Questions and Answers: Gluten-Free Food Labeling Final Rule


General

1. What is FDA announcing today about gluten? 
FDA is issuing a final rule to define the term “gluten-free” for voluntary use in the labeling of foods.

2. Who does the rule benefit?
It benefits people with celiac disease, an inherited chronic inflammatory auto-immune disorder that is estimated to affect up to 3 million Americans. For people who have celiac disease, consumption of gluten results in the destruction of the lining of the small intestine and the risk of other serious health conditions. The definition also benefits the food industry by establishing a level playing field among manufacturers of products labeled “gluten-free.”

3.How is “gluten-free” defined in the rule?
In general, foods may be labeled “gluten-free” if they meet the definition and otherwise comply with the final rule’s requirements. More specifically, the final rule defines "gluten-free" as meaning that the food either is inherently gluten free; or does not contain an ingredient that is: 1) a gluten-containing grain (e.g., spelt wheat); 2) derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour); or 3) derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food. Also, any unavoidable presence of gluten in the food must be less than 20 ppm.

4. Why is the FDA regulating gluten labeling on food?
The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) directed HHS to define and permit the use of the term "gluten-free" in the labeling of foods. FDA published a proposed rule in January 2007. The proposal defined the term "gluten-free" and announced FDA's intent to conduct a safety assessment for gluten exposure for people with celiac disease. In August 2011, FDA reopened the comment period on the proposal, and announced the availability of the gluten safety assessment, as well as its tentative conclusion to follow the approach in the proposed rule.

5. What products are covered by the final rule?
The final rule applies to all FDA-regulated foods, including dietary supplements. The rule excludes those foods whose labeling is regulated by the U.S. Department of Agriculture (USDA) and the Alcohol and Tobacco Tax and Trade Bureau (TTB). Generally, USDA regulates the labeling of meats, poultry, and certain egg products (FDA regulates the labeling of shell eggs). TTB regulates the labeling of most alcoholic beverages, including all distilled spirits, wines that contain 7 percent or more alcohol by volume, and malted beverages that are made with both malted barley and hops.

6. What is the effective date of the final rule and what is the compliance date?
The final rule becomes effective 30 days after publication in the Federal Register. Manufacturers will have a year after the date of publication of the rule to bring package labels into compliance. After this date, any food product labeled “gluten-free” that does not meet the criteria established in the final rule, including a food that contains 20 ppm or more gluten, would be deemed misbranded and would be subject to regulatory enforcement action.

Labeling

7. Are all FDA-regulated foods that meet the definition of “gluten-free” required to be labeled gluten-free?
No. The final rule establishes requirements for the voluntary use of gluten-free claims. The Food Allergen Labeling and Consumer Protection Act of 2004 directed the Secretary of Health and Human Services to issue federal regulations that “define” and “permit use of” the term “gluten-free” on the labeling of foods.

8. If a food manufacturer uses the gluten-free claim on some of its foods, does that mean that every food made by that manufacturer is free of gluten?
No. A manufacturer may make a wide variety of foods, including those that are gluten-free and those that contain gluten. Manufacturers can voluntarily use the gluten-free claim to clearly inform consumers about which of their foods meet FDA’s gluten-free requirements.

9. Does the final rule apply to gluten-free claims made for foods served in restaurants, including cafeterias and buffets?
With respect to restaurants, FDA guidance 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. This same approach would be followed with respect to “gluten-free” claims made in restaurants and other retail food service establishments.

10. Does the final rule apply to food products imported from other countries?
Yes. All foods imported into the United States must meet the same federal requirements as foods domestically produced. Therefore, if the label of an imported food subject to FDA regulations makes a gluten-free claim, that food must comply with the gluten-free labeling requirements.

11. Can foods that are by nature free of gluten be labeled gluten-free?
Yes. Whether a food is manufactured to be free of gluten or by nature is free of gluten (e.g., bottled spring water), it may bear a gluten-free labeling claim if it meets all FDA requirements for a gluten-free food. The claim is voluntary.

12. Can grains such as rice, buckwheat, or oats be labeled gluten-free?
Any grain other than the gluten-containing grains of wheat, rye, barley, or their crossbred hybrids like triticale can be labeled gluten-free, if the presence of any unavoidable gluten due to cross-contact situations (see question 15) is less than 20 ppm.

13. Do oats have to be certified as gluten-free to be labeled gluten-free?
No. However, as with any other non-gluten-containing grain, oats that are labeled gluten-free must contain less than 20 ppm gluten.

