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      Frequently Asked Questions About Celiac Disease   09/30/2015

      This Celiac.com FAQ on celiac disease will guide you to all of the basic information you will need to know about the disease, its diagnosis, testing methods, a gluten-free diet, etc.   Subscribe to FREE Celiac.com email alerts   What are the major symptoms of celiac disease? Celiac Disease Symptoms What testing is available for celiac disease? - list blood tests, endo with biopsy, genetic test and enterolab (not diagnostic) Celiac Disease Screening Interpretation of Celiac Disease Blood Test Results Can I be tested even though I am eating gluten free? How long must gluten be taken for the serological tests to be meaningful? The Gluten-Free Diet 101 - A Beginner's Guide to Going Gluten-Free Is celiac inherited? Should my children be tested? Ten Facts About Celiac Disease Genetic Testing Is there a link between celiac and other autoimmune diseases? Celiac Disease Research: Associated Diseases and Disorders Is there a list of gluten foods to avoid? Unsafe Gluten-Free Food List (Unsafe Ingredients) Is there a list of gluten free foods? Safe Gluten-Free Food List (Safe Ingredients) Gluten-Free Alcoholic Beverages Distilled Spirits (Grain Alcohols) and Vinegar: Are they Gluten-Free? Where does gluten hide? Additional Things to Beware of to Maintain a 100% Gluten-Free Diet What if my doctor won't listen to me? An Open Letter to Skeptical Health Care Practitioners Gluten-Free recipes: Gluten-Free Recipes Where can I buy gluten-free stuff? Support this site by shopping at The Celiac.com Store.

Fda´s New Gluten Free Labeling Regulations
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15 posts in this topic

http://www.livescience.com/38638-gluten-level-limits-fda.html

 

Hello, I am sure many of you have heard that the FDA set a new limit for labeling a product legally gluten free. This law states that a product can be labeled gluten free if it contains less than 20 parts per million gluten.
 

In one way, this is good news. It is good that gluten free foods are regulated through the FDA.

 

But, I am celiac living in Europe and we have the same laws regarding gluten free labeling. This labeling system is not good enough in my opinion. Because of the labeling law, I have to read every label on a product marked gluten-free and check for "purified gluten free" WHEAT strach. Don´t tell me wheat starch is gluten free. Many gluten free products that contain the "safe" level of gluten below 20 ppm make me sick for days.

 

Now, I may be a very sensitive celiac, but I do not agree that below 20 parts per million is a save level of gluten content for celiacs in general.

 

What do you guys think?

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Only time will tell.  It's not safe for me, that's for sure.  It took them a long time to come up with this regulation.  If it is found to be inadequate, how long will it take them to come up with a more strict version?

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I am very concerned. I'm very sensitive and I think ANY amount of gluten will set me off. Now I feel much less comfortable relying on the "gluten-free" label. This is not good.

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this law enables the fda to tighten labeling loopholes.  20 (or less) parts per 1,000,000 - that's a pretty small amount (if it actually contains any at all)  if you are this sensitive, you are probably not eating much of this stuff anyway.  there is plenty of food that is all naturally gluten free.  the gluten fairy is not going to come around and sprinkle 20 parts on your 1,000,000 if you already are eating a certain brand with no issues, you should be ok :)  outside the us, i don't know how this labeling ruling would affect you?  steph, you already eat a very clean diet, no?  

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Personally, I think that this is a big step forward for those with celiac. At least with this, you can be sure of what you're buying.

 

I'm sorry if you're that sensative that 20 or less parts per 1,000,000 will still make you sick. Maybe you can find a labratory thay can chemically engineer something you can eat.

 

Sorry if some are offended by my statement but this is a big step forward for something that has been over-looked by the FDA and the AMA for far to long.

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this law enables the fda to tighten labeling loopholes.  20 (or less) parts per 1,000,000 - that's a pretty small amount (if it actually contains any at all)  if you are this sensitive, you are probably not eating much of this stuff anyway.  there is plenty of food that is all naturally gluten free.  the gluten fairy is not going to come around and sprinkle 20 parts on your 1,000,000 if you already are eating a certain brand with no issues, you should be ok :)  outside the us, i don't know how this labeling ruling would affect you?  steph, you already eat a very clean diet, no?  

 

I do eat a clean diet and don't know if this will have any effect on me personally.  I eat naturally gluten-free foods, like you said.  I'm not so sure about other family members.  Time will tell.

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I think it's crazy.

 

They are only regulating using the term "gluten free". All this means is things that were labeled gluten-free now have to test. Gluten STILL doesn't need to be listed at all (only wheat as it's a Top 8 already).  

