The FDA's Gluten-Free Guidelines

The FDA's Gluten-Free Guidelines: Main Image
The FDA regulation stipulates that a food must contain less than 20 parts per million of gluten to be labeled 'gluten-free'

For the estimated 1% of people worldwide with celiac disease, completely avoiding the gluten protein found in wheat, rye, and barley is the only way to effectively manage the condition and prevent the damaging autoimmune response that occurs with gluten exposure. And it’s become increasingly popular to give the body a break from gluten for other reasons, with some people claiming to experience decreased inflammation in or finding the gluten-free eating model an easier way to limit carbohydrates.

It might seem like avoiding gluten is as easy as reading a few labels, but until 2013, the lack of a concrete “gluten-free” definition made that task complicated. Shedding much-needed light on the issue, the United States Food and Drug Administration released a new regulation in 2013 defining the term "gluten-free" for voluntary food labeling.

Not quite zero

The FDA regulation stipulates that in order to be labeled “gluten-free,” a food must contain less than 20 parts per million of gluten. Foods with the claims “no gluten,” “free of gluten,” and “without gluten” also must have less than 20 parts per million to meet the “gluten-free” definition.

Some in the celiac disease community are crying foul, because they only consider something truly gluten-free if it never had gluten in the first place. However, per the 2013 FDA definition, even foods and beverages that originally contained significant quantities of gluten can be labeled gluten-free, so long as they are processed to bring gluten levels in the final product down to less than 20 parts per million.

As an example of how this works, some breweries brew beer in the conventional way, using gluten-containing grains, then employ a process that removes the gluten from the finished beverage to bring the levels down to less than 20 parts per million. This beer is considered gluten-free per the FDA definition.

Why not zero?

The 20 parts per million definition is based on the scientific consensus that even people with celiac disease will not react to gluten at a concentration of less than 20 parts per million. However, if you want to keep your gluten exposure as close to zero as possible, stick to tried and true ways of avoiding it:

  • Read labels. With the 2013 rules, something labeled gluten-free may have begun with a gluten-containing ingredient. If you want to avoid foods that fall into this category, avoid items in the ingredient list with wheat, barley, and rye, and its many guises, such as bulgur, durum, faro, spelt, KAMUT wheat, gram flour, semolina, seitan, triticale, einkorn, and farina.
  • Identify possible culprits. Gluten can hide in a variety of items, including beer, lager, ale, soups, broths, flavored coffees and teas, medications, salad dressings, processed and lunch meats, seasonings, and sauces. Again, even if labeled gluten-free, these items may have begun life as a gluten-containing product, which was processed to meet the 20-parts-per-million rule.
  • Test it out. The 2013 definition is based on science, so it’s very likely you can eat any of the foods now labeled gluten-free without issue. If you want to do a trial run of the 2013 labeling criteria, slowly introduce a food or drink that originally was made with a gluten-containing grain, then brought down to less than 20 parts per million of gluten through final processing. Keep a detailed food and symptom record. If you notice a flare up of symptoms, you may need to stick with your original, gluten-free eating plan.

(Foods Labeled Gluten-Free Must Now Meet FDA's Definition. FDA [2014 Aug 5]. Available from URL:

Suzanne Dixon, MPH, MS, RD, an author, speaker, and internationally recognized expert in chronic disease prevention, epidemiology, and nutrition, has taught medical, nursing, public health, and alternative medicine coursework. She has delivered over 150 invited lectures to health professionals and consumers and is the creator of a nutrition website acclaimed by the New York Times and Time magazine. Suzanne received her training in epidemiology and nutrition at the University of Michigan, School of Public Health at Ann Arbor.

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