FDA Sets 'Gluten-Free' Labeling at 20 Parts Per Million

FDA gluten-free rules
FDA rules defining the term 'gluten-free'. U.S. Food and Drug Administration

You might think the official definition of a "gluten-free food" would be "a food that's 100% free of gluten." But if you did think that, you'd be wrong: The U.S. Food and Drug Administration (FDA) defines "gluten-free" foods as those containing less than 20 parts per million (ppm) of gluten.

No, that's not zero, even though it's still a tiny amount.

Some clinicians argue that it's effectively zero, since research has shown that some people with celiac disease can eat foods with up to 10 milligrams of gluten in them per day without experiencing symptoms. (Read more about this here: How Much Gluten Can Make Me Sick?)

Other advocates within the gluten-free community (me included) argue that the FDA should have required "no detectable gluten" as its standard, since plenty of people get sick at levels well below 20 parts per million. However, "undetectable" was dismissed as being too difficult to accomplish for the large and influential food manufacturers seeking to target the growing gluten-free market.

Under the FDA's rules, manufacturers legally can label a food "gluten-free" even if that food contains an ingredient that's made from wheat, barley or rye (or a crossbreed from those grains) as long as the ingredient has been processed to remove the gluten down to below that 20 parts per million level.

Are Manufacturers Following the Rules?

As of the day the rules were announced in August 2013, the FDA said that most manufacturers — 95% or more — already were following the rules. Product testing by the group Gluten Free Watchdog indicates that the vast majority of "gluten-free"-labeled products on the market remain in compliance with the FDA 20 parts per million standard.

The labels are voluntary, not mandatory — manufacturers that wish to cater to gluten-free consumers can add the labels to their packaging, but they aren't required to do so. The labels don't eliminate the need for us to learn to identify gluten on food labels, either, since the FDA's rules don't require manufacturers to disclose gluten-containing ingredients.

If you're particularly sensitive to trace amounts of gluten, remember that the FDA's definition still allows tiny amounts of gluten in gluten-free foods, which means it's still possible to get gluten symptoms from foods labeled as gluten-free. You're still responsible for knowing your own tolerance and monitoring your own reactions.

History of the FDA's Gluten-Free Label Rules

The FDA first proposed rules to govern gluten-free labeling in 2007. In August 2011, the agency reopened the public comment period on the regulations and announced plans to resume work on the regulations, and in February 2013, the FDA wrapped up its work on the gluten-free regulations and sent the final version on for further regulatory review.

The Food Allergen Labeling and Consumer Protection Act of 2004 requires manufacturers to disclose on food labels the presence of eight major allergens (including wheat, but not barley or rye). Those disclosures began in 2006. The law also requires the FDA to establish rules for gluten-free labeling.

The agency's proposed rules in 2007 defined "gluten-free" as containing less than 20 parts per million.