 

Overall, I think it sucks. 

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My reading of the decision is that they are not required to test. 

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Thank you "Notme!"  It says "Are manufacturers required to test for gluten to make a gluten-free claim on their food labels?

No. "

 

Then there are more details.

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My reading of the decision is that they are not required to test. 

 

Lol. So it sucks even more than I thought it sucked! 

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Are manufacturers required to test for gluten to make a gluten-free claim on their food labels?
No. The final rule does not specifically require manufacturers to test for the presence of gluten in their starting ingredients or finished foods labeled gluten-free. However, manufacturers are responsible for ensuring that foods bearing a gluten-free claim meet the requirements of the final rule. Among other requirements, this means that any unavoidable gluten present in a food labeled gluten-free is less than 20 ppm. Manufacturers may choose to use effective quality control tools to ensure that any foods they label gluten-free do not contain 20 ppm or more gluten, such as:

 

  • conducting in-house gluten testing of starting ingredients or finished foods,
  • employing a third-party laboratory to conduct in-house gluten testing,
  • requesting certificates of gluten analysis from ingredient suppliers, or
  • participating in a third-party gluten-free certification program.

 

Thank you "Notme!"  It says "Are manufacturers required to test for gluten to make a gluten-free claim on their food labels?

No. "

 

Then there are more details.

I think the details are important though. Even though they don't have to test, it looks like unless they want problems with the FDA and the public, they will.

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  1. How will FDA check that food manufacturers labeling their foods gluten-free comply with the requirements of the final rule?

    The manufacturer is responsible for ensuring that any gluten-free claim it makes on its food labels is truthful, not misleading, and complies with FDA regulations. FDA may use the full range of its routine post-market monitoring activities to enforce the final rule on gluten-free food labeling. These activities include periodic inspections of food manufacturing facilities; food label reviews; follow-up on consumer and industry complaints reported to the agency; and when needed, gluten analyses of food samples.

     

  2. Are manufacturers required to test for gluten to make a gluten-free claim on their food labels?

    No. The final rule does not specifically require manufacturers to test for the presence of gluten in their starting ingredients or finished foods labeled gluten-free. However, manufacturers are responsible for ensuring that foods bearing a gluten-free claim meet the requirements of the final rule. Among other requirements, this means that any unavoidable gluten present in a food labeled gluten-free is less than 20 ppm. Manufacturers may choose to use effective quality control tools to ensure that any foods they label gluten-free do not contain 20 ppm or more gluten, such as:

    • conducting in-house gluten testing of starting ingredients or finished foods,
    • employing a third-party laboratory to conduct in-house gluten testing,
    • requesting certificates of gluten analysis from ingredient suppliers, or
    • participating in a third-party gluten-free certification program.

       

  3. What gluten test methods should a manufacturer use if it elects to analyze its foods labeled gluten-free to ensure compliance with the final rule?

    Manufacturers who elect to analyze their foods for gluten can select the test methods most appropriate for them, considering the type of foods they manufacture. Manufacturers are not obligated to use any one specific method to check for gluten in their foods. FDA recommends the use of scientifically valid methods in order for the gluten test results obtained to be reliable and consistent. Conducting gluten testing using a scientifically valid method is an effective tool manufacturers can use to ensure that their foods labeled gluten-free do not contain 20 ppm or more gluten.

     

  4. What gluten test methods will FDA use in its enforcement program of its new regulations on gluten-free food labeling?

    In the enforcement of its regulations, FDA routinely uses scientifically valid methods that have undergone an independent multi-laboratory performance evaluation where the results have been published in the peer-reviewed scientific literature to ensure that the results obtained are accurate and reliable. FDA has currently identified two sandwich enzyme-linked immunosorbent assays (ELISA)-based methods 

    (see R-Biopharm: Food & Feed Analysis img_fdagov_exitdisclaimer.png  and

     Morinaga Institute of Biological Science, Inc.: Wheat Protein ELISA Kit (Gliadin) img_fdagov_exitdisclaimer.png ) that, when necessary, the agency will use in tandem to determine compliance with the final rule. However, as discussed in the final rule, FDA is aware that sandwich ELISA methods do not adequately detect gluten in fermented and hydrolyzed foods. Because scientifically valid methods currently are lacking that can do so, we intend to issue a proposed rule on this issue. 

     

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lolz - JINX, barty!

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It seems to be open to interpretation and enforcement.  I, personally, don't feel reassured, even for the less sensitive members in my family.  I think that things might have been better before.  Time will tell.

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