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Gluten-Free Food Labeling: The Food and Drug Administration Needs Your Input

Celiac.com 03/07/2007 - The Food and Drug Administration (FDA) recently proposed the following rule regarding the labeling of foods as "Gluten-Free (GF). The rule appears in the Federal Register, Docket No. 2005N-0279, titled Food-Labeling: Gluten Free Labeling of Foods," and includes a definition of the term "gluten-free."

There is no current Federal regulation to define the term "gluten-free" for labeling food. By clearly defining the term the FDA seeks to help those with celiac disease, along with their caregivers, to better identify packaged foods that are safe for consumption.

The FDA proposes to set the standard acceptable gluten level for products labeled "gluten-free" at no greater than 20 parts of gluten per million. More specifically, the FDA proposes that the term "gluten-free" on food labels will apply to food that is free of any or all of the following:

  • "Prohibited grains," meaning any species of wheat (e.g., durum wheat, spelt wheat, or kamut), rye, barley or their hybrids;
  • Ingredients derived from "prohibited grains," (e.g., wheat flour), that have not been treated to remove gluten.
  • Ingredients derived from "prohibited grains," (e.g., wheat flour), that HAVE been treated to remove gluten, but which results in 20 ppm (parts per million) or more of gluten per gram of food.
  • 20 ppm or more of gluten per gram of food.

Foods that are labeled "gluten-free," or claim to be "free of gluten," without gluten, or to contain no gluten," and which fail to meet the terms of the proposed definition of "gluten-free" would be designated as "misbranded."

One aspect of the FDA rules that seems to have caused some confusion concerns the status of oats. One recent posting making the rounds among celiac support groups claims that page 2798 of the Federal Register states: that None of the four U.S. celiac associations that responded to the survey considered oats to be an acceptable food for individuals with celiac disease. This quotation is from an April 2000 article by Tricia Thompson, titled: Questionable food and the gluten-free diet: Survey of Current Recommendations. However, page 2798 of the Federal Register actually states the CURRENT positions held by the organizations:

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According to more recent position statements of 3 of the 4 major celiac associations in the United States that responded to the earlier survey conducted by Thompson (Ref. 57), one of these associations continues to take the position that oats are not an acceptable food for individuals with celiac disease; but, the other two of these associations are not opposed to the inclusion of oats in the diets of individuals with celiac disease, provided that the oats do not contain gluten from other grains and that the daily amount of oats consumed is limited to 1 cup cooked (Ref. 56)."

The FDA held an initial public comment meeting for "gluten-free" food labeling in August 2005. Comments received during this meeting, coupled with other information compiled by the FDA, indicate that there is no consensus among either consumers or U.S. food manufacturers as to the nature of foods labeled "gluten-free." The FDA feels strongly that the establishment of clear definitions of "gluten-free," and of uniform guidelines for applying the term in labeling foods, will enable persons with celiac to obtain accurate and truthful information about the foods they purchase, and help to make sure they avoid the adverse health affects that can come consuming food that is mislabeled.

For more information the FDA has prepared a document titled:
Questions and Answers on the Gluten-Free Labeling Proposed Rule" The document is available for review through the following web-link:
http://www.cfsan.fda.gov/~dms/glutqa.html.

Act Now!
There is a 90-day public comment period for the proposed rule. Submit your comments by April 23, 2007 by clicking here, or comments can also be submit it in writing to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305) Rockville, MD 20852.

Celiac.com supports the FDA proposals, and encourages those with celiac disease and their supporters, to review the FDA document and to share your comments in support of these standards.

Celiac.com welcomes your comments below (registration is NOT required).





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2 Responses:

 
Jennifer Wood
Rating: ratingfullratingfullratingfullratingfullratingfull Unrated
said this on
21 Feb 2008 1:34:31 PM PDT
PLEASE do all that you can to help us get Gluten-Free labeling passed!

 
Deirdre Biddis
Rating: ratingfullratingfullratingfullratingfullratingfull Unrated
said this on
03 Aug 2008 6:54:33 PM PDT
Thank you for the valuable information pertaining to gluten-free labeling. Perhaps I will not have to take my gluten-free grocery shopping book for too much longer. I am excited for the gluten-free labeling as I am sure the others are as well.




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Hello I was diagnosed Dec 15 of last year and went totally gluten-free the next day. I actually got worse before I got better - it's a steep learning curve - but now, 4 1/2 months later I'm finally seeing improvement. Hang in there.

