On Thursday, November 19th, the Food & Drug Administration (FDA) announced that it had approved an application for AquAdvantage Salmon, a type of Atlantic Salmon that has been genetically engineered to grow to market size more quickly than other salmon.  The agency regulates genetically engineered (GE) animals such as AquAdvantage Salmon under the new animal drug provisions of the Federal Food, Drug & Cosmetic Act, as explained in FDA’s 2009 guidance document.  The approval of the application is historic as it marks the first time that FDA has approved the use of a genetically engineered animal intended for use as food.

FDA initially held a public hearing in September 2010 regarding the legal principles governing GE salmon and to solicit comments related to FDA’s consideration of whether there were any “material” differences between GE and non-GE salmon, and how food labels could truthfully and adequately disclose any such differences.  The agency noted that it reviewed over 30,000 written comments in response to the public hearing.  In announcing the approval of the AquAdvantage Salmon, FDA explained that extensive data demonstrated that the GE salmon is “as safe to eat and as nutritious as food from other non-GE Atlantic salmon and that there are no biologically relevant differences in the nutritional profile of AquAdvantage Salmon compared to that of other farm-raised Atlantic salmon.”  Because it determined that AquAdvantage Salmon was not materially different than other Atlantic salmon, FDA concluded that it was inappropriate to impose mandatory labeling requirements disclosing that the salmon was produced using modern biotechnology.

The agency also found that the approval would not have a significant impact on the U.S. environment because of the multiple forms of physical and biological containment proposed by the applicant, AquaBounty Technologies.  Notably, the application only permits AquAdvantage Salmon to be raised on land-based contained hatchery tanks in two specific facilities in Canada and Panama; it does not permit the salmon to be bred or raised in the United States.  The agency also noted that the salmon are reproductively sterile so they would be unable to interbreed even in the highly unlikely event that they would somehow be introduced into the wild.

At the same time as announcing the approval of the salmon, FDA released two guidance documents related to voluntary labeling of food from genetically engineered sources.  A separate blog post discusses the final guidance on voluntary labeling indicating whether food has or has not been derived from GE plants, which finalizes a January 2001 draft guidance.  The agency sets forth similar principles in a second guidance targeted to the issue of GE salmon, which it released in draft form, entitled “Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon”:

  • Mandatory labeling inappropriate.  The draft guidance explains that because of FDA’s conclusion that “there is no material difference between food derived from AquAdvantage Salmon and food derived from other non-GE, farm-raised Atlantic salmon,” the agency is not imposing unique mandatory labeling requirements on GE salmon.
  • Certain voluntary labeling claims acceptable.  The draft guidance notes that while FDA considers mandatory labeling requirements unsupportable due to the lack of material difference between GE and non-GE salmon, it recognizes that some consumers are interested in knowing whether a food is derived from GE salmon.  The draft guidance suggests use of the following statements on a voluntary basis to convey to consumers that a food is not derived from GE salmon:
    • “Not genetically engineered.”
    • “Not genetically modified through the use of modern biotechnology.”
    • “We do not use Atlantic salmon produced using modern biotechnology.”
  • Certain voluntary labeling claims potentially misleading.  The draft guidance notes that other currently used voluntary claims may be misleading to consumers, including “not genetically modified,” and “non-GMO” because FDA considers the term “genetic modification” to be a much broader and harder to substantiate term than “genetic engineering.”  Nonetheless, the draft guidance indicates that FDA does not intend to take enforcement action against foods using such claims, provided the food actually is not produced through the use of modern biotechnology.
  • Context is important for labeling claims.  The draft guidance emphasizes that manufacturers must consider the broader context in which claims appear in order to evaluate whether a particular claim is false or misleading.  For example, FDA notes that the claim “None of the ingredients in this food are genetically engineered” could be misleading if certain ingredients are incapable of being produced through genetic engineering (e.g., salt).  Moreover, a statement regarding the absence of genetic engineering would be misleading if the broader label suggests that the food is safer, more nutritious or otherwise materially different than the food produced using modern biotechnology.

The agency will accept comments on the draft guidance until January 25, 2016.