AHPA seeks ‘correction’ from FDA on Pinellia ternata ephedrine alkaloids warning letter

• By: AHPA
• On: 06/30/2023 01:13:18
• In: Regulation / Legislation

In a 2022 warning letter, the Food and Drug Administration accused a firm of selling a product containing prohibited ephedrine alkaloids, but through a subsequent review of public documents, the American Herbal Products Association concluded the agency failed to do its homework.

Josh Long | Jun 29, 2023

This story begins with an FDA inspection in 2021, which resulted in a 7-page warning letter the following year that “identified serious violations of the Federal, Food, Drug and Cosmetic Act (the Act) and applicable regulations.”

Among other observations, FDA identified an “adulterated” supplement whose product label listed a dietary ingredient called Pinellia ternata. The warning letter to Princess Lifestyles LLC said Pinellia ternata contains ephedrine alkaloids, which FDA banned in 2004 in dietary supplements based on a determination that the alkaloids “present an unreasonable risk of illness or injury.”

FDA, however, never tested Princess Lifestyles' product to verify the presence of ephedrine alkaloids prior to sending the warning letter, and even when it eventually sampled and analyzed the product as part of a follow-up inspection, the results did not identify “any ephedrine alkaloid at or above the detection threshold,” according to the American Herbal Products Association (AHPA).

AHPA is now awaiting a substantive response to a request that “FDA issue a public correction” regarding the adulteration allegation in the warning letter pertaining to the product labeled as containing Pinellia ternata.

“Absent such a specific statement,” AHPA President Michael McGuffin wrote in an April 19, 2023, letter to Cara Welch, Ph.D., the director of FDA's Office of Dietary Supplement Programs (ODSP), “I am concerned that Amazon, and possibly other retailers, will continue to require removal of products labeled as containing Pinellia ternata, even though that ingredient is a lawful dietary ingredient if it does not contain ephedrine alkaloids.”

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