Is 20ppm #Gluten Free Enough?

Not when even the FDA Office of Food Safety recommended in just May last year that the safe level to protect the most coeliacs from future damage and linked diseases is just 1ppm.

That’s a shocker isn’t it?

Let me say first off that I don’t anticipate that we would ever get to a zero ppm on a processed food; it is just not realistic or possible. But this has to make you think whether it is worth the risk of putting something tested at even 20ppm in your mouth, especially if you are one of the most sensitive gluten intolerants or coeliacs. Check too the previous post about the hazards of even being able to rely on a 20ppm label.

Incidentally, this report was sent in with thanks by Carolyn, when I asked why she thought that a product she had discovered had been tested at 5ppm was ‘too much of a risk’ for her.

The report, which you can access in full here, is:

Health Hazard Assessment for Gluten Exposure in Individuals with Celiac Disease:

Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten
Office of Food Safety
Center of Food Safety and Applied Nutrition
Food and Drug Administration
May 2011

The report is described as ” a health hazard assessment for gluten exposure in a sensitive subpopulation group, specifically individuals with celiac disease (CD).”

They were specifically looking at data for LOCs (levels of concern) of gluten ingestion that would cause clinical or morphological (villi) changes in coeliacs. The report is a long one but I copy here the summary for you and have highlighted what I think are major points and added a few comments about what I think it means. I confess I have not yet read through the whole thing, but I will. I thought the timing for this post was right though given the debate raging about 20ppm ruling now.

Here is the last sentence about 1ppm recommendation if you don’t want to read the whole summary:

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.

Here’s the whole summary for you. Bit technical but very useful:

Summary and Conclusions

Exposure to wheat, barley or rye, or the plant storage proteins of these grains, leads to the development of CD in genetically predisposed individuals. CD is a permanent hypersensitivity reaction that results in an immune-mediated enteropathy of the small intestine. The morphological damage and deterioration of the small intestine mucosa associated with CD is characterized by multipartite and specific histopathological
changes and abnormalities in the mucosal architecture that typically occur in phases that progress sequentially until the endstage of mucosal villous atrophy. The enteropathy
found in CD is tied, at least in part, to an array of clinical signs and symptoms (e.g., diarrhea, constipation, abdominal pain, nausea and/or vomiting), and also with other
sequelae (e.g., anemia, nutritional deficiencies, growth disturbances, weight loss) that are
associated with enteropathy-induced malabsorption.

However, not all of those afflicted
with CD exhibit clinical responses or these other possible sequelae in response to cereal grain triggers. Also part of the clinical presentations associated with CD and exposure to toxic cereal grains is increased risk of development of secondary disorders and diseases that include a number of autoimmune conditions, bone diseases and malignancies. [In other words, you don’t always get obvious symptoms and the risk of future linked diseases is still there. This is what I tell my patients daily – SO hard to get someone to go GF if they can’t feel it making a difference! Bane of my life!]

The effect of exposure to gluten on individuals with CD varies in a significant number of ways. Gluten can be an acute, subchronic and/or chronic toxin in those afflicted with CD.
In turn, acute, subchronic and chronic adverse effects can be clinical and/or morphological in nature. Evidence suggests that for those with CD, significant individual variability exists in the nature of their responsiveness to gluten. The type of clinical signs and symptoms seen, if any, and the timing of their emergence vary to a significant degree between sensitive individuals. [In other words, there is no one-size fits all with gluten avoidance. We can’t possibly know how much gluten each person can get away with so my advice is always don’t take the risk. If  I said anything else, I wouldn’t be doing my job to protect that person from future illness.]

Also, great variability across individuals with CD is seen
in the timing of the development and the degree of severity of the pathogenesis of the small intestine mucosa that occurs upon exposure to gluten. In addition, age differences
are suggested to play a role in the nature of the toxic reaction to gluten ingestion seen in CD sufferers. This includes the suggestion that adults may be a sensitive subpopulation of
those afflicted with CD.

