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What is Gluten-Free? FDA Has an Answer

Celiac.com 08/05/2013 - People with celiac disease can now have confidence in the meaning of a "gluten-free" label on foods.

The Food and Drug Administration (FDA) has issued a final rule that defines what characteristics a food has to have to bear a label that proclaims it "gluten- free." The rule also holds foods labeled "without gluten," "free of gluten," and "no gluten" to the same standard.

FDAThis rule has been eagerly awaited by advocates for people with celiac disease, who face potentially life-threatening illnesses if they eat the gluten found in breads, cakes, cereals, pastas and many other foods.

As one of the criteria for using the claim "gluten-free," FDA is setting a gluten limit of less than 20 ppm (parts per million) in foods that carry this label. This is the lowest level that can be consistently detected in foods using valid scientific analytical tools. Also, most people with celiac disease can tolerate foods with very small amounts of gluten. This level is consistent with those set by other countries and international bodies that set food safety standards.

"This standard 'gluten-free' definition will eliminate uncertainty about how food producers label their products and will assure people with celiac disease that foods labeled 'gluten-free' meet a clear standard established and enforced by FDA," says Michael R. Taylor, J.D., deputy FDA commissioner for foods and veterinary medicine.

Andrea Levario, executive director of the American Celiac Disease Alliance, notes that there is no cure for celiac disease and the only way to manage the disease is dietary—not eating gluten. Without a legal definition of "gluten-free," these consumers could never really be sure if their body would tolerate a food with that label, she adds.

"This is a tool that has been desperately needed," Levario says. "It keeps food safe for this population, gives them the tools they need to manage their health, and obviously has long-term benefits for them."

"Without proper food labeling regulation, celiac patients cannot know what the words 'gluten free' mean when they see them on a food label," says Allessio Fasano, M.D., director of the Center for Celiac Research at MassGeneral Hospital for Children, visiting professor of pediatrics at Harvard Medical School and member of the American Celiac Disease Alliance.

What Is Gluten?

Gluten means the proteins that occur naturally in wheat, rye, barley, and crossbreeds of these grains.

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As many as 3 million people in the United States have celiac disease. It occurs when the body's natural defense system reacts to gluten by attacking the lining of the small intestine. Without a healthy intestinal lining, the body cannot absorb the nutrients it needs. Delayed growth and nutrient deficiencies can result and may lead to conditions such as anemia (a lower than normal number of red blood cells) and osteoporosis, a disease in which bones become fragile and more likely to break. Other serious health problems may include diabetes, autoimmune thyroid disease and intestinal cancers.

Before the rule there were no federal standards or definitions for the food industry to use in labeling products "gluten-free." An estimated 5 percent of foods currently labeled "gluten-free" contain 20 ppm or more of gluten.

How Does FDA Define 'Gluten-Free'?

In addition to limiting the unavoidable presence of gluten to less than 20 ppm, FDA will allow manufacturers to label a food "gluten-free" if the food does not contain any of the following:

  1. An ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains;
  2. An ingredient derived from these grains and that has not been processed to remove gluten;
  3. An ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten.

Foods such as bottled spring water, fruits and vegetables, and eggs can also be labeled "gluten-free" if they inherently don't have any gluten.

The regulation will be published Aug. 5, 2013 in the Federal Register, and manufacturers have one year from the publication date to bring their labels into compliance. Taylor says he believes many foods labeled "gluten free" may be able to meet the new federal definition already. However, he adds, "We encourage the food industry to come into compliance with the rule as soon as possible."

Under the new rule, a food label that bears the claim "gluten-free," as well as the claims "free of gluten," "without gluten," and "no gluten," but fails to meet the requirements of the rule would be considered misbranded and subject to regulatory action by FDA.

Those who need to know with certainty that a food is gluten-free are heralding the arrival of this definition. "This is a huge victory for people with celiac disease," says Levario. "In fact, that's the understatement of the year."

Says Taylor, "FDA's 'gluten-free' definition will help people make food choices with confidence."

