Nutrition-wise blog

FDA defines 'gluten-free'

By Jennifer K. Nelson, R.D., L.D. and Katherine Zeratsky, R.D., L.D. August 21, 2013

At long last, the Food and Drug Administration has issued the final rule that defines what foods may carry the term "gluten-free" on their packaging. This is good news for the 3 million people in the U.S. who have celiac disease and others with gluten sensitivity.

In order to use the term "gluten-free" on a food label, the food must meet the following requirements:

  • The food is inherently gluten free (like fresh fruit or raw vegetables)
  • It does not contain an ingredient that is a gluten-containing grain (such as wheat, spelt wheat, rye or barley)
  • It does not contain an ingredient derived from a gluten-containing grain that that has not been processed to remove gluten (such as wheat flour)
  • It does not contain an ingredient derived from a gluten-containing grain that has been processed to remove gluten, but that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food
  • It does not contain any unavoidable presence of gluten in the food in amounts of 20 ppm or greater

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.

It's important to note that this rule holds true for look-alike claims appearing on labels, such as "without gluten," "free of gluten" or "no gluten." These terms will be interpreted to also mean "gluten-free." The rule applies to food products imported from other countries — so imported food products bearing the "gluten-free" claim must meet the above criteria. It also applies to dietary supplements.

Unfortunately, the new rule does not cover foods regulated by the U.S. Department of Agriculture (meats, poultry, certain eggs) or beverages regulated by the Alcohol and Tobacco Tax and Trade Bureau (alcohol, distilled spirits, wine, beer). However, the FDA will work with these agencies to ensure that labels for these products will follow suit. Likewise, the FDA is working internally on regulatory efforts to disclose gluten-containing ingredients in drug products.

Manufacturers will have one year to bring package labels into compliance. Thereafter, any food product containing the words "gluten-free" on its label that does not meet the criteria would be deemed misbranded and subject to regulatory enforcement.

I think this is good news and a step in the right direction. Thoughts?

- Jennifer

Aug. 21, 2013