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.
Lack of transparency, notice and due process
FDA clearly has the authority to formally ban a substance from dietary supplement products. Indeed, that was the case with ephedra wherein FDA went through formal rulemaking, including public comment, to ban the ingredient. (See Nutraceutical Corp. v. Von Eschenbach, 459 F.3d 1033, 1037 (10th Cir. 2006) (describing the process involving ban of ephedrine-alkaloid dietary supplements)).
By contrast, the advisory list was created without any public comment or input nor were any hearings held regarding its creation. The agency has not released any scientific or legal documentation supporting the inclusion of ingredients on this list other than, in some instances, prior warning letters. In short, neither the public nor the dietary supplement industry has been apprised of the information and criteria FDA considers prior to including an ingredient on the advisory list.
Similarly, with regard to the recent amendment to the advisory list wherein two ingredients were removed, the public and industry are left guessing as to what prompted this action. As stated in the advisory list, FDA “welcomes additional feedback and information that may support or refute the FDA’s preliminary assessment regarding the ingredients on the … list.” However, without knowing either the precise criteria, information or methodology for including or removing ingredients from the list, the public and industry are left in the dark.
FDA warning letters have often been held to be not “final agency action,” thereby insulating them from judicial review. (See, e.g., Holistic Candlers & Consumers Ass’n v. Food & Drug Admin., 664 F.3d 940, 944-45 (D.C. Cir. 2012)). While we are not aware of any judicial decisions construing the advisory list, it seems likely that a litigation challenge would produce a similar result—the advisory list is, at best, a guidance document not constituting final agency action and therefore protected from judicial oversight/review. The advisory list’s status as an agency guidance document means that, in the current political environment, dietary supplement companies that act in defiance of it do so at their peril.
The administration of former President Donald Trump went to great lengths to scale back the force and effect of agency guidance documents. In Executive Order 13891, Promoting the Rule of Law Through Improved Agency Guidance Documents, the president stressed, among other things, that guidance documents were to be “non-binding both in law and in practice.” Similarly, a pair of U.S. Department of Justice memoranda from 2017 and 2018 sought to limit the force and effect of executive agency guidance documents. (See DOJ Memorandum, Limiting Use of Agency Guidance Documents in Affirmative Civil Enforcement Cases, Jan. 25, 2018; Attorney General Memorandum, Prohibition on Improper Guidance Documents, Nov. 16, 2017).
For better or for worse, on his very first day in office, President Joe Biden rescinded Executive Order 13891 and several others. Attorney General Merrick Garland followed suit and revoked prior DOJ memoranda that limited the use of guidance documents. (See Attorney General Memorandum, Issuance and Use of Guidance Documents by the Department of Justice, July 1, 2021).
However, in relevant respect, these executive orders memorialized the existing requirements that govern agency action, and therefore, did not impose any additional limits. Indeed, like other federal administrative agencies, FDA is prohibited from acting in a way that is arbitrary and capricious or without process required by law. (See 5 U.S.C. § 706). Federal courts have made clear that where an agency promulgates a substantive rule that binds the regulated public and has legal effect (i.e., a company risks sanction if non-compliant), it must follow the formal notice and comment process prescribed by law before imposing that requirement on industry. (See Nat. Res. Def. Council v. Wheeler, 955 F.3d 68, 83 (D.C. Cir. 2020)).
The way forward
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.
Jack Wenik is a member of Epstein Becker Green in Health Care and Life Sciences and Litigation practices who focuses on guiding dietary supplement companies and health care providers to reduce the risks of litigation by the government. He has advised clients dealing with cases from fines to corporate integrity agreements, and Medicare/Medicaid exclusion. Jack is a regular speaker and commentator to the media on dietary supplement and drug topics.