14. Can a food be labeled gluten-free if it is made with small amounts of a gluten-containing grain or ingredients derived from such grains that were not processed to remove gluten, if the food contains less than 20 ppm gluten?
No. A food labeled gluten-free cannot be intentionally made with any amount of a gluten-containing grain (wheat, rye, barley, or their crossbred hybrids like triticale) or an ingredient derived from such grain that was not processed to remove gluten. The goal of manufacturing any food labeled gluten-free should be for the food to not contain any gluten or to contain the lowest amount possible that is less than 20 ppm gluten. One goal of FDA’s regulatory definition of the term “gluten-free” is to limit consumer confusion when reading ingredient lists of foods labeled gluten-free.

15. What does gluten cross-contact mean in the context of the final rule?
The term “cross-contact” is not defined in the final rule, but gluten cross-contact generally refers to the unavoidable presence of gluten in a food due to contact with a gluten-containing food (wheat, rye, barley, or their crossbred hybrids like triticale). The U.S. Grain Standards allow commodity grains, legumes, and seeds to contain a small percentage of another commodity grain as a result of commingling during production. The presence of gluten in a grain, legume, or seed that is naturally free of gluten from this type of commingling is an example of cross-contact. The typical practice of crop rotation, as well as the shared use of harvesting and transport equipment and storage silos, often results in gluten-containing grains coming into contact with other grains, legumes, and seeds that are naturally free of gluten. Furthermore, manufacturing facilities that use shared production equipment to produce foods both with and without gluten could result in gluten cross-contact. Any grain other than the gluten-containing grains of wheat, rye, barley, or their crossbred hybrids like triticale can be labeled gluten-free, if it meets the definition, including that the presence of any unavoidable gluten due to cross-contact situations is less than 20 ppm.

16. Will the labels of foods making a gluten-free claim look different than before the compliance date of the final rule?
It depends upon the food and the manufacturer. The packaging of some foods currently labeled as “gluten-free” may look the same after the compliance date of the final rule, because the food meets the requirements in the rule. FDA is not mandating any specific label formats based on the final rule. Most of the major provisions for gluten-free food labeling in FDA’s final rule and proposed rule are essentially the same. Therefore, no changes may be needed in the food’s formulation and labeling for those foods that were already labeled in a way that was consistent with the proposed rule.

17. Where should the gluten-free claim appear on the food label?
The final rule does not require manufacturers to place the voluntary gluten-free claim in any specific location on the food label. Manufacturers may choose where they place a gluten-free claim on their food labels, provided that the claim does not intervene with FDA mandatory labeling information and meets all other applicable statutory and regulatory requirements.

18. Why didn’t FDA adopt a symbol for manufacturers to uniformly use to identify foods that meet the agency’s definition of gluten-free?
The final rule does not require or recommend that manufacturers include any particular symbol on a food label to indicate that the food meets FDA’s definition of gluten-free. FDA is defining the term “gluten-free” in this final rule and is not requiring the use of a symbol alone or in combination with this term. However, FDA does have data indicating that U.S. consumers are very familiar with and favor the use of the term “gluten-free” over other wording to communicate to them that a food is free of gluten. Therefore, since FDA defines “gluten-free,” manufacturers have uniform requirements to use the term when making a labeling claim that their foods are free of gluten. On the other hand, the use alone of any symbol indicating the absence of gluten cannot serve as a substitute for the words “gluten-free” or the terms “no gluten,” “free of gluten,” or “without gluten”.

19. Can manufacturers include the logo of a gluten-free certification program on their food labels?
If so, which logo is more important for persons who are sensitive to gluten? Manufacturers may include the logo of a gluten-free certification program on their food labels, provided that its use is truthful and not misleading. FDA does not endorse, accredit, or recommend any particular third-party gluten-free certification program. However, the agency would expect that the criteria of any gluten-free certification program whose logo appears on a food label and which logo would otherwise suggest the food is “gluten-free” meet, at a minimum, FDA’s criteria defining the term gluten-free. Consumers with celiac disease and others sensitive to gluten should consult with their health care providers for advice about which gluten-free certification program would best meet their individual needs.

20. Where can the logo of a third-party gluten-free certification program be placed on the food label?
The final rule does not address the use of a logo of a third-party gluten-free certification program. The use of such logo must be consistent with any other FDA labeling regulations.

21. Are statements like “made with no gluten-containing ingredients” or similarly “not made with gluten-containing ingredients” permitted on labels of foods bearing a gluten-free claim?
Yes. Neither the final rule nor FDA’s general food labeling regulations prohibit the use of a statement like “made with no gluten-containing ingredients” or “not made with gluten-containing ingredients” on any food products, provided that the statement is truthful and not misleading. However, unless the label of the food including such a statement also bears a gluten-free claim, consumers should not assume that the food meets all FDA requirements for a gluten-free food.