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Source: August 2, 2013 - http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm363069.htm

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6 Responses:

 
J L
Rating: ratingfullratingfullratingfullratingfullratingempty Unrated
said this on
07 Aug 2013 12:54:46 PM PDT
I for one am a VERY sensitive celiac and cannot even tolerate gluten at the level that the FDA deems safe. In my opinion, repeated frequent exposure at even 20ppm will cause damage, but I don't think enough research has been done to push this point. Gluten-free should mean NO GLUTEN!

 
Susie
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said this on
13 Aug 2013 4:46:52 AM PDT
JL, I'm there with you! I can't tell you how many times I've gotten sick from "gluten free" foods. I can detect the slightest amount and not in a pleasant way! I'm worried that some companies will relax their standards and let more gluten pass through since their foods can have 20ppm and still be labeled "gf." Also, this ruling just applies to the ingredients in the product, nothing about cross contamination during the processing/production/packaging.

 
Rita
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said this on
13 Aug 2013 5:46:43 AM PDT
I agree, and am also super sensitive, but since no tests exist that are as sensitive as our guts, we will have to continue to be vigilant. However, be careful and conscious of other possible troublemakers. I complained for years that I could not travel without getting sick. It turned out I was allergic to xanthan gum and the reaction was identical to gluten reaction. I never used xanthan gum at home, relying on chick pea flour or flax meal or corn starch instead, but it was in almost every pre-made gluten-free product or mix. Xanthan gum is now showing up in everything from juices to skin care products. I also deeply suspect I have trouble with GMO corn. Particularly late diagnosed gluten sensitives may have developed other sensitivities.

 
StephH
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said this on
13 Aug 2013 6:11:19 AM PDT
I agree, JL. I am very sensitive as well and have to be really strict on what I eat. Now I will really need to watch the food that says gluten-free! It's a win in one sense but for others like us I feel it's something we will have to worry about. I expect gluten-free to mean no gluten; now that it can contain trace amounts, I fear that these products could end up making me sick. I just hope that the strict companies I rely on will not start changing their procedures to be more lax of cross contamination due to law.

 
AnnaH
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said this on
14 Aug 2013 3:47:56 PM PDT
How will this gluten-free rating be regulated? Is it left to the individual companies to self-regulate and test for 20ppm? Then we are sunk and the ruling means not much of anything new. I like the idea of an independent regulating group as we have now with the gluten-free symbols. (I only eat things with this symbol and also the non-gmo symbol). The companies have to pay for the independent testing of their products now.

 
Marilyn

said this on
15 Aug 2013 6:00:55 PM PDT
I responded when the FDA initially did their survey. People with nut allergies can't eat foods with 20 ppm peanuts in them, so why should celiacs be exposed to foods with 20 ppm gluten in them? Not a good solution.




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Cycling Lady, LMAO at IBeStumped! So true. Yes, he is trying the band aid approach it seems. That's probably the most frustrating thing of all. So yesterday I get a call back from his office and they say to stop taking the Viberzi and switch back to Imodium! I reminded them that Imodium didn't work, I had already used it 8 days with no changes. His assistant informed me that that is all he can recommend at this time until he sees me at my next appointment which is 5/24! I live near Chicago and I am about to make an appointment to go to the University of Chicago hospital which is the top celiac research hospital in the country. Hopefully they can give me better answers.

7Hi jen and welcome No-one can diagnose remotely via nterwe posts but if there was such a game as celiac / gluten sensitive bingo, I would be calling 'House!' having read your account above... Lots of things fit the pattern as I'm sure your lurking has revealed. It's a tricky condition to diagnose however so you may have a little wait before you join the coolest club in town and get your funky celiac membership card For now it's really important that you stay on gluten. Keep eating it as accurate testing requires it. Ask your doctor to check the boxes for celiac testing alongside your liver blood tests. There should be enough in your history to get this without hassle but if they're reluctant INSIST and don't be afraid to assert your reasonable suspicion and wish to clarify and exclude. A good liver specialis will be aware of the possible links so you should be ok. If not gt second opinion. Ask for a full celiac panel as there are variety of tests. Find further info here There's a lot to take in, but be positive, I think you are on the right track and if so, you could soon be feeling better than you ever thought possible!

