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On Feb. 6, the Food and Drug Administration (FDA) released a final regulation declaring dietary supplements containing ephedrine alkaloids adulterated under the Federal Food, Drug, and Cosmetic Act because they present an unreasonable risk of illness or injury.
Portions of the Q&A released in conjunction with the final rule appear below and give context to the regulatory action taken by the FDA.
Q: What did FDA do on Feb. 6, 2004?
A: FDA published a final rule concluding that dietary supplements containing ephedrine alkaloids (ephedra) present an unreasonable risk of illness or injury under conditions of use suggested or recommended in the labeling, or if the labeling is silent, under ordinary conditions of use, and are therefore adulterated under Section 402(f)(l)(A) of the Federal Food, Drug, and Cosmetic Act.
Q: How is this different than what was announced on Dec. 30, 2003?
A: On Dec. 30, 2003, FDA issued a consumer alert on dietary supplements containing ephedrine alkaloids. The purpose of the consumer alert was to let consumers know as quickly as possible about FDA’s determination. In addition, FDA sent letters to manufacturers who market such supplements, stating that FDA was preparing to issue a final rule declaring that such products present unreasonable risks. The purpose of the letters was to advise such manufacturers and distributors that when the rule becomes effective (60 days after publication), FDA may take enforcement action against them or the products if they do not cease distribution of the products.
Q: What do the firms that received the letters have to do next?
A: They have to take steps to ensure that they will be in compliance with the regulation once it becomes effective. We hope that many responsible firms will stop marketing dietary supplements containing ephedrine alkaloids right away, as a number of companies have done already. All firms will have to comply with the new regulation upon its effective date in 60 days. Firms that fail to cease distribution of their products by the effective date of the rule will face the possibility of FDA enforcement action without further notice.
Q: Is the FDA prohibiting the sale of ephedra?
A: That is, essentially, what the rule will do.
Q: Why didn’t FDA reach this conclusion sooner?
A: The law that governs how FDA can regulate dietary supplements, the Dietary Supplement Health and Education Act (DSHEA), requires FDA to bear the burden in determining that a lawfully marketed dietary supplement presents a significant or unreasonable risk and should be removed from the market. In contrast to drugs, which must be proven safe and effective to be marketed, DSHEA requires FDA to develop evidence after the supplements are already on the market that a dietary supplement presents an "unreasonable risk of illness or injury." FDA has no authority to require any studies of safety or effectiveness for dietary supplements.
FDA first proposed regulating ephedra in 1997, but commenters including the U.S. General Accounting Office generally believed that FDA had not developed sufficient evidence for certain actions proposed. We were determined to make our current decisions based upon the best available scientific evidence. In large part this came from the recent RAND analysis and a careful review of the Boozer et al six-month clinical study [which were not available to us until the last several months].
In March 2003, the Agency published a Federal Register (FR) notice reopening the comment period on its 1997 proposed rule on dietary supplements containing ephedrine alkaloids to seek comment on new scientific evidence about the risks of these products and on a proposed warning statement for the labels of these products. The FR announcement also sought comments on whether, in light of current information, FDA should determine that dietary supplements containing ephedrine alkaloids present a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in labeling, or under ordinary conditions of use if the labeling is silent. In order to make the determination regarding unreasonable risk, FDA had to examine the best available scientific evidence and take it into account in assessing whether the product’s known or reasonably likely risks outweigh its known or reasonably likely benefits.
FDA sought comment from health professionals, the supplement industry, and the general public on any additional data on ephedra’s safety, so that FDA could acquire the most complete picture possible of the product’s potential risks, as a basis for appropriate regulatory action.
Q: What has FDA done to meet the requirements to take action under the dietary supplement law?
A: FDA has gone to great lengths to obtain and review all of the relevant scientific evidence on ephedra, as well as adverse event information, even though FDA’s legal authorities to obtain this information are limited. FDA’s analysis of the scientific evidence includes: a comprehensive evaluation of the scientific literature through 2002 conducted by the RAND Corporation; and evaluation of adverse event reports. FDA also reopened the 1997 proposed rule for comment in March 2003, soon after the release of an agency "white paper" outlining the types of evidence and the legal standards that the agency was considering as a basis for further action. FDA has since received and reviewed tens of thousands of comments, and has included its formal evaluation of all relevant comments in the final rule.
Completing a major new rule on a never-before used legal standard with limited agency authorities and a significant burden of proof is difficult and time-consuming. FDA has worked as quickly as possible to complete the rule in a way that will stand up in court and thus will provide lasting protection for the public health.
Q: Why a rule?
A: The agency chose a rule in this case because it is the most efficient and powerful way to achieve successful enforcement of this provision against numerous companies. It will apply to all types of currently-marketed dietary supplements containing ephedrine alkaloids, not individual products.
Q: What types of enforcement actions are possible?
A: FDA has a variety of enforcement possibilities including seizure of the product, injunction against the manufacturers and distributors of such products, and criminal prosecution of violators.
Q: Is this rule final? Why wait 60 days?
A: The rule as published will be a final rule. The rule will become effective 60 days after publication so as to allow for congressional review [April 11, 2004].
Q: Are all products containing ephedra affected?
A: Essentially all currently marketed dietary supplements that contain ephedrine alkaloids will be affected by the rule. The scope of the rule does not pertain to traditional Chinese herbal remedies. It generally doesn’t apply to products like herbal teas that are regulated as conventional foods. Ephedra is not Generally Recognized as Safe for foods and not approved for use as a food additive.