Something Old, Something New: FDA’s Guidance Documents on Labeling of Genetically Engineered Foods – Including Salmon

By Ricardo Carvajal –

In tandem with its approval of genetically engineered (GE) salmon (see our previous post here), FDA issued two guidance documents on labeling of GE foods – a final guidance document applicable to foods derived from GE plants, and a draft guidance document specific to GE salmon.  The guidance documents are very similar in content, so it seems fair to speculate that the issuance of the final guidance for GE plant foods was prompted by the need to issue a draft guidance that addressed labeling of the newly approved GE salmon.  The latter is novel in the sense that it accompanies FDA’s first approval of a food derived from a GE animal.  However, the positions articulated in both guidance documents are hardly novel; rather, they echo positions staked out in the draft guidance on labeling of GE foods that FDA issued in 2001. 

In the GE plant foods final guidance, FDA continues to:

• Adhere to the view that bioengineered foods do not “differ from other foods in any meaningful or uniform way, or that, as a class, foods developed by the new techniques present any different or greater safety concern than foods developed by traditional plant breeding.”  By implication, labeling of GE foods as such cannot be required on those bases. 

• Frown on the use of the terms “genetically modified” and “GMO” on the grounds that the terms are less scientifically accurate than alternate terms such as “genetically engineered” or “bioengineered.”  However, the agency makes clear that it does not intend to take enforcement action when the term “GMO” is used in claims that a food was or was not produced through genetic engineering, provided that the claim is true “and the labeling is not otherwise false or misleading.” 

• Recommend against the use of the claim “GMO-free” due to the difficulties of substantiating that claim – difficulties that are addressed in the guidance in some detail.  Instead, FDA recommends that manufacturers use the process-oriented claims favored by the agency.

• Disfavor the incorporation of descriptors regarding bioengineering into a food’s common or usual name, on the ground that such descriptors constitute impermissible intervening material

FDA also continues to address voluntary labeling of foods that are derived from GE plants.  However, that discussion now follows the discussion of labeling of foods that are not derived from GE plants – perhaps a tacit recognition of greater interest in the latter than may have been anticipated in 2001. 

Not surprisingly, FDA’s guidance is silent on the question of whether GE foods can properly be labeled as “natural” – a question on which FDA recently asked for comment (see our previous post here).  However, coming on the heels of that request for comment, the issuance of the GE labeling guidance documents serves as an additional indication that FDA is ready and willing to engage on labeling issues that fall under its jurisdiction – an important development in and of itself.