A VRM, Inc. Publication January 2012

Also Inside:2012 Industry Forecast

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The dietary supplement industry’strade associations—American HerbalProducts Association (AHPA),

Consumer Healthcare ProductsAssociation (CHPA), Council forResponsible Nutrition (CRN), NaturalProducts Association (NPA) and UnitedNatural Products Alliance (UNPA)—joinedtogether to call for an overhaul of theFood and Drug Administration’s (FDA)Draft Guidance for Industry: DietarySupplements: New Dietary IngredientNotifications and Related Issues, which inits current form undermines both the letter of the law and the intent of theDietary Supplement Health & EducationAct (DSHEA) of 1994, according to theassociations.

The Draft Guidance issued by FDA inJuly, if implemented and enforced by FDA,would burden industry, placing unreason-able requirements on business, especiallysmaller firms, and create unreasonable bar-riers of entry for newer market entrants,without any related benefits for consumers,according to the five industry trade associa-tions. While the groups submitted separatecomments to reflect their own membershippriorities, the five associations stressed thatFDA should focus on the common themesin their respective submissions, rather thanlook for points of disparity as indicating anysubstantive differences of opinion amongthe groups. “We are all committed to see-ing a substantial overhaul of the draft guid-ance and are united in our common beliefthat the document is overreaching and

contravenes DSHEA,” the associationsannounced jointly.

Common key issues identified in thedraft guidance by the trade groups include:

• Requiring submission of a notificationfor virtually every product that contains anNDI from every manufacturer

• A shift in the burden of proof that an ingredient is not an NDI from FDA to individual companies

• FDA’s claim that there are no authoritative lists of “grandfathered”ingredients that can be used to establishthat a dietary ingredient is an Old DietaryIngredient (ODI), which dismisses the relevance of “grandfathered” lists submitted by the trade associations in1996-98 for establishing that dietaryingredients are pre-DSHEA ingredients

• Misinterpreting the meaning of theterm ‘‘chemically altered,’’ which signifi-cantly expands the category of ingredientsthat would constitute an NDI

• Stating that human synthesized con-stituents of botanical ingredients are differ-ent from those synthesized by the plant

• Imposing a level of data necessary todemonstrate the safety of an NDI similarto what is required for food additives, astandard already rejected by Congressand the courts

Manufacturers and suppliers are support-ive of the action. “We agree with the com-ments filed by the trade associations,” saidShaheen Majeed, marketing director forSabinsa Corporation (East Windsor, NJ). “Itis this consistent nature of comments that

sends a clear message to FDA that theguidelines need to be revised. We believein the safety of these ingredients in themarketplace, so we welcome such guid-ance, however, we do not feel the currentdraft guidelines actually deal with safety,rather they reflect the lack of understand-ing on many points by the FDA.”

“The trades really looked at it from thepoint of view that political interpretationcould have limited what was written,”added Beth Lambert, CEO of Herbalist &Alchemist (Washington, NJ). “I think theygave really constructive responses to FDA.”

Jarrow Formulas, Inc. (Los Angeles, CA)also called for a rewrite of the NDI DraftGuidance. “The Guidance goes directlyagainst the grain of U.S. hopes and goals atthis point in our history, and is truly an escortto the guillotine for the supplement industryand a gross violation and disrespect of thewill of the American people,” said JarrowRogovin, founder of the company.

The trade associations requested FDA tocarefully consider the comments to thedocket it has received and to issue guid-ance that addresses these serious concerns.They also urged for a timely response fromthe agency to provide industry with clarityand direction as the industry attempts tocomply with the requirements of the law,and the associations offered to work withFDA to achieve that goal.

For more information, visitwww.ahpa.org, www.chpa-info.org,www.crnusa.org, www.npainfo.org orwww.unpa.com.

Supplement Industry Calls for NDI Draft Guidance Overhaul

T he Health and NutritionVirtual Trade Show — a freeonline trade show and

educational conference for allmembers of the natural productsindustry — made its internetdebut in December and will remain“live” through the end of January, 2012.

