'Open wide!' Down the hatch go GMPs for dietary supplements (sidebar)

Not only are Good Manufacturing Practice regulations (GMPs) hanging over the collective heads of the dietary supplement industry, but so are new labeling requirements. If the writing is not yet on the label, it is certainly on the wall based on the draft recommendations from the White House-appointed Commission on Dietary Supplement Labels. The seven-person Commission issued its draft recommendations on June 24. They would require some changes in current supplement labels, which are produced in accordance with the Nutrition Labeling and Education Act (NLEA). These regulations kicked in during January 1994 for vitamin and mineral supplements. The NLEA has requirements on the listing of ingredients, and on health and nutrition claims. Passed the following October, the more specific Dietary Supplement Health and Education Act required revision of the nutrition labeling regulations as they applied to supplements. The Commission's draft recommendations touch on those required revisions. Annette Dickinson, director of scientific and regulatory affairs for the Council for Responsible Nutrition (CRN), was one of the members of the Commission. At a meeting on July 8, CRN companies endorsed the recommendations as "solid and reasonable," according to Dickinson. "I have talked with some of the other dietary supplement associations, and nobody is terribly exercised about the recommendations," she adds. The trade groups will be submitting comments though. Those comments will likely focus on the recommendations for nutritional support claims, and the notification letters companies are required to send to the Food and Drug Administration within 30 days after marketing a new product with a nutritional statement. The Commission report obliquely refers to industry unhappiness with these recommendations by stating: "Some members had serious reservation about the recommendations relating to the summaries of scientific evidence and to a consumer version of that summary." The FDA will ultimately decide which final Commission recommendations to implement and which to ignore. The agency must publish final rules two years after the Commission issues its final recommendtions. But the FDA is already moving separately against one class of dietary supplements, those containing ephedrine alkaloids, typically sold for help in losing weight, stimulating energy and in body building. In early June, the FDA proposed to require labels on those products warning consumers not to use the product for more than seven days. Products with claims that encourage short-term excessive intake to enhance the claimed effect, such as energy enhancement, would have to include a statement on the label saying: "Taking more than the recommended serving may result in heart attack, stroke, seizure or death." The FDA has had an adverse event monitoring system since 1993. It covers supplements, OTC drugs and prescription drugs. There have been 1길 incidents recorded, says Arthur Whitmore, an FDA spokesman. About half involved ephedrine alkaloids. There have been 38 deaths "associated with" ingestion of ephedrine alkaloids; two were confirmed by a medical examiner. No other dietary supplement has been "associated with" a death.