This posting describes the analytical methods the U.S. Food and Drug Administration (FDA) uses for testing products to determine if they contain ephedrine alkaloids. This testing is pursuant to the final regulation issued in February, 2004, which declared dietary supplements containing ephedrine alkaloids adulterated under section 402(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act (the Act). FDA is posting this methodology so the public is aware of FDA's course of action.
On February 11, 2004, FDA issued a final regulation (69 FR 6788) declaring dietary supplements containing ephedrine alkaloids adulterated under section 402(f)(1)(A) of the Act. FDA took this action because it found that ephedrine alkaloids present an unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling, or if no conditions of use are suggested or recommended in labeling, under ordinary conditions of use. The final rule became effective on April 12, 2004.
FDA took this action based upon the well-known pharmacology of ephedrine alkaloids, the peer-reviewed scientific literature on the effects of ephedrine alkaloids, and the adverse events reported to have occurred in individuals following consumption of dietary supplements containing ephedrine alkaloids.
Analyzing laboratories use the following published method for original analysis of each product sample: AOAC Official Method 2003.13 Ephedrine Alkaloids in Botanical and Dietary Supplements published as JAOAC Int. 2004 Jan-Feb: 87(1): 1-14; "Determination of Ephedrine Alkaloids in Botanicals and Dietary Supplements by HPLC-UV: Collaborative Study."
No further testing is applied for samples testing negative using the above method. Samples testing positive using the above method will undergo a confirmation analysis using the following method: JAOAC Int. 2003 Jul-Aug: 86(4): 657-68; "Determination of Ephedrine Alkaloids in Dietary Supplements and Botanicals by Liquid Chromatography/Tandem Mass Spectrometry: Collaborative Study." In some cases, the laboratory that performs the confirmation analysis will be different from the laboratory that performed the original HPLC-UV analysis. If different laboratories perform the original and confirmation analyses, the laboratory performing the original HPLC-UV analysis will provide the confirmatory laboratory with a sufficient quantity of product or composite for MS confirmation testing.