This letter is representative of the letters that were sent by the FDA on Dec. 30, 2003, to companies marketing ephedra dietary supplements.
December 30, 2003
Dear Sir or Madam:
This letter concerns your product [PRODUCT NAME], which appears to be marketed as a dietary supplement. The product labeling indicates [NAME OF BOTANICAL], a botanical source of ephedrine alkaloids, as an ingredient.
FDA intends to publish a rule in the coming weeks that finds that dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury under conditions of use recommended or suggested in the labeling of the product, or, if no conditions of use are suggested in the labeling, under ordinary conditions of use, and are therefore adulterated under Section 402(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act (the Act). This rule will become effective 60 days after publication so as to allow for congressional review in accordance with 5 U.S.C. 801-808. You can find the Act and its implementing regulations through links on FDA's Internet home page at www.fda.gov.
The preamble to the rule will contain a detailed explanation of the agency's basis for its determination. The purpose of this letter is to give you advance notice of the publication of this rule to facilitate your earliest compliance. FDA intends to begin enforcing the rule as soon as it becomes effective.
Joseph R. Baca
Source: U.S. Food & Drug Administration