Food Labeling; Gluten-Free Labeling of Foods
Federal Register, Volume 78 Issue 150 (Monday, August 5, 2013)
Federal Register Volume 78, Number 150 (Monday, August 5, 2013)
Rules and Regulations
Pages 47154-47179
From the Federal Register Online via the Government Printing Office www.gpo.gov
FR Doc No: 2013-18813
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
Docket No. FDA-2005-N-0404
RIN 0910-AG84
Food Labeling; Gluten-Free Labeling of Foods
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA or we) is issuing a final rule to define the term ``gluten-free'' for voluntary use in the labeling of foods. The final rule defines the term ``gluten-free'' to mean that the food bearing the claim does not contain an ingredient that is a gluten-containing grain (e.g., spelt wheat); an ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten (e.g., wheat flour); or an ingredient that is derived from a gluten-containing grain and 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 (i.e., 20 milligrams (mg) or more gluten per kilogram (kg) of food); or inherently does not contain gluten; and that any unavoidable presence of gluten in the food is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food). A food that bears the claim ``no gluten,'' ``free of gluten,'' or ``without gluten'' in its labeling and fails to meet the requirements for a ``gluten-free'' claim will be deemed to be misbranded. In addition, a food whose labeling includes the term ``wheat'' in the ingredient list or in a separate ``Contains wheat'' statement as required by a section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and also bears the claim ``gluten-free'' will be deemed to be misbranded unless its labeling also bears additional language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a ``gluten-free'' claim. Establishing a definition of the term ``gluten-free'' and uniform conditions for its use in food labeling will help ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled. We are issuing the final rule under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).
DATES: Effective date: The final rule becomes effective on September 4, 2013. Compliance date: The compliance date of this final rule is August 5, 2014. See section II.B.4 (comment 35 and response 35) for an additional explanation of the compliance date and implementation of this final rule.
FOR FURTHER INFORMATION CONTACT: Felicia B. Billingslea, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-2371, FAX: 301-436-2636, email: GlutenFreeFinalRuleQuestions@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Executive Summary
Purpose of the Rule
Need for the rule: Celiac disease is a hereditary, chronic inflammatory disorder of the small intestine triggered by the ingestion of certain storage proteins referred to as gluten occurring in wheat, rye, barley, and crossbreeds of these grains. Celiac disease has no cure, but individuals who have this disease are advised to avoid all sources of gluten in their diet to protect against adverse health effects associated with the disease. Many manufacturers currently label their food with a
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``gluten-free'' labeling claim. However, there is no current regulatory definition for the ''gluten-free'' claim in the United States. Establishing in this final rule a regulatory definition of the food labeling term ``gluten-free'' and uniform conditions for its use in the labeling of foods is necessary to ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled; this final rule is also necessary to respond to a directive of FALCPA (title II of Pub. L. 108-
282).
Legal authority: Consistent with section 206 of FALCPA and sections 403(a)(1), 201(n), and 701(a) of the FD&C Act (21 U.S.C. 343(a)(1), 321(n), and 371(a), respectively), we are issuing requirements for the use of the term ``gluten free'' for voluntary use in the labeling of foods.
Major Provisions of the Rule
The final rule defines and sets conditions on the use of the term ``gluten-free'' in foods, including:
Foods that inherently do not contain gluten (e.g., raw carrots or grapefruit juice) may use the ``gluten-free'' claim.
Foods with any whole, gluten-containing grains (e.g., spelt wheat) as ingredients may not use the claim;
Foods with ingredients that are gluten-containing grains that are refined but still contain gluten (e.g., wheat flour) may not use the claim;
Foods with ingredients that are gluten-containing grains that have been refined in such a way to remove the gluten may use the claim, so long as the food contains less than 20 ppm gluten/has less than 20 mg gluten per kg (e.g. wheat starch);
Foods may not use the claim if they contain 20 ppm or more gluten as a result of cross-contact with gluten containing grains.
For reasons discussed in more detail in this document, under limited circumstances we intend to exercise enforcement discretion with respect to the requirements for ``gluten-free'' labeling for FDA-
regulated beers that currently make a ``gluten-free'' claim and that are: (1) Made from a non-gluten-containing grain or (2) made from a gluten-containing grain, where the beer has been subject to processing that the manufacturer has determined will remove gluten below a 20 ppm threshold. We plan to issue a proposed rule to address our compliance approach to fermented or hydrolyzed products.
In addition, the final rule provides that:
A food that bears the claim ``no gluten,'' ``free of gluten,'' or ``without gluten'' in its labeling and fails to meet the requirements for a ``gluten-free'' claim will be deemed to be misbranded.
A food whose labeling includes the term ``wheat'' in the ingredient list or in a separate ``Contains wheat'' statement as required by FALCPA and also bears the claim ``gluten-free'' will be deemed to be misbranded unless its labeling also bears additional language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a ``gluten-free'' claim.
By defining ``gluten-free'' and the conditions under which a ``gluten-free'' claim can be used, the final rule makes it easier for individuals with celiac disease to make informed purchasing decisions. This will enable them to adhere to a diet they can tolerate without causing adverse health effects and to select from a variety of available gluten-free foods.
Costs and Benefits
Full compliance with the final rule would have annualized costs of about $7 million per year and annual health benefits of about $110 million per year:
Annual Benefit and Cost Overview
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Benefits..................... Health Gains for $110,000,000.
Individuals With
Celiac Disease.
Search Cost Reduction Unknown.
Costs........................ Relabeling of Foods.. $1,000,000.
Testing of Foods..... $5,800,000.
Net Benefits................. ..................... >$103,000,000.
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Table of Contents
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Background
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What is celiac disease?
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How prevalent is celiac disease in the United States?
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What did the Food Allergen Labeling and Consumer Protection Act of 2004 do with respect to celiac disease? What other activities did we conduct for this rulemaking?
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What did we propose to do?
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What issues did the comments raise? What are FDA's responses to the comments? What does the final rule say?
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What general comments did we receive? What regulatory approach should we take?
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What comments did we receive on the proposed rule?
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What is the legal authority for this rule?
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Analysis of Impacts--Final Regulatory Impact Analysis
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How does the Paperwork Reduction Act of 1995 apply to this final rule?
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What is the environmental impact of this rule?
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What are the federalism impacts of this rule?
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References
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Background
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What is celiac disease?
Celiac disease (also known as celiac sprue and gluten-sensitive enteropathy) is a chronic inflammatory disorder of the small intestine in genetically susceptible individuals. It is triggered by ingesting certain storage proteins, commonly referred to as ``gluten,'' that naturally occur in some cereal grains (Refs. 1 through 3). In such individuals, the consumption of gluten stimulates the production of antibodies and inflammatory cells, resulting in an abnormal immune response, which damages the tiny, fingerlike protrusions called ``villi,'' that line the small intestine and function to absorb nutrients from food (Ref. 4). Over time, continued dietary exposure to gluten can destroy the intestinal villi of individuals with celiac disease, leading to a lack of absorption of nutrients and a wide variety of other serious health problems (Ref. 4).
The symptoms and clinical manifestations of celiac disease are highly variable among affected individuals and differ in severity. The reasons for this variability are unknown, but may depend upon the individual's age and immunological status, the amount, duration or timing of the exposure to gluten, and the specific area and extent of the gastrointestinal tract involved in the disease (Ref. 5). Symptoms of celiac disease may be: (1) ``Classical,'' affecting the digestive tract (e.g., abdominal bloating; cramping and pain; chronic diarrhea; vomiting; constipation) and resulting in gastrointestinal malabsorption; or (2) ``atypical,'' affecting mainly other parts of the body (e.g., fatigue; irritability; behavior changes; bone or joint pain; tingling numbness in the legs; ulcers in
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the mouth; tooth discoloration or loss of enamel; itchy skin rash with blisters called dermatitis herpetiformis) (Refs. 1, 4, 6, and 7).
A large portion of the subpopulation that has celiac disease may not experience any symptoms at all, and these individuals are classified as having either the ``silent'' or ``latent'' form of celiac disease (Refs. 1 and 8). Persons who have the silent form of celiac disease have most of the diagnostic features commonly seen in individuals with classical or atypical celiac disease, such as specific serum antibodies and evidence of damaged intestinal villi. Those who have the latent form of celiac disease have specific serum antibodies, but no evidence of damaged intestinal villi (Ref. 1).
In addition to the aforementioned clinical symptoms and ailments, celiac disease is associated with a number of significant health problems and disorders, including iron-deficiency anemia, vitamin deficiencies, protein-calorie malnutrition, weight loss, short stature, growth retardation in children, delayed puberty, infertility, miscarriage, and osteoporosis (Refs. 1, 6, 9, and 10). Individuals with unmanaged celiac disease are at an increased risk of developing other serious medical conditions, such as Type I diabetes mellitus, intestinal cancers, and both intestinal and extraintestinal non-
Hodgkin's lymphomas (Refs. 7, 11, 12, and 13).
Celiac disease has no cure, but individuals who have this disease are advised to avoid all sources of gluten in their diet (Refs. 1 and 6). Over time, strictly avoiding consumption of gluten can resolve the symptoms, mitigate and possibly reverse the damage, and reduce the associated health risks of celiac disease (Ref. 14). For some individuals with celiac disease, failure to avoid consumption of gluten can lead to severe and sometimes life-threatening complications that can affect multiple organs of the body (Refs. 5, 6, and 15).
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How prevalent is celiac disease in the United States?
Precise prevalence data for celiac disease are not available. In the January 23, 2007, proposed rule (72 FR 2795 at 2797), we cited estimates regarding the overall prevalence of celiac disease in the United States ranging from about 0.4 percent to about 1 percent of the general population, or approximately 1.5 to 3 million Americans (Refs. 1 and 16). According to the National Health and Nutrition Examination Survey (NHANES) 2009-2010 survey data on medical conditions, 0.14 percent of the civilian, non-institutionalized population of the United States reported having been told by a medical professional that they have celiac disease (Ref. 17). Researchers examining serological data from a subset of the NHANES 2009-2010 study population for evidence of celiac disease estimated the prevalence of celiac disease at 0.71 percent (Ref. 18).
The discrepancy between estimated prevalence and diagnosed cases has been linked primarily to the fact that celiac disease can be silent or latent, as described in section I.A. Silent and latent forms of celiac disease may go undetected in an individual for years before the person develops symptoms causing him or her to seek medical attention. In addition, celiac disease is often mistaken for other gastrointestinal malabsorption disorders that have similar diarrheal symptoms (e.g., irritable bowel syndrome), which further delays its diagnosis (Ref. 19). Only recently has the medical community become more aware of the need to screen for celiac disease when patients experience health problems that may be associated with the disease or when patients have family members, especially first- and second-degree relatives, who have celiac disease (Ref. 1).
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What did the Food Allergen Labeling and Consumer Protection Act of 2004 do with respect to celiac disease? What other activities did we conduct for this rulemaking?
FALCPA, Title II of Public Law 108-282, was enacted on August 2, 2004. Section 206 of FALCPA directs the Secretary of Health and Human Services (HHS) (the Secretary), in consultation with appropriate experts and stakeholders, to issue a rule to define, and permit use of, the term ``gluten-free'' on the labeling of foods. This rulemaking implements section 206 of FALCPA.
FALCPA does not require that we establish a threshold level for gluten. Nonetheless, an important scientific issue associated with the issuance of this rule is the potential existence of a threshold level below which it is unlikely that an individual with celiac disease will have an adverse health effect.
To address this issue, among others, we established an internal, interdisciplinary group (the Threshold Working Group) to review the scientific literature on the issue of a threshold level for gluten. The Threshold Working Group's report, ``Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food'' (issued in draft and later revised, referred to herein as the ``Thresholds Report'' except where noted) (Ref. 20), summarized the current state of scientific knowledge with respect to a dose-response relationship for gluten, and presented the following four potential approaches that we might consider in establishing such a threshold level, if we chose to do so (Ref. 20, pp. 2 and 38-41; Ref. 21 at pp. 2 and 42-45):
Analytical methods-based--thresholds are determined by the sensitivity of the analytical method(s) used to verify compliance.
Safety assessment-based--``safe'' level is calculated using the No Observed Adverse Effect Level (NOAEL) from available human challenge studies, applying an appropriate ``uncertainty factor'' multiplier to account for knowledge gaps.
Risk assessment-based--examines known or potential adverse health effects resulting from human exposure to a hazard; quantifies the levels of risk associated with specific exposures and the degree of uncertainty inherent in the risk estimate.
Statutorily derived--uses an exemption articulated in an applicable law and extrapolates from that to other potentially similar situations.
As the Thresholds Report explained, the term ``threshold'' has multiple meanings, including toxicological and statutory (or regulatory) (see Ref. 20 at p. 10). The Threshold Working Group noted that ``understanding thresholds for gluten will help FDA develop a definition of `gluten-free' and identify appropriate uses of the term.'' The Threshold Working Group recognized that setting such a regulatory threshold likely would require consideration of additional factors not addressed in the Thresholds Report, such as ease of compliance and enforcement, concerns of stakeholders (i.e., industry, consumers, and other interested parties), economics (e.g., cost/benefit analysis), trade issues, and legal authorities (Ref. 20 at p. 41).
The Thresholds Report concluded that it was not possible for us to use the quantitative risk assessment-based approach due to the lack of sufficient data from human clinical trials and the lack of sufficient data on exposure, and that the statutorily derived approach is not viable in the absence of applicable statutory provisions (Ref. 20 at pp. 4, 60, and 61). Thus, the two approaches identified in that report as viable for establishing a threshold for gluten were the analytical methods-based approach and the safety assessment-based approach.
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In the Federal Register of June 17, 2005 (70 FR 35258), we published a notice announcing the availability of the draft version of the Thresholds Report. We invited interested persons to submit comments and any scientific data or other information to the docket during a 60-
day comment period that ended on August 16, 2005. The Threshold Working Group considered the comments, data, and information submitted, and made appropriate revisions to the draft Thresholds Report. On May 25, 2006, we posted our response (Ref. 22) to the comments, data, and other information that we received. We also posted the revised Thresholds Report (Ref. 21). Both documents are dated March 2006.
Additionally, in the Federal Register of May 23, 2005 (70 FR 29528), we announced that our Food Advisory Committee (FAC) would hold a public meeting on July 13 through 15, 2005, to evaluate the draft version of the Thresholds Report. One purpose of the meeting was for the FAC to determine whether the four approaches considered in the Thresholds Report for establishing a threshold level for gluten were scientifically sound. We invited experts to address a number of specific issues related to sensitivities to gluten. In addition, we invited interested persons to submit comments and any scientific data or other information relevant to the issues pending before the FAC.
During the public meeting, the FAC heard presentations from invited experts on the diagnosis and treatment of celiac disease, the quality of life issues faced by those who have celiac disease and their families, the relationship between gluten proteins in various grains and celiac disease, analytical methods for detecting and measuring the levels of gluten in food, the value and use of prospective and retrospective gluten tolerance studies, and a summary of existing national and international definitions of ``gluten-free'' for food labeling. Further, members of the general public, including those representing trade associations, industry, consumers, and other stakeholders, gave brief presentations before the FAC to share their perspectives on some of the same topics addressed by the invited experts. The speaker presentations, public comments, FAC discussions, and the FAC responses to a set of specific questions and the charge to the FAC posed by FDA's Center for Food Safety and Applied Nutrition (CFSAN) are recorded in the transcript of the meeting, which is available through the FDA Docket No. 2005N-0231 and is posted at CFSAN's Web site (http://www.fda.gov/ohrms/dockets/ac/cfsan05.html). Copies of the transcript materials that specifically address the topics of celiac disease and a gluten threshold level are also available through the docket for this rulemaking. A summary of the FAC responses to the questions is provided in the Summary Minutes (Ref. 23).
The FAC concluded that the Thresholds Report ``includes a comprehensive evaluation of the currently available data and descriptions of all relevant approaches that could be used to establish a threshold . . . for gluten in food'' (Ref. 23, p. 1). The FAC also identified the risk-assessment approach as the strongest of the four approaches proposed in the Thresholds Report, assuming the availability of sufficient data (Ref. 23, p. 1).
In the Federal Register of July 19, 2005 (70 FR 41356), we announced that we would hold a public meeting on August 19, 2005, to discuss the topic of gluten-free food labeling. We gave interested persons until September 19, 2005, to comment on a list of specific questions concerning food manufacturing, analytical methods, and consumer purchasing practices and views about gluten-free foods (70 FR 41356 at 41357). In addition, we invited experts to address these issues at the meeting, and invited members of the general public, including individuals with celiac disease and their caregivers, to share their views about foods produced and labeled as ``gluten-free.'' We received more than 2,400 comments about the public meeting or the list of questions cited in the notice announcing the meeting. The vast majority of these comments were from individuals with celiac disease, their caregivers, and celiac disease associations; we also received comments from the food industry. Most consumers said that they appreciate and use ``gluten-free'' labeling claims to identify packaged foods they can eat when trying to avoid gluten. Many consumers stated that a ``gluten-free'' labeling claim makes it easier to shop for groceries, saving the consumers both time and the frustration experienced when reading often lengthy and complicated ingredients lists that the consumers did not understand. Many consumers also stated that they primarily purchase packaged foods bearing a ``gluten-free'' labeling claim and that a standardized definition of the term ``gluten-
free'' for foods marketed in the United States would give them more assurance that foods bearing this claim are appropriate for individuals trying to avoid gluten. The comments reflected a consensus of opinion among individuals with celiac disease, and the organizations which represent them, that wheat, rye, and barley should be excluded from any products labeled as ``gluten-free.'' However, comments from these individuals and organizations varied with respect to whether we should exclude oats from any products labeled as ``gluten-free.''
