On November 19, 2015, FDA issued its final guidance for industry concerning the requirements for voluntarily indicating whether food products have or have not been derived from genetically engineered plants.  The final guidance updates the FDA draft guidance originally issued on January 18, 2001.  Under the guidance, food manufacturers may voluntarily label their foods with information about whether the foods were or were not produced using bioengineering, as long as such information is truthful and not misleading.  However, FDA suggests that food manufacturers use terms such as “not bioengineered,” “not genetically engineered,” and “not genetically modified through the use of modern biotechnology” rather than “not genetically modified,” “non-GMO,” or “GMO free.”  Also on November 19, FDA issued draft guidance on labeling genetically engineered salmon, a topic we cover in a separate blog post.

FDA uses the terms “genetic engineering” and “bioengineering” to describe the use of modern biotechnology to develop new plant varieties.  In technical terms, modern biotechnology means the application of in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombinant barriers and that are not techniques used in traditional breeding and selection of plants.  FDA prefers the terms “genetic engineering” and “bioengineering” over the broader term, “genetic modification,” based on the potential for the term, without additional qualifiers, to encompass virtually any kind of alteration to the genetic composition of a plant, rather than simply the modifications resulting from modern biotechnology techniques.

FDA also discourages the use of such claims as “GMO free,” “GE free,” “does not contain GMOs,” and “non-GMO” to indicate that a food is made without ingredients derived through the use of biotechnology.   FDA views  “free” to mean there is a  total absence of components derived through the use of biotechnology, and observes that a claim suggesting that a food product is entirely “free” of components derived from genetically modified plants could be difficult to substantiate.  FDA also takes issue with the “GMO” term, noting that the “O” refers to “organism,” and foods generally do not contain entire “organisms.”

Manufacturers can substantiate a genetic engineering-related labeling claim through a few means.

  • Manufacturers can substantiate claims using documentation of handling practices and procedures, including certifications from farmers, processors, and others in the food production and distribution chain.
  • Manufacturers can substantiate a “not genetically engineered” claim by using certified organic food, because foods that comply with 7 CFR part 205 (USDA organic regulations) would meet criteria to be labeled as not produced or handled using bioengineering.  Documentation of compliance with the USDA organic certification requirements and recordkeeping requirements for certified operations would be sufficient to substantiate a food labeling claim that a food was not produced using bioengineering.
  • Although validated analytical methods may be useful in confirming the presence of bioengineered material in food derived from genetically engineered plants or food ingredients, FDA cautioned that for many foods, particularly for highly processed foods such as oils, it may be difficult to differentiate between plant-derived food developed through bioengineering and plant-derived food developed using traditional breeding methods. Therefore, tests may be less useful in demonstrating the absence of bioengineered material in food derived from genetically engineered plants or food ingredients. Moreover, the specific analytical methods necessary to detect bioengineered material likely will change as new bioengineered plant varieties are introduced to the marketplace, so firms may have to update tests and then routinely and methodically (e.g., shipment by shipment or lot by lot) analyze their ingredients or products for bioengineered material. If validated test methods are not available or reliable because of the way a plant-derived food is produced or processed, it may be more practical to substantiate a claim for such foods differently, such as documenting handling practices and procedures.

As we covered in a previous blog post, FDA recently requested comments regarding the proper meaning and use of “natural” in the labeling of foods, including whether genetically engineered ingredients can be “natural.”