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-.*& RAND Marketing 4221 W. Eisenhower Blvd., Suite 1 Loveland, CO 80537 ~_ . . . _ . .I i ‘--‘fQ ;,If? --:r! t;j:y 6-t {“iii “2 f i February 23,2001 Office of Special Nutritionals, Center for Food Safety and Applied Nutrition Food and Drug Administration 200 c St. SW Washington, DC 20204 Re: Structure Function Claim - Super Shield Dear Sir or Madam: This is notification, in compliance with the CFR 21,101.93, that RAND Marketing, LLC has included a statement on a product label that may fall under the Federal Food, Drug, and Cosmetic Act section 403(‘r)(6). The statement listed below appears on Super Shield and refers to the ingredients Green tea leaf extract, Grape seed extract (95% proanthocyanidins) and RoseOx@, Enzogenol. “Super Shield is a state of the art antioxidant blend that works synergistically to attack the free radicals produced by our own metabolism and from the environment. Studies have shown that antioxidants can help reduce the effects of free radical damage, which has been shown to be a factor in many healthrelated issues, and slow the aging process.” Enclosed is a sample of the label for this product. RAND Marketing keeps susbstantiation on the premises that this statement is truthful and not misleading. SUER SHIELD is a state of the art antioxidant blend that works synergistically to attack the free radicals produced by our own metabolism and the environment;b Studies have shown that antioxidants can help to reduce the effects of free radical damage, which has been shown to be a factor in many health-related issues, and slow the aging pr0cess.t DliZECTiONS:Take two caplets daily or as directed byyour health care professional. IMP~RTANTIWTE Keep out of reach of children. Protect from heat, light and moisture. Store at 15-30°C [SS-86’4. Do not purchase if seal is broken. ’ iThis statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease. L Exclusiveiy formulated for and distributed by: ox y&e!+ International 8170 South UniversityAve., #1 IO Littleton, CO 80122 1-888-699-2473 Made in U.S.A. Amount Per Serving Global Ginsengs Standardized Extract Blend: American ginsengToot, Brazilian ginseng root, Chinese white ginseng root, Indian Ginseng root, Japanese ginseng root (Pmaxjaponicus), Korean red ginseng root, Mexican ginseng root. Tienchi 400 mg’ RAND-550700.0, lther ingredients: dicalcium phosphate, microcrystalline cellulose, croscarmellose sodium, steatic acid, magnesium stearate, silica, and pharmaceutical glaze, 7331 o&I ,
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5/5/2008
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