Amazon reportedly enforces erroneous FDA adulteration allegation
April 18, 2023
An American Herbal Products Association (AHPA) member recently informed AHPA that Amazon has prohibited the sale of products containing Pinellia ternata, presumably based on inaccurate information in a warning letter that the U.S. Food & Drug Administration (FDA) issued on February 23, 2022.
In March 2021, FDA conducted an inspection of dietary supplement manufacturer Princess Lifestyles LLC (San Gabriel, CA). In February 2022, FDA issued a warning letter to the manufacturer, alleging – among other details – that one of its products was “adulterated” because the product label “lists Pinellia ternata, a dietary ingredient which contains ephedrine alkaloids….” The warning letter references 21 C.F.R. § 119.1, the federal regulation deeming dietary supplements containing ephedrine alkaloids as “adulterated.”
The cited regulation, however, only deems as “adulterated” products actually containing ephedrine alkaloids. In 2004, FDA cited in the preamble to its final rule promulgating the prohibition on ephedrine alkaloids in dietary supplements one study published in a scientific journal in 1978 that claimed to isolate ephedrine hydrochloride from a tested sample described as dried tuber of Pinellia ternata. However, a 2021 analysis of 55 samples of Pinellia ternata tuber failed to detect ephedrine in any of the samples. This more-recent study also included DNA analysis to confirm the identity of the tested materials. Thus, there exists (at best) uncertainty about whether Pinellia ternata tuber actually contains ephedrine alkaloids.
Nonetheless, under its own regulations, FDA has the responsibility to confirm the presence of ephedrine alkaloids before asserting a violation of 21 C.F.R. § 119.1 and cannot rely only on a product label's identifying the presence of the herb. However, based on records provided by FDA in response to Freedom of Information Act (FOIA) requests, it appears that FDA neither collected nor analyzed any samples of Princess Lifestyles LLC's Pinellia ternata product before alleging that it contained ephedrine alkaloids in violation of the Agency's regulation.
Moreover, based on these records, it appears that FDA conducted laboratory analysis on a later-collected sample (i.e., months after issuance of the warning letter). FDA's own analysis determined that the sample collected from Princess Lifestyles LLC “did not show the presence for [sic] any ephedrine alkaloid at or above the detection threshold of 0.5 ug/g.” In other words, the Agency made a public allegation that the company's product violatively contained ephedrine alkaloids without a factual basis to do so and later confirmed the absence of any such basis through its own laboratory analysis.
In February 2023, FDA responded to written correspondence from AHPA calling attention to this matter and stated, “As a general matter, FDA agrees that the determination of a dietary supplement as adulterated under 21 CFR 119.1 should be based on the product containing ephedrine alkaloids. In the absence of clear evidence that a product contains ephedrine alkaloids, FDA agrees that such a product would not be adulterated under 21 CFR 119.1.”
Although AHPA's efforts seem to have resolved the issue at FDA, Amazon appears to treat the allegation in the 2022 warning letter that Pinellia ternata contains ephedrine alkaloids as valid.
“AHPA has expended significant staff time and resources in addressing this issue, and we will continue to advocate for the accurate interpretation of the robust regulations that govern dietary supplements under federal law,” said AHPA President Michael McGuffin. “With regard to the specific matter addressed here, AHPA will call on FDA to publicly acknowledge its error regarding Pinellia ternata and for Amazon to resume permitting sales of compliant Pinellia ternata dietary supplements on its platform.”
To further address this matter, AHPA will host a special meeting with members who would like to discuss this issue and other concerns regarding federal enforcement policies on Wednesday, April 26 at 10am PT / 1pm ET. Register for the Zoom meeting here.
If you have experienced similar issues, AHPA encourages you to confidentially share that information with Robert Marriott, AHPA Director of Regulatory Affairs, at email@example.com, and Michael McGuffin at firstname.lastname@example.org ahead of the meeting.