Dr Lester Crawford, Acting Commissioner of the FDA, has outlined the agency's science-based approach to protecting American consumers from unsafe dietary supplements.
Dr Crawford said the agency would soon provide further details about its plan to ensure that the consumer protection provisions of the 1994 Dietary Supplement Health and Education Act (DSHEA) are used effectively and appropriately.
The DSHEA sets up a distinct regulatory framework for dietary supplement products. It gives the FDA regulatory authority to act against supplements or supplement ingredients that present safety problems, are marketed with false or misleading claims, or are otherwise adulterated or misbranded.
|There are approximately 29,000 products currently available.|
"FDA is absolutely committed to protecting consumers from misleading claims and unsafe products," said Dr Crawford.
"Unlike most foods, some dietary supplements are pharmacologically active".
"And we have seen over the last 10 years a huge growth in the dietary supplements industry, including the introduction of products that seem far removed from the vitamins and minerals of the pre-DSHEA days".
"We have become increasingly aware of the potential health problems some of these products pose."
In the last 6 months, FDA has inspected 180 supplement manufacturers, sent warning letters to distributors, and refused entry to 1171 foreign shipments of dietary supplements. It has also seized or supervised voluntary destruction of almost $18 million worth of mislabeled or adulterated products.
"We will continue to aggressively enforce DSHEA against unsafe or mislabeled products," Dr Crawford said.
In March the FDA requested that 23 companies cease distributing dietary supplements containing androstenedione. These are marketed to stimulate testosterone and muscle growth but have anabolic steroid effects in the body.
Over the next several months FDA will provide additional information to explain and implement the tools available to the agency under DSHEA to act against unsafe supplements and false or misleading supplement labeling claims.
The FDA is also developing regulations for industry on good manufacturing practices (GMPs). When finalized, this rule, proposed last spring, will help protect consumers from dietary supplements that contain impurities or contaminants as a result of how they are manufactured or handled.
FDA is, in addition, putting dietary supplement labeling under closer scrutiny. Dietary supplement labels cannot claim the supplement will treat or cure a disease, and since December 2002 FDA has worked with the Federal Trade Commission to challenge false claims of supplement effectiveness for treating a range of diseases.
To support its consumer protection actions, the agency is developing approaches to systematically review the evidence about the safety of individual dietary supplements. The FDA expects to evaluate the available pharmacology, published literature, evidence-based reviews, and adverse event information.
When DSHEA was passed a decade ago, there were about 4000 supplements on the market, including vitamins, minerals, amino acids, and herbs and other botanicals. Congress determined that these products were more like foods than drugs, and that like foods dietary supplements should in general be given the benefit of the doubt as to safety.
A recent Institute of Medicine report, sponsored by FDA, estimated that American consumers spend $18 billion annually on dietary supplements. There are approximately 29,000 products currently avialable; another 1000 new products are introduced each year.