The Gluten-Free Label and Gluten Sensitivty

A Gluten-Free Product that has been processed to removal Gluten
A Gluten-Free Label

The Gluten-Free Label

In 2013, the FDA created a regulation defining “gluten-free” as it pertains to food labeling. This regulation is the primary source of legal authority governing manufacturers who label their food products as gluten-free. While this rule has undoubtedly helped those with celiac disease select food unlikely to cause much maligned health consequences, the rule is still imperfect, if not complete.  This is because research and published material continue to highlight the adverse health consequences gluten consumption has on those without celiac—i.e., those with gluten sensitivity or gluten intolerance.  Thus, the gluten-free label as it stands today is not the be-all-end-all, and consumers should remain scrupulous when buying gluten-free products containing trace amounts of gluten.

To further explain this, lets look at the wording of the FDA’s regulation.

The Regulation: 21 CFR 21. Part 101. Section 101.91—Gluten-free labeling of food

Gluten (meaning glue in Latin) is a protein composite that acts as an adhesive material to hold flour together to make a variety of bread-like products.  This protein tends to cause many issues for those with celiac disease—a chronic inflammatory disorder of the small intestine—and the FDA proposed and adopted a rule clarifying which products manufacturers could label as gluten-free to help those with celiac.

The rule is found in Title 21 of the Code of Federal Regulations, Part 101, Section 101.91.  After a brief statement of definitions, the rule explains what is meant by gluten-free. Unsurprisingly, any food bearing the label cannot contain an ingredient that is either a gluten-containing grain (e.g., spelt wheat) or and ingredient that is derived from a gluten-containing grain and that has not been processed to eliminate the gluten (e.g., wheat flour).  The final clause, however, is the one of interest.  It states that Gluten free means a food that does not contain the following: “An ingredient that is derived from a gluten-containing grain and that has been processed to remove gluten . . . if the use of that ingredient results in the presence of 20 parts per million (ppm) or more of gluten in the food.” In other words, a gluten containing food can still bear the gluten-free label as long as the presence of gluten is below 20 ppm gluten.

The FDA chose 20 ppm as the cut-off because this level has been shown to be safe for people with celiac—as established in a 2007 study.  This is also the standard adopted adopted in the European Union.  While limiting gluten to this threshold does not cause inflammation in the small intestine that affects people with celiac, it may still pose a problem for those who have a gluten-sensitivity.

Gluten Sensitivity is Different than Celiac Disease and Regulatory Interpretation

A food sensitivity is a response from the immune system and someone is “gluten-sensitive” if they react to gluten with a perceptive inflammatory response.  This category of individuals is much larger than the celiac population, and this group should be skeptical of a gluten-free label because the FDA’s regulation is only concerned with gluten as it relates to those with celiac.

This can be gleaned by taking a textual approach (relying on the regulation’s text alone) in interpreting the regulation[1] and looking at how the FDA defines the term gluten: “[T]he proteins that naturally occur in a gluten-containing grain and that may cause adverse health effects in persons with celiac disease.  There is no mention of gluten as it pertains to those without celiac.

Additionally, interpreting the text in light of the regulation’s statement of basis and purpose confirms the FDA was only concerned with gluten vis-à-vis celiac disease.[2]  In the “purpose of the rule” section, the FDA states that this rule is necessary “to ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information. . . .”  Again, there is no mention of gluten-sensitive individuals in the FDA’s purpose of the rule statement; only a preoccupation with Celiac-inflicted consumers.

As this analysis illustrates, the FDA was not concerned with non-celiac consumers, so that label shouldn’t confer a health halo upon gluten-free foods that have been processed to remove gluten.[3]  As one commentator states, we know “very little about non-celiac gluten sensitivity, [so] we can’t yet determine what a safe level for that population is for that population without further studies.”[4]  While we may know very little about gluten sensitivity compared to celiac disease, there is still enough evidence to suggest many of us are gluten-sensitive, and so, need to be cautious when buying gluten-free products.  The remainder of this article is devoted to explaining some common issues with consuming gluten for the non-celiac.  My goal is to inform the most conscientious consumer to think twice before buying a product once tainted with gluten, but subsequently removed through processing, so that they may either stay away from that product completely or at the very least make a fully informed decision when buying.           

