Nutrition-wise blog

Defining 'gluten-free' — Is it all or nothing?

By Jennifer K. Nelson, R.D., L.D. and Katherine Zeratsky, R.D., L.D. September 14, 2011

In August the Food and Drug Administration (FDA) reopened the comment period for the proposed rule on the term gluten-free on food labels. This extension is your last chance to comment before the rule is adopted.

The FDA proposes to allow use of the term gluten-free for foods that do not contain any of the following:

  • An ingredient that is a species of wheat, rye, barley or a crossbred hybrid of these grains
  • An ingredient derived from these grains that has not been processed to remove gluten
  • A processed ingredient derived from these grains that adds 20 parts per million (ppm) or more of gluten
  • Any food containing 20 ppm or more of gluten

It may seem contradictory for the agency to say that a food that contains gluten — even less than 20 ppm — is gluten-free. However, analytical methods are not available that can reliably detect lower levels of gluten.

In addition, this level was vetted by an expert panel that examined existing research to determine a "safe" level — the point at which no or few adverse effects occur. It's also important to note that 27 other countries currently use this level. Finally, the FDA has said that it's open to revising the standard in future if more sensitive methods are developed for determining gluten levels.

Some people might be tempted to discount the proposed rule because they feel no amount of gluten is acceptable in a food labeled as gluten-free. However, not adopting some set of criteria means that people with celiac disease will remain in the dark when trying to interpret food labels. Claims such as "made on equipment that shares processing with wheat" or ingredient names such as "wheat starch flour" are confusing and don't provide meaningful guidance.

For those with celiac disease it is critical to have foods with the lowest possible amount of the offending grain — preferably none. Defining gluten-free in a realistic and enforceable way is a good first step.

What are your thoughts? Share them with FDA now — the link appears in the reference list.

- Jennifer

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Sep. 14, 2011