22. Are advisory statements, such as “made in a factory that also processes wheat products” permitted on labels of foods bearing a gluten-free claim?
Yes. The final rule does not prohibit the inclusion of an advisory label statement, such as “made in a facility that also processes wheat,” on foods labeled gluten-free, provided that the statement is truthful and not misleading. FDA would need to evaluate food labels on a case-by-case basis to determine whether a specific advisory statement included along with a gluten-free claim would be potentially misleading to the consumer. However, any food whose label bears a gluten-free claim, regardless of whether it also has an advisory statement, must meet all the requirements of the final rule.

Gluten Levels

23. Why didn’t FDA adopt zero ppm gluten rather than less than 20 ppm gluten as one of the criteria for a food labeled gluten-free? FDA used an analytical methods-based approach to define the term gluten-free and adopted < 20 ppm gluten as one of the criteria for a food labeled gluten-free because the agency relies upon scientifically validated methods for enforcing its regulations. Analytical methods that are scientifically validated to reliably detect gluten at a level lower than 20 ppm are not currently available. In addition, some celiac disease researchers and some epidemiological evidence suggest that most individuals with celiac disease can tolerate variable trace amounts and concentrations of gluten in foods (including levels that are less than 20 ppm gluten) without causing adverse health effects.

24. A manufacturer’s foods labeled gluten-free are certified by a third-party organization to contain either less than 5 or 10 ppm gluten, which is lower than the final rule’s criterion of less than 20 ppm for a food labeled gluten-free. May manufacturers state on the label that their foods contain less than 5 or 10 ppm gluten?
The final rule does not prohibit manufacturers from stating any truthful and nonmisleading information on their food labels, including declaring the maximum amount of gluten the food may contain. However, doing so would mean that each food bearing the label statement does not contain gluten at a level that exceeds the amount declared. (Also see questions 31 and 32.)

25. Would foods labeled gluten-free be a better choice for persons with celiac disease and others sensitive to gluten than foods not labeled gluten-free?
Not necessarily. Gluten-free is a voluntary claim that manufacturers may elect to use in the labeling of their foods, provided that those foods meet all final rule requirements for a gluten-free food. Some manufacturers may have to specially process, or reformulate foods in order for them to be free of gluten and to be eligible to bear a gluten-free labeling claim. Producers of foods that are by nature free of gluten (e.g., bottled spring water, fresh fruits and vegetables, and fresh seafood) may not choose to label these foods gluten-free even though the foods could be consumed as part of a gluten-free diet. For foods that are by nature free of gluten, but are at high risk of gluten cross-contact (e.g., products made from grains, legumes, and seeds), the appearance of a gluten-free claim on the labels would provide consumers with the expectation that any gluten present is less than 20 ppm. Persons with celiac disease or who are otherwise sensitive to gluten should seek the advice of their health care providers for selecting appropriate foods they can consume following a gluten-free diet.

26. If a person sensitive to gluten eats a product labeled gluten-free and becomes ill or otherwise experiences adverse health effects, what should this person do?
First, anyone who becomes ill or otherwise experiences adverse health effects they believe are associated with having eaten a particular food, including individuals with food allergies and those with celiac disease, should seek appropriate medical care. Afterward, the agency encourages individuals to report such incidents with FDA-regulated foods (see question 2) to the Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System called “CAERS” at 240-402-2405. In addition, consumers and manufacturers can report any complaint they may have about an FDA-regulated food (e.g., potential misuse of gluten-free claims on food labels) to an FDA Consumer Complaint Coordinator in the state where the food was purchased. A list of FDA Consumer Complaint Coordinators is posted at FDA’s website.

Compliance

27. Will products labeled gluten free that are currently on grocery store shelves have to be removed if they do not comply with the final rule?
The compliance date for the foods labeled gluten-free to meet all requirements of the final rule is one year after date of publication. The compliance date allows the food industry sufficient time to make whatever changes are needed in the formulation or labeling of their foods bearing a gluten-free claim in order to legally market them in the United States. However, manufacturers are responsible for ensuring that their product labels are truthful and not misleading. Therefore, FDA anticipates that manufacturers are likely to choose to follow the requirements of the final rule as soon as possible.

