FDA’s Proposed Gluten-Free Labeling Law

I have put off writing this post for over a month because my thoughts and opinions on the matter have not been clear.  I have concluded that there is no easy answer, but I believe that you all need to be aware of what is going on with labeling, so I will attempt to present the information to you.

Thanks to the efforts of 1in133.org, the Food and Drug Administration (FDA) is moving forward on establishing a law for the use of the term”gluten free” on labels.  As part of this effort, the FDA has opened the comment period on their proposal.  That comment period ends October 3rd. You can find information about how to comment near the end of this post.

The Proposed Level of Less Than 20 Parts Per Million (ppm) Gluten

For some time now I have not been happy with the proposed level of less than 20 ppm of gluten being allowed in products labeled as gluten free.  I fully understand that zero gluten is not only impossible to test for, but it is essentially impossible to attain in processed foods.  There is too much gluten in this world, and some degree of contamination is going to happen during manufacturing, processing, and/or transportation.

It is my understanding that the European standard has been 20 ppm since 2008.  Other countries, in particular Australia and New Zealand, require no detectable gluten.

I am not convinced that 20 ppm is safe for people with celiac disease.  The problem is that there have not been enough studies done on this topic.  One study done by the Center for Celiac Research only included 13 people and lasted only three months.  While not insignificant, that is a pretty small and short study.  I would like to see more extensive studies done.

I have to be honest and say that my main concern over the 20 ppm standard is not scientifically based, but rather based on experiences.  Some people might scoff at that, but when you are a sensitive celiac, it is frustrating when people don’t take you seriously.  Most people who are sensitive know when they have ingested gluten because the symptoms are distinct from symptoms that they get from other food intolerances or viruses.

For years I was a very sensitive celiac.  Now I am more sensitive than some, but not as sensitive as others, and definitely not as sensitive as I used to be.  However, I have always heard and read that we cannot base what is okay for us to eat on our symptoms because some people with celiac have no immediate symptoms from ingesting gluten.  So even though I am less sensitive, I try to be just as careful as I was previously.

Now I have a son who is gluten free, and although he tested negative for celiac, he is just as sensitive to gluten as I used to be.  I have tried products that are tested to the proposed 20 ppm and he reacts to them.  Sometimes I get mild reactions too.  Products that are tested to 10 ppm, he seems to do okay with.  I know of other individuals who are the same.

So yes, my distrust of 20 ppm is based on personal experience and the experiences of others I know and read about.  One of my concerns is that there are people who are not “sensitive” in terms of outward reactions who are reacting internally (villi damage) to these same products that some people show outward reactions to.  I’m simply not convinced that 20 ppm is safe.

Despite my opinion on the proposed standard, I was prepared to support it simply because it is better than no law at all.  It is a starting place, but then the FDA opened the comment period which gives me an opportunity to say what I really think.  They also released a safety assessment….

The FDA Safety Assessment

The FDA released a Safety Assessment.  It is a very long report which I cannot summarize here.  I will quote one statement from page 46 (CD=celiac disease GFD=gluten free diet):

“In sum, these findings indicate that a less than 1 ppm level of gluten in foods is the level of exposure for individuals with CD on a GFD that protects the most sensitive individuals with CD and thus, also protects the most number of individuals with CD from experiencing any detrimental health effects from extended to long-term exposure to gluten.”

You read that correctly.  The FDA found that based on studies that have been conducted, a level of 1 ppm protects the most number of people with celiac disease.

If you are interested, you can also read an external peer review of the safety assessment.

Safety-Based Approach vs. Analytical Method Approach

Basically, the FDA has two ways of approaching how they set the standard for gluten-free labeling.  The safety-based approach would mean recommending a level based on the lowest amount of gluten considered toxic.  The analytical method approach would be based on the sensitivity of testing methods.  So, even though 1 ppm may protect the most number of people, there are no tests available that can reliably test foods to 1 ppm.

The FDA is proposing to use the analytical method approach.  You can read more about their concerns regarding a very low threshold in the next section.

