AHPA Files Petition on Ephedrine

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AHPA Update

March 16, 2004

 

 

AHPA Committee Files Petition of Final Rule on Ephedrine

- Seeks Clarification of 'Professional' Use of 'Traditional Formulas' -

 

 

On Friday, March 13, 2004, AHPA’s Chinese Herbal Products Committee

filed a petition for stay and reconsideration of FDA’s final rule on

dietary supplements containing ephedrine alkaloids. The petition was

joined later that day by the Acupuncture and Oriental Medicine

Alliance, Gig Harbor, WA.

 

The petition for reconsideration specifically requested that FDA

“recognize that dietary supplements that contain ephedrine alkaloids

do not present an unreasonable risk of illness or injury under

conditions of use that include formulation as a traditional Asian

herbal formula or as a traditional Ayurvedic herbal formula, and that

are for dispensing by a licensed health care practitioner within the

practitioner’s scope of practice and in a manner consistent with

traditional practice.”

 

The final rule, as published by the agency on February 11, 2004, and

due to become effective on April 12th, determined that all dietary

supplements that contain ephedrine alkaloids present an unreasonable

risk and are therefore adulterated. At the same time, in the preamble

of the February 11th Federal Register, the agency made numerous

comments to the effect that the final rule would not apply to

“traditional Asian medicines” that contain ephedrine alkaloids and

that the rule “does not change how these products are regulated.”

 

“Based on these statements it appears as if FDA intended to continue

to allow access by acupuncturists and other health providers to

traditional formulas that contain herbs such as ephedra and pinellia,”

stated Michael McGuffin, AHPA’s President. “AHPA members in our

Chinese Herbal Products Committee who sell traditional herbal formulas

as dietary supplements have asked in this petition that the agency’s

intention be clarified in the rule itself.”

 

The petition also requested that the final rule be stayed, but “only

insofar as it pertains to traditional herbal formulas.” A copy of the

petition is posted at AHPA’s website:

http://www.ahpa.org/04March12PetitionReconsiderationAndStayCHP.pdf.

 

 

 

 

 

 

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