On April 16, 2019, under the guise of “modernizing the FDA’s oversight of the dietary supplement industry,” the agency announced the promulgation of a “Dietary Supplement Ingredient Advisory List.” The advisory list identifies ingredients that, according to FDA, “do not appear to be lawful” and that dietary supplement companies “may wish to avoid selling, making or distributing” products containing the ingredients. (See statement of FDA Deputy Commissioner Frank Yiannas on April 16, 2019).
More recently, on Oct. 29, 2021, for the first time ever, FDA removed two ingredients from this list, higenamine and hordenine, with limited explanation as to what prompted this action. (See FDA advisory list, current as of Oct. 29, 2021). Although FDA appears to have now determined these ingredients are “new dietary ingredients” that require an NDI notification (NDIN), FDA said it has not received any such NDIN. Therefore, FDA will argue products that contain these ingredients are “adulterated.”
FDA’s actions undeniably change the enforcement landscape for companies marketing products that include these ingredients. Thus, it now seems like a good time to discuss the utility and implications of FDA’s advisory list. ...
While the stated goal of FDA’s advisory list is laudable (to provide prompt notice to consumers of potentially unlawful and unsafe ingredients), the list’s unintended harms may outweigh its intended good. Courts have recognized an important public interest in ensuring administrative agencies adhere to due process. And the lack of transparency and finality around FDA’s advisory list threatens the public’s confidence in that process as it eliminates any opportunity for meaningful participation necessary to ensure fair and balanced decision-making. We encourage persons aggrieved by the agency’s advisory list to seek such participation, even if through invocation of the judicial process that may be available to them.