Sponsored by Vitamin Retailer maga-zine, the Health and Nutrition VirtualTrade Show features virtual exhibits byleading industry manufacturers, alongwith an Auditorium, Learning Centerand Library where attendees can watcheducational health videos and downloadvarious articles and resource materials.

According to show management, the

virtual show has been an overwhelmingsuccess to date, with hundreds of natural product retailers and otherindustry members visiting during its first month.

Exhibitors featured at the Health andNutrition Virtual Show include: NorthAmerican Herb & Spice, Carotech, E.W.Packaging, Therapipe, Mother EarthMinerals, Once Again Nut Butter,Orgenetics, Pain & Stress Center, PinesInternational, The Natural Dentist,

RU-Ved, Magnascent Iodine, Vaxa, Xlear and Life Extension.Various show specials, productinformation and video presentations by exhibitors canbe viewed at the virtual booths

located in the show’s Exhibition Hall.Educational videos by such health

experts as Jacob Teitelbaum, M.D.,Amber Lynn Vitse, Dr. Andrew Weil, and Dr. Virender Sodhi are featured inthe show’s Auditorium, with new educational materials being made available each week.

To attend the Health and Nutrition Virtual Trade Show, go towww.marketplace365.com/healthandnutritionshow.

Virtual Trade Show Open Through January!

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nyone who has experi-enced heartburn knowshow uncomfortable itcan make a person.Eating something that

“doesn’t agree” can cause a sensationof tightness, pain, discomfort or burningin the chest. The irritation caused byheartburn can make it difficult to con-centrate on a task or sleep soundly.

Occasional heartburn is fairly com-mon; in fact, in any six- to 12-monthperiod, 20 to 40 percent of healthy peo-ple will experience heartburn symptoms,according to Cheryl Myers, head of edu-cation and scientific affairs forEuroPharma USA (Green Bay, WI). “Inthe past, we may all had an image ofthe typical heartburn sufferer as being

middle-aged and male, but heartburnand GERD (gastroesophageal reflux dis-ease) affect people of a variety of back-grounds across the board,” she said. Butif the pain becomes persistent, a personmay be suffering from acid reflux.

Acid reflux disease (also known asGERD) occurs when stomach acid isregurgitated up into the esophagus.Health professionals at the AmericanGastroenterological Association esti-mate that 33 percent of people in theU.S. have acid reflux disease.Additionally, acid reflux disease is themost expensive chronic gastrointestinaldisorder in the U.S., costing Americansapproximately $10 billion each year.

“The market for heartburn/acid refluxsupplements is very large today with

approximately 65 million Americansexperiencing heartburn daily. That’s alot of people seeking relief,” saidBrenda Watson, founder and presidentof ReNew Life Formulas (Palm Harbor,FL). “Many choose pharmaceuticalproducts that either stop hydrochloricacid (HCl) production or simply neutral-ize stomach acids. Neither of theseoptions addresses the real causes ofheartburn such as poor digestion, over-eating, alcohol consumption and more.Savvy consumers are increasingly turn-ing to natural supplements for relief,creating exciting potential for realadvancements and natural alternativesin this category.”

According to Watson, the standardAmerican diet (SAD) is one of the

Naturalproducts

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digestive distress.

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biggest contributors to poordigestive health. The SAD ishigh in calories, is filled withprocessed foods, and is low innutrients and essential fiberfound in fresh fruits and vegetables. “Most people donot consume nearly enough ofthe heart-healthy fats that arehigh in beneficial omega-3 andomega-9 fatty acids,” sheexplained. “One of the manyhealth implications of thisimbalanced diet is an increase in poordigestion and heartburn, which exacerbate further health problemsdown the line.”

