Amy Burkhart, MD, RD

Amy Burkhart, MD, RD

Amy Burkhart, MD, RD, is a board-certified emergency medicine physician and registered dietitian. She also trained in integrative medicine with Dr. Andrew Weil at the Arizona Center for Integrative Medicine. Her practice is located in Napa, CA.
1100 Lincoln Ave. Suite 200 Napa, CA 94558 (707) 927-5622 Office

The FDA’s gluten-free labeling rule, announced on August 2nd, 2013, will have a significant impact on the ability of people with celiac disease and non-celiac gluten sensitivity to safely choose products at the grocery store. Here is a simple but comprehensive guide describing the federal requirements.

1. What does the new rule say?

If a company wants to label a product “gluten-free,” it will have to comply with the new federal definition of what “gluten-free” means.

2. How does the FDA define “gluten–free”?

A food may be labeled gluten-free if:

1. It is inherently gluten-free AND any unavoidable presence of gluten in the food is less than 20 ppm;


2. It contains a gluten-containing grain (wheat, rye or barley or a crossbreed like triticale) or an ingredient derived from a gluten-containing grain AND has been processed to contain less than 20 parts per million (ppm) of gluten.

3. What about similar terms we sometimes see on packaging?

The terms “no gluten,” “free of gluten” and “without gluten” are considered synonymous with “gluten-free” and their use must be in compliance with the rule.

4. What about other claims on a label such as “no gluten ingredients” or “not made with gluten-containing ingredients”?

Unless the product is also labeled “gluten-free,” you cannot assume the product contains less than 20 ppm gluten. These statements are permitted as long as they are truthful and not misleading, but they do not account for cross contamination and may not indicate that the product is safely below 20 ppm.

5. When does the rule take effect?

Food manufacturers are encouraged to adopt the new standard as soon as possible, although they have until August 2014 to be in compliance.

6. Do all foods now have to be labeled for gluten?

No. This is a voluntary rule. If a company wants to put a ”gluten-free” claim on their product, they must comply with the rule. It does not require information about gluten on the packaging if the package is not labeled “gluten-free.”

7. Does this mean that gluten will now be considered a “top allergen” and be listed along with the other top eight allergens?

No. A product that is not labeled “gluten-free” could still contain non-wheat sources of gluten that are not obvious.

Wheat, the most common source of gluten in packaged products, is a “top eight” allergen covered by the Food Allergen and Consumer Protection Act of 2004, so it must be clearly labeled and cannot be a hidden ingredient.

However, barley and rye, are not “top eight” allergens and are not covered by the 2004 law. The new rule does not change this. If a product is not labeled “gluten-free,” it might still contain gluten-containing ingredients derived from barley, such as malt vinegar.  It’s easy to spot rye in a product, as it has a strong flavor and only appears in obviously rye-flavored products.

8. Why did the FDA choose 20 ppm as a cut-off?

This level was based on a study done in 2007, which showed this level of gluten to be safe for the majority of people with celiac disease. The level of 20 ppm is widely accepted as safe and is the international standard adopted as part of the Codex Alimentarius and implemented in the European Union. A statement by Alessio Fasano, MD, explains the reasons for choosing a level of 20 ppm. Given the fact that we know very little about non-celiac gluten sensitivity, we can’t yet determine what a safe level is for that population without further studies.

9. If a food is labeled at 5 or 10 ppm is that better?

Some members of the gluten-free community would prefer the limit to be only 5 or 10 ppm gluten. Most gluten-free products on the market are testing well under 20 ppm. The 20 ppm limit gives companies a “cushion” that accounts for a margin of error and slight variations in production or supplies. Current testing methods have not proven reliable at levels below 20 ppm so we don’t know if testing at this level is even valid.

It would be ideal if the level could be zero to eliminate any risk of illness, but that is considered by experts to be unobtainable and unnecessary. This is a difficult subject of scientific study as most persons with celiac disease are not willing to knowingly ingest gluten for the sake of science. We don’t have monitoring parameters for the gluten-sensitive population so a study in that population can’t be done yet.

10. What if foods are naturally gluten-free already, such as water or milk? Can they be labeled “gluten-free”?

Yes, but a company must still comply with the guidelines if it labels a product “gluten-free,” even if it is naturally gluten-free.

11. What does the rule say about oats?
Oats are not mentioned in the rule itself, but according to FDA guidance on the rule, oats can be labeled gluten-free if they contain less than 20 ppm gluten, as with other foods. They do not need to be certified gluten-free.

12. What products are covered or not covered under this new labeling rule?

Covered by the ruling

– All FDA regulated foods, including dietary supplements

Not covered by the ruling

– Foods regulated by the USDA, including meat, poultry and certain egg products*

– Medications

– Distilled spirits or wines with 7 percent or more alcohol by volume, and malted beverages made with malted barley and hops*

*FDA will be working with both USDA and the Alcohol and Tobacco Tax and Trade Bureau (TTB) to harmonize their respective labeling requirements.

13. Do companies have to state when products are made on shared equipment or in a shared facility?

No. The rule does not require that companies do this. It does allow them to make a statement on packaging about shared manufacturing facilities if it is truthful.

14. Do all companies have to now test their food for the presence of gluten if the product contains a “gluten-free” label?

No, the rule does not require companies to do testing. However, manufacturers are responsible for ensuring that their products comply with the rule, and that may include testing.

15. How will the rule be enforced?

The FDA states that it enforces regulations “primarily through inspections of food processing facilities, examination of imports, collection and testing of food products on the market, and imposition of enforcement measures as required to protect consumers.” In reality, resources for enforcement are limited.

16. How do gluten-free certification programs fit into this picture?

There are several independent third-party testing organizations and each tests to levels of gluten below 20 ppm, such as 5 or 10 ppm. They are not regulated by the FDA and their practices vary. The FDA will continue to allow third-party certification labels, evaluating them on an ongoing basis, as long as they are truthful.

17. Will there be a new FDA-approved logo on products that are complying with the rule?


18.  How does the new rule affect restaurants serving gluten-free meals?

We are not sure yet. According to the guidance on the rule, the FDA is suggesting that a gluten-free claim on restaurant menus should be consistent with the respective regulatory definition. We aren’t sure what that means in practice. The American Celiac Disease Alliance asked the FDA for clarification on this point and will report that information on their website as soon as it becomes available.

19. Does the rule apply to foods imported from other countries?
Yes. All imported foods must meet the same federal requirements as foods domestically produced.

More information and resources on the new FDA rule can be found here.

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