August 21, 2006
WASHINGTON—The Food and Drug Administration (FDA) sends out warning letters to manufacturers and marketers of dietary supplements. Similarly, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) issues “Cyber Letters” to Internet Web site operators promoting dietary supplement products that claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases. Matters described in all FDA “Warning Letters” may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter.
The Power Mall was informed its Web site features a number of products marketed with claims that cause them to be drugs. Among the violating products are Taurine Spray, AsmaSpray™, DLenolate, Curcumin98™, OxySorb™, Eskimo 3 Fish Oil, Gastro Enzymes, Q Gel, and AstaXanthin—which are marketed for treatment of diseases, including common cold, fever, neuralgia, tonsillitis, bronchitis, rheumatic arthritis, asthma, glaucoma, yeast infections, Alzheimer’s, colitis, ulcers and cardiovascular disease.
Driftwood Management LLC was notified its Web site includes marketing claims that various therapeutic essential oils—black pepper, clary sage, clove, fennell, helichrysum, lavender, lemon, peppermint, pine, ravensara, rosemary, thyme, and ylang ylang—can address various diseases, such as arthritis, asthma, bronchitis, colitis, flu, migraines, acne, high blood pressure, mild depression, diarrhea, anorexia, herpes, tuberculosis and viral hepatitis. Such claims cause these products to be unapproved drugs.
High Power Inc. was alerted a review of its Web site and inspection of its facilities revealed the marketing and distribution of numerous brands of dietary products—selenium, coenzyme Q10, tetrazine, N-Acetyl Cysteine, pantothenic acid, green tea and various sports and topical formulas—involve disease and condition claims that cause these products to be unapproved drugs. The company was also warned numerous of its weight control products feature unsubstantiated structure/function claims.
Cyanotech Inc. received a cyber letter concerning drug claims used to market its BioAstin® product via its Web site. Offending language includes claims BioAstin is “nature’s anti-inflammatory” and “has been proven to combat inflammation in several human clinical trials involving people with rheumatoid arthritis and carpal tunnel syndrome.”
Scandanavian Formulas was informed its shark liver oil products are promoted for conditions that cause them to be unapproved drugs. The offenses include statements that shark liver oil is a natural bacteria fighter, a remedy for slow healing wounds, and may reduce side effects related to chemotherapy and radiation treatments.
Dynamic Health Products Inc. was cautioned its Lycium Barabarum Goji Juice is an unapproved drug due to therapeutic claims it can combat periodontal disease, reduce cholesterol, regulate hypertension, and is anti-allergenic. Also, its pomegranate juice product is marketed as having antiviral, antifungal and antibacterial properties.
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