FDA Holds Public Hearing on the Labeling of Food Made from AquAdvantage Salmon
On September 21, 2010, the U.S. Food and Drug Administration (FDA) held a public hearing on the issue of labeling food made from the genetically engineered (GE) fish AquAdvantage Salmon, an Atlantic salmon produced by AquaBounty Technologies, Inc. The purpose of this hearing was to present the relevant legal principles for food naming and labeling, and describe information made available prior to the hearing about characteristics of AquAdvantage Salmon (e.g., the chemical composition and standardized methods used to identify species in the market place) that may be relevant to food naming and labeling. The FDA sought comment on the application of the relevant food labeling principles to products that are made from AquAdvantage Salmon. The FDA’s August 2010 background document is available online.
According to the FDA, the following five key principles for labeling foods are applicable to the issue of labeling foods made from GE animals, such as AquAdvantage Salmon:
- Food labeling that is false is prohibited;
- Food labeling that is misleading is prohibited, particularly in light of material facts about the product;
- Voluntary labeling about production methods is allowed, as long as the labeling is not false or misleading;
- The label must include a name that accurately describes the basic nature of the food; and
- FDA cannot require additional labeling about production methods, unless it is necessary to ensure that the labeling is not false or misleading.
The FDA sought input on two issues:
- Which facts about the AquAdvantage Salmon seem most pertinent for FDA’s consideration of whether there are any “material” differences between foods from the GE salmon and foods from other Atlantic salmon? The FDA asked stakeholders to keep in mind that the use of genetic engineering does not, in and of itself, constitute a “material” difference under the law.
- If the FDA determined there are “material” differences, how would the differences be described on a food label in a way that is truthful and non-misleading? FDA noted that it is the difference in composition, or in functional, organoleptic, or other material properties that must be described, not the underlying methods of production.
Speakers presented many comments to and asked questions of the FDA panelists, expressing their views for and against labeling the GE AquAdvantage Salmon. Some of the views shared included:
- The safety of GE foods;
- The difference in taste of GE foods versus non-GE foods;
- Endogenous allergens in fish;
- Country of origin labeling;
- Lack of adequate means to assess the origin of food;
- Uses in modern agriculture to increase productivity;
- Absence labeling;
- Relationship of material fact to nutritional value;
- Food ingredient analysis;
- Labeling as a risk management tool;
- Proper safety assessments;
- Food ingredient concerns;
- Environmental impact associated with production;
- Use of sound science as basis for regulation;
- Cost to consumers for a mandatory label;
- Examples of previously released GE foods; and
- Emphasis on food surveys to determine consumer opinion on labeling.
The FDA noted that the Veterinary Medicine Advisory Committee (VMAC) planned a separate public meeting to consider issues regarding the safety and effectiveness of the new drugs that are the subject of the new animal drug application (NADA) concerning AquAdvantage Salmon. If the FDA approves the NADA, public comments from the September 21 hearing on labeling of food from AquAdvantage Salmon will assist the FDA in the application of its food labeling principles. These principles will determine if the FDA should require labeling for such food, beyond that required for food from other varieties of Atlantic salmon.