FDA Announces Guide to Help Small Businesses Comply with Gluten-Free Labeling Requirements

CFSAN Constituent Update

June 25, 2014

The U.S. Food and Drug Administration has issued a guide for small food businesses to help them comply with new federal requirements for the voluntary use of the term "gluten-free" on food products. The Small Entity Compliance Guide provides a plain-language question and answer overview of FDA’s regulatory requirements for use of the term “gluten-free” on food labels.

FDA published the final rule on “gluten-free” labeling in August 2013 so that consumers, particularly those with celiac disease, can depend on the accuracy and reliability of the claim. Celiac disease is an autoimmune digestive disorder that can be managed effectively only by eating a gluten-free diet.

Starting August 5, 2014, the compliance date of the rule, all FDA-regulated food products labeled on or after that date and bearing the gluten-free claim must comply with the rule’s requirements.

FDA is issuing the Small Entity Compliance Guide as required by the Small Business Regulatory Enforcement Fairness Act of 1996. The guide covers the key requirements of the regulation, including food products subject to the rule; the definitions of the terms "gluten" and "gluten-free"; and when FDA considers a food labeled "gluten-free" to be misbranded.

FDA encourages the public to submit comments on the guide. The comment period opens June 26, 2014. Electronic comments should be submitted to Written comments should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2005-N-0404.

For additional information:

Page Last Updated: 06/25/2014
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