Amarin Pharma Inc. has challenged FDA’s arguments that the U.S. International Trade Commission (Commission) should refrain from opening an investigation into certain omega-3 fish oil products sold as dietary supplements.
In a 36-page letter filed with the Commission by its outside counsel, the pharmaceutical company proclaimed FDA failed to consider “the statutory scheme under Section 337 of the Tariff Act," one of the laws at the center of Amarin’s complaint against Nature’s Bounty, Nordic Naturals and other prominent players in the dietary supplement industry.
Amarin has alleged unfair methods of competition under Section 337 of the Tariff Act of 1930 based on false advertising under the Lanham Act and violations of the Federal Food, Drug and Cosmetic Act (FDCA). Earlier this month, FDA maintained the Commission isn’t the appropriate agency to examine such allegations. Congress gave FDA authority to decide whether products are drugs or dietary supplements, FDA officials advised the Commission in a letter.
Amarin insisted its complaint is a proper one to be decided under the Tariff Act. “Amarin's complaint alleges the types of claims that have repeatedly been the subject of Commission Section 337 investigations, specifically unfair trade practice actions under the Lanham Act and under the standards established by other federal agencies," the company wrote in an Oct. 13 letter signed by Jeffrey M. Telep of the law firm King & Spalding LLP.
Amarin also refuted FDA’s assertion that the complaint is an unlawful attempt to bring a private right of action under the FDCA.
“Rather, it is simply seeking the remedies that Congress authorized under the Lanham Act and Section 337 by asking the Commission to police the marketplace," wrote Amarin’s lawyers, who characterized the market as “rife with literally false statements based on the understandings of the meanings of the terms ‘dietary supplement’ and ‘drug’ in the FDCA by suppliers and purchasers of the synthetically produced omega-3 products at issue here…."
The Commission, Amarin added, “has ample authority and capacity to determine whether the products at issue are falsely labeled or promoted in violation of the Lanham Act and Section 337, and doing so would not require unique expertise like that of FDA."
In asking the Commission to refrain from an investigation, FDA officials expressed concern that such a probe would provide others an incentive to file similar complaints over FDA-regulated products, creating the prospect of conflicting findings by two federal agencies—FDA and the Commission.
Amarin responded that honoring FDA’s request to decline an investigation in the fish oil case and other matters involving FDA-regulated products would protect wrongdoers.
“If the Commission were to abdicate its jurisdiction in this matter, and in all matters affecting FDA-regulated products, as FDA requests, then it would not only subvert Congress's objectives in enacting Section 337 and the Lanham Act, but also effectively provide a shield for wrong-doing," the company wrote to the Commission.
The Commission has until Oct. 27 to decide whether to open an investigation into the importation or sale in the United States of what Amarin called “synthetically produced omega-3 products" being promoted as dietary supplements. At issue: the legality of omega-3 products predominantly containing eicosapentaenoic acid (EPA) in either ethyl ester or re-esterified form.
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), a trade association representing the dietary supplement industry, said he would have preferred FDA had gone a step further in its letter to the Commission by acknowledging it doesn’t have a problem with the products subject to Amarin’s complaint. He said FDA has been aware of the products while visiting facilities, reviewing structure/function claims on product labels submitted to FDA and when a citizen’s petition was filed with the agency regarding a health claim for omega-3 fish oil.
“FDA has through its silence on this issue … implicitly acknowledged that they are legitimate supplements," Mister told INSIDER in a phone interview earlier this month.
Amarin has expressed a different view on the legality of the fish oil products marketed as supplements.
The products don’t meet the definition of a dietary ingredient and are unapproved new drugs, Amarin’s lawyers alleged in the complaint filed with the Commission. The company further argued products containing purified EPA in ethyl ester form (E-EPA) are precluded from being sold in dietary supplements because E-EPA was first studied as a drug in the mid-1980s, and it was not marketed previously as a food or supplement.
Vascepa, Amarin’s FDA-approved drug, contains purified E-EPA. “To adequately protect investment in drug development and the resulting innovation, E-EPA, which gained recognition in the marketplace as a ‘new drug’ … cannot be marketed as, or incorporated into, ‘dietary supplements,’" Amarin’s complaint asserted.
Some of the respondents accused of illegal conduct have expressed the view echoed by others including FDA that Amarin’s complaint isn’t one the Commission has any authority to investigate.
“The supposed FDCA violation is the linchpin of Amarin’s claim; without it, its purported Lanham Act claim does not exist," Pharmavite LLC, DSM Nutritional Products LLC and other DSM entities asserted in an 18-page brief filed in September and signed by Jordan L. Coyle of the law firm Orrick, Herrington & Sutcliffe LLP. “But, as this Commission has already recognized, it is the ‘Food and Drug Administration,’ not this Commission, that ‘is charged with the administration of the Food, Drug and Cosmetic Act,’ precisely because it is the FDA that possesses the expertise and policy judgment necessary to determine whether the FDCA has been violated."