Doctors in the celiac community, including Dr. Fasano and Dr. Guandalini support the analytical method approach.  You can find out more at 1in133.org: What the Experts Are Saying About FDA’s Labeling Proposal.

Personally, I don’t have a problem with using the analytical method approach.  Setting a limit that can’t be tested makes no sense.  However, I don’t believe that limit has to be 20 ppm.  There are certification programs that test to 5 ppm and 10 ppm, so I believe it is possible to test to a level lower than 20 ppm.  However, the FDA states:

“At the current time, FDA is not aware of any analytical methods that have been validated to reliably and consistently detect gluten below 20 ppm.”

Regarding two testing methods (the FDA recommends the ELISA method), the Gluten-Free Certification Program which tests to 10 ppm has this to say on their FAQ page:

“Research to be published shortly suggests that both ELISA and Skerritt may have weaknesses that can be complimented by using both methods. We feel that by using both methods, we are able to more accurately assure GF status.”

I understand that the FDA would want to use a method of testing that they are sure about.  I would like to see them look into it further, though.

The Federal Register – Proposed Rules

You can read the Federal Register dated August 3, 2011.  In it, the FDA states,

“To the extent it is possible to do so and protect public health, we believe that we should set a gluten threshold level for ‘‘gluten free’’ labeling that best assists most individuals with celiac disease in adhering life-long to a ‘‘gluten-free’’ diet without causing adverse health consequences.”

“Most individuals” is a key phrase.  It sounds like they have decided that protecting everyone, including the most sensitive people, is just not realistic nor beneficial overall, and I’m not necessarily arguing that point.

The FDA has proposed that the term “gluten-free” would mean that the food does not contain:

  • “an ingredient that is any species of wheat, rye, barley, or a crossbred hybrid of these grains”
  • “an ingredient that is derived from a prohibited grain and that has not been processed to remove gluten”
  • “an ingredient that is derived from a prohibited grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 ppm or more gluten in the food”
  • 20 ppm or more gluten
    In the Federal Register, the FDA lists concerns they have about setting a threshold that is much lower than 20 ppm.  Their concerns include:
  • Some manufacturers might discontinue labeling their products as gluten free because they could not meet the lower level.
  • Other companies might be discouraged from producing foods labeled gluten free for the same reason.
  • There could be a significant increase in the cost of gluten-free foods.
  • It could negatively affect the trade of gluten free foods and therefore affect the availability of gluten free foods.

Dr. Fasano addresses these issues in his article In Defense of 20 Parts Per Million and in this video (in case you’re tired of reading).  One important point that Dr. Fasano makes is that there is a margin of error for the tests that are done to determine the level of gluten in a food.  If the threshold is very low, then a product might be under that threshold one day, but the exact same product could test higher the next day and be over the threshold.

Low Gluten

Australia and New Zealand have two terms they use on foods, “gluten free” and “low gluten.”  While “gluten free” means no detectable gluten, “low gluten” means less than 200 ppm.  The FDA would like comments regarding the use of the term “low gluten” in the US, both whether the term should be used and if so, what the threshold should be.

The general consensus from what I have read is that a “low gluten” label would not be helpful and would likely cause confusion.

How Will I Comment?

As I said a the beginning, I don’t think there is an easy answer to this.  I understand the reasons for going with an analytical method approach, and I understand the reasons for not wanting to set a threshold that is extremely low.

However, because I feel that 20 ppm may be too high, I will communicate that my preference is to set the threshold at 10 ppm.  I don’t believe that level is as restrictive as 5 ppm would be, but it would provide a higher degree of safety.  I understand that would be contingent upon a testing method or methods that are accurate.  Even if they decide to go with 20 ppm at this point, I hope they would consider a lower level in the future if better testing or more information about testing becomes available.

Regarding how that will affect the importing of gluten-free foods, it seems to me that there are many companies here in the US who produce gluten-free foods, and the number seems to be growing all the time.

I will also let the FDA know that I do not support a “low gluten” category for foods.

