On November 23, 2015, the U.S. Food and Drug Administration (FDA) issued a guidance to assist food and feed manufacturers that would like to label their plant-derived food products or ingredients as produced with or without the use of genetic engineering.  On a voluntary basis, a manufacturer may choose to label its food as produced with or without genetically engineered plants, as long as the labeling is truthful and not misleading.  The FDA identifies acceptable labeling statements including “not bioengineered,” “not genetically engineered,” “our corn growers do not plant bioengineered seeds,” and declarations such as “genetically engineered” or “some of our growers plant soybean seeds that were developed through modern biotechnology to be drought tolerant.”  The guidance contains specific recommendations on the use of the term GMO for genetically modified organism.

The guidance outlines the types of statements that may be false or misleading.  For example, if a label claims that one ingredient was not bioengineered, but is silent as to whether a different ingredient was bioengineered, the label could be misleading.  The FDA may deem misleading claims that no ingredients were genetically engineered, if an ingredient such as salt could not possibly be bioengineered.  If labeling suggests or implies a food is safer, healthier or more nutritious than a food that was not genetically engineered, the FDA will consider such a statement to be false or misleading. Statements about bioengineered ingredients that indicate an ingredient is functionally improved may be misleading if the amount of the ingredient present in the food is not enough to confer the properties claimed on the labeling.

FDA requires substantiation of a manufacturer’s claim that a food or its ingredients is or is not bioengineered.  The guidance lists several methods by which a statement that a food has not been produced using genetic engineering could be substantiated, including documentation of practices and handling procedures or documentation of compliance with U.S. Department of Agriculture organic certification requirements.  Finally, labels of genetically engineered foods must comply with existing FDA requirements on ingredient labeling and misbranding.  For example, if a genetically engineered food has a different nutritional property or contains an allergen that is not present in a non-bioengineered counterpart, the label must disclose the presence of such properties.

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