Genetically Modified Food Does Not Need Special Labeling, FDA Rules

Despite growing public concern over the potential health risks associated with genetically modified organisms (GMOs), the FDA is not requiring mandatory labeling, allowing voluntary labeling of GMO foods. 

This week, the FDA issued a Final Draft Guidance on foods made with genetically modified organisms (GMO) or GMO bioengineering. The guidance allows manufacturers to decide whether to place labels on their products indicating they are made using GMOs or made with non-GMO ingredients.

The rules indicate manufactures may place labels on their food products saying food was not “bioengineered,” or not produced “using genetically modified biotechnology,” that it was “not genetically engineered,” or it is a “non-GMO” food.

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The guidance does not require food manufacturers to place a label indicating if the food was genetically modified in some way, which some say could lead to confusion for consumers.

In 2013, 93% of the acreage of planted soybeans and  90% of the U.S. acreage  for corn was bioengineered, according to the FDA, making it very difficult for consumers to avoid GMO plants in many cases.

The guidance follows a recent FDA approval of the first genetically engineered animal intended for food, AquaAdvantage Salmon. The product, made by AquaBounty Technologies, is Atlantic Salmon genetically bioengineered to reach market size more quickly than non-genetically engineered farm-raised Atlantic salmon.

The FDA said it evaluated data on the new salmon and “determined they have met the regulatory requirements for approval, including that food from the fish is safe to eat.” The FDA statement indicates there are “no biologically relevant differences in the nutritional profile compared to that of other farm-raised Atlantic salmon.”

The new bioengineered salmon has been approved to be raise in only two facilities, one in Canada and another in Panama. The salmon is also engineered to be “reproductively sterile” to prevent the fish from interbreeding or establishing populations outside of the facilities.

The FDA regulates genetically engineered animals under the new animal drug provisions of the Food, Drug and Cosmetic Act. Specifically, because the recombinant DNA (rDNA) construct introduces a trait that causes the AquaAdvantage Salmon to grow much faster, meeting the definition of a drug.

The agency said it would not take action against companies that use bioengineering, or those indicating they are free of GMOs, as long as the product is labeled correctly.

“The FDA can only require additional labeling of foods derived from genetically engineered sources if there is a material difference – such as a different nutritional profile,” said the FDA statement.

The agency said they were unaware of “valid science” that revealed GMO foods differ from other foods in any meaningful way. The FDA only calls on companies to label foods derived from a genetically engineered plant that differs from its traditional counterpart.”

This does not refer to typical GMO foods. Canola oil that has been genetically modified to have more lauric acid must be labeled “laurate canola oil.” Soybean oil containing higher levels of oleic acid must be labeled “high oleic soybean oil,” but neither is required to be identified as a GMO.

Currently the European Union, Australia and China all require GMO labeling. Many consumer groups have advocated for the FDA to require labels on GMO foods, but the FDA continues to assert there is no need. Some fear genetically modified genes can be harmful to humans or the environment.


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