The FDA on Aug. 2 reopened the comment period for its 2007 proposal on labeling foods as “gluten-free.” The agency also is making available a safety assessment of exposure to gluten for people with celiac disease (CD) and invites comment on these additional data.
The comment period will close on or about Oct. 1.
One of the criteria proposed is that foods bearing the claim cannot contain 20 parts per million (ppm) or more of gluten. The agency based the proposal in part on the available methods for gluten detection. The validated methods could not reliably detect the amount of gluten in a food when the level was less than 20 ppm. The threshold of less than 20 ppm also is similar to “gluten-free” labeling standards used by many other countries.
People who have celiac disease cannot tolerate gluten, a protein in wheat, rye and barley. Celiac disease damages the small intestine and interferes with absorption of nutrients from food. About 1 percent of the U.S. population is estimated to have the disease.
“Before finalizing our gluten-free definition, we want up-to-date input from affected consumers, the food industry and others to help assure the label strikes the right balance,” said Michael Taylor, deputy commissioner for foods. “We must take into account the need to protect individuals with celiac disease from adverse health consequences while ensuring that food manufacturers can meet the needs of consumers by producing a wide variety of gluten-free foods.”
The proposed rule conforms to the standard set by the Codex Alimentarius Commission in 2008, which requires foods labeled as “gluten-free” not contain more than 20 ppm gluten. This standard has been adopted in regulations by the 27 countries composing the Commission of European Communities.
The FDA encourages members of the food industry as well as state and local governments, consumers and other interested parties to offer comments and suggestions about gluten-free labeling in docket number FDA-2005-N-0404 at www.regulations.gov. The docket will officially open for comments after noon on Aug. 3, and will remain open for 60 days.
To submit your comments electronically to the docket go to www.regulations.gov and:1. Choose “Submit a Comment” from the top task bar
2. Enter the docket number FDA-2005-N-0404 in the “Keyword” space
3. Select “Search.”
To submit your comments to the docket by mail, use the following address:The Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Include docket number FDA-2005-N-0404 on each page of your written comments.
For more information:
Federal Register Notice (www.ofr.gov/inspection.aspx?AspxAutoDetectCookieSupport=1)
Gluten-Free Portal (scroll to Gluten-Free): www.fda.gov/Food/LabelingNutrition/FoodLabelingGuidanceRegulatoryInformation/Topic-SpecificLabelingInformation/default.htm#gluten
FDA’s Proposed Rule on the Gluten-Free Labeling of Foods (www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/ucm077926.htm)
Questions and Answers on the Gluten-Free Labeling Proposed Rule (www.fda.gov/Food/LabelingNutrition/FoodLabelingGuidanceRegulatoryInformation/Topic-SpecificLabelingInformation/ucm265309.htm)
Consumer Update on the Gluten-Free Labeling Proposed Rule (www.fda.gov/ForConsumers/ConsumerUpdates/ucm265212.htm)