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FDA Gluten-Free Labeling Rule

FDA Gluten-Free Food Labeling Rule Information

FDA Gluten-Free Labeling Rule

The U.S. Food and Drug Administration (FDA) finalized a standard definition of "gluten-free" in August 2013.  As of August 5, 2014, all manufacturers of FDA-regulated packaged food making a gluten-free claim must comply with the guidelines outlined by the FDA.

Please explore these free resources on the FDA’s gluten-free labeling regulations and learn what the rule means for the gluten-free consumer.

Reporting a Problem

  • To report a problem with an FDA-regulated product* labeled as gluten-free, use the FDA's Consumer Complaint System. FDA Consumer Complaint Coordinators (CCC) will listen, document your complaint and follow up as necessary.  CCCs vary by location and a list of the appropriate phone numbers to call can be found here.  Consumers and manufacturers can make a complaint through CCCs.
  • The MedWatch form should be used to report adverse events for medical products, like prescription or over-the-counter medications, cosmetics and food and beverage.  Learn more about which products should be reported through MedWatch or begin a report here.

*FDA-regulated products include packaged foods, dietary supplements, bottled water, food additives, infant formulas and other food products.  For more information on which products are covered under the jurisdiction of the FDA, click here.

Product Recalls

To learn if a product has been recalled and for what reason, visit the FDA's product recall section.

NFCA Addresses Frequently Asked Questions

Visit this web section to learn what the term "gluten-free" means on a food label under the new rule.  Content includes:

  • The full FDA criteria for a food to be labeled "gluten-free"
  • NFCA's Gluten-Free Labeling Fact Sheet
  • Presentation explaining gluten testing methods

Do you have questions about the ruling?
E-mail them to webinars@celiaccentral.org. Your questions will help NFCA continue to learn more about the needs of both gluten-free consumers and food manufacturers so that we can determine how best to help our community eat safely. It’s essential that we use a unified and consistent voice to amplify the medical need for a gluten-free diet and how essential safe food is for the health of those with gluten-related disorders.

NFCA Press Release about FDA Gluten-Free Labeling Rule

NFCA Webinars about FDA Gluten-Free Labeling Rule

NFCA Webinar Archive: Understanding the FDA's Gluten-Free Labeling Rule Part 1: What You Need to Know

Download the free archive version of this webinar, which provided an overview of the FDA's rule, discussed what is and isn't covered and provided insights on how the rule may affect the manufacturing industry.  This webinar featured Matthew Cox, Marketing Director at Bob’s Red Mill Natural Foods and Tricia Thompson, MS, RD, expert celiac disease dietitian and founder of Gluten Free Watchdog.

Free NFCA Webinar: Understanding the FDA's Gluten-Free Labeling Rule Part 2: Focusing on Compliance

Download the free archive version of this webinar, which provided a recap of the rule's parameters and information on the consumer's role in manufacturer compliance.  This webinar featured Suzanne M. Wolcoff, MS, RD, Senior Regulatory Review Officer, Labeling Regulations and Implementation Team, ONLDS/CFSAN/FDA.

FDA Resources

Additional Resources and News

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