Warning Letters 31146

FDA advised Global InformationConcepts that a review of its Web site, www.kcweb.com,revealed the use therapeutic claims for products, such as echinacea, choline andmagnesium. The agency noted such claims establish the offending products asdrugs, which cannot be marketed without prior FDA approval; the products arealso not GRAS (generally recognized as safe) for the conditions referenced inthe offending claims, thereby rendering the products new drugs.

FDA warned Health Image itsWeb site, www.health-image.com, contains products marketed as drugs by the useof therapeutic claims. Vitamin E & Selenium Complex, Green Tea ExtractCapsules, and Bee Propolis 500 mg are promoted for conditions such as asthma,cancer, heart disease and rheumatoid arthritis; they are also not GRAS for the disease conditions.

FDA notified Ridgecrest HerbalsInc. its Web site, www.ridgecrestherbals.com, usestherapeutic claims to market its products Blood Sugar Balance, ClearLungs Redand VisionAid, causing them to be considered drugs.The agency further noted theabsence of GRAS status for these products and the conditions referenced in theoffending claims.

FDA alerted Lifeline Foods LLC itsWeb site, www.lifelinefoods.com, markets supplements Acute Cold & Flu andADD Attention for conditions that cause the products to be positioned as drugs.Numerous vitamin, mineral and herbal ingredients in Acute Cold & Flu arepromoted as antimicrobials, antiseptics, expectorants and anti-inflammatories;ADD Attention was cited because its title suggests it is intended to treat, cureor mitigate attention deficit disorder (ADD). The agency further classified theproducts as new drugs, as they are not GRAS for the referenced conditions andtherapeutic actions.

FDA cautioned Austin NutritionalResearch numerous products on its Web site,www.anrvitamins.com, are promoted for conditions that render the products asdrugs. Vitamin A, niacinamide, pantothenic acid, phoasphatidyl choline,inositol, vitamin C, vitamin E, calcium, ginger and histadine are a few of theoffending products, which are also not GRAS for the conditions referenced in thetherapeutic claims.

FDA issued a group warning to UrbanNutrition for its many Web siteswww.urban-nutrition.com,www.urbannutritioninc.com, www.findlongevitynow.com, www.findserenitynow.com andwww.mydailydose.comthat market products with therapeutic claims. Urbanproducts Longevity, Serenity and MyDailyDose are promoted to treat or mitigateconditions and diseases, including multiple sclerosis, asthma, depression andgeneral degenerative disease. The agency further noted personal testimonials onthe sites also utilize disease claims.

Priority One NutritionalSupplements Inc. also received an FDA Warning Letter,following two inspections of the firms Lynden, Wash., facility. According tothe agency, several dietary supplements were misbranded with disease claims,including Protozyme (promoted for reducing tumors) and Vana-Trace (reported tobe helpful for diabetes and high blood pressure). The companys productreference guide further included a Diagnostic Index listing numerousdisease conditions and suggested dietary supplement products. FDAs lettersaid it considers the products misbranded with significant labeling deviations.