On November 24, 2015, FDA issued a final guidance indicating that manufacturers can voluntarily decide whether to label their foods as having been or not having been derived from genetically engineered ("GE") plants. FDA does not require GE foods to be labeled as such, and it states that it is not aware of "any information showing that bioengineered foods differ from other foods in any meaningful or uniform way, or that, as a class, foods developed by the new techniques present any different or greater safety concern than foods developed by traditional plant breeding." On the other hand, FDA states manufacturers may voluntarily label their foods with information about whether the foods were not produced using bioengineering, as long as such information is truthful and not misleading. In addition, the guidance states FDA's preference for the use of the term "genetic engineering" as opposed to "genetic modification" or "genetic modified organisms (GMOs)," and recommends not using "GMO free" or similar claims due to the potential challenges of substantiating a "free" claim.
At the same time, FDA approved the sale of GE AquAdvantage Salmon, representing the first time the agency approved the sale of a GE animal product for public consumption. The salmon is engineered to grow faster, but not larger, than the naturally occurring variety. In support of the New Animal Drug Application related to AquAdvantage Salmon, the agency conducted an Environmental Assessment ("EA") and made a Finding of No Significant Impact ("FONSI") on the human environment. The EA and FONSI were issued under certain commitments, such as limiting where the salmon could be grown or the physical containment conditions used, among others.
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