Dockets Management Branch
Food and Drug Administration
Department of Health and Human Services
Room 1-23
12420 Parklawn Drive
Rockville, MD 20857

CITIZEN PETITION

                The undersigned submits this petition under the Federal Food, Drug and Cosmetic Act to request the Commissioner of Food and Drugs to issue final rules for dietary supplements containing ephedrine alkaloids.

A. ACTION REQUESTED

                The petitioner requests the Commissioner to issue final rules for dietary supplements containing ephedrine alkaloids pursuant to the proposed rule published in the Federal Register on June 4, 1997. (62 Fed. Reg. 30677) Specifically, the petitioner requests that the Food and Drug Administration (FDA) make a finding that a dietary supplement is adulterated if it contains 8 milligrams (mg) or more of ephedrine alkaloids per serving, or if its labeling suggests or recommends conditions of use that would result in intake of 8 mg or more in a 6-hour period or a total daily intake of 24 mg or more of ephedrine alkaloids; require that the label of dietary supplements that contain ephedrine alkaloids state "Do not use this product for more than 7 days"; prohibit the use of ephedrine alkaloids with ingredients, or with ingredients that contain substances, that have a known stimulant effect (e.g., sources of caffeine or yohimbine), which may interact with ephedrine alkaloids; prohibit labeling claims that require long-term intake to achieve the purported effect (e.g., weight loss and body building); require a statement in conjunction with claims that encourage short-term excessive intake to enhance the purported effect (e.g., energy) that "Taking more than the recommended serving may result in heart attack, stroke, seizure or death"; and require specific warning statements to appear on product labels. 

B. STATEMENT OF GROUNDS

                The petitioner, the American Obesity Association (AOA), relies on the statements of the FDA and on the FDA's analysis of the many adverse reactions suffered in connection with the ingestion of dietary supplements containing ephedrine alkaloids. (62 Fed. Reg. 30677) The comment period for regulations concerning dietary supplements containing ephedrine alkaloids was originally scheduled to close on August 18, 1997. On September 18, 1997, the FDA reopened the comment period an additional 75 days, until December 2, 1997. (62 Fed. Reg. 48968) In the notice of reopening, the FDA stated that it did not intend to provide any additional extensions of the comment period. "Because of the serious and significant adverse events associated with the use of dietary supplements containing ephedrine alkaloids, FDA is concerned about the adverse impact that a prolonged comment period may have on the public health." (62 Fed. Reg. 48968)

                Despite the FDA's own estimation that 40 deaths and several hundred serious injuries (such as myocardial infarctions, strokes, seizures, and psychiatric events) can be attributed annually to the use of dietary supplements containing ephedrine alkaloids (62 Fed. Reg. 30708), the agency has failed to timely issue final rules. Since the FDA has proposed a period of 180 days before final rules as published take effect (62 Fed. Reg. 30678), the FDA's delay in issuing these final rules endangers the lives and health of many Americans.

                In submitting this petition, the petitioner relies completely on the information published by the FDA in the June 4, 1997 Federal Register. (62 Fed. Reg. 30677)

C. ENVIRONMENTAL IMPACT

                The petitioner relies on the FDA's statement, published June 4, 1997, in the Federal Register, that the final rules on dietary supplements containing ephedrine alkaloids "will not have a significant impact on the human environment." (62 Fed. Reg. 30712)

D. ECONOMIC IMPACT

                A statement of economic impact will be submitted if requested by the Commissioner.

E. CERTIFICATION

                The undersigned certifies that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition.

(Signature)______________________________

Morgan Downey