Firm fined for FDC Act violations

U.S. District Judge B. Lynn Winmill fines Tribravus Enterprises $125,000 for distributing dietary supplements that contain synthetic steroids in violation of the Food, Drug and Cosmetic Act. She also imposed stricter testing protocols, including testing all of the firm's products for banned steroids. The judge ordered financial disclosures by the firm, which does business as iForce Nutrition. The Arizona company recently crossed paths with FDA when it recalled its Reversitol dietary supplements because they contain an aromatase inhibitor (Also see "FDA Recalls – April 13, 2011" - Pink Sheet, 25 April, 2011.).

Supplement/antibiotic mix-up spurs recall

Multi-Mex Distributor Inc. of Tucker, Ga., recalls Amoxilina and other dietary supplements after FDA found consumers confusing Amoxilina with the antibiotic amoxicillin, which is available OTC in Mexico. The agency said four children in Texas were admitted to a medical center for treatment of worsening illnesses, after their parents gave them Amoxilina believing it to be amoxicillin. Although labeled in English and Spanish, "the packaging appears to be an intentional marketing ploy to mimic antibiotics and directed at Hispanic buyers," FDA said May 9. The recall covers retailers and distributors in nine states.

AloeElite deemed unapproved drug

FDA chastises Plantation, Fla.-based AloeElite for inappropriate claims about its digestive supplement on the product's Facebook page and website. Claims that AloeElite can be used for Crohn's disease, irritable bowel syndrome, ulcers, Celiac disease and other ailments that are not amenable to self-diagnosis misbrand the product, the agency said. In addition, FDA said in a March 30 warning letter, the claims make the product an unapproved drug.

Green tea cancer claims earn warning

FDA warns San Francisco-based Ten Tea that claims on its website and at least one label make the teas misbranded drugs. Specifically, the agency took issue with claims that several of the firm's tea products "help prevent cancer," and "reduces cholesterol," according to a May 6 warning letter. The agency also warned the firm to discontinue use of an unauthorized health claim that green tea "decreases the risk of heart attacks, stroke and cancer." FDA reminded Ten Tea that it told the industry in February that it is considering exercising enforcement discretion for the qualified health claim for green tea: "Drinking green tea may reduce the risk of breast or prostate cancer. FDA does not agree that green tea may reduce the risk because there is very little scientific evidence for the claim."

FDA warns on weight loss supplement

The agency advises consumers not to take Slim Xtreme Herbal Slimming Capsule because the product’s label claims it is "100% natural," when in fact it contains the now-withdrawn Rx drug sibutramine. The ingredient in Abbott's Meridia was found to increase blood pressure in patients with a history of heart trouble, FDA said in the May 10 public notice. The notification also informed the public of a "growing trend" of products marketed as dietary supplements that contain prescription drugs. Most often these products are for sexual enhancement, weight loss and bodybuilding. Slim Xtreme is distributed by Globe All Wellness of Hollywood, Fla.

Doctor's CarbRite Diet bars on recall

FDA says 12 stock-keeping units of 2-ounce Doctor's CarbRite Diet bars and 3-ounce Universal Hi Protein bars were recalled due to the potential for undeclared peanuts and missing allergy alert labeling. New Brunswick, N.J.-based Universal Nutrition said May 10 it is recalling the bars from health food stores, gyms and e-commerce websites nationwide.

Enforcement In Brief

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