Industry comments submitted in response to the 2005 public meeting or to the list of questions cited in the notice announcing the meeting indicated that currently there is no universal understanding among manufacturers of what the term ``gluten-free'' means and there is no uniform industry standard for producing foods bearing this labeling claim. Several industry comments expressed the opinion that a standardized definition for ``gluten-free'' could help promote fair competition among packaged foods marketed as gluten-free in the United States, because all manufacturers would have to adhere to the same requirements if they label their products ``gluten-free.''
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What did we propose to do?
In the Federal Register of January 23, 2007 (72 FR 2795), we published a proposed rule to define the term ``gluten-free'' and allow its voluntary use in the labeling of foods. In brief, the proposed rule would:
Define the term ``gluten-free'' for voluntary use in the labeling of foods, to mean that the food does not contain any of the following: An ingredient that is any species of the grains wheat, rye, barley, or a crossbred hybrid of these grains (collectively referred to in the proposed rule as ``prohibited grains''); an ingredient that is derived from a prohibited grain and that has not been processed to remove gluten (e.g., wheat flour); an ingredient that is derived from a prohibited grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 ppm or more gluten in the food; or 20 ppm or more gluten.
Deem a food to be misbranded that bears the claim ``gluten-free'' or similar claim in its labeling and fails to meet the conditions specified in the proposed definition of ``gluten-free.''
Deem a food to be misbranded if it bears a ``gluten-free'' claim in its labeling if the food is inherently free of gluten and if the claim does not refer to all foods of that same type (e.g., ``milk, a gluten-free food'' or ``all milk is gluten-free'').
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Deem a food made from oats that bears a ``gluten-free'' claim in its labeling to be misbranded if the claim suggests that all such foods are ``gluten-free'' or if 20 ppm or more gluten is present in the food.
The proposed rule would create a new Sec. 101.91 entitled ``Gluten-free labeling of food.'' In the preamble to the proposed rule (72 FR 2795 at 2803), we stated that, after publication of the proposed rule, we would conduct a safety assessment for gluten exposure consistent with the safety assessment-based approach described in the Thresholds Report. We requested comments providing data relevant to the safety assessment. We stated that we would publish a notice in the Federal Register seeking comment on the draft safety assessment and its potential use in the final rule and that we would consider public and peer-review comments in revising the safety assessment, as appropriate. Under the safety assessment-based approach, the labeling threshold would be determined at least in part on the basis of a ``safe'' level or ``tolerable daily intake'' (TDI) of a substance as calculated using the NOAELs and the Lowest Observed Adverse Effect Levels from available dose-response data in animals or humans and applying one or more appropriate ``uncertainty factors'' to account for gaps, limitations, and uncertainty in the data and for inter-individual difference (i.e., variability among individuals within the target population).
We subsequently completed a health hazard assessment of the adverse health effects of gluten exposure in individuals with celiac disease that included a safety assessment for gluten, and we submitted a report on this health hazard assessment, the ``Gluten Report,'' to scientific experts for peer review. In the preamble to this final rule, we generally use the term ``safety assessment'' to mean the entire analysis reported in the ``Gluten Report'', because this language is consistent with the Thresholds Report's use of the term ``safety assessment-based approach.'' We revised the ``Gluten Report'' after considering the experts' comments and made a report concerning the peer review available at our Web site at http://www.fda.gov/downloads/Food/ScienceResearch/ResearchAreas/RiskAssessmentSafetyAssessment/UCM264152.pdf.
In the Federal Register of August 3, 2011 (76 FR 46671), we published a notice (2011 notice) that reopened the comment period for the proposed rule, in part, to announce the availability of the ``Gluten Report'' and to invite comments on the report. We also asked whether and if so, how, the safety assessment should affect FDA's proposed definition of ``gluten-free'' in the final rule. Finally, we sought comment on our tentative conclusion that the safety assessment-
based approach may lead to a conservative, highly uncertain estimation of risk to individuals with celiac disease associated with very low levels of gluten exposure, and that the final rule should adopt the proposed rule's approach to defining the term ``gluten-free.'' We also sought comment on a few other matters unrelated to the questions about the safety assessment and its potential use in the final rule.
