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Small Entity Compliance Guide: Gluten-Free Labeling of Foods June 2014

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Guidance Issuing Office
Center for Food Safety and Applied Nutrition

On August 5, 2013, FDA (or we) published in the Federal Register a final rule that established a regulatory definition of the term “gluten-free” for voluntary use in the labeling of foods (see 78 FR 47154). The rule implements part of the Food Allergen Labeling and Consumer Protection Act of 2004, Title II of Public Law 108-282, enacted on August 2, 2004, which directed the Secretary of Health and Human Services to issue a regulation to define and permit use of the food labeling term “gluten-free.”  Firms are not required to label their foods “gluten-free,” but if firms whose foods are regulated by FDA voluntarily choose to make this labeling claim, those products must conform to our definition for a “gluten-free” food.  This final rule is intended to provide a uniform definition of the term “gluten-free” so that consumers, particularly those who have celiac disease, will know what it means when they see it on the labeling of food. 

The final rule became effective on September 4, 2013, but August 5, 2014 is the date when FDA-regulated foods labeled “gluten-free” must comply with all requirements established by the final rule. However, we encourage manufacturers that wish to make a “gluten-free” claim for their foods to comply voluntarily before this date. 

We have prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). This guidance document restates in plain language the requirements set forth in the regulation at 21 CFR 101.91 concerning use of the term “gluten-free” in the labeling of foods. The “gluten-free” regulation is binding and has the full force and effect of law.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in our guidances means that something is suggested or recommended, but not required. 

In the remainder of this guidance, “you” refers to entities that choose to make a “gluten-free” claim on their food labels. We have organized this guidance in a question/answer format and also identify the relevant regulation in parentheses after each answer. 

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2005-N-0404.

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