WASHINGTON, D.C., U.S. — The U.S. Food and Drug Administration (FDA) on Nov. 19 issued guidance on the voluntary labeling of food products or ingredients that indicates whether they were derived or not from genetically engineered plants. The FDA prefers such labeling terms as “not bioengineered” over such terms as “non-GMO.” The guidance also gave examples of potentially misleading labeling terms.
The FDA recommends terms such as “not bioengineered,” “not genetically engineered,” and “not genetically modified through the use of modern biotechnology.” However, the FDA will not take enforcement action against a label using the acronym “GMO” as long as the food is not derived from a genetically engineered plant and the food’s labeling is not otherwise false or misleading.
The FDA discourages any “free” claims such as “GMO-free,” “GE-free,” “does not contain GMOs” and “non-GMO.”
“The term ‘free’ conveys zero or total absence unless a regulatory definition has been put in place in a specific situation,” the FDA said and added substantiating such “free” claims presents potential challenges.
The National Grain and Feed Association (NGFA) commended the FDA for rejecting the argument of those urging mandatory GMO labeling that genetically engineered foods are somehow materially different, as a class, than food derived from traditional breeding techniques.
"FDA states correctly, in our view, that the determination of whether labeling should be required should not be depend on the process used to produce a food, without regard to its effect on the food," NGFA said. "Instead, a material difference designation should be reserved for if and when a biotech-enhanced trait alters the functional, nutritional or compositional characteristics, allergen city or other attributes of a food or feed, which biotech ingredients, as a class, clearly do not."
The National Corn Growers Association (NCGA) commended the FDA for the science-based guidance. This guidance, which importantly stresses that the FDA only has purview to require mandatory labels in the case of material difference, addresses consumer interests with a clear outline of recommendations for food companies wishing to label their products.
“The FDA’s approach to voluntary labeling of food products would provide American consumers with truthful information in a clear manner that respects regulatory processes already in place,” said NCGA President Chip Bowling, a farmer from Newburg, Maryland, U.S. “In maintaining a science- and process-based approach to mandatory labels while laying out a thoughtful, conscientious path for voluntary labeling, the FDA stood firmly both with the people who grow our food and those who buy it. A voluntary labeling system, like the one outlined, provides information that would allow consumers to make choices based in facts and not in fear.”
Establishing a uniform standard for voluntary labeling has been a key part of the American Soybean Association’s (ASA) push to reduce consumer confusion about which foods do and do not contain ingredients derived from biotechnology.
“ASA is happy to see the guidance from FDA today that affirms that voluntary rather than mandatory labeling is the correct science-based and health policy,” said ASA President and Texas farmer Wade Cowan. “This concept has been at the heart of our work on a legislative solution that would provide more clarity to consumers, and we’re encouraged to see that part of the process move forward.”
In its guidance, the FDA said it also has problems with the “O.” that refers to “organism” in “GMO” (an acronym for genetically modified organisms) since most foods do not contain entire organisms.
The FDA gave examples of a statement that may be truthful but still misleading. For one example, a statement saying a particular ingredient in a food product was not bioengineered might be misleading if another ingredient in the food product was bioengineered.
A statement may be false and misleading if it suggests or implies that a food product or ingredient is safer, more nutritious or otherwise has different attributes than other comparable foods because the food product was not genetically engineered, according to the FDA.
Any type of non-bioengineered or non-GMO reference on a product’s ingredients list also may lead to problems with the FDA. For example, “soybean oil” should appear on the ingredient list without any non-bioengineered or non-GMO reference. Such information could appear on the display panel or an information panel. For example, the principal display panel on a bottle of soybean oil could say, “Made from certified non-GE soybeans.”
The FDA said it uses the terms “genetic engineering” and “bioengineering” to describe the use of modern biotechnology. The FDA said 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. The term “modern biotechnology” alternatively may be described as “recombinant DNA (rDNA) technology,” “genetic engineering” or “bioengineering,” according to the FDA.
The House of Representatives in July, with strong bipartisan support, passed its version of a national standard for food and feed labeling for those who voluntarily wish to label their products as either containing or not containing biotech-enhanced ingredients, a bill the NGFA strongly supported. The focus is now on the Senate.
Lawmakers are considering using the omnibus spending package as a vehicle to preempt states from mandating GMO labels on foods that contain ingredients made through biotechnology. Congress has until Dec. 11 to pass the fiscal 2016 spending bill, while the first state labeling law takes effect in Vermont next July.
Click here for more on the FDA guidance.