Is FDA’s gluten-free labeling requirement of less than 20 ppm gluten really safe?

photo_3

Dear Gluten-Free Community,

I’m confused. And I need your help!

One summer morning, last month, I turned over in bed, opened my sleepy eyes and turned on the radio to hear the 7 am news.  I was amazed to hear the FDA ruling on gluten-free labeling had been finalized – and had made NPR headline news! BUT I didn’t jump up and down with glee. I laid in bed a while longer, as I struggled to come to terms with my emotions. Is this really great news?

Over the course of the day, I watched gluten-free people everywhere virtually high-fiveing, as they rejoiced in celebration over Twitter and other social media. Meanwhile, I was feeling down, a little confused, and very alone in my thoughts.

Here’s why:

Depending on which study you read, 74 % to 92% of celiacs who go on a gluten-free diet never heal[1], [2].  That’s huge! Why are we not talking more about this? And why does everyone keep pushing the gluten-free diet as we know it, if its not really helping people that much? 

The traditional gluten-free diet (GFD as its called in medical literature) is defined as a diet that is void of wheat, barley and rye. Oats are not even considered part of the GFD anymore (although I’m not sure I agree with this).

So why aren’t most people healing on the GFD? One likely possibility is because 32% of inherently gluten-free grains are cross-contaminated with more than 20ppm of gluten. This means that if your buckwheat or millet or quinoa is not labeled gluten-free, don’t assume it is! And you may not see that gluten-free label on such single-ingredient packages anytime soon, anyway. Dr. Petersen discusses that more here.  

New legislation now requires foods that are labeled gluten-free to have less than 20ppm (parts per million) of gluten in then.  So foods labeled ‘gluten-free’ are not really gluten-free!  They are low-gluten. Read Dr. Anderson’s article for more discussion on what exactly does it mean for products to have less than 20 parts per million of gluten?

But now that we have standards in place (it will still take a year for them to go into effect), will you at least be able to trust those packaged food products that are labeled as gluten-free? As of mid-2013, most manufacturers of gluten-free foods were already voluntarily producing foods with this standard in place, so we probably won’t see any drastic changes to our GF food system.[3] The new legislation will just ensure that manufacturers new to the gluten-free industry will also comply with the 20ppm standard. But is that enough? Is 20ppm of gluten actually safe? If so, why did Australia and New Zealand rule that it should be 3ppm?

One study by Dr. Alessio Fasano and colleagues, is continually referenced to support the idea that 20ppm or less is deemed to be safe.[4] However, upon reading the entire study, I don’t see where it actually says that 20ppm is safe. They say that 50 mg of gluten per day is a “minimum [emphasis mine] dose required to produce measurable damage” and that “the threshold of 20 ppm keeps the intake of gluten from “special celiac food” well below the amount of 50 mg/d, which allows a safety margin for the variable gluten sensitivity and dietary habits of patients.” 

They conclude that the

intake of 50 mg gluten/day produced significant damage in the architecture of the small intestine in patients being treated for CD. However, the sensitivity to trace intakes of gluten showed large interpatient variability, a feature that should be accounted for in the implementation of a safe gluten threshold… Finally, the relation between the intestinal damage induced by trace intakes of gluten and the long-term complications of CD remains to be elucidated.

What this says to me: We know 50 mg/d of gluten causes intestinal damage. We don’t know at what point trace amounts of gluten cause damage. And it’s different from one person to the next. So let’s arbitrarily pick 20ppm because if you eat several gluten-free foods that contain 20ppm of gluten in one day, at least you won’t reach the 50 mg per day that we know causes damage.

I believe that this study is inherently flawed.

It assumes that unless there is measurable intestinal damage, then gluten is not harming us.

First, villous atrophy actually happens in a patchy distribution[5], so a biopsy that shows no histological changes, does not necessarily always indicate a disease-free patient.

Second, there are many other ways that gluten can affect a person besides the gut. For instance, dermatitis herpetiformis (DH), is a gluten-induced skin disorder associated with celiac disease, but its been shown that 20% of DH patients show “apparently normal small bowel mucosal architecture”.[6] As another example, gluten ataxia is a very serious disorder that affects the brain and yet, patients have developed “severe neurological symptoms” without “gluten?dependent small bowel mucosal atrophy.” This supports the notion that coeliac disease clearly exists beyond villous atrophy, [and]… small intestinal villous atrophy is only one manifestation of genetic gluten intolerance.”[7]

And what about the other approximately 200 other medical conditions associated with gluten? While celiac disease is an autoimmune disorder that affects less than 1% of the population, (and mucosal damage is most often how it is diagnosed), Non-Celiac Gluten Intolerance (NCGI) now called Gluten Sensitivity (GS) affects 8 to 12% percent of the world’s population (and possibly even much more)[8]. GS patients exhibit symptoms similar to celiac disease, but biopsies and blood tests come back negative for celiac disease. In fact, 50 to 75% of GS patients never even complain about digestive distress![9] So how do we know that trace amounts of gluten aren’t still hurting is, especially if we know, as already stated, that 74% to 96% of patients on the standard GFD do not heal!?

