FDA To Propose Good Manufacturing Practices Regulations For Dietary Supplements
Ephedra has been in the news, and a health concern since at least 1997 (Beware of Herbal Phen-Fen!).
HHS Secretary Tommy G. Thompson today announced that he has asked the Food and Drug Administration (FDA) to evaluate the best scientific evidence available and recommend the strongest possible mandatory warning label possible for ephedra products.
In addition, the FDA is developing proposed regulations regarding Good Manufacturing Practices (GMPs) for dietary supplements. The FDA has sent a draft Notice of Proposed Rulemaking to the Office of Management and Budget (OMB) for its review and clearance.
GMPs create manufacturing standards for the dietary supplement industry to insure that the products purchased by consumers are what the label indicates. The Dietary Supplement Health and Education Act (DSHEA) provides the FDA with the authority to establish GMPs. Once the OMB has finished its review the proposed regulation will be published for public comment.
"Based on the best scientific data available, we will take appropriate steps to protect the public health," Secretary Thompson said. "We will move as aggressively as the law and the science allow us to protect the public from the potential dangers of ephedra and other products, including taking actions to stop unlawfully marketed drug products." Today's actions do not preclude further measures that may be taken in response to the findings of a review of ephedra that is currently being conducted by the Rand Corporation.
"Consumers should use the same kind of care when using dietary supplements as they would when using any pharmacologically active product, said FDA Deputy commissioner, Dr. Lester M. Crawford.
In addition, the FDA today announced a new program to proactively analyze all herbal ephedra products to ensure that they contain natural ingredients and not synthetic ingredients as required by law. The Agency also noted that it is illegal for companies to market non-herbal synthetic ephedrine alkaloid products as dietary supplements.
The FDA will analyze ephedra products to determine if natural ingredients are being used. This is in addition to recent FDA action in June when the agency issued warning letters to six marketers of products containing ephedrine compounds that appeared to be synthetically derived.
The FDA also is continuing its efforts to prevent marketers from advertising
ephedra products as alternatives to street drugs. Yesterday, the FDA sent a
warning letter to Xoch Linnebank, who operates a Web site based in the
Netherlands. The website was advertising the Ephedra product Yellow Jacket as
"herbal XTC." The website stated, "the Yellow Jacket has an
extremely stimulating rush, with sensations one would attribute to E or
amphetamines." Earlier this year, the FDA sent a warning letter to Herbtech,
Church Hill, Tenn., which was marketing two ephedra products as street drug
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Portions of the above information has been provided with the kind permission of the U.S. Food and Drug Administration, Press Release #P02-41, October 8, 2002. (www.FDA.gov)