In addition, if you read through the Federal Register, there are a number of points on which the FDA wants comments.  I will comment of some of these, but will not take the time to spell is all out here.  While there is an option below to sign a pre-written comment, I think you should  at least read through the Federal Register yourself and then consider leaving your own comment.

How You Can Comment

The FDA wants to hear from you!  Please let them know what you think and why. You can find complete commenting information in the Federal Register.  To comment online, go to regulations.gov then:

1. Choose “Submit a Comment” from the top task bar
2. Enter the docket number FDA-2005-N-0404 in the “Keyword” space
3. Select “Search”

Another option is to electronically sign a comment written by the American Celiac Disease Alliance. If nothing else, it may be helpful to you to read their comment.

Additional Resources

G-Free Labeling Part II – Harris Whole Health
Concerning the FDA’s Federal Register Notice – Gluten Free Dietician
FAQs Regarding Gluten-Free Labeling of Foods – 1 in 133




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Comments

  1. Excellent post Linda. I think your points are extremely valid and you’ve stated them in a very readable fashion. Thank you so much for sharing your thoughts and I completely agree with you on the 10ppm standard.

  2. Thanks so much for this info, Linda! I have found that I am extremely sensitive to gluten, with reactions to products already marked as less than 20 ppm. With your assessment in hand, it will be easier for me to make sense of the register and then make my own, informed comment to the FDA.

    • Jill, when you are extremely sensitive, it’s nice to know you are not alone. You’re not! I’m glad you are going to comment.

  3. Linda, this is an excellent post. I agree with your concerns about the 20 ppm. I will be sharing this on our site’s Facebook page. Thanks.

  4. Linda, thank you so, so much for this info. I am super sensitive and this article may help those who aren’t understanding to see what I’m up against. Thanks! again.

    • Jean, you’re very welcome. It is nice to know you are not alone when you are extremely sensitive. I hope you will comment on the proposed law.

  5. Well said Linda. Thanks for taking the time to communicate it all and give us the information that we need in order to communicate well and intelligently when we weigh-in.

  6. Linda,

    Our household is certainly having a great deal of difficulty with 20 ppm testing standards. I try very hard to avoid products that are not tested to at least 10 ppm or lower and have still wound up in trouble just recently when I tried making my flour blend with flours that were only tested to 20 ppm. I didn’t think to check, and even though nothing else in the house was tested at that standard, my husband and I both got sick and kept getting sicker for two weeks, until I could determine where the gluten was coming from. Miserable! I am planning to comment and have been encouraging others to do so as well. This post helps me as I ponder how to form word what I would like to say.
    Angie

    • Hi Angie. I think it’s very important for the FDA to hear from people like you who have trouble with products tested to 20 ppm. You’re not alone! Thanks for taking the time to comment and for encouraging others to do so.

  7. Linda,
    Thank you for this very thought-provoking post. I will direct this to my celiac husband and he will comment to the FDA. Thanks again for taking the time to explain something that I find to be very confusing.
    By the way, I made my cheesy grits recipe recently and made some gluten free sausage to go on top, and my husband really liked it!
    Kay http://www.georgiagirlwithanenglishheart.blogspot.com

    • Hi Kay. I agree that it is very confusing, and it took me a long time to sort it all out. I’m glad I can of help to you. Those grits sound great!

  8. Thank you for this very educational and interesting post. Growing up in Europe, where 20 ppm and less is the standard for gluten free goods, I have always felt that less than 20 ppm seemed to work for me. However, I am not a sensitive celiac at all, and the idea that I could be poisoning myself without noticing concerns me. I agree that 10 ppm would be a safer guideline and would probably feel even safer about buying products labeled as gluten free by that standard, but I fear that many products that might be okay for most celiacs will lose their labeling based on a stricter standard.

    Other than you, I would find a differentiation between “gluten free” and “low gluten” acceptable, as long as “low gluten” would be 20 ppm and less and “gluten free” would mean no detectable gluten. That way, celiacs could decide for themselves whether they feel comfortable with eating a certain product.

