An estimated 3 million people in the United States have celiac disease. In people with celiac disease, foods that contain gluten trigger production of antibodies that attack and damage the lining of the small intestine. Such damage limits the ability of celiac disease patients to absorb nutrients and puts them at risk of other very serious health problems, including nutritional deficiencies, osteoporosis, growth retardation, infertility, miscarriages, short stature, and intestinal cancers.
On August 2, 2013, FDA issued a final rule defining “gluten-free” for food labeling, which will help consumers, especially those living with celiac disease, be confident that items labeled “gluten-free” meet a defined standard for gluten content.
- Proposed Rule for Gluten-Free Labeling of Fermented or Hydrolyzed Foods November 2015
- Constituent Update - Foods Labeled Gluten-Free Must Now Meet FDA's Definition
- Questions & Answers: FDA's Final Rule on Gluten-Free Labeling Updated June 15, 2015
- News Release: FDA defines "gluten-free" for food labeling - The regulation will provide a uniform standard for manufacturers who choose to label their products as “gluten-free.” August 2, 2013
- Federal Register Notice for the Gluten-Free Labeling Final Rule
- Guidance for Industry: Gluten-Free Labeling of Foods; Small Entity Compliance Guide
- Consumer Update: What is Gluten-Free? FDA Has an Answer - People with celiac disease can now have confidence in the meaning of a “gluten free” label on foods.
- Food Facts: Gluten and Food Labeling: FDA’s Regulation of “Gluten-Free” Claims
- Blog: A New Era of “Gluten-free” Labeling Updated August 5, 2014
- Blog: Gluten-Free Labeling Consumers Can Count On August 2, 2013
- FDA’s Responses to Comments on the Report Titled ‘Health Hazard Assessment for Gluten Exposure in Individuals with Celiac Disease (PDF - 156KB)
- Health Hazard Assessment for Gluten Exposure in Individuals with Celiac Disease (PDF - 469KB)
- External Peer Review of the FDA/CFSAN Draft Health Hazard Assessment for Gluten in Individuals with Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten (PDF - 246KB)
- Proposed Rule: Food Labeling; Gluten-Free Labeling of Foods
January 23, 2007
Questions and Answers on the Gluten-Free Labeling Proposed Rule[ARCHIVED]
January 1, 2007
Food Allergen Labeling And Consumer Protection Act of 2004 Questions and Answers
July 18, 2006
- Transcript of Public Meeting on Gluten-Free Labeling [ARCHIVED]
August 19, 2005
Food Allergens Guidance Documents & Regulatory Information Celiac Disease Awareness Campaign