The estimated TDIs [Total Daily Intake] for gluten in individuals with CD across the different durations of exposure are in the low mg level (or possibly lower) range for morphological effects, and in the low ug level range for clinical effects. Because of the significant degree of individual variability in the sensitivity and responsiveness to gluten found in those with CD and the apparently narrow margin in the dose level between the no and low adverse effect levels, the UFs [uncertainty factors] used in the safety assessment may not be adequate. Other UFs may be warranted to provide a sufficient level of protection for gluten-sensitive individuals, especially those who are the most sensitive within this subgroup of individuals with CD, and possibly to account for the limited dose-effect information available on the risk of secondary gluten-induced medical conditions. [We may well need to review the current safety recommendations to suit the CD population as our risk assessment levels may be out.]

Next, the TDI values derived for gluten in this health hazard assessment apply only to exposure to wheat gluten. In turn, the “wheat gluten food” LOCs was derived from the overall
principal TDI that was based on data that directly assessed and quantified the toxicological effects of wheat gluten in CD. Thus, these LOC values are reflective of the adverse effects associated with CD that are directly attributed to exposure to this wheat
cereal protein. Information on the relative potency of relevant CD-inducing storage proteins in wheat, rye and barley is lacking; thus, extrapolation of quantitative data and
estimates derived from wheat gluten studies to other toxic grains is problematic at this point. But, if it is the case that the toxic potency of wheat gluten is comparable to the
gluten-like proteins in rye and barley as assumed in this assessment, then the LOC values that also account for exposure to rye and barley are similar to those that considered only
the consumption of wheat.

Additional research that investigates the low dose-response adverse effects data of relevant rye and barley proteins involved in CD along with information on their relative toxic potency to wheat gluten is needed. [These findings were based on wheat gluten/gliadin ingestion so bear no relation to that which comes from rye or barley – or even other grain glutens – but the report suggests the effect on clinical and villi changes would likely be comparable.]

Last, after the evaluation of all low dose-response data available on the adverse CD related health effects of gluten, the tolerable daily intake level for gluten in individuals with CD was determined in a safety assessment to be 0.4 mg gluten/day for adverse
morphological effects and 0.015 mg gluten/day for adverse clinical effects. Some evidence suggests that the possibility that the TDI for morphological effects based on a
derivation that incorporated a 10-fold UF for inter-individual differences may not include a margin of error (or safety) that protects all individuals with CD.

The LOC values for gluten in food that correspond with these TDI values at the 90th percentile level of intake are less than 1 ppm for both morphological (~0.5 ppm) and clinical (~0.02 ppm) adverse effects. [To avoid villi changes and clinical symptoms, the levels are assessed at way below 20ppm.]

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. [To protect coeliacs generally and, especially because we cannot know what level of intake is capable of triggering clinical symptoms, villi damage or future linked diseases, they estimate, based on the findings, that a safe ingestion of gluten is less than 1ppm.]

How this could ever happen with the myriad problems of cross-contamination, mis-labelling etc etc, goodness only knows. The recommendation for 20ppm is certainly a step in the right direction but may not protect many coeliacs, let alone non-coeliac gluten sensitives. But it certainly makes you think.

The debate will rage on, not least because a lot of big companies make a lot of money out of gluten free food production but also because we want to make life easier for ourselves by accessing convenient foods – and believe me, I do understand that as someone who gets fed up to the back teeth of cooking everything from scratch! However, this only serves to show me that we still have a lot to learn about gluten and the variable effects it can have on us. For me – and it seems people like Carolyn – we choose not to take the risk and avoid processed gluten free foods even if they do say 20ppm. It is a choice for every individual to make based on the available evidence.

Incidentally, I also came across the peer review report for this document too, so worth a read if you want to see how it was looked at critically too. You can find that here.

Phew, I’m off for a cuppa (organic green tea leaves, hopefully no gluten!)