    • What you propose regarding “low gluten’ and “gluten free” would be acceptable to me. However, since they are looking at low gluten being less than 200 ppm, I don’t think that helps anybody. I have a question for you. The European Union adopted 20 ppm standard in 2008. Prior to that it was 200 ppm. I’m wondering though if individual countries were using the 20 ppm standard before that. Do you know?

      • I agree that 200 is too high to be considered safe for celiacs. I did a quick search and wasn’t able to find any information to back this up, but I remember that “gluten free” was already defined as less than 20 ppm in Germany before the EU made it the standard. I would have to double check that. Unfortunately, I don’t know what the situation was like in the other European countries before the regulation.

  9. Hi Linda,
    Sounds like our views are aligned! I’m surprised at how little I’ve heard of dissenting opinions, and I’m glad to see discussion on the issue.
    Thanks for linking to my post.

    • Hi Cheryl. Yes, everybody I have heard from through comments and email have been in agreement. Hopefully they are all commenting to the FDA also.

  10. Linda, you really did an outstanding job on this post! It seems that I should consider moving to Australia and New Zealand as I really can’t seem to tolerate any gluten. I reacted to three products from a company certified by the GFCO to less than 10 ppm. One of them only registered 0.5 ppm gluten. Now Dr. Fasano said in his presentation that the testing is only accurate at the 5 ppm gluten, so that 0.5 ppm gluten might really be 5 ppm gluten, but even consdiering that data, it’s clear that I react to a level far lower than the proposed standard of less than 20 ppm.

    I still don’t understand so many of the “disconnects” and they disturb me. You’ve covered most of them here. I realize that thse decisions must be based on facts, yet like you I don’t think we’re heeding the facts. We see the facts stated that less than 1 ppm is what we need to be safe, but then we are given data about what the industry can support, the levels used in Europe, and statements from the FDA that testing is only accurate to 20 ppm yet as you indicated there are certification programs that certify to far less. Like you, I believe we need a lower level. I’d love far less than 5 ppm, but I’ll settle for 10 ppm. I suspect that those of us who are the most sensitive will just have to stick to more and more real foods that cannot be contaminated.

    Another factor that greatly concerns me is whether or not these products at less than 20 ppm are causing a new source of issues. It seems that more and more gf folks use products at the 20 ppm level, and lots of these products. Many of these folks are experiencing new autoimmune issues and/or a recurrence of symptoms/problems that they had before going gf, but they don’t seem to be making a connection. I believe there is a connection and that this level is not safe.

    I appreciate all this info and will go share my own experiences and endorse a decision. Thanks, Linda!

    Shirley

    • Shirley, I consider 10 ppm to be a compromise. As you said, I’ll settle for it. It may be that some people can tolerate more than others, or it may be that some show more symptoms, and as you pointed out, those with fewer symptoms may be developing other problems as a result. I wish we knew for sure. However, I’m willing to compromise because if it is true that a very strict standard such as 5 ppm or lower would mean few products available, then some people would end up cheating or giving up on the diet. I also think it’s more likely the FDA would go with 10 ppm than 5 ppm at this time. Thanks for you input!

  11. Thank you for the posts, very interesting. I’ve depended upon GF labeling. How in the world do you know or find how much gluten is in a product. I’ve never seen it on labeling. I think I need more resourced.

    • Hi Lynn. You pretty much have to contact the company. Even though there is no regulation yet, most companies that put “gluten-free” on their labels test to at least 20 ppm. If the company uses a certification program such a GFCO it could be less. You can sometimes find information on the company web site also.

  12. Reggie Corpus says:

    You pretty much have to contact the company. Even though there is no regulation yet, most companies that put “gluten-free” on their labels test to at least 20 ppm. If the company uses a certification program such a GFCO it could be less. You can sometimes find information on the company web site also. VIsit http://www.registrarcorp.com/fda-food/index.jsp?lang=en where Registrar Corp actively works to provide product labels for companies that are reviewed by us to prevent costly errors.

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