FDA Approves First Genetically Engineered Seafood | Practical Law

FDA Approves First Genetically Engineered Seafood | Practical Law

In response to an application from AquaBounty Technologies, Inc., the Food and Drug Administration (FDA) has issued its first approval for a genetically engineered animal intended for human consumption: AquAdvantage Salmon.

FDA Approves First Genetically Engineered Seafood

Practical Law Legal Update w-000-9615 (Approx. 4 pages)

FDA Approves First Genetically Engineered Seafood

by Practical Law Commercial Transactions
Law stated as of 20 Nov 2015 • USA (National/Federal)
In response to an application from AquaBounty Technologies, Inc., the Food and Drug Administration (FDA) has issued its first approval for a genetically engineered animal intended for human consumption: AquAdvantage Salmon.
On November 19, 2015, the Food and Drug Administration (FDA) issued a press release announcing that it has approved AquaBounty Technologies, Inc.'s original animal drug application (NADA) for AquAdvantage Salmon, a genetically engineered (GE) animal intended for human consumption. This is the first time that the FDA has approved a GE animal intended for food.
After a comprehensive review and analysis of the scientific evidence AquaBounty submitted, the FDA determined that:
  • Food from AquAdvantage Salmon is as safe to eat and as nutritious as food from other non-GE Atlantic salmon.
  • The rDNA construct (the piece of DNA that modifies the salmon and makes it grow faster) is safe for the fish itself.
  • AquAdvantage Salmon meets AquaBounty's claim about faster growth.
  • There are no biologically relevant differences in the nutritional profile of AquAdvantage Salmon compared to that of other farm-raised Atlantic salmon.
In its approval letter to AquaBounty, the FDA set specific conditions related to the manufacture and sale of the GE food product, including:
  • The methods used in, and the facilities and controls used for, manufacturing, processing, and packing AquAdvantage Salmon. For example, AquAdvantage Salmon can be raised only in land-based, contained hatchery tanks in two specific facilities in Canada and Panama.
  • The methods and controls for breeding and shipping AquAdvantage Salmon.
  • The FDA's right to inspect AquaBounty's facilities.
  • The labeling requirements for AquAdvantage Salmon.
  • AquaBounty's recordkeeping requirements concerning its business, adverse events, and drug experience reports.
In addition to this approval, the FDA issued two guidance documents for labeling GE food:
These nonbinding recommendations are intended to assist manufacturers who want to label their products as containing ingredients from GE or non-GE sources. These guidance documents do not establish legally enforceable responsibilities. However, when labeling food products, a party must adhere to the FDA's general rules for being truthful and not misleading (see Practice Note, FDA Food Labeling: Overview). Otherwise, the products could be considered misbranded and subject the party to extensive liability.
For more information on the federal laws regulating the production and sale of food products in the US, see Practice Note, FDA Food and Dietary Supplement Regulations.