We received a number of comments concerning our safety assessment. To the extent those comments address the potential use of the safety assessment in the final rule, we describe and respond to them in part II. We discuss and respond to comments that focused on the safety assessment's methodology in ``FDA's Responses to Comments on the Report Titled `Health Hazard Assessment for Gluten Exposure in Individuals With Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten,' '' (Ref. 24) which is available at http://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafetyAssessment/UCM362401.pdf. We received nearly 2,000 submissions in response to both the proposed rule and to the 2011 notice announcing the reopening of the comment period. Most submissions came from individuals, and we also received comments from industry and trade associations, consumer and advocacy groups, academic organizations, and foreign government agencies. For example, many comments from consumers stated that they currently must search the list of ingredients on each product and that it is difficult to do so because the presence of gluten is not always evident to a layperson from the information on the label. Some comments noted that consumers often contact the manufacturer to confirm if the food contains gluten and that this task requires significant time and effort. The comments stated that foods labeled ``gluten-free'' according to a standard definition would provide an easier and faster way to identify such foods. Despite the apparent broad consensus among comments about the need for a standard definition of ``gluten-free,'' the comments raised many distinct issues about how such a definition should be developed and implemented.
We discuss the issues raised in the comments on the proposed rule as well as the 2011 notice, and also describe the final rule, in section II. For ease of reading, we preface each comment discussion with a numbered ``Comment,'' and each response by a corresponding numbered ``Response.'' We have numbered each comment to help distinguish among different topics. The number assigned is for organizational purposes only and does not signify the comment's value, importance, or the order in which it was received.
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What issues did the comments raise? What are FDA's responses to the comments? What does the final rule say?
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What general comments did we receive? What regulatory approach should we take?
As explained in sections I.C and I.D, the Thresholds Report summarized the current state of scientific knowledge with respect to a dose-response relationship for gluten, and presented four potential approaches that we might consider in establishing such a threshold level. We decided to issue a proposed rule that used one of those approaches, an analytical methods-based approach, under which the thresholds are determined by the sensitivity of the analytical method(s) used to verify compliance. However, we also conducted a safety assessment in which we reviewed available human challenge studies, exposure data, and other information, applying certain specified assumptions and appropriate ``uncertainty factor'' multipliers to account for knowledge gaps, to arrive at an estimation of risk to individuals with celiac disease associated with very low levels of gluten exposure. In the safety assessment we estimated level of concern (LOC) values for individuals with celiac disease, depending upon the corresponding age group and whether the adverse health effects are clinical or morphological and/or physiological in nature, at the 90th percentile level of intake of ``all celiac disease grain foods.'' As described in the ``Gluten Report,'' the estimated gluten LOC values for individuals with celiac disease range from 0.01 to 0.06 ppm. However, as we noted in the 2011 notice, this estimation of risk to individuals with celiac disease associated with very low levels of gluten exposure may be conservative and highly uncertain.
Many comments supported our tentative conclusion to use the analytical method-based approach, rather than the safety assessment-
based approach, and supported our proposed
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criteria for defining the term ``gluten-free,'' including the proposed requirement that food bearing a ``gluten-free'' claim not contain 20 ppm or more gluten. Some comments argued that the safety assessment-
based approach should be followed. The comments on our approach raised four primary points concerning which approach to use in the final rule, addressed in more detail in the following bulleted list. These were:
The potential impact of the choice of approach on the availability of foods that could be labeled ``gluten-free'';
The potential impact on the health of individuals with celiac disease of the choice of approach for establishing a regulatory definition of ``gluten-free'';
The availability of analytical methods to evaluate compliance and to enforce a regulatory definition of ``gluten-free'' at different levels; and
The relationship between FDA's definition of ``gluten-
free'' and that of international bodies.
1. How would the choice of approach affect the availability of gluten-
free foods?
(Comment 1) Several comments stated that using an extremely low level of gluten, such as those estimated in the safety assessment, to define ``gluten-free'' could cause some manufacturers to stop identifying food as gluten-free. The comments explained that, under the safety assessment-based approach, a manufacturer might stop identifying a food as gluten-free because the food could not meet a very low gluten threshold (e.g., 0.01 ppm gluten) for reasons such as an ingredient's cross-contact with gluten-containing grain during agricultural production or supply stages or difficulty separating gluten-containing and gluten-free products in mixed-use processing facilities.
Many comments from individuals with celiac disease stated that they rely on products labeled ``gluten-free'' to reduce the time spent reading ingredient lists on products to determine if the foods are safe for them to eat. These comments expressed concern that if we establish a gluten content that is lower than The possibility that the analytical methods we chose would become outdated quickly. The comment indicated that there are two or more additional commercially available test kits that offer peer reviewed performance that is at least equivalent to the analytical methods (the ELISA R5- Mendez Method and the Morinaga method) we had identified in the 2011 notice (76 FR 46671 at 46672).
