Govt. Lawyers: Amarin Sought to Enforce FDCA in Fish Oil Complaint Before ITC

The U.S. International Trade Commission (ITC) properly dismissed a complaint filed against certain fish oil products marketed as dietary supplements because Amarin Pharma Inc. improperly sought to enforce the Federal Food, Drug & Cosmetic Act (FDCA), government lawyers argued this week in a court document.

FDA last year asked the ITC to refrain from commencing an investigation into a complaint filed against members of the fish oil industry because FDA hadn’t determined whether the products subject to the complaint were drugs or dietary supplements.

In choosing not to investigate Amarin’s complaint, the ITC noted FDA is charged with administering the FDCA. The decision prompted Amarin to file an appeal with the U.S. Court of Appeals for the Federal Circuit.

The ITC correctly decided the FDCA bars Amarin’s claims, according to a March 26 brief filed by lawyers representing FDA, the Department of Health and Human Services and U.S. Department of Justice.

“Private parties are expressly prohibited from bringing ‘proceedings for the enforcement, or to restrain violations, of’ the FDCA,” government lawyers wrote in their 28-page brief [download brief below]. “Yet that is precisely what Amarin seeks to do here. Amarin’s claims, though nominally brought under the Tariff Act, attempt to enforce or restrain violations of the FDCA because they seek—as a necessary component of the stated cause of action—to prove FDCA violations and compel obedience to the FDCA through the remedies provided by that statute.”

Amarin alleged in its complaint that certain fish oil products don’t qualify as dietary supplements and are new drugs. The pharmaceutical company brought actions under the Tariff Act and Lanham Act, which respectively bar unfair acts and methods of competition in the importation of articles into the United States, and false advertising. Amarin’s claims, however, are based on alleged violations of the FDCA, the U.S. government observed.

FDA and Justice Department lawyers said Amarin’s claims can’t go forward simply because the company must prove additional matters beyond violations of the FDCA.

“In sum, Amarin seeks to prove a series of alleged FDCA violations and to remedy those violations by excluding unapproved, adulterated and misbranded drugs from importation into the United States,” government lawyers maintained. “In advancing this claim, Amarin provides no reason, other than the alleged violations of the FDCA, to conclude that the importation of the accused articles constitutes an ‘unfair act’ within the meaning of the Tariff Act.”

Distinguishing POM Wonderful

In partial support of its appeal that the ITC abused its discretion, Amarin leaned on a 2014 court decision. POM Wonderful had sued Coca-Cola, arguing its juice blends were misleading. While it prominently displayed the words “pomegranate” and “blueberry” on the product’s label, the juice only contained small amounts of each substance.

In POM Wonderful LLC v. Coca-Cola Co., the U.S. Supreme Court rejected the argument that the FDCA barred claims brought under the Lanham Act; it found the two statutes complemented each other.

“POM Wonderful thus stands for the proposition that the FDCA does not occupy the field of food labeling,” FDA and Justice Department lawyers advised the Federal Circuit. They added the FDCA does not preclude false-advertising claims “simply because the FDCA independently regulates food labeling.”

Government lawyers, however, described Amarin’s reliance on the Supreme Court’s decision as “fundamentally misplaced.” They observed POM Wonderful had neither cited the FDCA nor alleged Coca-Cola’s labeling had violated the statute.

The issue before the Federal Circuit, the U.S. government contended, is a distinct one from POM Wonderful and concerns whether Amarin is barred from seeking to establish and stop violations of the FDCA by filing a cause of action under a separate statute.

“Amarin alleges that the labeling on the accused articles constitutes an ‘unfair act’ under the Tariff Act, and ‘false’ advertising under the Lanham Act, solely because the articles allegedly violate the FDCA’s requirements,” government lawyers asserted. “Amarin’s claims thus come into direct conflict with the government’s exclusive enforcement authority under the FDCA. And POM Wonderful expressly left open the question whether the FDCA precludes private causes of action brought under other statutes where those statutes and the FDCA ‘cannot be implemented in full at the same time.’”

FDA and Justice Department lawyers did not comment on the underlying merits of Amarin’s complaint. It concerns the legality of omega-3 products predominantly containing eicosapentaenoic acid (EPA) in either ethyl ester or re-esterified form.

Amarin can only prevail if the ITC finds the products subject to the complaint “are unapproved ‘new drugs’ rather than ‘dietary supplements’ under the FDCA," FDA officials wrote in a 2017 letter to the ITC, an independent quasi-judicial federal agency. “The complaint here is predicated on open questions of law and policy on which FDA has not reached final conclusions. Any such findings by the Commission on those issues may conflict with later determinations by FDA."