June 21, 2004
FDA Warning Letters WASHINGTONFDA continues its oversight of natural products companies, and has issued several warning letters in the past month for companies allegedly making claims outside of the allowance of the Dietary Supplement Health & Education Act (DSHEA). Literature and Web site claims for Supreme Greens with MSM were collected during an FDA visit to ITV Direct. FDA warned the company that its claims position the product as a drug, and as such it is an unapproved new drug; in addition, structure/function claims on the product are allegedly unsubstantiated, making the product misbranded. Noni products from Mundo Natural were investigated by FDA, and found to contain claims about disease cures. FDA noted claims about noni being used to treat diabetes, arthritis, cancer, etc., position the products as new drugs that have not been approved with a New Drug Application and are therefore in violation of federal law. PRO BITES products from Peak Performance Foods were singled out in an FDA warning letter for disease claims (obesity) and misbranded because of claims about fat and carbohydrate levels. In addition, FDA said the serving size and servings per container are not in compliance with federal requirements. KNL Pharmaceutical Co. received a warning letter about its Cancerfx170 (also called Canserfx170), marketed on the KNL Web site as a safe herbal cancer treatment. In addition to the cancer-related claims, FDA singled out the company for including FDA documents that suggests FDA has approved or otherwise sanctioned the marketing of your product. FDA reported serious violations of federal regulations in a warning letter to Hyalogic LLC regarding the product Synthovial Seven. The product is marketed for relief of arthritis and fibromyalgia and claims to support increased mobility and faster wound healing, which FDA claims are unsubstantiated and make the product misbranded. HBX Inc. received a warning letter about the labeling of its product GE-132 OXY Germanium. According to FDA, the HBX Web site claims cancer patients, diabetics and Alzheimers patients need to take germanium, and germanium has shown to be remarkably effective in treating lung cancer, cancer of the bladder, breast cancer... In addition, FDA noted the Web site displays the FDA seal in several places, which the agency believes is intended to imply FDA sanction of the product, making it misbranded.
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