Limiting the testing options for food manufacturers and regulatory and commercial laboratories. The comment expressed concern that identifying specific analytical methods in the final rule could result in problems when a specific kit becomes unavailable on a temporary basis or if the kit was changed or removed from market for any reason.
Limiting our flexibility to use improved technology as it becomes available and dissuading test kit manufacturers from developing improved methods.
Another comment supported our selection of the ELISA R5-Mendez Method, but stated that ``analysts should be free to use any method that provides comparable results'' and that ``other methods may be equivalent.'' Another comment urged us to ``remain flexible as to the method of test validation'' and added that not specifying analytical methods would ``permit a more rapid development of dependable and affordable technologies for testing gluten.'' Additional comments recommended that FDA develop performance criteria rather than identify particular analytical methods to enable the widest choice among gluten-
detection methods that the Agency and other entities could consider using to determine compliance with a ``gluten-free'' claim. However, the comments did not provide any data or information on performance criteria that FDA should consider.
(Response 21) Upon further consideration, we agree that specifying the analytical methods in the final rule could limit our flexibility and possibly deter the development of new and better analytical methods. We also note that specifying the analytical methods we would use for compliance purposes, as part of the final rule, would not be binding on food manufacturers because neither the proposed rule nor this final rule requires them to use the same analytical methods to determine the gluten content. To the extent that food manufacturers or other interested parties want to know the specific scientifically valid method we intend to consider using when determining compliance, we can identify this method through other means (such as through a guidance document).
If we were to specify analytical methods in the final rule that FDA is to use to determine compliance with the final rule, and the methods are revised, we would have to, by regulation, change the methods specified in the rule. The revisions to the methods may be more than a technical change and require notice and comment rulemaking. As one comment recognized, if we had to engage in rulemaking to revise or update analytical methods, we would run the risk that the analytical methods specified by regulation would become outdated or obsolete quickly (especially if the methods were revised or updated frequently) and that we would deter the development of better test methods. We have, however, revised Sec. 101.91(c) by inserting ``scientifically valid'' before ``method'' to make clear that we will use a scientifically valid method for purposes of compliance testing.
As for the comments regarding the use of performance criteria, the comments did not provide any data and information on which the Agency could rely to support such an approach. Therefore, we are not making changes in response to this comment.
(Comment 22) Many comments discussed how manufacturers might comply with the rule. The comments asked that we require foods (including oats) to be ``certified'' or verified that they do not contain 20 ppm or more gluten and to meet all other FDA requirements for a gluten-free food before being labeled ``gluten-free.'' The comments argued that certification would provide assurance that foods bearing this claim do not contain levels of gluten at or above 20 ppm. Many comments expressed the concern that cross-contact with gluten-containing ingredients could result in the inadvertent presence of gluten in a food labeled ``gluten-free.''
(Response 22) We decline to revise the rule to require certification that foods comply with the definition and requirements regarding a ``gluten-free'' claim. Under sections 403(a)(1) and 201(n) of the FD&C Act, manufacturers must ensure that all statements they include on their food labels are truthful and not misleading. The final rule defines the term ``gluten-free,'' but does not require manufacturers to use a
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particular test methodology or to certify their products.
Additionally, given the range of food products and methods of manufacturing, it would be impractical and an inefficient use of our resources for us to require, through regulation, a precise manner in which manufacturers must or should certify or verify the gluten content of their products. Manufacturers are free to develop their own methods that best suits their particular needs to determine the gluten content of their products. In addition, other methods may be used for quality control, specifications, contracts, surveys, and similar non-regulatory functions. Some companies may choose, but are not required, to have third parties certify or verify the gluten content of their product to ensure their products labeled as ``gluten-free'' are within the definition of ``gluten-free.''
4. Miscellaneous Comments
Several comments addressed matters that were not specific to a particular provision in the proposed rule or issues not covered by the rule. We address those comments here.
