The U.S. Court of Appeals for the Federal Circuit ruled to uphold the U.S. International Trade Commission (USITC) 2017 decision not to investigate a complaint brought by a pharmaceutical company that alleged omega-3 products used unfair marketing practices because they were being sold as dietary supplements.
Two of three judges who decided the case backed USITC’s ruling that Amarin Pharma Inc. did not present a “cognizable claim based on an unfair method of competition or an unfair act.”
Seen as a victory for the supplement industry, this ruling confirms FDA’s jurisdiction to enforce the Federal Food, Drug and Cosmetic Act (FD&C), industry sources said.
"We ... hold that a complainant fails to state a cognizable claim under § 337 [of the Tariff Act of 1930] where that claim is based on proving violations of the FDCA and where the FDA has not taken the position that the articles at issue do, indeed, violate the FDCA,” Chief Judge Sharon Prost wrote in the opinion. "Such claims are precluded by the FDCA."
Circuit Judge Todd Hughes joined in Prost’s opinion.
In a dissenting opinion, Circuit Judge Evan Wallach concurred with the majority’s conclusion that the USITC did not err in declining to commence an investigation into Amarin's complaint brought under the Tariff Act. But he argued the USITC's decision was not an "appealable final determination" and, consequently, the court didn't have jurisdiction to review the agency's decision.
Organizations representing the dietary supplement industry lauded the majority's ruling.
"Given GOED’s [the Global Organization for EPA and DHA Omega-3s] long-standing position that the ingredients in question are old dietary ingredients, GOED is pleased the U.S. Court of Appeals for the Federal Circuit affirmed the prior decision by the International Trade Commission not to institute the investigation requested by Amarin," said Ellen Schutt, executive director, GOED.
“This decision is significant and beneficial for the dietary supplement industry as it confirmed FDA’s exclusive jurisdiction to interpret and enforce the provisions of the Food, Drug and Cosmetic Act,” said Steve Mister, president and CEO, the Council for Responsible Nutrition (CRN). “CRN recognized that Amarin was seeking to impose restrictions that could have created a market monopoly for pharmaceutical companies over a subset of omega-3 products, hindered responsible manufacturers from selling beneficial fish oil supplements and removed consumers’ abilities to buy affordable products that benefit their health and well-being.”
In a statement updated May 2 on its website, Amarin expressed disappointment with the appeals court ruling and said it was "analyzing its options going forward."
Amarin, marketer of Vascepa, an eicosapentaenoic acid (EPA) omega-3 drug that’s used to lower high triglyercides, launched its broad attack on the fish oil industry in a complaint filed in August 2017 with the USITC, an independent quasi-judicial federal agency.
In October 2017, the USITC declined to open an investigation into the importation or sale in the U.S. of what Amarin called “synthetically produced omega-3 products" being promoted as dietary supplements. Amarin alleged the products were unapproved new drugs under the FD&C. Therefore, the false labeling of the products, Amarin asserted, constituted an unfair act or method of competition under Section 337 of the Tariff Act of 1930 because the acts violate the Lanham Act and standards the FD&C established.
However, USITC found Amarin failed to “allege an unfair method of competition or an unfair act cognizable under" the Tariff Act of 1930, and noted that FDA, not the USITC, has the jurisdiction over dietary supplements and is charged with enforcing FD&C.
FDA asked the commission to refrain from an investigation because the agency hadn’t determined whether the products subject to the complaint were drugs or dietary supplements. At the time, FDA noted it had not reached any final conclusions. And in June 2018, a U.S. Department of Justice (DOJ) attorney noted a guidance from FDA on the regulatory classification of these articles would not be forthcoming.
The majority didn't answer whether Amarin's claims would have been precluded if FDA had published guidance on the issues above.
"We note that this limited holding is consistent with the Commission’s arguments in its briefing, which indicated that Amarin’s claims are precluded at least until the FDA has provided guidance as to whether the products at issue are dietary supplements," Prost wrote. "We also note that the United States, as amicus, appears to seek a broader ruling—that all such claims are precluded regardless of whether the FDA has provided guidance ... we need not address that broader question here, as the FDA has not provided guidance as to whether the products at issue properly qualify as 'dietary supplements.'"
CRN previously argued similar statements about FDA’s authority over supplements and noted the agency has not objected to GRAS (generally recognized as safe) petitions for substances for use in concentrated omega-3 supplement products.
Amarin Pharma countered by filing a petition for review of the USITC’s decision and a petition for a writ of mandamus in the U.S. Court of Appeals for the Federal Circuit, which would have reversed the USITC’s decision and directed it to institute an investigation. Amarin’s lawyers contended the commission abused its discretion for three reasons: First, Amarin advised the appeals court its complaint properly invoked the USTIC’s jurisdiction; second, Amarin leaned on a decision from the U.S. Supreme Court (POM Wonderful LLC v. Coca-Cola Co.) to refute the premise that FD&C bars Amarin’s allegations under the Lanham Act; and third, Amarin noted nothing in Amarin’s complaint required the USTIC to enforce the FD&C or resolve any issue that would require scientific expertise.
In a January 2018 brief, Amarin added that USITC’s preclusion argument was contrary to the law, arbitrary and capricious, and a violation of its statutory obligations.
CRN and GOED called for the dismissal of Amarin’s complaint in a March 2018 joint amicus curiae brief. At the time, Mister claimed in a statement that Amarin “sought to create a market monopoly over a subset of omega-3 products, which would directly hinder legitimate manufacturers from selling fish oil supplements.”
FDA and DOJ lawyers argued Amarin’s claims couldn’t go forward because the pharmaceutical company must have proven additional matters beyond violations of the FD&C since FDA holds the authority on that law.
Companies named in Amarin’s complaint included many prominent players in the dietary supplement industry, including DSM Nutritional Products, J.R. Carlson Laboratories Inc., Nature’s Bounty, Nordic Naturals and Pharmavite LLC.