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FDA Releases Safety Assessment on Gluten and Celiac Disease and Reopens Comment Period on "Gluten-free" Proposed Rule

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Center for Food Safety and Applied Nutrition - Food and Drug Administration

August 2, 2011

The U.S. Food and Drug Administration (FDA) today reopened the comment period for its 2007 proposed rule that stated that one of the criteria for food labeled as gluten-free is that they could not contain 20 ppm or more of gluten.  In the proposed rule, the FDA is committed to performing a safety assessment of gluten exposure in people with celiac disease (CD). FDA has completed a health hazard assessment concerning gluten (PDF, 462KB), which includes the safety assessment, and a report about this work (PDF, 292KB) was also released today.

A more detailed description of FDA’s safety assessment on gluten and celiac disease is available at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm265838.htm

The FDA encourages members of the food industry, 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.

  • To submit your comments electronically to the docket go to:  www.regulations.gov

    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

    Be sure to include docket number FDA-2005-N-0404 on each page of your written comments.  

For more information:

Federal Register Notice of availability August 3, 2011: Docket No. FDA–2005-N-0404

Questions and Answers on the Gluten-Free Labeling Proposed Rule are available at: