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    Scott Adams
    Scott Adams

    FDA Reopens Comment Period on Proposed Gluten-free Food Labeling Rule

    Reviewed and edited by a celiac disease expert.
    FDA Reopens Comment Period on Proposed Gluten-free Food Labeling Rule -

    Celiac.com 08/02/2011 - The U.S. Food and Drug Administration today reopened the comment period for its 2007 proposal on labeling foods as “gluten-free.” The agency is also making available a safety assessment of exposure to gluten for people with celiac disease (celiac disease) and invites comment on these additional data.

    One of the criteria proposed is that foods bearing the claim cannot contain 20 parts per million (ppm) or more 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.

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    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 United States 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 that 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 that 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, 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 Open Original Shared Link. The docket will officially open for comments after noon on Aug 3, 2011 and will remain open for 60 days.

    To submit your comments electronically to the docket go to Open Original Shared Link
    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
    HFA-305
    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 (scroll to FDA--temporary link will update when document publishes on Aug. 3):
      Open Original Shared Link
    •  Gluten-Free Portal (scroll to Gluten-Free):Open Original Shared Link
    •  FDA’s Proposed Rule on the Gluten-Free Labeling of Foods:
      Open Original Shared Link
    •  Questions and Answers on the Gluten-Free Labeling Proposed Rule:Open Original Shared Link
    •  Consumer Update on the Gluten-Free Labeling Proposed Rule:Open Original Shared Link
     Source:
    • Open Original Shared Link


    User Feedback

    Recommended Comments

    Guest Carol Litfin

    Posted

    Excellent article. It is imperative that we as gluten intolerant people have the opportunity to get real gluten-free foods without the worry of becoming very ill.

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    Guest someone with Celiac

    Posted

    Gluten free should mean ZERO gluten, PERIOD. The only reason to dither is that celiac is a small community of people who don't have the power of force to defend themselves. If just one powerful person was to be diagnosed, this would not still be in discussion.

     

    Celiac can kill those who can't "tolerate" it. Why are the lives of the ill less valued?

     

    Why are drug manufacturers allowed to put gluten in medications?

    Why are restaurants allowed to advertise gluten free items and then contaminate them in their kitchens?

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  • About Me

    Scott Adams

    Scott Adams was diagnosed with celiac disease in 1994, and, due to the nearly total lack of information available at that time, was forced to become an expert on the disease in order to recover. In 1995 he launched the site that later became Celiac.com to help as many people as possible with celiac disease get diagnosed so they can begin to live happy, healthy gluten-free lives.  He is co-author of the book Cereal Killers, and founder and publisher of the (formerly paper) newsletter Journal of Gluten Sensitivity. In 1998 he founded The Gluten-Free Mall which he sold in 2014. Celiac.com does not sell any products, and is 100% advertiser supported.


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    In 2004, the Food Allergen Labeling and Consumer Protection Act (FALCP) gave the FDA four years to create and implement final rules for gluten-free food labeling.
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    In 2007, the FDA followed FALCP's mandate by issuing a proposed rule "Food Labeling: Gluten-Free Labeling of Foods." The proposed rule states that a food is gluten-free if the food does not contain any of the following:
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