July 17, 2019

July 16, 2019

Subscribe to Latest Legal News and Analysis

July 15, 2019

Subscribe to Latest Legal News and Analysis

FDA Removes Import Alert for GE Salmon

U.S. Food and Drug Commissioner Scott Gottlieb, M.D., announced on March 8, that the Agency was deactivating a 2016 import alert that prevented genetically engineered (GE) salmon from entering the U.S. By way of background, in 2015, FDA approved a New Animal Drug Application (NADA) related to AquAdvantage Salmon after determining that it met the statutory requirements for safety and effectiveness under the Federal Food, Drug, and Cosmetic Act. AquaAdvantage Salmon contains intentional genomic alterations (IGAs) and is genetically engineered to reach market size more rapidly than its non-GE, farm-raised Atlantic salmon counterpart.

However, in 2016, Congress directed FDA not to allow food that contains GE salmon into commerce until final GE labeling guidelines were in place. As a result, FDA implemented the import alert that prevented GE salmon from entering the U.S. With the import alert still in place, in 2018, FDA approved a supplemental NADA submitted by Maynard, Massachusetts-based AquaBounty Technologies, Inc. requesting FDA’s approval to raise AquaAdvantage Salmon at a land-based contained facility near Albany, Indiana. The original NADA only specified AquaBounty’s facility on Prince Edward Island, Canada, where the salmon eggs are produced, and the company’s grow-out facility in Panama.

FDA stated, in a press release, that it believes that the Congressional mandate was satisfied when the U.S. Department of Agriculture (USDA) issued the final rule implementing the National Bioengineered Food Disclosure Standard (for more information on the final rule, see our Dec. 20, 2018 blog). “Therefore, the FDA is deactivating the import alert that prevented food from AquAdvantage Salmon, including salmon eggs used to grow the fish, from entering the U.S.,” the Agency wrote. FDA added that it “is committed to supporting innovation and ensuring safety in the biotechnology space, including the use of IGAs in animals.”

Not everyone agrees with FDA’s decision. In a press release issued the same day that FDA made the announcement, U.S. Senator Lisa Murkowski (R-AK) stated, “USDA’s new guidelines don’t require adequate mandatory labeling and don’t suffice as giving consumers clear information. Instead, they will only confuse people. I continue to have serious concerns about splicing DNA from two animals to produce a new marketable fish, essentially creating a new species.”

The next steps for AquaBounty Technologies is to have its Albany, Indiana recirculating aquaculture system (RAS) facility certified by state authorities and then begin production, Sylvia Wulf, the company’s new CEO, told Undercurrent News (registration required). Since once the eggs arrive from Canada it will take about 18 months to grow the fish to market size, Wulf predicted that sales of product from the company’s Albany facility would begin about the third quarter of 2020.

© 2019 Keller and Heckman LLP


About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...