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FDA Has Yet To Finalize Rules for Gluten-Free Food Labels

By , About.com Guide

Updated October 23, 2011

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The U.S. Food and Drug Administration 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.

Despite the uncertain regulatory climate, manufacturers that label their foods "gluten-free" seem to be following the FDA's proposed rules on what can — and can't — be labeled gluten-free.

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). Those disclosures began in 2006. The law also requires the FDA to establish rules for gluten-free labeling.

The agency issued proposed rules in 2007 that defined "gluten-free" as containing less than 20 parts per million (ppm) of gluten. For products labeled gluten-free, those proposed rules also would:

  • prohibit wheat, barley and rye as ingredients, and
  • allow ingredients derived from gluten grains if the ingredient in question has been processed so that it contains less than 20 parts per million

In addition, the proposed rules would allow gluten-free labels on foods that are naturally gluten-free (such as pure naturally gluten-free grains) as long as their labels also included a statement that all foods of that type are naturally gluten-free (i.e., "all millet is gluten-free").

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

There's some speculation that the FDA intends to finalize its gluten-free labeling rules by the end of 2011. In the meantime, manufacturers seem to be honoring the proposed 20ppm standard.

However, if you're particularly sensitive to trace amounts of gluten, remember that the FDA's proposed definition still allows tiny amounts of gluten in gluten-free foods, and it's still possible to get gluten symptoms from labeled gluten-free foods.

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