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Before the Official FDA Rule: Gluten-Free Food Labeling FAQs


Please note this FAQ was developed prior to the FDA's official rule on gluten-free labeling, which occurred on August 2, 2013.  For the most up-to-date information on the FDA ruling, visit www.CeliacCentral.org/FDA.

There's been a lot of talk about gluten-free food labeling in the celiac and gluten-free community. If it's thrown you for a loop, here's a quick background review on this important topic.

Why is gluten-free labeling such an issue?

For celiac and gluten sensitive individuals, the safety of gluten-free products is a major concern. Currently, there are no rules to dictate when or how food is labeled “gluten-free.” That means products that contain gluten could be incorrectly labeled as gluten-free.

For individuals with gluten sensitivity, consuming a product that contains gluten may cause mild or severe discomfort. For individuals with celiac disease, prolonged exposure to gluten can cause internal damage and lead to other health complications.

Since the gluten-free diet is the only treatment for celiac disease, access to gluten-free food is critical. Standardized labeling regulations can help those needing a gluten-free diet monitor their overall wellness. Without this guidance, gluten-free consumers may be putting their health at risk by purchasing food that is unsafe.

Shouldn’t a manufacturer know if there’s gluten in a product?

It’s not always that easy. Even if a product does not contain wheat, barley or rye, it still could contain gluten if it is processed on a line that also processes gluten products OR if it contains a gluten derivative like malt and brewer's yeast.

What is the FDA’s role in this?

The Food and Drug Administration (FDA) is the government body that regulates the sale of food and drugs in the U.S.

The Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 requires manufacturers to indicate when any of the top 8 food allergens are included in a product. While wheat is considered a top allergen, gluten is not. Therefore, manufacturer warnings about gluten are voluntary.

However, FALCPA also tasked the FDA with creating a standardized definition of gluten-free. While a proposed rule was published in 2007, a final rule was never enacted.

What’s happening now?

On Aug. 3, 2011, after releasing new studies on the subject, the FDA reopened the public comment period for the proposed gluten-free labeling rule. Gluten-free consumers, manufacturers, medical professionals, scientific experts, and other interested parties are invited to share their opinions about the proposed definition of gluten-free. Comments are being accepted through Oct. 3, 2011.

What did the FDA propose?

In summary, it is proposed that "gluten-free" means the food does not contain any of the following:

  • An ingredient that is a prohibited grain
  • An ingredient derived from a prohibited grain that has not been processed to remove gluten
  • An ingredient derived from a prohibited grain that has been processed to remove gluten, if 20 ppm (parts per million) or more gluten will remain in the food
  • 20 ppm or more gluten

Why 20 ppm?

Research indicates that 20 ppm is a safe level for the majority of individuals with celiac disease. It also is the accepted standard in many other countries and the World Health Organization. While many celiac and gluten-free consumers would prefer a level of zero ppm, current testing isn’t sensitive enough to confirm a level that low.

For additional information about 20 ppm, read Dr. Alessio Fasano's letter: In Defense of 20 Parts Per Million

How can I comment?

To be part of a unified response from the celiac and gluten-free community, sign 1in133.org’s Letter to the FDA. It’s a fast and easy way to make your voice heard. This response supports less than 20 ppm as the proposed definition of gluten-free.

If you’d prefer to submit your own comments, visit www.regulations.gov. Select “Submit a Comment,” enter the docket number FDA-2005-N-0404 in the “Keyword” space and then select "Search."

Alternatively, you can submit your comments to the docket by mail using the following address:  

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

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

For more FAQs, see 1in133.org’s Proposal Resources.

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