How Honest Are Gluten Free Food Claims?

GlutenFreeImage courtesy Foodio / Dreamstime.comIf you have been to the market or out to eat in recent days you will have surely noticed that “Gluten Free” foods are popping up everywhere.

What began as a marginal movement among people with severe gastrointestinal problems has grown to become one of the biggest trends in the food industry. According to , sales of Gluten Free products have already topped $7.59 billion market annually, and all signs point to continued growth.

To be sure, there’s plenty of nonsensical marketing hype in the GF food sections of the nation’s grocery stores. But there is also considerable science to support the idea that in some people, gluten adversely affects the gut-brain connection and the GI microbiome; and that celiac disease and non-celiac gluten sensitivity are associated with a host of autoimmune diseases, inflammation and joint pain, and neurological issues like anxiety, depression, ADHD, bipolar disorder and schizophrenia.

There’s no lack of anecdotal evidence that for many people, elimination of gluten-contaning foods leads to better overall health and wellbeing. Just ask your patients who’ve tried it.

But with so many food manufacturers, restaurant chains, and even personal care companies jumping on the GF bandwagon, we need to ask ourselves an important question: Can we trust that GF products are truly “Gluten Free”?

No Longer Rare

For those new to the discussion, gluten is a form of protein found naturally in wheat, barley, rye, triticale (a wheat hybrid) and other grains related to wheat. While not inherently problematic for many people, gluten can wreak havoc on the health of those with celiac disease.

According to the Celiac Disease Foundation (, one in every 100 people suffers from celiac. That’s roughly one percent of the population. The actual number may be far higher, because an estimated 83% of people that suffer from celiac go undiagnosed or mis-diagnosed for many years.

Gluten can also cause problems for individuals with wheat allergies, and also for those deemed gluten intolerant or gluten sensitive. Wheat is one of the eight most allergenic foods next to milk, shellfish, peanuts, tree nuts, fish, and soy.

In 2004, The Department of Health and Human Services was directed under The Food Allergy and Consumer Labeling Act, to define “Gluten Free” for purposes of labeling packaged foods to ensure consumer safety and to establish a level of confidence for those needing to avoid gluten.

The 20 ppm Threshold

In 2007, the Food and Drug Administration (FDA) published a proposed rule defining the term “Gluten Free,” and began working closely with the scientific and medical communities, as well as celiac advocacy groups to establish safety standards and acceptable levels of gluten exposure.

On August 5, 2013, the FDA issued the final rule defining “Gluten Free” for purposes of voluntarily labeling and marketing packaged food products and dietary supplements. Manufacturers were given a one-year grace period in which to comply with the new standards.

According to the FDA, “Gluten free is defined as the food being either inherently gluten free; or does not contain an ingredient that is: 1) a gluten-containing grain (e.g., spelt wheat); 2) derived from a gluten-containing grain that has not been processed to remove the gluten (e.g., wheat flour); or 3) derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch) if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food. Also any unavoidable presence of gluten in the food must be less than 20 parts per million (ppm)”.

Labels that state, “Made with Gluten Free ingredients” or “Does not contain gluten” do not qualify as GF unless the company can prove that the product meets the guidelines established under the rule. The rule does not cover products that fall under the Tobacco Tax and Trade Bureau, or products regulated by the US Department of Agriculture, though the FDA is working with the both the USDA and the TTB to ensure a consistent message regarding GF labeling.

What is the significance of 20 ppm?

With the help of the scientific and medical communities, FDA established a threshold for an allowable presence of gluten in packaged foods. Although trace amounts of gluten as low as 5ppm and 10ppm had been suggested, officials determined that 20 ppm was the smallest amount that could be accurately verified and not be deemed unsafe for those highly sensitive to gluten. This equates to no more than roughly 50 mg per day.

Truth in Labeling

During the period of July 2015 to August 2016 the FDA tested 702 samples from 250 food products labeled “Gluten Free”. They found that 99.5% of the products were in compliance with the rule. Only one product out of the 250 was not. That product was voluntarily recalled, the root cause of the contamination assessed, and ultimately corrected.

The results of the sampling are both impressive and encouraging. Assuming one agrees that 20 ppm is an acceptable threshold, the report offers considerable credibility to the term “Gluten Free,” and a strong measure of security to those who must avoid gluten.

But anyone concerned about gluten should also be aware that a manufacturer’s decision to label a food as GF is entirely voluntary. Companies in the burgeoning GF space are largely self regulated. They are not required to test their products for compliance or provide documentation to the FDA, though they are responsible for ensuring that their products meet the requirements under the rule.

Manufacturers can insure compliance either through obtaining assurances or certifications from the suppliers of their raw materials or through doing their own product testing.

The other problem with the current labeling regulations is that any packaged food product—even if it is inherently gluten free such as oatmeal or bottled water-- can be labeled as GF for marketing purposes. This can create a lot of confusion for consumers.

The FDA does not support or endorse any GF certifying entity or lab, nor does it endorse any particular symbol denoting a product is GF.

That said, it seems the agency does take the gluten issue seriously. The FDA’s website states that the administration uses “a full-range of post-market monitoring activities to enforce the rule such as sampling, periodic inspections of food manufacturing facilities, food label reviews, consumer and industry complaints and when necessary gluten analyses of food samples.”

Consumers who have adverse reactions to GF-labeled products, or have reason to believe such a product actually contains gluten, are encouraged to notify the FDA as soon as possible.

The reality is that GF foods can be easily contaminated at any point along the trajectory from seed to shelf. It is heartening to know that the vast majority GF food makers are doing all they can to ensure their products reach market without contamination.

While the FDA’s report indicates that consumers can feel confident in GF-labeled products, it is important to remember that an individual’s reaction to gluten is highly variable. Some people will react to trace amounts of gluten. For most of these people, packaged foods—even those labeled GF—will be problematic. In these cases, whole foods and home-prepared meals are always going to be the best option.



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