FDA Issues Labeling Guidance for Foods Derived from GE Plants, GE Salmon

In conjunction with its decision to approve the first genetically engineered (GE) animal for human consumption, the U.S. Food and Drug Administration (FDA) has published final labeling guidance for foods derived from GE crops and draft labeling guidance for GE salmon.

Titled “Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants,” the final guidance document seeks to assist “food and feed manufacturers that wish to voluntarily label their plant-derived food products or ingredients (for humans or for animals) as having been made with or without bioengineering.” In addition, the agency’s draft labeling guidance—“Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon”—describes the preferred labeling terms for products marketed as containing or avoiding transgenic salmon.

Emphasizing that such labeling should be “truthful and not misleading,” the agency recommends that manufacturers wishing to identify their products as not derived from GE ingredients use phrases such as “not bioengineered” or “not genetically modified through the use of modern biotechnology,” as opposed to “GMO free,” “GE free,” “does not contain GMOs,” “non-GMO,” or similar claims. In particular, the labeling guidance pertaining to GE-derived plant ingredients advises manufacturers that the term “free” is not only difficult to substantiate, but the acronym “GMO” may confuse consumers because “most foods do not contain entire organisms.”

“However, FDA does not intend to take enforcement action against a label using the acronym ‘GMO’ in a statement indicating that the product (or an ingredient) was not produced through the use of modern biotechnology, as long as the food is, in fact, not derived from a genetically engineered plant and the food’s labeling is not otherwise false or misleading, as further discussed in this guidance,” notes FDA. “Similarly, we do not intend to take enforcement action against a label using the acronym ‘GMO’ in a statement indicating that the product (or an ingredient) was produced through the use of modern biotechnology, as long as the statement was true and the food’s labeling is not otherwise false or misleading.”

Both guidance documents also address the substantiation of GE ingredient claims, including, where appropriate, (i) “the documentation of handling practices and procedures”, (ii) “the use of certified organic food,” and (iii) “the use of validated test methods.” FDA will accept comments on the draft labeling guidance for foods derived from GE salmon beginning November 23, 2015.

Issue 585