F.D.A. provides guidance on voluntary G.E. labeling

by Jeff Gelski
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Box of corn flakes with "Not Bioengineered" label on it
The F.D.A. recommends terms such as “not bioengineered."

WASHINGTON — The Food and Drug Administration 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 F.D.A. prefers such labeling terms as “not bioengineered” over such terms as “non-G.M.O.” The guidance also gave examples of potentially misleading labeling terms.

The F.D.A. recommends terms such as “not bioengineered,” “not genetically engineered” and “not genetically modified through the use of modern biotechnology.” However, the F.D.A. will not take enforcement action against a label using the acronym “G.M.O.” 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 F.D.A. discourages any “free” claims such as “G.M.O.-free,” “G.E.-free,” “does not contain G.M.O.s” and “non-G.M.O.”

“The term ‘free’ conveys zero or total absence unless a regulatory definition has been put in place in a specific situation,” the F.D.A. said and added substantiating such “free” claims presents potential challenges.

The F.D.A. also has problems with the “O.” that refers to “organism” in “G.M.O.” (an acronym for genetically modified organisms) since most foods do not contain entire organisms.

The F.D.A. 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 F.D.A.

Any type of non-bioengineered or non-G.M.O. reference on a product’s ingredients list also may lead to problems with the F.D.A. For example, “soybean oil” should appear on the ingredient list without any non-bioengineered or non-G.M.O. 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-G.E. soybeans.” 

The F.D.A. said it uses the terms “genetic engineering” and “bioengineering” to describe the use of modern biotechnology. The F.D.A. 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 F.D.A.

More on the F.D.A. guidance may be found at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm059098.htm.
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