Why Should We Avoid Gluten

            The book Grain Brain, David Perlmutter’s New York Times bestseller, concisely summarizes the research looking at gluten and its effect on our body and brain.  The biggest concern is the potential for neurological decline and inflammation in places other than the small intestine—the type of inflammation that occurs in those with celiac.  Researchers have drawn the following conclusions:

  • “Gluten sensitivity is common in patients with neurological diseases of unknown cause and may have etiological significance.”[5]
  • Gluten interferes with the body’s neural networks and is linked to neurological harm in patients with and without evidence of celiac disease.[6]
  • “People with celiac have significantly increased production of free radicals, and they exhibit free radical damage to their fat, protein, and even DNA.”[7]
  • “[T]he immune system’s reaction to gluten leads to activation of signaling molecules that basically turn on inflammation and induce what’s called the COX-2 enzyme, which leads to increased production of inflammatory chemicals.”[8]
  • “Gluten sensitivity—with or without the presence of celiac—increases the production of inflammatory cytokines, and these inflammatory cytokines are pivotal players in neurodegenerative conditions.”[9]

As these bullet points illustrate, non-celiac consumers need to be wary of eating gluten.  With such grave consequences documented in the scientific literature, relying on an FDA regulation that only addresses gluten in the context of celiac disorder is unadvisable.

I hope this post draws attention to the mono-focused FDA rule and allows the consumer to tread carefully when deciding to buy a gluten-free product, which may still contain trace amounts of gluten.[10]




[1] While courts have not developed a consistent approach to regulatory interpretation, decisions sometimes rely on the regulations text. See e.g., Chase Bank USA, N.A. v. McCoy, 131 S. Ct. 871, 880 (2011) (concluding a phrase in a regulation was ambiguous because the “text alone does not permit a more definitive reading.”).

[2] See Generally, Kevin M. Stack, Interpreting Regulations, 111 Mich. L. Rev. 355 (arguing that courts should take a purposive approach when interpreting agency regulations, which consists of looking at the regulation’s statement of basis and purpose or preamble); See also Secretary of Labor, Mine Safety & Health Administration ex rel. Bushnell v. Cannelton Industries, Inc., 867 F.2d 1432, 1438 (D.C. Cir. 1989) (J. Ginsberg) (agreeing with agency interpretation because, in part, it was “fully consonant [with the] administrative history and purposes.”

[3] A health halo causes consumers to overestimate the healthfulness of the Natural food item See John Tierney, Health Halo Can Hide the Calories, N.Y. Times, Dec. 2, 2008, at D1; 5 Most Confusing Health Halo Food Terms, Health, (last visited May 13, 2016).


[5] Perlmutter, Grain Brain, 52 (citing Marios Hadjivassiliou, et al., “Does Cryptic Gluten Sensitivity Play apart in Neurological Illness?” Lancet 347, no. 8998 (February 10, 1996): 369-371.

[6] Perlmutter, 60 (citing Rodney P. Gord, “The Gluten Syndrome: A Neurological Disease,” Medical Hypotheses 73, no. 3 (September 2009): 438-40.

[7] Perlmutter, 60 (b citing Gianna Feretti, et al., “Celiac Disease, Inflammation and Oxidative Damage: A Nutrigenetic Approach,” Nutrients 4, no. 4 (April 2012): 243-257.

[8] Perlmutter, 62 (citing Gianna Feretti, Ibid).

[9] Id.

[10] There may also be issues with gluten-free products because of the fillers and additives used to supplement the absence of gluten. These fillers can spike your blood sugar enormously, which can cause a host of other medical issues.


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