Jump to content
This site uses cookies. Continued use is acceptance of our Terms of Use and Privacy Policy. More Info... ×
  • Welcome to Celiac.com!

    You have found your celiac tribe! Join us and ask questions in our forum, share your story, and connect with others.




  • Celiac.com Sponsor (A1):



    Celiac.com Sponsor (A1-M):


  • Get Celiac.com Updates:
    Support Our Content
    eNewsletter
    Donate
  • Record is Archived

    This article is now archived and is closed to further replies.

    Jefferson Adams
    Jefferson Adams

    FDA to Issue Gluten-Free Allergy Labeling Rule in 2012

    Reviewed and edited by a celiac disease expert.

    Celiac.com 04/26/2012 - A recent statement by the FDA announces that the agency is gathering data to respond to calls for an "alternative approach" to determining a specific gluten threshold level other than the proposed level of under 20 parts per million gluten as one of the criteria to define the term “gluten-free.”

    The statement directly acknowledges that people with celiac disease must avoid gluten for life in order to prevent harmful health effects.

    Celiac.com Sponsor (A12):
    Photo: CC--ms4jahThe statement also notes that, in 2011, the Agency, through its Center for Food Safety and Applied Nutrition (CFSAN) conducted the following actions involving accurate gluten labeling of food products: 

    It finished a safety assessment of gluten exposure in individuals with celiac disease, and that it had gotten that assessment peer-reviewed.

    This was done to gather more data regarding possible alternative approaches to establishing a specific gluten threshold level as one of the criteria to define “gluten-free.”  

    These would be alternative approaches that differ from the "analytical methods-based approach" used by the FDA in its proposed rule for "gluten-free" products. That proposal established product ingredients under 20 parts per million gluten as one of the criteria for defining the term “gluten-free.”

    The FDA statement also noted that CFSAN had published a Federal Register notice in August 2011, reopening the comment period on the Agency’s proposed rule on “gluten-free” food labeling. 

    The notice announces the publication of the FDA's safety assessment on gluten exposure in people with celiac disease, and asks for public comment on the safety assessment, and on any other issues that might affect the definition of the term “gluten-free” in the Agency's final rule. 

    Lastly, the statement announces that the FDA will review and consider those public comments before issuing its final rule defining “gluten-free” for labeling food products, including dietary supplements. The FDA intends to complete the entire process and issue the rule by the end of fiscal year 2012.

    Source:

    • Open Original Shared Link


    User Feedback

    Recommended Comments

    Guest Anne

    Wonder what the "alternative approaches" are?

    Link to comment
    Share on other sites
    Guest Sarah

    Posted

    This was a long time coming! Good information, thanks.

    Link to comment
    Share on other sites
    Guest Heather

    Posted

    Does not really explain what (if anything) is changing - but it is nice to see that the FDA is taking the issue seriously.

    Link to comment
    Share on other sites
    Guest ALO

    Yay!

    Link to comment
    Share on other sites
    Guest Linda

    Posted

    By definition "gluten-free" denotes that a product is "free" of all gluten proteins--as in Zero...(or am I missing something?)

    As a newly diagnosed celiac I'm concerned about any gluten exposure. I have been the recipient of cross-contamination (griddle not cleaned). It was not pretty.

    Wondering what the threshold for PPM might be before patients experience symptoms.

    Link to comment
    Share on other sites
    Guest admin

    Posted

    By definition "gluten-free" denotes that a product is "free" of all gluten proteins--as in Zero...(or am I missing something?)

    As a newly diagnosed celiac I'm concerned about any gluten exposure. I have been the recipient of cross-contamination (griddle not cleaned). It was not pretty.

    Wondering what the threshold for PPM might be before patients experience symptoms.

    There is not test for gluten that goes down to zero, so a level must be set somewhere. The lower the level, the more expensive the tests are. 20 ppm is a level deemed safe by many experts, and one that will not cause a drastic increase in price for products labelled "gluten-free."

    Link to comment
    Share on other sites
    Guest Donna

    Posted

    Am I the only one who is worried that the "alternative approach" they may be aiming for is something that does not include an actual measurement? For example, we know many things are "naturally gluten free", will that be sufficient to pass their labeling standards? I hope not, since it doesn't address cross-contamination! An analytical method is the only one that will make me happy.

    Link to comment
    Share on other sites
    Guest Denise Bryan

    Posted

    You are not the only one worried about their "alternative approach". I sure hope they don't do it that way. That would ease the requirements too much for some of us Celiacs that are sensitive to even the smallest amount of gluten.

    Link to comment
    Share on other sites
    Guest Jefferson

    Posted

    Am I the only one who is worried that the "alternative approach" they may be aiming for is something that does not include an actual measurement? For example, we know many things are "naturally gluten free", will that be sufficient to pass their labeling standards? I hope not, since it doesn't address cross-contamination! An analytical method is the only one that will make me happy.

    Be careful about your reading here. The FDA is NOT calling for an alternative approach. They are responding to calls FOR an alternative approach; most likely so they can then dismiss those calls and stick to the prevailing scientific approach. I would look for the FDS to set the level under 20ppm, similar to the European standard.

    Link to comment
    Share on other sites
    Guest Melissa

    Posted

    What I want to know is how can we all help? There must be something we can do to encourage new legislation that will protect our health!

    Link to comment
    Share on other sites
    Guest Robert

    All I need is a list of foods that are free of gluten, not pages and pages of pure nonsense.

    Link to comment
    Share on other sites
    Guest Amy
    Am I the only one who is worried that the "alternative approach" they may be aiming for is something that does not include an actual measurement? For example, we know many things are "naturally gluten free", will that be sufficient to pass their labeling standards? I hope not, since it doesn't address cross-contamination! An analytical method is the only one that will make me happy.

