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FDA Issues Long-Awaited Regulations on Use of “Gluten-Free” Claims in Food Labeling

Monday, August 05, 2013
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration issued Aug. 2 a final rule defining and setting conditions on the voluntary use of the term “gluten-free” in food labeling. This rule will be applicable to both imported and domestically produced foods once full compliance is enforced as of Aug. 5, 2014.

Under this rule, foods may use the “gluten-free” claim if they:

- do not contain gluten (e.g., raw carrots or grapefruit juice); or

- have ingredients that are gluten-containing grains that have been refined in such a way to remove the gluten (e.g., wheat starch), so long as the food contains less than 20 ppm gluten (i.e., less than 20 mg gluten per kg).

The “gluten-free” claim may not be used for foods that:

- have any whole, gluten-containing grains (e.g., spelt wheat) as ingredients;

- have ingredients that are gluten-containing grains that are refined but still contain gluten (e.g., wheat flour); or

- contain 20 ppm or more gluten as a result of cross-contact with gluten-containing grains (e.g., the use of shared production equipment in manufacturing facilities that produce foods both with and without gluten).

The FDA intends to exercise enforcement discretion with respect to the requirements for “gluten-free” labeling for FDA-regulated beers that currently make such claims and are (1) made from a non-gluten-containing grain or (2) made from a gluten-containing grain, where the beer has been subject to processing that the manufacturer has determined will remove gluten below a 20 ppm threshold. The FDA plans to issue a proposed rule to address its compliance approach to fermented or hydrolyzed products.

The new final rule will be effective as of Sept. 4, 2013, but compliance will not be required until Aug. 5, 2014. As a result, manufacturers will have a year to bring package labels into compliance.

After Aug. 5, 2014, a food that bears the claim “no gluten,” “free of gluten” or “without gluten” in its labeling and fails to meet the requirements for a “gluten-free” claim will be deemed to be misbranded. In addition, a food whose labeling includes the term “wheat” in the ingredient list or in a separate “contains wheat” statement as required by a section of the Federal Food, Drug and Cosmetic Act and also bears the claim “gluten-free” will be deemed to be misbranded unless its labeling also bears additional language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a “gluten-free” claim. In both cases, such foods would be subject to regulatory action.

For more information on this rule and its effects, please contact Shelly Garg at (305) 894-1043 or Lee Sandler at (305) 894-1000.

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