Called my GI doctor today to make sure he is going to look at my small intestine and do biopsy for Celiac for my EGD and he is. Thanks for the tip everyone about have to start eating gluten again. The office told me to break my gluten free diet and start eating gluten everyday until my EGD. Here's to being miserable again for a few weeks ???

I can completely relate! The horrible mental effects that I have been living with for years is the absolute worst side effect of eating gluten, HANDS DOWN. Worse than the endless tummy aches, worse than the constant diarrhea, worse than the week long migraines, worse than the daily fatigue and body pain.... I honestly though there was something seriously wrong with me and hated my life because of how I felt mentally. I always felt like I was drowning, not in control of my thoughts, trapped in some unexplained misery. My head was always so cloudy, and I was mad because I always felt so slow and stupid. I would feel so lethargic and sad and empty while at the same time be raging inside, wanting to rip out of my own skin. I was mean, terrible, would snap at the people closest to me for no good reason and just felt like I hated everyone and everything. Think of how crappy you feel when you have a terrible cold and flu - I felt that crappy, but mentally. Some days were really bad, some were mild. I always thought it was because I was getting a migraine, or because I had a migraine, or because I had just overcome a migraine, because I didn't sleep well, because....always a random reason to justify why we have all these weird unrelated symptoms before we get diagnosed. I'm happy to say that I have been gluten-free for about 2 months now and though I am not symptom free, the first thing that improved was my mood. I no longer feel foggy and miserable. For the first time in years, my head is clear, I can actually think, and I feel positive and like I am in control of what's going on in my head. I don't hate the world. I don't spend every day bawled up on the corner of the couch depressed and angry. The release of these horrible symptoms is enough to never make me want to cheat, no matter what I have to miss out on. So insane how a little minuscule amount of a stupid protein can wreck such havoc.

I wanted to collect some of the info on NCGI in one place so that visitors who test negative but may still have an issue with gluten can be directed there. I'll add to this post as I find new links, but feel free to add or contribute anything you think may be of use! Matt --- Useful links: An overview from Alessio Fasano, one of the world's leading researchers on celiac and gluten sensitivity: https://www.youtube.com/watch?v=VvfTV57iPUY Umberto Volta, another leading researcher in the field gives some of the latest findings about NCGI: Presentation slides from Dr Volta's visit to Coeliac UK - NCGS about halfway through A scholarly overview from celiac disease magazine: https://www.researchgate.net/profile/Knut_Lundin/publication/232528784_Non-celiac_Gluten_Sensitivity/links/09e415098bbe37c05b000000.pdf A good overview from a sceptical but fair perspective: https://sciencebasedmedicine.org/a-balanced-look-at-gluten-sensitivity/ Another overview: https://celiac.org/celiac-disease/understanding-celiac-disease-2/non-celiac-gluten-sensitivity-2/ University of Chicago's excellent celiac site's take: http://www.cureceliacdisease.org/category/faq-non-celiac-gluten-sensitivity/ A compelling account in the British Medical Journal from an NCGI patient: http://www.bmj.com/content/345/bmj.e7982 Here's some positive news about a potential new test: http://www.medicaldaily.com/non-celiac-gluten-insensitivity-blood-test-392850 NCGI in children: NCGI and auto immune study: https://www.ncbi.nlm.nih.gov/pubmed/26026392 Also consider: Fodmaps: http://www.kcl.ac.uk/lsm/research/divisions/dns/projects/fodmaps/faq.aspx This Monash study: http://fodmapmonash.blogspot.co.uk/2015/03/the-truth-behind-non-celiac-gluten.html suggested some who think they're reacting to gluten should actually be reducing fodmaps Sibo: http://www.webmd.boots.com/digestive-disorders/small-intestinal-bacteria-sibo

I was just diagnosed in March and I totally feel you. I'm having a hard enough time with determining which lip glosses are safe, let alone all my face products etc. I feel like this 'grey area' is the biggest annoyance with Celiac. So many foods/cosmetics I thought were safe after reading the ingredient list are actually not safe at all! One website says it's safe, one says its not. All these unfamiliar ingredients and even after googling term after term still so many grey areas!! I'm sure in time it gets easier and second nature and you learn by trial and error but holy this constant uncertainty is super annoying haha.