Just because 20ppm of gluten ingested (several times over the course of a day) doesn’t show histological damage (the majority of time in one study) does not prove that its safe! In fact, one study has shown that there are indeed patients for whom even just a milligram of gluten a day causes mucosal harm.[10] For more information, watch Dr. Tom O’Bryan’s discussion on the study.

In 2013, Dr. Fasano and his colleagues published an article that looked at a group of people who did not heal on the GFD and asked them to go on what they called a Gluten Contamination Elimination Diet (GCED), which was essentially a grain-free diet, in an effort to remove any chances of being cross-contaminated by trace amounts of gluten. Only white and brown rice were allowed. And what was the response rate?  82% of patients on a diet that removed trace amounts of gluten responded well to the treatment.[11]

Clearly, the gluten-free diet as it stands now is not enough, and removing trace amounts of gluten has met with great response. There is plenty of anecdotal evidence to support this. Just look at the sheer number of people adopting the “paleo” diet (a grain-free diet) because they did not respond well to the standard GFD. (You can read our paleo-month blog post here and here from this past July for just a few of these personal accounts).

As far as I can see, Dr. Fasano’s 2007 study has not proven that 20ppm is safe for the majority of the general gluten-sensitive population.

The only people that are really benefiting from the 20ppm threshold are gluten-free food manufacturers, who (combined) are making billions of dollars a year off consumers who think that gluten-free products are healthier for them[12]. In fact, you can almost read between the lines, when Dr. Fasano says in his letter, In Defense of 20ppm[13]that setting a safe gluten-free threshold below 20 ppm would be harmful to manufactures because the limits are too restrictive and that US manufacturers would not be able to “compete successfully in the gluten-free global marketplace.” So is that what it’s really about?  As Fasano says, “Under these restrictive limits, manufacturers would either discontinue gluten-free products or be forced to create much more expensive and much less palatable products, resulting in a drastic loss of selection and quality.”

That would be a shame, because gluten-free sensitive people everywhere would be forced to get the majority of their calories from fresh, whole foods.

It was only toward the end of that August day that I tweeted with two very prominent individuals in the gluten-free space, Shauna Ahern and Jennifer Esposito.  It turns out they shared my sentiments. @JennifersWayJE tweeted:

bullshit. If u eat this stuff everyday/every meal it adds up-its 1/8of a tsp gets us ill.

And @glutenfreegirl tweeted:

this is all a call to arms for those of us who are gluten-free: cook real food.

I was happy to know that I’m not alone in my thoughts anymore.

But I’m still confused. 

Why was there so much celebration on the passing of this regulation, if most people on the standard gluten-free diet never heal, and what they’ve already been eating won’t be affected much by the law? 

I am mostly worried about the newly diagnosed celiac or gluten-sensitive patient, who will be roaming grocery store shelves for help, and will be inundated with GF products that they believe are going to help them finally get better, after months, maybe years of agony.  But will they really get better?

So now I ask you – where do you stand on this? How long have you been gluten-free? Why did you go gluten-free? And are you feeling better on the traditional GFD, or have you had to go beyond what we are now allowed to call gluten-free (but which is really low gluten)? Please comment…. I really want to hear your thoughts!

 

 


[1] Intestinal Damage from Celiac Disease Persists in Adults, Even with Gluten-free Diet. National Institute of Diabetes and Digestive and Kidney Diseases. September 2011. http://celiac.nih.gov/TissueDamage.aspx

[2] Lanzini A, Lanzarotto F, Villanacci V, Mora A, Bertolazzi S, Turini D, Carella G, Malagoli A, Ferrante G, Cesana BM, Ricci C. Complete recovery of intestinal mucosa occurs very rarely in adult coeliac patients despite adherence to gluten-free diet. Aliment Pharmacol Ther. 2009 Jun 15;29(12):1299-308.