(Comment 23) In the preamble to the proposed rule, we recognized that even those foods that comply with the proposed definition of ``gluten-free'' nonetheless could contain some amount of gluten up to 20 ppm (72 FR 2795 at 2803). We questioned whether the potential presence of some gluten below 20 ppm would be a material fact that would make a ``gluten-free'' claim potentially misleading. We invited comments on whether the use of additional qualifying language (e.g., ``does not contain 20 ppm or more gluten per gram of food'') would be necessary to inform individuals with celiac disease that a food labeled as ``gluten-free'' nonetheless may contain the amount of gluten permitted under whatever threshold level is established in the final rule. The 2011 notice repeated the invitation for comments and provided an example of such qualifying language in the form of ``a possible asterisk after the term `gluten-free' and an associated statement that says, e.g., `does not contain 20 ppm or more gluten' '' (76 FR 46671 at 46675).
We received comments both supporting and opposing the addition of language to indicate that foods labeled ``gluten-free'' could have the potential presence of less than 20 ppm gluten in the product. Comments supporting the inclusion of this language on the label explained that this would inform consumers about the meaning of the ``gluten-free'' claim. Many comments indicated that the public should receive truth in labeling and therefore the label should indicate the presence of even trace amounts of gluten.
In contrast, comments opposing the additional qualifying language stated that it would likely confuse consumers without providing any additional benefits. One comment noted that there appears to be no other health-related claims (e.g., fat-free, sugar-free, low-sodium) that define or further qualify the regulatory definition via additional labeling statements and that ``a good labeling regulation does not distort a valid, established public health standard.'' In addition, some comments suggested the additional language could discourage manufacturers from making a ``gluten-free'' claim on products that are inherently gluten-free and produced under cGMPs. The comments said that manufacturers whose foods had gluten content well below 20 ppm could refrain from labeling their food as ``gluten-free'' because the qualifying language could mislead consumers into assuming most products contain the maximum levels of gluten.
(Response 23) We agree with the comments opposing the use of qualifying language to inform individuals with celiac disease that a food labeled as ``gluten-free'' nonetheless may contain less than 20 ppm of gluten because the final rule defines the criteria and requirements for the ``gluten-free'' labeling claim. The lawful use of the federally defined term ``gluten-free'' on a food label will inform both consumers and industry of the fact that the food bearing the ``gluten-free'' claim may not contain 20 ppm or more gluten. Education and outreach programs will be important to ensure that individuals with celiac disease and other consumers understand the definition and the changes set forth by these regulations.
We also agree with the comment that additional qualifying language that would, in effect, restate Sec. 101.91(a)(3) would be inconsistent with other FDA regulated labeling claims (e.g., fat-free, sugar-free) that define the term without the need to further qualify that regulatory definition elsewhere on the label.
We also agree with the comments suggesting that additional qualifying language could create a disincentive for manufacturers to make a ``gluten-free'' claim. For example, if a manufacturer's food had less than 5 ppm gluten, but the final rule would require the manufacturer to state ``does not contain 20 ppm or more gluten'' in addition to the ``gluten-free'' claim, the manufacturer might decide to remove the ``gluten-free'' claim rather than risk creating the misimpression that its food contained up to 20 ppm gluten. Additionally, if a manufacturer could improve its manufacturing or processing operations to create a food with less than 5 ppm gluten, but the final rule would require the statement of ``does not contain 20 ppm or more gluten,'' the manufacturer might decide to forego those improvements because the statement would only refer to ``20 ppm or more gluten.'' Requiring the additional qualifying language, therefore, could result in fewer ``gluten-free''-labeled foods being available and limit the ability of individuals with celiac disease to follow a gluten-free diet.
We do not agree with the comments supporting the additional qualifying language. While we acknowledge the desire of some consumers to know the exact gluten content of foods, we adopted an analytical methods-based approach, with a threshold level of 20 ppm gluten, because we determined that this level is appropriate, enforceable, and practical after considering multiple types of information, including the scientific literature on the sensitivity of consumers with celiac disease and information on the methods available to reliably detect and quantify gluten in a wide variety of foods.
Therefore, the final rule does not require the use of additional qualifying language (e.g., ``does not contain 20 ppm or more gluten'') to inform individuals with celiac disease that a food labeled as ``gluten-free'' nonetheless may contain less than 20 ppm gluten.
(Comment 24) A few comments asked about the inclusion of wheat starch in foods labeled ``gluten-free.'' Proposed Sec. 101.91(a)(3)(iii) would allow a food to bear a ``gluten-free'' claim provided that any ingredient that is derived from a prohibited grain has been processed to remove gluten (e.g., wheat starch), if the use of the ingredient does not result in the presence of 20 ppm or more gluten in the finished food. Wheat starch is an ingredient derived from wheat (a gluten containing grain) that has been processed to remove gluten. As discussed in our response to comment 17 (regarding a
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