gluten free aisle

FDA open for comments on gluten-free labeling

Last week, the FDA reopened a comment period for anyone to submit evidence, information, or thoughts on the proposed definition and labeling for gluten-free foods—a long overdue but welcome step forward for gluten-free manufacturers and consumers. Here’s how to add your voice to the FDA’s process.


After years of delay by the FDA on establishing a definition of gluten free, there's finally hope on the horizon: Last week, the FDA opened a 60-day comment period on a proposed "gluten-free" food-labeling rule.

During this timeframe, consumers, scientists, manufacturers and anyone else with an interest in gluten-free definition, labeling and testing standards can submit comments and suggestions electronically or by mail, the first step in the FDA's process to create and establish a uniform, scientifically based definition for gluten free.

The current gluten-free situation

People with celiac disease or gluten sensitivity cannot tolerate gluten, a protein in wheat, rye, and barley, as well as their derivatives; and this common "allergen" is widely used in foods and other products, hidden under various names. Current gluten-related label claims range from "no gluten ingredients used" to "free of gluten," "no gluten," "made in a gluten-free facility," and more. No wonder shoppers are confused. Given how prevalent gluten has become in the food supply and the rise of gluten-related symptoms in both children and adults, the clamor for reliable, government-approved testing and labeling standards has steadily increased.

Alfalfa's gluten-free section. Photo by Glenn Asakawa.Independent agencies have devised their own certifications to help gluten-free consumers easily identify packaged foods that are safe to eat. But the gold standard remains an FDA gluten-free label, so gluten-free advocates are rejoicing that the agency is finally moving forward on this important health issue. According to the FDA news release, the proposed rule conforms to a 2008 standard, which requires that foods labeled "gluten free" contain no more than 20 parts per million (ppm) gluten.

Twenty-seven countries have already adopted these regulations.

"It's encouraging to see the FDA taking action on gluten-free labeling after four years of delay," says Alice Bast, founder and president of the National Foundation for Celiac Awareness (NFCA). "We now have a solid timeline for establishing a [gluten-free] threshold by the third quarter of 2012. There is light at the end of the tunnel for gluten-free consumers!"

What does the comment period seek to accomplish?

Before finalizing its definition, the FDA's comment period "is a call to action for scientists, consumers, and manufacturers to share all they know so that the

FDA can consider all relevant evidence to make an informed ruling," says Rachel Begin, RD, NFCA advisory board member and blogger at "I urge both consumers and manufacturers to make their voices heard. Take the time to read and thoroughly understand the docket and then submit your thoughts to the FDA so they have the information they need to enact a labeling rule that is relevant and protects gluten-free consumers."

How to participate in the process

You've got 60 days to add your comments, whether scientific, personal or professional. Go to, click "Submit a Comment" and enter the docket number FDA-2005-N-0404 in the "Keyword" space; then click "Search." Click on the Title of the docket to read it; then click "Submit a Comment."

Or send a letter to:

The Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Include docket number FDA-2005-N-0404 on each page of your written comments.


Photo by Glenn Asakawa.

TAGS: Regulatory
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