond to CSPIpressure.

The CSPI seems to have drawn astalemate in its scientific challengegame with the Salt Institute. CPSItakes pleasure in saying that morepeople agree with them about toomuch salt in the diet. The SaltInstitute says 9 out ten commentson www.regulations.gov say “no”to FDA changes and that 167research studies say too little saltwill kill more people than too muchsalt. Who is deceiving who? Moreresearch must be done to solve thissavory fight.

The U.S. Budget for FY 2013 isdown by a miniscule amount butstill facing another $1 Trilliondeficit that will be added to thenational debt for a third year in arow. Congress gave FDA a lotmore work to do and the President

gave it only $11.5 million more todo its work this year. The FTC ispaying much of its own way withfines, but the agency asked for less.An election in November 2012could change the way the U.S.spends taxpayer money and thatelection has been underway formonths. The contest is about to getstarted in earnest.

Across the Atlantic Ocean, the ECwill take a controversial vote onEFSA claims opinions about thetime you receive this issue. Thiswill set the stage for health claimson herbal and supplement products

for years toc o m e .Scotland istalking aboutadding moreVitamin D tofood, Greecehas reducedsome debtand stiffed

bond holders, and other membersof the EU will have to deal withbudget reductions soon. It is acontentious world, but a good placeto be as we work to become fit.

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