FDA Reopens Comment Period for Gluten-Free Labeling of Foods

By Cassandra A. Soltis –

The Food and Drug Administration (“FDA”) has reopened the comment period for its proposed rule on “gluten-free” labeling of food to announce the availability of, and seek comments on, its report titled “Health Hazard Assessment for Gluten Exposure in Individuals with Celiac Disease:  Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten,” which discusses FDA’s gluten safety assessment.  FDA also requests comments on a number of related issues, including whether and how this safety assessment should affect the proposed “gluten-free” definition in the final rule and on FDA’s tentative conclusion to adopt the proposed rule’s analytical methods-based approach to define the term “gluten-free.”

If you recall, FDA proposed to define “gluten-free” for voluntary use in food labeling as a food that does not contain any of the following:  (1) an ingredient that is any species of wheat, rye, barley, or a crossbred hybrid of these grains; (2) an ingredient derived from one of these grains and that has not been processed to remove gluten; (3) an ingredient derived from one of these grains and has been processed to remove gluten if the use of that ingredient results in the presence of 20 ppm or more gluten in the food (i.e., 20 micrograms or more gluten per gram of food); (4) 20 ppm or more gluten.  72 Fed. Reg. 2795 (Jan. 23, 2007). 

In the Federal Register notice announcing the reopening of the comment period, FDA states that it has “tentatively concluded” that it will “use both the ELISA R5-Mendez Method and the Morinaga method” to “assess compliance with [the] gluten threshold level for foods bearing ‘gluten-free’ labeling claims,” and that these methodologies will be included in the codified language of the final rule.  76 Fed. Reg. 46671, 46672-73 (Aug. 3, 2011).  However, because there are no currently available validated methods to assess the gluten content of certain foods, such as fermented or hydrolyzed foods, “FDA is considering whether to require manufacturers of such foods to have a scientifically valid method that will reliably and consistently detect gluten at 20 ppm or less before including a ‘gluten-free’ claim in the labeling of” these foods.  Id. at 46673 (footnote omitted).  

Because the proposed rule’s definition of “gluten-free” would permit foods not completely free of gluten to bear the claim, FDA seeks comments on whether it would be necessary for a “gluten-free” claim to be qualified with a statement such as “does not contain 20 ppm or more gluten.”  Id. at 46675.  In addition, in light of FDA’s safety assessment, which suggests that a level below 20 ppm for a “gluten-free” claim might be more protective for the most sensitive individuals with celiac disease, FDA invites comments on whether a gluten threshold level lower than < 20 ppm should be adopted and, if so, what impact this might have on both manufacturers of foods with “gluten-free” claims and on consumers of these foods.  Id.  FDA also requests comments on whether a “low-gluten” claim should be defined, and if so, what threshold level should be used.  Id. at 46676.

Comments on the proposed rule and the other issues highlighted by FDA are due October 3, 2011.