The words "Gluten Free" written on a black chalk board with a check box in front that has an "X" in it.

10 Facts About the FDA Gluten-Free Food Labeling Rule

The new FDA gluten-free labeling rule goes into effect today!

According to this new rule, when a manufacturer puts “gluten-free” on packaging, the item must comply with this FDA definition of the term – less than 20 parts per million (ppm) of gluten.

Foods that are gluten-free do not have to be labeled “gluten-free”, but any food product conforming to the less than 20 parts per million standard may be labeled “gluten-free,” even if it’s naturally gluten-free (i.e., water or fresh produce).

Below is a list of facts from The Celiac Disease Foundation regarding the rule.

1. What food products are covered by this rule?

  • All FDA-regulated foods
  • Dietary Supplements (vitamins, minerals, herbs, amino acids)
  • Imported food products that are subject to FDA regulation

Not Covered:

  • Meat, poultry and unshelled eggs (and any other products regulated by the USDA)
  • Distilled spirits and wines that contain 7% or more alcohol by volume*
  • Malted beverages made with malted barley or hops*

* These alcoholic beverages are regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB). The FDA says it will work with the TTB to “harmonize” gluten-free labeling requirements between the two agencies.

2. What food products may be labeled gluten-free?

A food product regulated by the FDA may be labeled gluten-free if:

A. It does NOT contain wheat, rye, barley or their crossbred hybrids like triticale (a gluten-containing grain) OR

B. It contains a gluten-containing grain or an ingredient derived from a gluten-containing grain that has been processed to less than 20 parts per million (ppm) of gluten.

3. May food products that are naturally gluten-free be labeled “gluten-free”, like bottled water or tomatoes?


4. May oats be labeled gluten-free?

Oats that contain less than 20 ppm of gluten may be labeled “gluten-free.” Oats do not need to be certified gluten-free.

5. Will there be a symbol to identify foods that meet the FDA definition of gluten-free?

No. The FDA has determined that consumers favor the label “gluten-free” to communicate that a food is free of gluten. Manufacturers are allowed to include a symbol as long as it is truthful and not misleading.

6. Are manufacturers required to test for gluten to label a product “gluten-free”?

No. Manufacturers are not required to test for the presence of gluten in ingredients or in the finished “gluten-free” labeled food product. However, they are responsible for ensuring that the food product meets all labeling requirements. Manufacturers will need to determine how they will ensure this.

7. How will the FDA enforce gluten-free labeling requirements after August 5, 2014?

The FDA may perform food label reviews, follow-up on consumer and industry complaints, and analyze food samples. Consumers and manufacturers may report a complaint to an FDA Consumer Complaint Coordinator in the state where the food was purchased.

8. Why did the FDA adopt < 20 ppm of gluten as the standard instead of zero ppm? Why does CDF support this?

The FDA adopted the standard based upon the recommendations of the scientific and medical communities, and because there are no analytical methods available that are scientifically validated to reliably detect gluten below 20 ppm. The CDF Medical Advisory Board supports the < 20 ppm of gluten standard for gluten-free labeling. According to Dr. Peter Green, director of the Celiac Disease Center at Columbia University, “The 20 ppm is a scientifically determined level of gluten that has been shown to be tolerated by those with celiac disease. It is in line with standards in other countries.”

9. Does this rule apply to foods served in restaurants?

The FDA suggests that restaurants and other retail food service establishments use the same definition for gluten-free. This is not a requirement.

10. What are the FDA and CDF doing about gluten-containing ingredients in medications?

The FDA’s Center for Drug Research and Evaluation (CDER) is reviewing the public comments it has received regarding options to limit gluten exposure from consumption of drug products.

Sourch: Celiac Disease Foundation


Milo graphic

Milo says….

Maizy’s rule is that I CAN NOT get on her bed. I have my own bed, though, and she gives me a SNACK when she says “It’s bedtime!” and I get in it. Rules are GOOD when snacks are involved!

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