FDA Investigates The Risks Of Using Ephedra Supplements.

ephedra and its effects on your health

fda cracks down on firms marketing ephedrine alkaloids

this article is in 3 parts this is part 3

In seeking comment on these issues, FDA is reopening a proposed rule entitled "Dietary Supplements Containing Ephedrine Alkaloids." That proposal would have required a warning statement for these products, as well as restrictions on their potency and composition.

FDA later withdrew parts of this proposed rule because of concerns about the specific scientific evidence in the proposal, expressed by the General Accounting Office.

In a broad action against potentially dangerous products, FDA today sent more than two dozen warning letters to firms marketing dietary supplements that contain ephedrine alkaloids. The letters, targeted particularly at products making claims for athletic performance, explain that any claims their products make about effects on the structure and function of the human body must be truthful and not misleading. They outline FDA's view in light of the RAND report that the claims being made are not adequately substantiated by scientific data, and they direct the companies to submit any data supporting the claims within 15 days.

The letters also warn firms that they must not make claims about their products' ability to treat or cure a disease or condition such as obesity. Under the Federal Food, Drug and Cosmetic Act, unapproved products making these "disease claims" are unapproved new drugs and therefore subject to other prompt regulatory actions, including injunctions against firms and seizures of their products.

FDA will also continue to work closely with the Federal Trade Commission to ensure that dietary supplement products containing ephedra do not make false and misleading claims. "If an ad says a product is 'safe,' the advertiser's must have competent and reliable evidence to prove the claim," said Timothy J. Muris, Chairman of the Federal Trade Commission. "Consumers depend on advertising for factual information and deceptive ad claims can put a consumer's health at risk. That's why the FTC is currently investigating a number of weight loss products containing ephedra and we will continue to pursue aggressively marketers making unsubstantiated claims about product safety or effectiveness."

In addition, FDA today proposed a warning label for all ephedra-containing dietary supplements. The proposed label warns about the risks of serious adverse events, including heart attack, seizure, stroke, and death; cautions that the risk can increase with the dose, with strenuous exercise, and with other stimulants such as caffeine; specifies certain groups (such as women who are pregnant or breast feeding) who should never use these products; and lists other conditions, such as diseases and the use of certain medications, that rule out the use of ephedrine alkaloids.

"The steps being announced today demonstrate FDA's commitment to taking the most effective actions possible under current law, given the state of the scientific evidence," said Dr. McClellan. "It may be possible to use ephedra safely, in small doses, for some purposes. But in the face of continued serious adverse events following the use of ephedra, there is a problem. It is a problem we are determined to fix."

Once the 30-day comment period has ended, FDA will analyze the comments and publish its conclusions about the most appropriate approach to reducing the risk of using dietary supplement products containing ephedrine alkaloids.

The National Advisory Council for the National Center for Complementary and Alternative Medicine, part of NIH, is meeting March 17th to assess the evidence on ephedra's safety and effectiveness in order to develop a research agenda on ephedra. FDA will give that committee an opportunity to comment on today's notice, should the committee find it appropriate to do so. All interested parties may send written comments on these issues involving ephedra until April 7, 2003, electronically or by regular mail to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

FDA Press Release

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