Defining “Gluten-Free”

October 3 deadline to comment on FDA’s new “gluten-free” labeling rule quickly approaching

The Oct. 3, 2011 deadline by which comments may be submitted to The Food and Drug Administration (FDA) on its proposed rule on the labeling of food “gluten-free,” is quickly approaching. The proposed rule, which was first introduced in 2007, defines “gluten-free” to mean “that the food does not contain an ingredient that is any species of wheat, rye, barley, or a crossbred hybrid of these grains (collectively referred to as ‘‘prohibited grains’’); an ingredient that is derived from a prohibited grain and that has not been processed to remove gluten (e.g., wheat flour); an ingredient that is derived from a prohibited grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food; or 20 ppm or more gluten.” (72 FR 2795)

After conducting a safety assessment of gluten exposure in individuals with celiac disease, the FDA recently released a report entitled, “Health Hazard Assessment for Effects of Gluten Exposure in Individuals with Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten” (Gluten Report). The Agency is now seeking comment on what, if any, impact the Gluten Report should have on the FDA’s proposed definition of “gluten-free” and on a number of related issues.

The FDA has tentatively concluded that less than 20 ppm gluten is the appropriate threshold level to use as the criteria to define the food labeling term “gluten-free.” The Agency is concerned that if it were to adopt a lower threshold it would have the unintended and unwanted effect of actually making it more difficult for those with celiac disease to adhere to a life-long gluten-free diet. As such, the FDA is seeking feedback from food manufacturers of multi-ingredient foods, particularly grain-based products, as to whether such manufacturers could comply with a gluten threshold level which is lower than the less than 20 ppm gluten level. 

Specifically the FDA has stated that, “[e]ven if a lower gluten threshold level could be enforced, we do not know if it would: (1) Influence some U.S. food manufacturers to discontinue labeling their products ‘gluten-free’ because they cannot consistently and reliably meet a lower gluten threshold level, (2) discourage other U.S. food companies from becoming manufacturers of foods labeled ‘gluten-free,’ (3) result in a significant increase in the cost of foods labeled ‘gluten-free,’  or (4) negatively affect international trade of foods labeled ‘gluten-free,’ thereby affecting the availability of certain foods to those individuals with celiac disease.” (76 FR 46675)

Two other parts of the proposal that have been highlighted for comments are: (1) the FDA’s proposal to require manufacturers of certain 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 their foods,” since there are no currently available methods to accurately test the gluten level in some foods, such as fermented or hydrolyzed foods; and (2) the FDA’s proposal to require a disclaimer on food labels indicating that the product does not contain more than 20 ppm or more gluten, and whether it is necessary, in light of the safety assessment.

“Questions and Answers on the Gluten-Free Labeling Proposed Rule” can be found on the FDA’s website at www.fda.gov.