Q & A On The Gluten-free Labeling Proposed Rule

Questions And Answers

I. Introduction

The Food and Drug Administration (FDA) is proposing to define the term "gluten-free" for voluntary use in the labeling of foods. A definition for the term "gluten-free" established by FDA would assist those who have celiac disease (also known as celiac sprue or gluten-sensitive enteropathy) and their caregivers to more easily identify packaged foods that are safe for persons with celiac disease to eat. This proposed action is in response to the Food Allergen Labeling and Consumer Protection Act of 2004, Title II of Public Law 108-282, enacted on August 2, 2004, which directs the Secretary of Health and Human Services to propose and later make final a rule that defines and permits the use of the food labeling term "gluten-free."

II. Questions and Answers

1. What is celiac disease?

   Celiac disease is a chronic inflammatory disorder of the small intestine in genetically susceptible individuals. It is triggered by ingesting certain proteins, commonly referred to as "gluten" which is naturally present in some cereal grains.

2. What is the estimated prevalence of celiac disease in the U.S.?

   Experts estimate that the percentage of the general population in the United States who has celiac disease is as high as 1%.

3. Can celiac disease be cured?

   No, but health care professionals advise that it can be managed with diet. Typically, individuals who have this disease are advised to avoid all sources of gluten in their diet. Over time, strictly avoiding consumption of all gluten sources can improve the symptoms and reduce the associated health risks of celiac disease.

4. What is gluten?

   The term "gluten" technically refers to a specific complex of proteins that forms when wheat flour is mixed with a liquid and physically manipulated, such as in the kneading of bread.

5. How is the term "gluten" used in the context of celiac disease?

   In the context of celiac disease, the term "gluten" is used to collectively refer to gluten in wheat, and to the proteins in other grains that have been demonstrated to cause harmful health effects in individuals who have celiac disease. These grains are wheat (including different varieties such as spelt and kamut), rye, barley, cross-bred hybrids (e.g., triticale, which is a cross between wheat and rye), and possibly oats.

6. What is the FDA''s proposed definition of the term "gluten"?

   FDA is proposing to define the term "gluten" to mean the proteins that naturally occur in a prohibited grain and that may cause adverse health effects in persons with celiac disease.

7. What is the FDA''s proposed definition for "prohibited grain"?

   FDA is proposing to define the term "prohibited grain" to mean any one of the following grains:

   • Wheat, meaning any species belonging to the genus Triticum
   • Rye, meaning any species belonging to the genus Secale
   • Barley, meaning any species belonging to the genus Hordeum
   • Crossbred hybrids of wheat, rye or barley (e.g., triticale, which is a cross between wheat and rye)
8. Does the agency have a current definition for "gluten-free"?

   No. Currently, there is no FDA regulation that defines the term "gluten-free." However, FDA has not objected to the use of the term "gluten-free" in the labeling of foods, provided that when such a claim is made, it is truthful and not misleading.

9. Why is FDA proposing a regulation to define the term "gluten-free"?

   FDA is directed to define the term "gluten-free" to comply with a statutory mandate. Title II of Public Law 108-282, also known as the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), directs the Secretary of Health and Human Services to issue a proposed rule that will define and permit the use of the term "gluten free" on the labeling of foods by no later than two years after the law''s enactment date (August, 2006), and a final rule by no later than four years after the law''s enactment date (August, 2008).

10. How is the FDA proposing to define the term "gluten-free"?

    FDA proposes to define the term "gluten-free" to mean that a food bearing this claim in its labeling does not contain any one of the following:

    • An ingredient that is a prohibited grain
    • An ingredient that is derived from a prohibited grain and that has not been processed to remove gluten
    • An ingredient that is derived from a prohibited grain and that has been processed to remove gluten, if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food or
    • 20 ppm or more gluten
11. Will foods that meet the definition for "gluten-free" be required to bear a "gluten-free" claim?

    No. FDA is proposing to define the term "gluten-free" for voluntary use in the labeling of foods. In other words, once a final federal definition of the term is in effect, if a manufacturer wishes to label his product as "gluten-free," it may do so at its own discretion, but only if the food bearing the label meets the proposed regulatory definition.

12. Is the FDA proposing any synonyms for the term "gluten-free"?

    Yes. The following are proposed synonyms for the "gluten free" labeling claim:

    • "free of gluten"
    • "without gluten"
    • "no gluten"
13. Is the FDA proposing claims for foods which are naturally gluten-free?

