11 Useful Facts About the FDA Gluten-Free Labeling Rule


The FDA’s new rules governing the labeling of gluten-free foods and beverages was announced on August 2, 2013 and become fully effective tomorrow, August 5, 2014. According to the rule, when a manufacturer chooses to put “gluten-free” on food packaging, the item must comply with the new FDA definition of the term – less than 20 parts per million (ppm) of gluten. The purpose of the rule, according to the FDA, is to help consumers, especially those living with celiac disease, be confident that items labeled “gluten-free” meet a defined standard for gluten content. You can read more detail from the FDA here.

Since the new rules were published, there have been some questions about how exactly they will work and how they will affect gluten-free consumers, both celiac and those with gluten sensitivity. Below are 11 useful tips to help you navigate what it all means.

1. What food products are covered by the FDA gluten-free labeling rule?


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

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*
  • Cosmetics
  • Pet food
  • Prescription and non-prescription drugs
    * 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. After August 5, 2014, what food products may be labeled gluten-free?

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

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

2. 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. That means you may see the word “wheat” on the ingredient label of a “gluten-free” food, but it will be followed by a note stating that it has been processed to allow the food to meet the gluten-free requirements.

3. May food products that are naturally gluten-free be labeled “gluten-free”?

Yes. Food products that are naturally gluten-free, like bottled spring water or tomatoes, may be labeled “gluten-free” as long as they meet the <20 ppm requirement.

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. Any foods that are labeled with the words “gluten-free”, “no gluten”, “free of gluten” and “without gluten” must meed the new standards. Manufacturers are allowed to include a symbol of their choice 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? 

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. This standard is supported by numerous celiac disease organizations, including the Celiac Disease Foundation, the National Foundation for Celiac Awareness, and the Gluten Intolerance Group. 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.”

Dr. Alessio Fasano, of the Center for Celiac Research states, “Twenty parts per million, or 20 parts of gluten per one million parts of food sample, is an accepted standard in many parts of the world for products that are labeled gluten-free. The evidence-based research published by our Center, which has been confirmed by studies from colleagues around the world, conclusively supports the 20 ppm level as a suitable safety threshold for gluten-free products.” According to the Center’s website, “research from the Center has shown that 10 milligrams per day of gluten consumption is a safe level for the vast majority of individuals with celiac disease.” The Center’s website goes on to state that 10 milligrams is roughly the equivalent of one-eighth of a teaspoon of flour, or 18 slices of bread with each slice containing 20 ppm of gluten.

9. Does the FDA rule gluten-free labeling 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 is the FDA 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.

11. Why do I still see some foods labeled “gluten-free” with the statement “processed in a facility that also processes wheat”?

The “processed in a facility that also processes wheat” statement is a voluntary allergen advisory statement that manufacturers can choose to include on ingredient labels. Even if this statement appears on a label, if the food is labeled gluten-free, it still must comply with the FDA standards and contain <20 ppm of gluten.


National Foundation for Celiac Awareness (NFCA)

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