ephedra ban

[Guest guest]

The Food and Drug Administration said it was sending the following

letter to more than 60 companies that make ephedra-containing products:

 

" This letter concerns your product product name, which appears to be

marketed as a dietary supplement. The product labeling indicates name

of ingredient, 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.

 

 

Chinese Herbs

 

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