Going NaturalWhile many consumers reach for anantacid when the symptoms of heartburn or acid reflux start to appear,they may be doing more harm thangood. Taking antacids masks symptomswhile suppressing a persons natural HCIlevels and essential stomach acids,which can have negative effects onmany systems in the body. “I think theoverall market for heartburn relief isprobably quite strong, once you caneducate people to leave the commonantacids and PPI’s (proton pumpinhibitors) alone,” said Myers. “Whatmany people don’t realize is how dan-gerous long-term use of these productsis. PPI’s can double your risk of bonefractures by interfering with the body’snatural nutrient absorption of beneficialminerals, deplete vitamin B12 and create a permanent state of too littlestomach acid.”

EuroPharma’s Advanced HeartburnRescue™ helps stop the symptoms ofheartburn and promotes a healthier bal-ance of stomach acid and overall diges-tive health. The company also offersGut Soothe™, which features a clinical-ly-studied DGL(deglycyrrhizinatedlicorice) extract thatdoesn’t need to bechewed, combinedwith a highly-effec-tive probiotic,Lactobacillus para-casei, for additionalimmune and diges-tive support.

Recently,EuroPharma part-nered with Dr. Jacob Teitelbaum tolaunch Immediate Heartburn Relief™, achewable tablet that can help providerelief while someone is also taking

Advanced Heartburn Rescuefor a long-term regimen.

Enzymes play an essential role inevery function in the human body,including eating and digestion. In thedigestive tract, enzymes break downfoods by breaking apart the bonds thathold nutrients together. “Enzymes havea direct impact on not only breakingdown food to its simplest components,but also relieving stress on the digestivetract,” said DaveBarton, director ofeducation forEnzymedica Inc. (PortCharlotte, FL).

ReNew Life has aline of products thatincludes Digest MoreUltra, a full-spectrumdigestive blend thatcontains a high-dose100,000 HUT pro-tease blend, animportant protein-digesting enzyme, plus13 more enzymes designed to helpdigest an array of food types. The com-pany recently introduced the STOP lineof natural digestive solutions, featuringproducts such as GasSTOP,HeartburnSTOP and IndigestionSTOP.ReNew Life’s newest formulation isHeartBURN OUT, a natural quick-spray

mist that is sprayedinto the throat forinstant relief from theeffects of occasionalheartburn.

Enzymedica offersAcid Soothe capsules,which provide enzymesto help speed diges-tion of foods andmove them out of thestomach as quickly aspossible. This reduces

the body’s need to make acid, and pro-vides zinc carnosine to protect and forti-fy the damaged areas of the lining ofthe stomach. Additionally, Acid Soothe

capsules provide soothing herbs to calm the irritated stomach lining reducing the distress the consumer may besuffering. The company recentlyintroduced chewable AcidSoothe tablets, which contain nofillers, and contain fast-acting,natural soothing ingredients plusdigestive enzymes, according tothe company.

“Consumers are becomingmore educated and more

accustomed to seeking natural alternatives for maintaining optimalhealth,” said Barton. “Enzymedica iscommitted to expanding on this con-sumer education so as to further drivethem to their local health food stores.”

Retail TipsOffering customers samples to see theeffectiveness of a product can go a longway. EuroPharma takes it a step furtherand offers a money back guarantee.Retailers can also place products by the

register for customers to grabwhile checking out or createeye-catching displays aroundholidays when people are morelikely to eat larger, heaviermeals than usual.

But one of the most impor-tant things retailers can do iseducate themselves so cus-tomers feel comfortable ask-ing their advice. Shoppersmay visit a store to explain thesymptoms they are experienc-ing and want to be pointed in

the right direction of whatproduct they should be using. Whenspeaking to a customer, Barton sug-gested that retailers “ask how oftenthe consumer experiences digestiveissues, [and] demonstrate the need fora product that may help their cus-tomers feel better with all naturalingredients.”

“Most importantly, I think makingyour store a ‘health info destination’ isone of the best bets,” said Myers. “Be ahost to seminars. Reiterate how closelyconnected gut health and overall healthreally are—because I believe many people still think of them in terms ofisolated systems.” VR

� Enzymedica, Inc., (888) 918-1118� EuroPharma USA, (866) 598-5487� ReNew Life Formulas,

(800) 830-4778

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