US: Gluten-Free Labeling

Posted By: Selerant RSA

On November 18, 2015, the Food and Drug Administration (FDA) proposed to establish requirements concerning “gluten-free” labeling for foods that are fermented or hydrolyzed or foods that contain fermented or hydrolyzed ingredients. These include foods such as: cheese, yogurt, vinegar, sauerkraut, pickles, green olives, beers, and wine. These rules would also be relevant for foods containing hydrolyzed plant proteins used to improve flavor or texture in processed foods, such as soups, sauces, and seasonings.


Gluten, a protein occurring in wheat, rye, barley, and crossbreeds of these grains is known to trigger celiac disease, a hereditary, chronic inflammatory disorder of the small intestine.

Celiac disease has no cure, and individuals who have this disease are advised to avoid all sources of gluten in their diet to protect against adverse health effects associated with the disease.

Gluten-Free Labeling Rule from 2013

Under section 206 of FALCPA, in the Federal Register of August 5, 2013, the final rule (21 CFR 101.91)  was published defining the term “gluten-free” and establishing requirements as to the voluntary use of that term in food labeling. It is intended to help ensure that individuals with celiac disease are not misled and receive truthful and accurate information with respect to foods labeled as “gluten-free.” The final rule does not require manufacturers who label their foods as “gluten-free” to test those foods for the presence of gluten. In any case, food bearing a “gluten-free” claim must contain less than 20 ppm of gluten. A food that bears the claim “no gluten,” “free of gluten,” or “without gluten” in its labeling and fails to meet this requirements would be considered as misbranded.

What is in the Proposed Rule?

FDA has issued this proposed rule to provide alternative means for the agency to verify compliance for fermented or hydrolyzed foods labeled “gluten-free” based on records that are made and kept by the manufacturer.

The proposed rule, when finalized, will require the manufacturers to make and keep records demonstrating assurance that:

- the food meets the requirements of the gluten-free food labeling final rule prior to fermentation or hydrolysis, and

- the manufacturer has adequately evaluated its process for any potential gluten cross-contact, and

- where a potential for gluten cross-contact has been identified, the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process.

FDA is accepting public comments until February 16, 2016. To electronically submit comments to the docket, visit and type docket number “FDA-2014-N-1021” in the search box.

More information: Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods.

Interested in learning about labeling rules in the US? Try RegData®, our global food legislation library that contains comprehensive, easy-to-use labeling guides created by our in-house experts.

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