In its letter to the ITC, FDA “respectfully submits” that the Commission not initiate an investigation, citing several reasons.
Weighing in on a continuing dispute between pharmaceutical firm Amarin Pharma (Bedminster, NJ) and the supplement industry’s leading omega-3 marketers and suppliers, FDA sent a letter to the United States International Trade Commission (ITC) on October 6, 2017, arguing that the Commission decline Amarin’s request to investigate said supplement firms’ practices.
Some background: Amarin Pharma, maker of a synthetic EPA omega-3 drug in ethyl ester form that it markets as Vascepa, filed a complaint with the ITC alleging that synthetically produced omega-3 dietary supplements predominantly comprising EPA in either the ethyl ester (EE) or re-esterified (rTG) form are synthetic and therefore not considered “dietary ingredients” under Section 201(ff)(1) of the Federal Food Drug and Cosmetic Act (FDCA).
Because such an allegation implies that the supplements aren’t dietary supplements at all, but rather are unapproved new drugs, Amarin asks in its complaint that the ITC investigate the “unlawful importation or sale in the United States of synthetically produced omega-3 products” that it believes are “falsely labeled, and/or promoted for use as, or in ‘dietary supplements.’”
In its own letter to the ITC, FDA “respectfully submits” that the Commission not initiate an investigation for several reasons. Among them, FDA notes that Amarin’s claims that supplement companies engaged in unfair competition based on false advertising can succeed only if the ITC itself finds that the supplement products in question are unapproved “new drugs” rather than “dietary supplements” under the provisions of the FDCA-yet such a determination Congress has delegated solely to FDA to make.
Further, FDA states that Amarin’s complaint “is predicated on open questions of law and policy on which FDA has not reached final conclusions.” In other words, FDA has several kettles simmering on issues that Amarin raises, and were the ITC to undertake the requested investigation, its findings may conflict with later-finalized FDA guidance on the matters.
FDA also expressed concern that action on the current Amarin request could “create an incentive for other parties to file similar complaints about other FDA-regulated products” ranging from foods and drugs to biologics, medical devices and vaccines, among others. And for good measure, FDA noted that while Congress granted FDA the tools to enforce the FDCA, it prohibited private parties from bringing any such enforcement actions themselves. As the agency states in its letter, “FDA cannot administer and enforce the FDCA effectively if core FDA issues-such as whether a product is a ‘new drug’ or a dietary supplement under the FDCA-are decided in actions brought by private parties.”
FDA’s comments follow a public interest statement and non-institution letter that the Council for Responsible Nutrition (CRN; Washington, DC) filed in response to the ITC’s Notice of Complaint and complement the CRN’s efforts to engage allies on Capitol Hill to contact the ITC to request non-institution.