    Yes. FDA is proposing that with the exception of a food made from oats, any food that is naturally free of gluten may bear the claim "gluten free" provided both of the following requirements are met:

    • The wording of the claim clearly indicates that all foods of the same type, not just the brand bearing this labeling claim, are gluten-free (e.g., "milk, a gluten-free food," "all milk is gluten-free"); and
    • The food does not contain 20 ppm or more gluten.
14. Are there examples of food products that are naturally "gluten-free"?

    Yes. The following are examples of, but are not limited to, foods that are naturally gluten-free:

    • milk; nonfat dry milk)
    • 100 percent fruit or vegetable juices
    • Fresh fruits and vegetables that are not coated with a wax or resin that contains gluten
    • A variety of single ingredient foods: butter; eggs; lentils; peanuts; seeds like flax; tree nuts like almonds; non-gluten containing grains like corn; fresh fish like cod; fresh shellfish like clams; honey; and water.
15. What are examples of food products that would be prohibited from using the term "gluten-free" in their labeling under the proposed rule?

    The following are examples of, but are not limited to, foods that would not be able to use the term gluten-free in their labeling:

    • Barley, common wheat, rye, spelt, kamut, triticale
    • Farina, vital gluten, semolina, malt vinegar
16. Why did FDA not include oats as one of the "prohibited grains" in its proposed definition of the term "gluten-free"?

    FDA did not include oats as one of the "prohibited grains" in its proposed definition of the term "gluten free" for the following reasons:

    • There is no consensus among nutrition experts or authorities on the unconditional exclusion of oats from the diet of individuals with celiac disease. For example, the following celiac disease experts/authorities do not support the unconditional exclusion of oats: The National Institutes of Health, the American Dietetic Association, and some celiac disease research/treatment centers.
    • Research data suggest that the majority of individuals with celiac disease can tolerate a daily intake of a limited amount (e.g., 50 grams) of oats that are free of gluten from wheat, rye, barley or their crossbred hybrids.
    • Oats are reported to add variety, taste, satiety, dietary fiber, and other essential nutrients to the diet of individuals with celiac disease and may make their diet more appealing.
    • Allowing oats free of gluten from wheat, rye, barley or their crossbred hybrids, to bear a "gluten-free" labeling claim would make it easier for consumers to identify such oats in the marketplace and may serve as an incentive for more manufacturers to produce such oats.
17. Why did FDA include "20 ppm or more gluten" as a criteria in its definition of "gluten-free"?

    The level is proposed based on the available analytic methods. Data from peer-reviewed scientific literature demonstrate that current analytic technology can reliably and consistently detect gluten in wheat, rye, and barley at levels of 20 ppm in a variety of food matrices.

18. What other criteria might be used to define "gluten-free"?

    The preamble to the proposed rule advises that FDA is planning to conduct a safety assessment for gluten, under which scientific data and methods would be used to estimate a "safe" level of gluten exposure. We intend to publish a notice in the Federal Register seeking comment on the draft safety assessment and its potential use in the final rule.

19. How is FDA proposing to enforce "gluten-free" label claims?

    In the enforcement of FDA-regulated food labeling claims, the agency would deem the product to be misbranded on the basis of the result of one of the following:

    • review of labels
    • on-site inspections of food manufacturers
    • analysis of food samples
20. Are there potential benefits to industry in having a standardized definition for the term "gluten-free"?

    Yes. A standardized definition of the term "gluten-free" could assist food producers by providing them with a clearly codified definition of the term, thereby eliminating any uncertainty or misunderstandings as to how they may label their products.

21. What are the potential benefits to consumers in having a standardized definition for the term "gluten-free"?

    A standardized definition for the term "gluten-free" can serve to protect the public health by providing consumers with celiac disease, and others who must avoid gluten in their diet, the assurance that the foods bearing this labeling meet a clear standard established and enforced by FDA as to the meaning of "gluten-free".

22. How do I find more detailed information on this proposal?

    The proposal is on display at the Office of the Federal Register, and at FDA''s Dockets Management Branch. It is also available on the web: 72 FR 2795.

    The public also can learn about new FDA issues that are open for public comment through the agency''s Dockets Management Page.

23. Can I comment on this proposal?

    Yes, comments should be submitted in writing by April 23, 2007 to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305) Rockville, MD 20852.