Foreign-made drugs, nutritional supplements and medical devices imported into the United States with false or misleading labeling or designed to look like an established competing product in violation of the Lanham Act could also violate 19 U.S.C. § 1337, and thus may be stopped at the U.S. border by U.S. Customs and Border Protection based on an exclusion order issued by the U.S. International Trade Commission.
False advertising claims in the life sciences sector frequently involve false or misleading statements about a product’s composition, its efficacy for treating a disease, its regulatory approval status, and similarities and differences with respect to a competing product. Section 337 authorizes the ITC to investigate unlawful and unfair trade with respect to imported drugs, dietary supplements and medical devices that may also be regulated by a government agency, such as the U.S. Food and Drug Administration. A narrow exception to the ITC’s broad jurisdiction was recently articulated by the U.S. Court of Appeals for the Federal Circuit in Amarin Pharma Inc. v. ITC.
Amarin, the manufacturer of Vascepa (an FDA-approved drug) filed a complaint in the ITC alleging violations of the Lanham Act. In the complaint, Amarin alleged that the labeling of imported Omega-3 products as “dietary supplements” constituted false advertising because the products are alleged to be unapproved “new drugs,” not “dietary supplements,” according to the Federal Food, Drug and Cosmetic Act.[1] Amarin requested that the ITC institute an investigation and issue an exclusion order to stop the importation of the allegedly unapproved new drugs.
Soon after the complaint was filed, the ITC received comments from the FDA requesting that the commission decline to initiate an investigation in this instance because initiating an investigation would require the commission to decide “open questions of law and policy on which the FDA had not reached final conclusions.” Agreeing with the FDA’s recommendation, the ITC concluded that Amarin’s Lanham Act claims are precluded by the FDCA and declined to institute an investigation. Amarin appealed the ITC’s decision to the Federal Circuit. Amarin argued that Section 337, which states “the following are unlawful, and when found by the Commission to exist shall be dealt with,” required institution of an investigation. The Federal Circuit did not agree and affirmed the ITC’s decision to not institute an investigation.
However, the Federal Circuit’s ruling in Amarin is narrow and does not prevent the ITC from instituting investigations based on Lanham Act claims involving FDA regulations. Rather, the Amarin opinion narrowly addressed situations where the regulatory agency has not decided...
