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
- Questions & Answers: FDA's Final Rule on Gluten-Free Labeling Updated June 15, 2015
- 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
Where are we now?
Three Years Later, What is the Impact of the Gluten-Free Labeling Standard? - A Conversation with Carol D'Lima and Alessio Fasano on the impact of the gluten-free labeling regulation. October 2017
- FDA's Responses to Comments on the Report Titled Health Hazard Assessment for Gluten Exposure in Individuals with Celiac Disease
- Health Hazard Assessment for Gluten Exposure in Individuals with Celiac Disease
- 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
- Proposed Rule: Food Labeling; Gluten-Free Labeling of Foods
- Food Allergen Labeling And Consumer Protection Act of 2004 Questions and Answers
- Celiac Disease Awareness Campaign