28. How long will it take for FDA-regulated foods that have an “old” gluten-free claim on the label to be cycled off grocery store shelves?
The length of time will vary depending on inventory, product shelf life, consumer popularity of the product, and other variables. However, as stated, FDA anticipates that manufacturers are likely to follow the requirements of the final rule as soon as possible. We note that many foods currently labeled as “gluten-free” may already be able to meet the new federal definition.

29. How will FDA check that food manufacturers labeling their foods gluten-free comply with the requirements of the final rule?
The manufacturer is responsible for ensuring that any gluten-free claim it makes on its food labels is truthful, not misleading, and complies with FDA regulations. FDA may use the full range of its routine post-market monitoring activities to enforce the final rule on gluten-free food labeling. These activities include periodic inspections of food manufacturing facilities; food label reviews; follow-up on consumer and industry complaints reported to the agency; and when needed, gluten analyses of food samples.

30. Are manufacturers required to test for gluten to make a gluten-free claim on their food labels?
No. The final rule does not specifically require manufacturers to test for the presence of gluten in their starting ingredients or finished foods labeled gluten-free. However, manufacturers are responsible for ensuring that foods bearing a gluten-free claim meet the requirements of the final rule. Among other requirements, this means that any unavoidable gluten present in a food labeled gluten-free is less than 20 ppm. Manufacturers may choose to use effective quality control tools to ensure that any foods they label gluten-free do not contain 20 ppm or more gluten, such as:

  • conducting in-house gluten testing of starting ingredients or finished foods,
  • employing a third-party laboratory to conduct in-house gluten testing,
  • requesting certificates of gluten analysis from ingredient suppliers,
  • orparticipating in a third-party gluten-free certification program.

31. What gluten test methods should a manufacturer use if it elects to analyze its foods labeled gluten-free to ensure compliance with the final rule?
Manufacturers who elect to analyze their foods for gluten can select the test methods most appropriate for them, considering the type of foods they manufacture. Manufacturers are not obligated to use any one specific method to check for gluten in their foods. FDA recommends the use of scientifically valid methods in order for the gluten test results obtained to be reliable and consistent. Conducting gluten testing using a scientifically valid method is an effective tool manufacturers can use to ensure that their foods labeled gluten-free do not contain 20 ppm or more gluten.

33. What gluten test methods will FDA use in its enforcement program of its new regulations on gluten-free food labeling?
In the enforcement of its regulations, FDA routinely uses scientifically valid methods that have undergone an independent multi-laboratory performance evaluation where the results have been published in the peer-reviewed scientific literature to ensure that the results obtained are accurate and reliable. FDA has currently identified two sandwich enzyme-linked immunosorbent assays (ELISA)-based methods (see R-Biopharm: Food & Feed Analysis and Morinaga Institute of Biological Science, Inc.: Wheat Protein ELISA Kit (Gliadin) ) that, when necessary, the agency will use in tandem to determine compliance with the final rule. However, as discussed in the final rule, FDA is aware that sandwich ELISA methods do not adequately detect gluten in fermented and hydrolyzed foods. Because scientifically valid methods currently are lacking that can do so, we intend to issue a proposed rule on this issue. Will FDA authorize third-parties to inspect facilities of manufacturers that label foods gluten-free or to verify if such foods meet the regulatory definition of gluten-free? Currently, FDA does not have plans to authorize third-parties to inspect facilities of manufacturers that label foods gluten-free or to verify if such foods meet the regulatory definition of gluten-free. FDA periodically inspects food manufacturing facilities for compliance with the agency’s regulatory requirements. Manufacturers subject to FDA inspection that label their foods gluten-free are accountable for using that claim in a truthful and not misleading manner and for complying with all requirements established by the final rule.

34. Are there specific recordkeeping requirements for manufacturers who label foods gluten-free?
No. The final rule does not impose any specific new recordkeeping requirements for manufacturers who make a gluten-free claim on their food labels.

35. Will FDA work with USDA and TTB to harmonize the requirements for the foods labeled gluten-free among agencies?
Yes. FDA will continue to work with USDA and TTB on the issue of gluten-free food labeling to harmonize the requirements for foods labeled gluten-free among agencies whenever possible.

36. Because the final rule only applies to the labeling of foods, what efforts does FDA have underway concerning the disclosure of gluten-containing ingredients in drug products?
On December 21, 2011, FDA’s Center for Drug Research and Evaluation (CDER) issued a Federal Register notice (76 FR 79196) to request information and public comments on a series of questions related to the presence of gluten in drug products (i.e., prescription, nonprescription, biologic, and homeopathic drug products). CDER is considering the public comments it received in response to this notice as it evaluates options to help individuals with celiac disease limit gluten exposure from consumption of drug products.

 

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