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The “Gluten Free” Market: Trends, Label Claims, and Regulatory Guidance: Everything You Need to Know

Updated: Feb 11, 2022

According to Food Business News, sales of “gluten free” foods have exploded over recent years, into a $9 billion dollar market in 2014. It is estimated that within the next three years these numbers will increase by 60%.[1] Why are so many people going gluten free? Recent reports claim that diets high in gluten are linked to diseases such as depression, anxiety, arthritis, autism and obesity[2]. Also, recent polls also show that a high percentage of people think that following a gluten-free diet would improve their physical or mental health.[3] For these aforementioned reasons, consumers are being more aware of gluten and gluten free options.

Gluten is a structural protein complex composed of gliadins and glutenins, and gluten occurs naturally in barley, rye and wheat. This protein complex is used in the production of many foods due to its ability to hold foods together in a palate pleasing way (Sapone et al., 2012). Some naturally gluten-free foods include fresh eggs, beans, seeds and nuts (unprocessed form), fruits and vegetables, most dairy foods, fresh non-breaded meats, fish and poultry. Some of the manufactured foods that contain gluten are: baked goods, soups, pasta, cereals, sauces, salad dressings, food coloring, malt vinegar, candies and beer.[4]

Gluten free has been associated with a healthier lifestyle, but a gluten free diet (a diet that excludes gluten) only really benefits those that have celiac disease (CD) or non-celiac gluten sensitivity (NCGS). CD is a hereditary autoimmune disorder where the ingestion of gluten leads to damage in the small intestine. Ingestion of gluten in those with CD causes the body to mount an immune response that attacks the small intestine, leading to damage on the villi and decreasing nutrient absorption. [5] According to a collaborative report by Sapone et al., 2012, NCGS, also an immune response, shares many symptoms with CD , however, individuals have a prevalence of extra-intestinal issues such as headache, “foggy mind,” joint pain, and numbness in the legs, arms or fingers. These symptoms appear hours and even days after the ingestion of gluten triggering an innate immune response.[6]People that have CD or are non-celiac gluten sensitive, must always be cognizant that the foods they choose to consume are labeled as “gluten-free”. Consumers should check the ingredients list and or, if there is any doubt call manufacturers in order to keep themselves informed on products safe for them to eat.

Although gluten free in general has been associated with a healthier lifestyle, those following a gluten free diet should be aware that lack of gluten in the body may discourage beneficial bacteria in the gut; therefore, people that are on gluten free diets are encouraged to consume gluten free probiotic-containing products. Interestingly, recent testing performed by the Celiac Disease Center at Columbia University Medical Center (CUMC) using liquid chromatography-mass spectrometry found that more than half of the top selling probiotics (12) contained traces of gluten (less than 20 parts per million which would be considered gluten-free by the Food and Drug Administration (FDA).[7] However, four of the brands (18 percent of the total) contained in excess of that amount and two of the brands using the claim of gluten free were in the excess the 20 parts-per million (ppm), the limit set by the FDA.[8] Companies and brands must always be careful that any claims used on a product follow the guidelines and parameters set by the FDA.

In 2013, the FDA issued a regulation that defined “gluten free” for food labeling. This regulation provided consumers the guarantee that the gluten free food they purchased was indeed gluten free. Gluten free is a claim that is used by manufacturers voluntarily, but if it is used, it must conform to the FDA regulation of less than 20 ppm gluten. Manufacturers may label their products as “gluten free”, “free of gluten”, “no gluten” and “without gluten” if their product has less than 20 ppm gluten, which is the lowest level that can be detected consistently. Before this regulation was implemented, consumers had no guarantee that the food they purchased, and thought was gluten free, conformed to a specific level. [9]

According to the regulation, a “gluten free” claim is not required to be in any specific location on the food label. The claim can be used on foods that are manufactured to be gluten free or are naturally free of gluten. Manufacturers are not required to add a gluten free claim to foods, however, when they do add the claim, it cannot interfere with any mandatory labeling information and the product must meet the gluten free regulatory requirements. A “gluten free” certification logo can be used, however, the FDA does not endorse, accredit or recommend any third party certification program.

August of 2014 was the deadline for manufacturers to make changes to their formulations and labeling for their foods in order to make a gluten-free claim and bring their labels into compliance. Currently, manufacturers that fail to meet the requirements set by the FDA will be subject to regulatory action.

[1] Food Business News February 24, 2015.

[2] Nash, D.T. and Sluzky, A.R. (2014) Gluten sensitivity: new epidemic or new myth? Baylor University Medical Center Proceedings, Volume 27, Number 4

[3]Consumer Reports.  “6 Truths about a gluten free diet.” November 2014.


[2] Nash, D.T. and Sluzky, A.R. (2014) Gluten sensitivity: new epidemic or new myth? Baylor University Medical Center Proceedings, Volume 27, Number 4

[3] Consumer Reports.  “6 Truths about a gluten free diet.” November 2014.

[4] Mayo Clinic. “Nutrition and Health Eating: Gluten Free Diet.”

[6] Celiac Disease Foundation. “What is Celiac Disease?”

[7] Humans are born with an innate immune system. An innate immune response is not antigen specific, meaning that it is nonspecific as to the type of organism it fights. Although its response is immediate against invading organisms, the innate immune system does not have an immunological memory to invading organisms. Its response is not directed towards self-tissue, which would result in autoimmune disease; <<>>.

[8] The Food and Drug Administration. “Gluten and Food Labeling.” Page Last Updated: 05/27/2015

[9] New Hope Media. Engredea News & Analaysis. “Many probiotics tested contaminated with gluten.” May 18, 2015.

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