    I agree. So many people who don't have celiac disease don't understand how a small amount of contamination affects us people with celiac disease, especially in restaurants. They say the item is gluten-free but then fry it in the same oil that has been contaminated.

    Link to comment
    Share on other sites


    Guest
    This is now closed for further comments

  • Get Celiac.com Updates:
    Support Celiac.com:
    Donate
  • About Me

    Jefferson Adams

    Jefferson Adams is Celiac.com's senior writer and Digital Content Director. He earned his B.A. and M.F.A. at Arizona State University. His articles, essays, poems, stories and book reviews have appeared in numerous magazines, journals, and websites, including North American Project, Antioch Review, Caliban, Mississippi Review, Slate, and more. He is the author of more than 2,500 articles on celiac disease. His university coursework includes studies in science, scientific methodology, biology, anatomy, physiology, medicine, logic, and advanced research. He previously devised health and medical content for Colgate, Dove, Pfizer, Sharecare, Walgreens, and more. Jefferson has spoken about celiac disease to the media, including an appearance on the KQED radio show Forum, and is the editor of numerous books, including "Cereal Killers" by Scott Adams and Ron Hoggan, Ed.D.

    >VIEW ALL ARTICLES BY JEFFERSON ADAMS

     


  • Celiac.com Sponsor (A17):
    Celiac.com Sponsor (A17):





    Celiac.com Sponsors (A17-M):




  • Related Articles

    Scott Adams
    This update comes to us from Frederik Willem Janssen, The Netherlands: Open Original Shared Link
    About a week ago I promised to post info about agenda item 4 (Gluten Free Food) as dealt with at the meeting of Codex Alimentarius NFSDU (Nutrition and Food for Special Dietary Uses) which was held in September in Berlin Germany. As usual this meeting starts on Monday and continues till Wednesday, Thursday is a day off (time for the secretariat to draw resolutions) and on Friday these draft resolutions are discussed. Unfortunately I wasnt able to stay till Friday. However, the resolutions as discussed on Friday were handed to me afterwards however and I pass them with some corrective changes accepted during that day. For those of you who have no interest in reading this clerical...


    Scott Adams
    Celiac.com 09/01/2005 - The Food and Drug Administration (FDA) will hold a public meeting to obtain expert comment and consultation from the public to help them define and permit the voluntary use on food labeling of the term ``gluten-free. The meeting will focus on food manufacturing, analytical methods, and consumer issues related to reduced levels of gluten in food. Celiac.com needs your help to speak out to make sure that this regulation will be written in such a way as to provide the greatest benefit to the gluten-free community, and to make sure that the new regulation will not create an undue burden on any exiting and future gluten-free food manufacturers.
    To have an influence on this process please Open Original Shared Link and send your comments no later than September...


    Gryphon Myers
    Petition for Gluten-Free Labeling on White House Website
    Celiac.com 10/08/2012 - Since 2004 when Congress passed the Food Allergen Labeling and Consumer Protection Act, sufferers of celiac disease have awaited some sort of finalized action from the FDA to set a rule for gluten-free labeling. The FDA proposed a gluten-free food labeling rule in 2007 and since then, there have been multiple open comment periods for it, but as of yet, there has been no finalized action to control gluten-free labeling in food products. In an effort to expedite this process, “Jennifer I” of Sebastopol, CA started a petition on the White House's official website.
    Part of the concern driving this petition stems from the fact that for many, the gluten-free diet is one of necessity, not of choice. 'Gluten-free' has become something of a new marketing buzzword, as the...


    Jefferson Adams
    Celiac.com 02/06/2015 - Australia is home to some of the most stringent gluten-free product standards in the world. Under current standards, all “gluten free" products sold in Australia must contain about three parts or fewer per million.
    The food industry would like the standard set at 20 parts per million, which would bring Australia into line with the United States, and the EU.
    Moreover, Coeliac Australia, a major celiac advocacy group, has suggested that Australia’s strict standards are becoming unworkable, as improved tests permit detection of smaller and smaller amounts of the gluten protein. The group has signaled an openness to the industry plan to lower the standards to 20ppm gluten content.
    Such a move would allow a much wider range of products to be sold in Australia as ...


  • Recent Activity

    1. - knitty kitty replied to jmiller93's topic in Celiac Disease Pre-Diagnosis, Testing & Symptoms
      5

      What do my test results mean?

    2. - knitty kitty replied to HWB's topic in Related Issues & Disorders
      16

      strange symptoms/ diagnosis accuracy

    3. - Wheatwacked replied to HWB's topic in Related Issues & Disorders
      16

      strange symptoms/ diagnosis accuracy

    4. - sh00148 posted a topic in Celiac Disease Pre-Diagnosis, Testing & Symptoms
      0

      Nighttime Soiling (5 year old)

    5. - captaincrab55 posted a topic in Publications & Publicity
      0

      Scientists have discovered a cause of inflammatory bowel disease. They said it's a 'holy grail' discovery that could transform other autoimmune treatments.


  • Celiac.com Sponsor (A19):



  • Member Statistics

    • Total Members
      125,728
    • Most Online (within 30 mins)
      7,748

    Jessmn
    Newest Member
    Jessmn
    Joined

  • Celiac.com Sponsor (A20):


  • Forum Statistics

    • Total Topics
      120.8k
    • Total Posts
      1m

  • Celiac.com Sponsor (A22):




  • Who's Online (See full list)


  • Celiac.com Sponsor (A21):



  • Popular Now

    • jmiller93
      5
    • MomofGF
    • Louise Broughton
      4
  • Popular Articles

    • Scott Adams
    • Scott Adams
    • Scott Adams
    • Scott Adams
    • Scott Adams
  • Upcoming Events

×
×
  • Create New...