[3] Anderson, Jane. How Much Trace Gluten is In Your Food?  CeliacDisease.About.com. http://celiacdisease.about.com/od/PreventingCrossContamination/a/Different-Trace-Gluten-Levels.htm

[4] Catassi C, Fabiani E, Iacono G, D’Agate C, Francavilla R, Biagi F, Volta U, Accomando S, Picarelli A, De Vitis I, Pianelli G, Gesuita R, Carle F, Mandolesi A, Bearzi I, and Fasano A. A prospective, double-blind, placebo-controlled trial to establish a safe gluten threshold for patients with celiac disease.  Catassi,  Carlos, et al.  Am J Clin Nutr 2007. 85:160 – 6.

[5] Arzu Ensari, MD, PhD, Gluten-Sensitive Enteropathy (Celiac Disease). Controversies in Diagnosis and Classification. Arch Pathol Lab Med. 2010;134:826–836.

[6] Latent coeliac disease or coeliac disease beyond villous atrophy? Katri Kaukinen, Pekka Collin, Markku Mäki. Gut. 2007 October; 56(10): 1339–340. 

[7] Ibid.

[8] Anderson J. Mon-Celiac Gluten Sensitivity Research. New Research Explains How Gluten Sensitivity Differes From Celiac Disease. CeliacDisease.About.Com http://celiacdisease.about.com/od/glutenintolerance/a/Gluten-Intolerance-Research_2.htm

[9] Petersen V and Petersen R. The Gluten Effect. How “Innocent Wheat is Ruining Your Health. True Health Publishing. 2009. 403 pp.

[10] Biagi F, Campanella J, Martucci S, Pezzimenti D, Ciclitira PJ, Ellis HJ, Corazza GR: A milligram of gluten a day keeps the mucosal recovery away: a case report. Nutr Rev 2004;62:360-363.

[11] Hollon J, Cureton P, Martin M, Puppa E and Fasano, A. Trace gluten contamination may play a role in mucosal and clinical recovery in a subgroup of diet-adherent non-responsive celiac disease patients. BMC Gastroenterology 2013, 13:40

[12] Gluten Free is Still Going Gang Busters. PackagedFacts.com. http://www.packagedfacts.com/about/release.asp?id=3033

[13] “In Defense of 20 Parts Per Million” A Letter from Alessio Fasano, M.D., and The University of Maryland Center for Celiac Research. August 2011. http://www.glutenfreediet.ca/img/Fasano_letter.pdf

13 thoughts on “Is FDA’s gluten-free labeling requirement of less than 20 ppm gluten really safe?

  1. Anonymous

    Amen Heather. We have not been helped by this ruling. More work needs to be done. We all deserve and should demand our health and products be better!

    Reply
  2. Gluten Dude

    Way to put yourself out there Heather. I've been intentionally quiet about the ruling. I know how hard some people worked for years to get the FDA to do SOMETHING. And I am beyond appreciative of their efforts. But like you, I feel it falls short and it puts the needs of the inflicted a bit below the needs of the food companies.

    Reply
    1. Heather Jacobsen Post author

      Yes, I know, GD. There are some people who have worked hard on this, and I appreciate all they've done to draw attention to the issue. I hope that I don't offend them. But I just haven't been able to rest easy on this issue for the past month, so I had to air my opinion. Thanks for your comment.

      Reply
  3. Jeanne

    Thanks for writing this. I know this was a victory for the advocates who worked for years to make this happen & it is good that the FDA legitimizes gluten free. But the ruling was weak. The 20ppm standard was disappointing (I agree on all your points) but it was expected. More disappointing to me were the details. A gluten free claim is voluntary and the FDA allows products derived from  gluten-containing grain  - so a product made from wheat or barley is ok if "processed" to eliminate gluten & tests low. NOT FOR MY FAMILY! They even acknowledge that testing for these processed grains is not accurate - but they allow it anyway. Of course, oats do not have to be certified gluten free. Scary!  As for compliance, manufacturers will be self regulated. Testing is technically not required, testing methods are up to the manufacturer, records do not need to be kept, the FDA "may" check up & violators will be "investigate". So, Christmas came early to manufacturers who have been interested in a piece of the gf pie but feared high standards. It is what it is but that doesn't mean we just deal with it, companies need to know that us guys with the wallets, our standards are higher.

    Reply
    1. Heather Jacobsen Post author

      Thanks so much for elucidiating, this Jeanne. I missed the NFCA webinar, which I heard was happening just about the same time that I finished writing this post. But I'm hoping to get a copy of it.

      Each of these points you bring up are alarming to say the least. Its almost angering.

