Although “gluten-free” wheat starch meets or attempts to meet the legal definition of “gluten-free” (i.e., “<20 ppm of gluten” or “<20 mg of gluten per kg of food”), there are multiple concerns regarding the use of it in products that are labeled “gluten-free” and intended for consumption by those with celiac disease.
Testing Wheat Starch
Gluten Free Watchdog, an independent testing organization, recommends that individuals with celiac disease and other gluten-related disorders completely avoid consuming products made with gluten-free wheat starch.
There are several reasons for concern, including (but not limited to):
- The gluten content in wheat starch may be underestimated.
- There are multiple methods to hydrolyze gluten, some of which may remove less gluten than others.
- Not all methods can be tested with the same tests since gluten can be partially degraded during the manufacturing process leading to a loss of the second epitope required for recognition by the sandwich ELISA.
(Gluten Free Watchdog’s opinions are more fully explained here: 1.) “Does Wheat Starch Belong in a Gluten Free Diet?” 2.) “What the FDA Has to Say about Wheat Starch and Hydrolyzed Gluten” and 3.) “Wheat Starch in Gluten-Free Foods in 2023: An Update from Gluten Free Watchdog”.)
Defining Gluten-Free and Celiac-Safe
What is “gluten-free”?
Unfortunately, the FDA set a legal definition for “gluten-free” labeling that essentially means a low gluten content that is <20 parts per million (ppm) of gluten. It does not mean that there is no gluten in the product or that it is safe for individuals with celiac disease or other gluten-related disorders to consume.
This threshold was based on a study that evaluated the effects of gluten at 0, 10, and 50 mg per day. Sadly, this study is often referenced and misquoted in published articles and studies claiming that the study demonstrated that 10 mg of gluten was “safe” for individuals with celiac disease and thus justified the <20 ppm threshold. In reality, the study authors were quoted as stating, “These results confirm that an abnormal small-bowel morphology persists in a significant proportion of CD patients treated with a GFD, despite full resolution of their symptoms…” and “because of the limited number of patients, we were not able to reach firm conclusions about the potential toxicity of 10 mg gluten/d, which remained a “gray” area.”
Why did the FDA set the gluten threshold at “<20 parts per million” (i.e., milligrams of gluten per kilogram of food)?
In the Thresholds Report, as well as in the proposed rule, FDA noted that the Agency’s decisions in setting a threshold for gluten would require consideration of factors, such as ‘‘ease of compliance and enforcement, stakeholder concerns (i.e., industry, consumers, and other interested parties), economics (e.g., cost/benefit analysis), trade issues, and legal authorities’’ (Ref. 1 at p. 45 and 72 FR 2795 at 2800).– Food and Drug Administration
One might argue that profits were prioritized over the health of people with celiac disease.
what is “celiac-safe”?
The FDA determined that 0.01 ppm (0.011 mg of gluten per day) was “the lowest gluten and most conservative [Level of Concern] (LOC) value associated with a [Tolerable Daily Intake Level] (TDI) that was estimated to (1) Be protective of the vast majority of individuals with celiac disease ages 1 year and older, including those most sensitive to gluten and (2) not cause clinical, morphological, and/or physiological adverse health effects.”
Why This Matters
The disparity between the legal threshold and what was considered to be safe for those with celiac disease is alarming.
In a recent mass transglutaminase autoantibodies (TGA) screening for celiac disease in 9,973 children, study results show that approximately 70% of those identified were asymptomatic. As previously demonstrated in other studies, this confirmed that symptoms, or lack thereof, did not correlate with serological test results in spite of clear evidence of the presence of active celiac disease.
Studies indicate that patients inadvertently consume vastly more gluten than what has been determined to be safe for individuals with celiac disease to consume and that there is evidence of inadvertent consumption of gluten in a significant number of patients despite reporting adherence with a “gluten-free” diet.
Most concerning are the findings of the largest study of it’s kind regarding the long-term health outcomes and mortality risk in 49,829 patients with celiac disease. Despite diagnosis and access to a “gluten-free” diet, patients were found to have a significant risk of early death due to cancer, cardiovascular disease, and respiratory disease, such as pneumonia.
This discrepancy in our food labeling laws is why we should all be contacting our state and federal legislators to request that they lobby on behalf of the celiac community to implement food labeling laws that provide us with “informed consent” and a gluten threshold that actually protects us all – as has been done in Australia and New Zealand.
Regardless of whether or not a gluten-free or certified gluten-free label is present, to avoid unintentional development of a number of symptoms and conditions associated with celiac disease, ZERO For Life does not recommend individuals with celiac disease consume products containing any gluten-containing ingredient (i.e., Wheat, Barley, or Rye), including “gluten-free” wheat starch, in amounts above 0.01 ppm (0.011 mg of gluten per day).
We have one life to live. Let’s make choices that help us live as healthy as we can for as long as we can.