The U.S. Court of Appeals (USCA) for the Federal Circuit has upheld the decision of the International Trade Commission (ITC) to dismiss a complaint from Amarin Pharma, Inc., that certain companies were falsely labeling and advertising omega-3 products as “dietary supplements,” when they were actually “new drugs” as per the Food, Drug, and Cosmetic Act (FDCA).
Amarin markets Vascepa, a prescription drug capsule containing 1 gram of eicosapentaenoic acid (EPA). It is FDA approved as a drug, as noted by the USCA’s written opinion. On August 30, 2017, Amarin filed a complaint alleging that certain companies were illegally selling drugs under the guise of supplements. The complaint argued that the sale of these products was an unfair method of competition and violated the Tariff Act. It sought an order excluding synthetically produced omega-3 products from entry into the U.S., and a cease-and-desist order to prohibit the sale of those products.
Following the complaint, FDA submitted a letter urging the ITC to dismiss the complaint. In the letter, dated October 6, 2017, FDA noted that investigating the claim would require ITC to decide whether or not synthetic EPA is a drug or a dietary supplement, which falls under the jurisdiction of FDA. The letter made it clear that FDA had not determined whether synthetic EPA was a drug or a new dietary ingredient.
FDA’s letter added that, while FDA can act on violations of the FDCA, private companies cannot. Private companies bringing actions to enforce the FDCA would compromise FDA’s ability to enforce the FDCA, and would risk losing uniformity of administration. FDA argued that, beyond USCA’s inability to make the final decision, Amarin couldn’t even bring the case to court.
On October 27, 2017, according to the USCA opinion, ITC issued its decision to dismiss the complaint. In December 2017, Amarin filed a petition for review with USCA.
USCA upheld ITC’s dismissal, coming to the conclusion that deciding whether or not the sale of synthetic EPA products constitutes “unfair competition” would require ITC to decide whether or not synthetic EPA is a drug or a new dietary ingredient, violating the FDCA and FDA’s exclusive right to enforce the FDCA.
The Council for Responsible Nutrition (CRN) released a statement applauding the decision. Steve Mister, president and CEO, noted in the statement that CRN has been involved in challenging Amarin’s actions since 2017, when CRN urged ITC not to derail FDA’s authority. In 2018, CRN and the Global Organization for EPA and DHA Omega-3s (GOED) filed a joint amicus brief to USCA, noting again that anything but dismissal would interrupt FDA’s authority. CRN and GOED also noted that halting the sale of these supplements would decrease consumer access to the health benefits associated with EPA, and would raise the prices of EPA drugs and remaining omega-3 supplements.
Mister said in CRN’s statement: “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 FDCA. 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. We continue to be committed to fighting for our member companies in this space and for proper jurisdiction of FDA.”