       

      Reply
  4. Ann

    Hi – Just returned from the International Celiac Disease Conference in Chicago.  They did a presentation on this topic and Dr. Fasano and the woman from the FDA were there.  Without getting into too much of the science, I am convinced the 20ppm is without a doubt safe.  You would have to consume alot of gluten free replacement products to make any changes in your antibody tests and even more to make changes in your biopsy.  Dr. Fasano did another study of people who remain with symptoms.  Of 1200 patients, 2.3% had symptoms on a GFD.  He placed them on a whole foods diet (no GF replacement foods).  Their symptoms improved and then they were able to tolerate GF foods again.  Not sure how long they were on the whole foods diet.  I try to limit our replacement foods to the bare necessities to make life manageable with teenagers and mostly eat a paleo diet with rice and potatoes and so far so good.Another presenter presented a study about wheat starch – randomized trials with no ill effects to CD patients.  Too bad though on the ruling for oats – I guess you need to check with manufacturers and only buy trusted sources and not buy other GF products with oats as an ingredient.  They are also working on guidelines for fermented and hydrolyzed foods such as yoghurt – that will be coming so in the meantime none of those foods are regulated.

    Reply
    1. Heather Jacobsen Post author

      Thank you for sharing your opinion. Yes, I cited that study that you mention (#11) . They were eating whole foods for 3 to 6 months.

      What is confusing to me is that he says 2.3% of patients "had symptoms", whereas studies #1 and #2 that I cited, say pretty much the opposite. So why does he believe the standard GFD is fine for most people, and yet two other independent researchers say that the standard GFD is not helping 74 – 92% of CD Patients?!

      Just curious, how did the wheat starch presenter define "ill effects to CD patients?"

       

      Reply
      1. Ann

        I am typing up my notes now and will send you info when I get organized – it was a bit overwhelming, each speaker only had about 10 minutes so, lots of info in a short amount of time.  I did get a booklet of summaries of studies – I can find that reference for you in the next day or two.  Lots of talk about FODMAPs as a potential reason for continuing symptoms.  Age at diagnosis is also a factor as well as dysbiosis, SIBO being the main culprit.  The field is really exploding – lots of people looking at the great mysterious microbiome so I think we will have more answers in the coming years.  They were all quick to admit that there are still so many unanswered questions especially in the areas of non-celiac gluten sensitivity and why so many adults in particular still have symptoms after a GFD.  I was just treated for SIBO – will be curious to see if I can tolerate FODMAPs again and and the occasional restaurant meal.  I know I have been trying to figure things out on my own because I have had no luck with GI docs, but now I am thinking I need to go to a celiac center and try to have them figure out what is wrong and also to raise awareness among the docs that GFD isn't the end of the story.    Its a journey! 

        Reply
        1. Heather Jacobsen Post author

          It is most definitely a journey! Yes, there is still so much to learn. I look forward to us unraveling the mystery.  I did see that FODMAP/GS study, although I haven't had a chance to dig deeply into it yet.

          Reply
  5. Pat Minnigh

    I appreciate all all of the comments on this. Interestingly enough, I did help advocate for it with Jules Shepard when she made the 2 story GF cake in DC to spur the politicians to make a decision. This may not be the best threshold of acceptable gluten for several of us, but studies have shown that it is acceptable for the majority of celiacs. Not having a standard, as we have had for a long time, has allowed anyone and everyone to claim their product is gluten free even though it isn’t! One fellow in our group purchased a bag of GF pretzels that were not GF at all and he was very sick! If you are sensitive, as I am, you look for the certified seals on you favorite GF products from CSA or GIG. They test at 5 to 10 ppm. Our purchasing habits will dictate how the manufacturers decide the gluten content. I have a question, have any of you reacted to Bob’s Red Mill products?

    Reply
    1. Heather Jacobsen Post author

      Thank you for your comment, Pat. I can't say for sure if I've reacted to Bob's Red Mill. I can say that I'm mostly on a paleo diet now, because eating meals made with GF flour and GF grains, did not help me to feel better. 12 years ago, when I  went GF, there were not a lot of GF products on the market, so I did not eat a lot of baked goods, and especially no processed foods. And I felt fine back then! But in the past couple of years, as I started experimenting with GF baking, snacking on GF crackers, etc. I started feeling ill again.  I'm assuming this is because of gluten cross-contamination but I don't know for sure. I do know that I am very sensitive to gluten, though.

      Reply
  6. Pingback: Seven Things You Should Know About Going Gluten-Free. And Why Going Gluten-free Really Should Be Going Paleo. | Stuffed Pepper ™

Add Comment Register



Leave a Reply

Your email address will not be published. Required fields are marked *


+ seven = 11

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>