Regulatory Update Part 1: FDA Announces Guidance for Industry on Labeling of Genetically Engineered Foods

Regulatory Update Part 1: FDA Announces Guidance for Industry on Labeling of Genetically Engineered Foods

December 2, 2015

By RDBA Executive Director, Annette Maggi, MS, RDN, LD, FAND

It’s been an active few weeks on the regulatory front as it relates to genetically engineered foods. Today’s article provides an overview of the Food and Drug Administration’s (FDA) guidance for industry on Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants. Next week we’ll provide an update on the AquAdvantage Salmon.

History on the labeling of genetically engineered (GE) foods goes back 23 years. In 1002, FDA announced a policy indicating there were no specific labeling requirements for foods from bioengineered plants as these foods were not different in any meaningful way than their non-GE counterparts and there were no different or greater safety concerns with GE foods. In 2001, the FDA drafted guidance on labeling of GE goods, and received more than 150,000 comments on the drafted guidance. The agency has been silent on the topic until November 24, 2015.

In the current announcement, the FDA is clear that this document provides guidance for those manufacturers who choose to voluntarily label their products. It is not regulation, and there is no requirement for the industry to label. FDA stands behind their original stance that genetic engineering does not change the food in any meaningful way and that there are no different or greater safety concerns. This document is focused on providing guidance to ensure that those who choose to label GE ingredients or foods are consistent with the core tenant of food labeling which indicates all information must be “truthful and not misleading.”  

Key elements of the guidance are:

  • Avoidance of the term “genetically modified.” FDA indicates that modification in this content means the alteration of a plant’s genetic composition from adding, deleting or changing hereditary traits, regardless of the method. This modification can occur through traditional hybridization or breeding techniques, and therefore, this term could apply to most cultivated food crops today.  Instead, FDA is recommended terms such as not bioengineered, not genetically engineered, or not genetically modified through the use of modern biotechnology be used on the label.  
  • Avoidance of GMO free, GE free, non-GMO and similar claims. The term free conveys total absence unless a regulatory definition has been put in place by the FDA. In light of the challenges of substantiating a free claim in this situation, FDA recommends that manufacturers avoid claims that indicate zero presence of ingredients derived through the use of biotechnology. Additionally, because the “O” in GMO refers to organism and most foods do not contain organisms, the FDA is recommending avoidance of this term.
  • Ensure all label statements are not misleadingLabeling statements that highlight one ingredient not developed through GE while there is another ingredient in the food that was bioengineered would be considered misleading by the FDA. If a food label claims “none of the ingredients in this food is genetically engineered” when some ingredients cannot be produced through GE (think salt), this would also be considered misleading. If a label suggests a non-GE food is safer, more nutritious or has other benefits compared to the GE counterpart could also be considered misleading.
  • List common or usual name in the ingredient dec. Regulations for ingredient declarations clearly indicate there cannot be intervening material listed. To this end, “Non-GE” and other similar statements cannot be listed as a part of the ingredient name within the ingredient declaration. These types of statements, such as made from certified non-GE soybeans, are allowed on other parts of the label.
  • Label differences if they exist. If a food derived from GE plants is significantly different or has significantly different nutrition from its traditional counterpart, the name of the new food must be changed to a term that accurately describes the new food or the label must describe the nutritional differences.  An example would be oil with a different fatty acid profile derived through bioengineering. If a food derived through genetic engineering contains an allergen that consumers would not expect to be present in the food based on the name of the food, the presence of that allergen must be disclosed on the label.

To read the full guidance document, click here.

Coming next week: Part II of our regulatory update focused on FDA’s approval of AquAdvantage Salmon and their proposed labeling requirements.