FDA Announces Public Hearing and Advisory Committee Meeting on Genetically Engineered Salmon

By Riëtte van Laack

In anticipation of the possible approval of the New Animal Drug Application (“NADA”) for genetically engineered AquAdvantage Salmon (“GE salmon”), FDA announced a public hearing on September 21, 2010, concerning the labeling of food made from such salmon.

This is the first time FDA is considering a NADA for a GE animal intended for food use. A GE animal is an animal drug because the DNA that is introduced into the GE animal is intended to affect the animal’s structure or function (see here). GE salmon is intended to grow faster than conventionally bred salmon. If the Agency approves the NADA, the fish eggs, young fish, and fish sold to growers will include a label that identifies those eggs and fish as genetically engineered. However, the labeling of food derived from the fish will not be determined by the NADA.

The hearing will focus on whether data suggest that food derived from GE salmon is materially different from food made from non-GE salmon, and if so, how that food should be labeled. (Safety of the food is considered in the approval of the NADA). Labeling of a food must be truthful and not misleading. This principle applies both to GE food and traditionally produced food.

FDA invites the public to share its views on which facts about GE are pertinent to FDA’s determination of whether food from GE salmon is materially different from other Atlantic salmon. It is FDA’s position, and courts have agreed, that the mere fact that a product is genetically engineered does not constitute a material difference and, therefore, does not warrant different labeling. Moreover, FDA cannot and does not require additional labeling based on consumer interest alone. Only if the genetic engineering causes the food derived from the GE salmon to be materially different in a property such as composition, nutritional composition, functional characteristics, and organoleptic properties, will different labeling be warranted. If material differences exist, the next question will be how these differences should be described to assure that the labeling is truthful and not misleading.

The hearing follows a two-day meeting of the Veterinary Medicine Advisory Committee concerning the NADA for GE salmon scheduled for September 19-20, 2010. If the NADA is not approved, FDA need not consider the labeling issue.