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FDA's Gluten-Free Proposal Will Benefit Millions of Celiacs

Celiac.com 01/25/2007 - Under an FDA proposal published yesterday, food companies will have to meet new standards before labeling their products as gluten-free. It also provided a new definition for gluten-free which will give individuals with celiac disease greater confidence that specially labeled foods are in fact, safe for them to eat, according to the American Celiac Disease Alliance (ACDA).

The Food Allergen Labeling and Consumer Protection Act (FALCPA) passed by Congress in 2004, requires food manufacturers to clearly state if a product contains any of the eight major food allergens: milk, eggs, peanuts, tree nuts, fish, shellfish, wheat, and soy. It also required the FDA to develop and implement rules for using the term ‘gluten-free’ on food packaging.

Adhering to the gluten-free diet is the only course of treatment for celiac disease, a genetic digestive disorder. The condition, triggered by eating the protein gluten which is found in the grains wheat, rye, and barley, and hybrids of these grains affects an estimated 2 to 3 million Americans.

There is no single, world-wide accepted definition of gluten-free labeling. The levels of acceptable gluten vary from country to country, as do the symbols and terminology, permissible in the labeling. Research establishing a safe threshold of gluten consumption for those with celiac disease was recently published in the American Journal of Clinical Nutrition. The study, conducted by members of the ACDA at the University of Maryland and referenced by the FDA, concludes that celiacs can safely tolerate up to 20 parts per million (ppm) of gluten a day.

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“The FDA listened to patients, food manufacturers, and members of the scientific community and came up with a well thought out proposal,” said Andrea Levario, Executive Director of the ACDA.

  • There is so little research about the gluten-free diet and safe consumption levels that the agency is seeking comments on a number of related issues including:
    • The appropriateness of 20 ppm gluten as the proposed threshold level as determined using an ELISA based testing method;
    • The effect that adoption of a lower threshold level would have on individuals with celiac disease and on industry;
    • Whether a lower threshold level might effect (limit availability of) commercially available foods labeled gluten-free in the United States;
    • Whether a reduced availability would have a negative impact individuals with celiac disease; and
    • Whether oats should be included in the definition of prohibited grains.

In the absence of federal rules, food companies have been using a variety of standards in manufacturing gluten-free products. This creates confusion and skepticism among individuals whose health depends on clear, accurate labeling. With only 90,000 out of an estimated 2 million celiacs diagnosed, manufacturers know that uniformity and consistency will benefit them as well consumers, said Levario.

The FDA has prepared a series of questions and answers to help consumers understand the provisions of the proposal. For a copy go to: http://www.cfsan.fda.gov/~dms/glutqa.html ; and for a copy of the gluten-free labeling guidelines go to: http://www.cfsan.fda.gov/~lrd/fr070123.html .

About the ACDA
The American Celiac Disease Alliance (ACDA) was established in March 2003 to provide leadership on public policy issues affecting those with celiac disease, an inherited autoimmune disorder affecting children and adults. The non-profit serves as a national umbrella organization representing all segments of the celiac community -- research centers, physicians, patients, food manufacturers, print media, and the service industry.

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1 Response:

 
an unknown user
Rating: ratingfullratingemptyratingemptyratingemptyratingempty Unrated
said this on
17 Dec 2007 4:27:50 PM PDT
The rules will ruin the US gluten-free export market because no one else will accept oats.




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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.