One Fish, Two Fish, Red Fish, Drugs Are Fish? Decision Shows FDCA’s Broad Definition of “Drug”

February 21, 2020

Consumers may not think of salmon as a drug, but according to a recent opinion out of the Northern District of California, certain genetically modified (GMO) salmon qualify as drugs under the Food, Drug, and Cosmetic Act (FDCA). The opinion not only demonstrates the broad definition afforded to drugs by the U.S. Food and Drug Administration and the courts, but also provides a reminder to industry stakeholders that GMO animals may be regulated under FDA’s authority over drugs.

In Institute for Fisheries Resources v. Hahn, a series of environmental groups and industry actors sued FDA, alleging that the agency exceeded its authority over GMO salmon. FDA approved plaintiff AquaBounty Technologies’ application to create a salmon that reached maturity more quickly than normal salmon. As part of its approval, FDA imposed certain restrictions on how and where GMO salmon could be grown in an effort to prevent mixing with non-GMO salmon. The agency based its conditional approval on its ability to regulate drugs under the FDCA. According to FDA, it interprets the FDCA’s definition of “drug” to include certain rDNA constructs, including the rDNA construct used by AquaBounty.

The plaintiffs sued, in part, by launching a “broadside attack on the FDA’s authority to regulate the genetic engineering of animals.” The Institute for Fisheries Resources court started its Dec. 19, 2019, opinion by holding there was a “head-scratching element” to their attack on FDA’s authority. The court held that the plaintiffs failed to explain how GMO animals would otherwise be regulated, meaning its attack would result in GMO animals being “without meaningful regulatory oversight.”

Even without considering the consequences of the plaintiffs’ position, however, the court held that FDA’s actions were clearly valid under the FDCA’s definition of “drug” as “articles (other than food) intended to affect the structure of any function of the body of man or other animals.” Based on this definition, FDA issued Guidance for Industry 187, which governed “those animals modified by rDNA techniques, including the entire lineage of animals that contain the modification.”

While the plaintiffs attempted to rely on the “ordinary meaning” of “drug” in opposition to FDA’s authority, the court found this logic unavailing. Relying on the U.S. Supreme Court’s 1969 holding in United States v. Article of Drug . . . Bacto-Unidisk, the district court held that the definition of “drug” under the FDCA was “broad and dynamic by design” and that GMO animals presented many of the same risks that prompted FDA’s regulation of growth hormone treatments in animals. As a result, the court held that the government offered “the best interpretation of the” FDCA and it granted the government judgment on the pleadings as to the plaintiffs’ broadside attacks.

Institute for Fisheries Resources provides a stark reminder of the FDCA’s expansive reach. In addition to GMO salmon, FDA has interpreted “drug” to include chickens producing certain egg whites that treat an enzyme disorder and rabbits producing milk capable of treating hemophilia. As a result, producers and manufacturers should remember that GMO animals may be subject to FDA’s rulemaking as a drug under the FDCA. Given the opinion, FDA will likely continue expanding the definition of drugs to other GMO animals and beyond.