Going Gluten-FreeAugust 7, 2013

Understanding FDA's New Gluten-Free Rule

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Posted by Alicia Woodward

The FDA announced its gluten-free labeling rule last Friday, August 2nd. Thrilling news for the gluten-free community, the announcement has elevated awareness about celiac disease and the gluten-free diet to new heights.

We now have a gluten-free standard. But what does the rule mean? What exactly does it offer you? The American Celiac Disease Alliance offers this practical explanation:


Consistency By August 2014, all products labeled “gluten-free” will contain less than (<) 20 ppm of gluten. 

Clarity No more guessing if “no gluten” or “free of gluten” means the same thing as “gluten-free.” It does.

Consumer-Friendly Product selection will take less time, because consumers know that “gluten-free” on a label can mean just one thing: The product contains less than (<) 20 ppm.

Confidence Gluten-free consumers will have clear information to make safe food choices.


5 Key Facts About the Gluten-Free Labeling Rule

1. Products labeled gluten-free must contain less than 20ppm. This includes food products regulated by the FDA, either made in or imported to the United States. Dietary supplements are also covered. The effective date for compliance is August 5, 2014.

Not covered:

  • Food under USDA’s jurisdiction, meat, poultry, and certain egg products are not covered. 
  • Distilled spirits or wines with 7 percent or more alcohol by volume* are not covered.
  • Malted beverages made with malted barley and hops* are not covered.
*These items are regulated by the Bureau of Alcohol and Tobacco Tax and Trade Bureau (TTB), which provided guidance on the labeling of such beverages. FDA will be working with both USDA and TTB to harmonize their respective labeling requirements.

2. Food manufacturers will not be required to test their products. They are responsible for ensuring that the food product meets all labeling requirements.

3. The rule is voluntary. A manufacturer may opt-out of labeling a product gluten-free even if it doesn’t contain gluten.  

4. A label which reads “no-gluten,” “free of gluten,” or “without gluten” will be interpreted to mean “gluten-free” and is subject to the labeling rule.

5.  It is unclear how the new regulation will affect restaurants that make gluten-free claims on their menus. In its rule summary, FDA “suggests that any use of an FDA-defined food labeling claim (such as “fat free” or “low cholesterol”) on restaurant menus should be consistent with the respective regulatory definitions.” The American Celiac Disease Alliance has asked FDA for clarification on this point and will report that information on its website (americanceliac.org) as soon as it is available.

For the actual text of FDA’s gluten-free ruling, click here.

Living Without is a proud member of the American Celiac Disease Alliance (ACDA), which serves as the unified voice of the celiac community. ACDA initiated and led the advocacy efforts which produced two historic achievements for the celiac community: Passage of the Food Allergen Labeling and Consumer Protection Act and FDA’s Gluten-Free Labeling Regulation. We thank the ACDA for these momentous achievements!

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