FDA Releases Proposed Rule to Establish "Gluten-Free" Labeling Compliance Requirements for Fermented, Hydrolyzed and Distilled Foods

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February 12, 2016

FDA to Reopen Comment Period on Proposed Rule on Gluten-Free Labeling of Fermented and Hydrolyzed Foods

In response to requests from the public, the FDA has decided to add an additional 60 days to comment on the following proposed rule that appeared in the Federal Register on November 18, 2015:

We are sending and posting this Constituent Update to notify stakeholders that we will be providing more time to comment on this proposed rule. Although the comment period is technically closing on February 16, 2016, we will be reopening it to extend the timeframe to comment for 60 additional days. The new deadline will be 60 days from the date that a notice reopening the comment period appears in the Federal Register. We are taking this action in response to multiple requests for an extension to allow interested persons additional time to develop and submit meaningful comments to the proposed rule.

On January 21, 2016, due to an error of conflicting dates, FDA reopened the comment period only for information collection issues under the Paperwork Reduction Act of 1995.

January 21, 2016: Comment Period Reopened for Information Collection Issues in Proposed Rule for Fermented or Hydrolyzed Foods Until February 22, 2016

The FDA reopened the comment period for information collection issues under the Paperwork Reduction Act (PRA) for the proposed rule to establish requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, and bear the “gluten-free” claim. The comment period regarding information collection issues will now end on February 22, 2016. Due to an error, the proposed rule “Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods,” contained conflicting dates for submitting comments about information collection issues under the PRA. FDA is committed to providing the public with more time to submit comments regarding information collection issues in the proposed rule. The comment period for all other aspects of the proposed rule remains unchanged. The FDA will review all public comments and information submitted for this rulemaking.

For more information:

Original Constituent Update

November 17, 2015

The U.S. Food and Drug Administration today released a proposed rule to establish requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, and bear the “gluten-free” claim. The proposed rule, titled “Gluten-Free Labeling of Fermented or Hydrolyzed Foods,” pertains to foods such as yogurt, sauerkraut, pickles, cheese, green olives, vinegar, and FDA regulated beers.

In 2013, the FDA issued the gluten-free final rule, which addressed the uncertainty in interpreting the results of current gluten test methods for fermented and hydrolyzed foods in terms of intact gluten.  Due to this uncertainty, the 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, would require these 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.

Distilled foods such as distilled vinegars are also included in the proposed rule. Distillation is a purification process that separates volatile components from non-volatile components such as proteins.  Thus, when properly done, gluten should not be present in distilled foods. The proposed rule states that FDA would evaluate compliance of distilled foods by verifying the absence of protein (including gluten) using scientifically valid analytical methods that can detect the presence of protein or protein fragments in the distilled food.

The FDA is accepting public comments beginning Wednesday, November 18. To electronically submit comments to the docket, visit and type docket number “FDA-2014-N-1021” in the search box.

To submit comments to the docket by mail, use the following address. Be sure to include docket number “FDA-2014-N-1021” on each page of your written comments.

Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

For more information:


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