Hello, I am in a job that I travel every 3rd week...It gets challenging becuase many times I am doing audits of warehouses and they dont even have a cafeteria. I usually bring gluten-free protein bars as a back up if I have to miss a meal and then eat when I get back to the hotel. Just a suggestion because they certainly fill me up....Have a safe trip...Kelly

Hello all, I'm a new member here but have lurked for a while. I'm looking for some advice regarding my medical history, possible symptoms of celiac and next steps. General info: female, low level smoker, drink alcohol, aged 32. I started having bad gastro issues when I was around 17. Since then I've consistently suffered from chronic diarrhoea, frequent discomfort in the tummy area, feelings of dehydration despite drinking at least eight glasses a day and frequent fatigue for no real reason. In 2008/9 I visited the doctor as my diarrhoea was having an effect on my studies at the time. The doctor tested me for allergies; eggs, fish, gluten and lactose and did a "standard" blood test. Everything came back fine except my liver results, which were elevated to double (I did not the see the results for myself so can't say which enzymes etc). I was told to drink less and take Imodium. The doctor implied that perhaps I was stressed and / or anxious and, still being young plus a student who regularly went out drinking, I accepted this advice and carried on with my life. I would here add that I am not an unusually stressed person - in fact, learning to deal with my unpredictable bowels has forced me to be quite a laid-back person! Fast forward to 2016. I had been living with my partner for two years by this point who had noticed my bowel habits and informed me that this was definitely not normal. He encouraged me to try out a gluten free diet since I was apprehensive about visiting a doctor only to be fobbed off with Imodium again. I did the diet as strictly as a newbie can for around two months before we set off travelling. During the diet I noticed that after a couple of weeks of extreme tiredness I felt quite a lot better - I kept a food journal at the time which showed that I almost immediately had diarrhoea once after eating an ice-cream, i felt bloated and unwell after an attempt to make oat muffins (maybe i didn't cook them very well though!) and I felt bloated and had diarrhoea after eating some fish fried in flour (We made a mistake in ordering them but I didn't want to complain). My partner also reported that my mood swings (which I admit can be a little unpredictable) were much better. Once we started travelling I gave up and ate what I was given as we were staying with friends etc much of the time. Toward the end of our trip I started to feel extremely tired, to the point of having to stay in for "rest" days, and my guts were very unhappy. I chalked it up to irregular eating patterns, too many beers and late nights in general. During the trip I also had an extreme hangover after drinking wheat beer. And, while of course I accept that any overindulgence can make you ill, I really felt that that level of hangover was quite out of the ordinary. Finally, I developed a strange lump under my armpit during this period. Now back at home, I decided to go to the doc and check out the odd lump under my armpit. The doctor was pretty confident that it was nothing to worry about cancer-wise but she ordered a battery of blood tests just to be sure. The lump is fine (good news) but the results showed elevated GGT, high-ish ALT and normal AST liver enzymes plus signs of dehydration in red bloods / higher (but not concerning) levels of white bloods. I'm scheduled to go back for another blood test to double-check liver function and discuss results - if it is again high she will send me for a ultrasound. Does this history chime with anyone here? I know that the correct course in basic health terms is to stop drinking for some time (easily done) and stop smoking forever (easy to say...) but I cannot help but think that something else is going on here. I will discuss this with my doctor and make clear that my bowel issues have not been resolved and that the initial IBS diagnosis wasn't based on any thorough testing so to speak. In the meantime - does anyone have any advice for me in times of avenues to research or experience of similar symptoms? Gluten remains in my diet but in all other respects it could be regarded as very healthy, I think anyway... (pescatarian, plenty of fruit and veg, little to no sugar on a daily basis, not much dairy to speak of...) Thanks in advance and sorry for bending everyone's' ear about this... I guess it's just taken a long time for me to admit I might be sick and I need some help. Jen

Wish I could give you a hug. Unfortunately I know how that feels with Neurologists, Internists, Endocrinologists, Rheumatologists, GIs..... I got so tired of crying my drive home after refusing yet another script for Prozac. I do hope your GI can give you some answers even if it is just to rule out other possible issues. Keep on the gluten and we are here for you.