The Food and Drug Administration (FDA) estimates that about 5 percent of foods currently labeled "gluten-free" actually contain 20 parts per million (ppm) or more of gluten. That's about to change.
As of August 5, 2014, food manufacturers who wish to label foods "gluten-free" must comply with a new FDA rule that allow a food to be labeled gluten-free only if:
- It is inherently gluten-free.
- It does not contain an ingredient that is a gluten-containing grain (e.g., wheat, rye, barley) or a crossbreed of these grains.
- It does not contain an ingredient derived from a gluten-containing grain that has not been processed to remove gluten.
- It has less than the lowest detectable amount of gluten (20 ppm).
It may seem contradictory to say that a food that contains less than 20 ppm gluten is gluten-free. However, research shows that most individuals with celiac disease can tolerate this amount of gluten without adverse health effects.
The FDA rule also clears up the confusion often caused by advisory statements such as "made in a factory that also processes wheat products." If the label says "gluten-free," the food must meet the new criteria.
This also applies to imported food products and dietary supplements. Given the public health significance of gluten-free labeling, the FDA expects that restaurants with gluten-free claims on their menus will work to be consistent with the new criteria.
And there are consequences for companies that don't comply. A food labeled "gluten-free," "free of gluten," "without gluten" or "no gluten" that fails to meet the criteria will be considered misbranded and subject to regulatory action.
I welcome this latest development, along with the estimated 3 million other Americans with celiac disease who face potentially life-threatening illness if they eat gluten.
Aug. 15, 2014
- Questions and answers: Gluten-free food labeling final rule. U.S. Food and Drug Administration. http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm362880.htm. Accessed July 31, 2014.
- Summertime Spotlights: Gluten-free labeling. FDA/CFSAN News for Educators. http://emailtoweb.com/wp/2014/07/31/fdacfsans-news-for-educators-julyaugust-2014-summertime-spotlights/. Accessed July 31, 2014.