Don’t Be So Sure That Dietary Supplements Are Safe; The F.D.A. Isn’t

In the first 10 months of 2008 the U.S. Food and Drug Administration (F.D.A.) received 948 reports of health problems associated with dietary supplements, but not necessarily directly caused by them, according to a report from the federal Government Accountability Office (G.A.O.). Those included 9 deaths, 64 life-threatening illnesses and 234 hospitalizations. The F.D.A. recently estimated that there are more than 50,000 minor and serious health problems a year related to dietary supplements.

For purposes of the G.A.O. report, dietary ingredient means an ingredient that is included in the dietary supplement definition in the Dietary Supplement Health and Education Act of 1994 (DSHEA), such as vitamins, minerals, and herbs or other botanicals.

Many consumers do not know that dietary supplements, unlike drugs, do not need agency approval and that their makers do not have to prove their safety and efficacy before they enter the market and go on sale. The Federal Food, Drug, and Cosmetic Act requires that the F.D.A. demonstrate a significant or unreasonable risk or that the dietary supplement is otherwise adulterated. Under DSHEA, dietary supplements are broadly presumed safe.

Further, the F.D.A. lacks mandatory recall authority of tainted products. For example, the F.D.A. recently published a report citing 69 brands of weight-loss supplements that illegally contained active drug ingredients that could be harmful to consumers. So far, only three of the brands have been voluntarily recalled. Dietary supplement makers do not have to identify themselves as makers of specific supplements or supply the agency with product information. Companies are not required to provide the F.D.A. with information on the products they sell, such as the product name and ingredients.

As a result, FDA has limited information on the companies and products it is required to regulate, and more complete information could help FDA analyze adverse event reports. One way for companies to circumvent the F.D.A.s safety standard required for food additives is to market a food product as a dietary supplement.

For example, in August 2007, the F.D.A. identified a company marketing an iced tea mix containing stevia, an herb that has not been approved as a food additive because of potential safety concerns, including reproductive and cardiovascular effects. The F.D.A. issued a warning to the company, and the company changed the product label to classify the product as a dietary supplement rather than a food so that it could continue to add stevia to its product.

More than half of all American adults, or at least 114 million people, use dietary supplements like vitamin pills, diet pills, herbs and energy drinks. And the market for dietary supplements is growing: $25 billion on such products last year up from about $23.7 billion in 2007.

To improve oversight, the G.A.O. report recommended that the F.D.A. seek authority to require supplement makers to register as such, provide lists of products and copies of product labels, and to disclose all reports of health problems not just hospitalizations and deaths, as they have been required to do since the end of 2007, after ephedra was banned.

In 2007, FDA took several actions in response to the new serious adverse event reporting requirements for dietary supplements and has subsequently received an increased number of reports. Since mandatory reporting requirements went into effect, the agency has seen a threefold increase in the number of all adverse events reported compared with the previous year.

The G.A.O. report found that without a clear understanding of the safety, efficacy, and labeling of dietary supplements, consumers are exposed to risks such as potentially harmful drug-supplement interactions associated with the uninformed use of these products.

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