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Federal Register Proposed Rule - 72 FR 2795 January 23, 2007: Food Labeling; Gluten-Free Labeling of Foods
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[Federal Register: January 23, 2007 （Volume 72, Number 14）]
[Proposed Rules]
[Page 2795-2817]
From the Federal Register online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23ja07-10]
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Proposed Rules
Federal Register
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This section of the FEDERAL REGISTER contains notices to the public of the proposed issuance of rules and regulations. The purpose of these notices is to give interested persons an opportunity to participate in the rule making prior to the adoption of the final rules.
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[[Page 2795]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 2005N-0279]
RIN 0910-ZA26
Food Labeling; Gluten-Free Labeling of Foods
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration （FDA） is proposing to 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 （all noted grains are collectively referred to 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 parts per million （ppm） or more gluten in the food; or 20 ppm or more gluten. A food 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'' would be deemed misbranded. FDA also is proposing to deem misbranded a food bearing 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''）. In addition, a food made from oats that bears a gluten-free claim in its labeling would be deemed misbranded if the claim suggests that all such foods are gluten-free or if 20 ppm or more gluten is present in the food. Establishing a definition of the term ``gluten-free'' and uniform conditions for it use in the labeling of foods is needed 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 proposed action is in response to the Food Allergen Labeling and Consumer Protection Act of 2004 （FALCPA）.
DATES: Submit written or electronic comments by April 23, 2007.
ADDRESSES: You may submit comments, identified by Docket No. 2005N-
0279, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
Federal eRulemaking Portal: http://www.regulations.gov1.
Follow the instructions for submitting comments.
Agency Web site: http://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management （HFA-305）, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal or the agency Web site, as described in the Electronic Submissions portion of this paragraph.
Instructions: All submissions received must include the agency name and Docket No（s）. and Regulatory Information Number （RIN） （if a RIN number has been assigned） for this rulemaking. All comments received
may be posted without change to http://www.fda.gov/ohrms/dockets/default.htm, including any personal information provided. For detailed instructions on submitting comments and additional information on the rulemaking process, see the ``Comments'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
Docket: For access to the docket to read background documents or comments received, go to http://www.fda.gov/ohrms/dockets/default.htm and insert the docket number（s）, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Rhonda R. Kane, Center for Food Safety and Applied Nutrition （HFS-820）, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD, 301-436-2371, FAX: 301-436-2636, e-mail: rhonda.kane@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. Celiac Disease
B. Prevalence of Celiac Disease in the United States
C. Gluten and the Grains of Concern for Individuals with Celiac
Disease
1. Meaning of the Term ``Gluten''
2. Grains of Concern to Individuals with Celiac Disease
3. Uncertainty about Including Oats in the Diet of Individuals with Celiac Disease
D. FDA's Prior Statements on Gluten-Free Food Labeling
E. Food Allergen Labeling and Consumer Protection Act of 2004 and
Related Activities
1. Food Allergen Labeling and Consumer Protection Act of 2004
2. FDA's Threshold Working Group and Its Report on Approaches to Establish Thresholds
3. Food Advisory Committee Meeting of July 13-15, 2005
4. Gluten-Free Food Labeling Public Meeting of August 19, 2005
II. Proposed Rule
A. Legal Basis
B. Definitions and Criteria for the Use of the Term Gluten-Free in Food Labeling
1. Definitions of the Terms ``Prohibited Grains'' and ``Gluten''
2. Definition of the Term ``Gluten-Free''
3. Use of the Term Gluten-Free in the Labeling of Foods That Inherently Do Not Contain Gluten
4. Use of the Analytical Methods-based Approach in this Proposed Rule to Set a Threshold Level of 20 ppm to Define the Term Gluten-Free
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C. Compliance and Enforcement of an FDA Gluten-Free Food Labeling Claim
III. Preliminary Regulatory Impact Analysis
A. Need for This Regulation
B. Proposed Regulatory Options
C. Impacts of the Proposed Regulatory Options
1. Option One: Take No Action
2. Option Two: Take the Proposed Action--Do Not Permit Firms to Make Gluten-Free Claims on Foods Containing the Prohibited Grains or Ingredients That Have Been Derived From Those Grains and Have Not Been Processed to Remove the Gluten; Do Not Permit Firms to Make Gluten-Free Claims on Foods Containing Ingredients Derived From the Prohibited Grains That Have Been Processed to Remove the Gluten, If the Level of Gluten Is 20 ppm or Greater; Do Not Permit Firms to Make Gluten-Free Claims on Foods Containing 20 ppm or More Gluten, Regardless of How the Gluten Got Into the Food; and Restrict Wording of Gluten-Free Claims on Foods That Inherently Do Not Contain Gluten
a. Overview
b. Costs
c. Benefits
d. Summary
3. Option Three: Take the Proposed Action, Except Do Not Permit Firms to Make Gluten-Free Claims on Foods Containing Ingredients Derived From the Prohibited Grains That Have Been Processed to Remove The Gluten, If the Level of Gluten Is Some Specified Level Other Than 20 ppm, and Do Not Permit Firms to Make Gluten-Free Claims on Foods Ifthe Level Of Gluten Is Some Specified Level Other Than 20 ppm, Regardless of How the Gluten Got Into the Food
a. Overview
b. Costs
c. Benefits
d. Summary
4. Option Four: Do Not Permit Firms to Make Gluten-Free Claims on Foods Containing 20 ppm or More Gluten, Regardless of the Ingredients They Use to Make Them, and Restrict the Wording of Gluten-Free Claims on Foods That Inherently Do Not Contain Gluten
5. Option Five: Take the Proposed Action, Except Delete Wording Requirements for Gluten-Free Claims on Foods That Inherently Do Not Contain Gluten
6. Option Six: Take the Proposed Action, but Also Define the Food Labeling Claim ``Low Gluten''
7. Option Seven: Take Proposed Action, Except Include Oats in the List of Grains That We Propose to Prohibit in Foods That Firms Label as Gluten-Free
IV. Regulatory Flexibility Analysis
A. Proposed Regulatory Options
B. Impacts of the Proposed Regulatory Options on Small Entities
1. Option One: Take No Action
2. Option Two: Take the Proposed Action--Do Not Permit Firms to Make Gluten-Free Claims on Foods Containing the Prohibited Grains or Ingredients That Have Been Derived From Those Grains and Have Not Been Processed to Remove the Gluten; Do Not Permit Firms to Make Gluten-Free Claims on Foods Containing Ingredients Derived From the Prohibited Grains That Have Been Processed to Remove the Gluten, If the Level of Gluten Is 20 ppm or Greater; Do Not Permit Firms to Make Gluten-Free Claims on Foods Containing 20 ppm or More Gluten, Regardless of How the Gluten Got Into the Food; and Restrict Wording of Gluten-Free Claims on Foods That Inherently Do Not Contain Gluten
3. Option Three: Take the Proposed Action, Except Do Not Permit Firms to Make Gluten-Free Claims on Foods Containing Ingredients Derived From the Prohibited Grains That Have Been Processed to Remove the Gluten, If the Level of Gluten Is Some Specified Level Other Than 20 ppm, and Do Not Permit Firms to Make Gluten-Free Claims on Foods If the Level of Gluten Is Some Specified Level Other Than 20 ppm,Regardless of How the Gluten Got Into the Food
4. Option Four: Do Not Permit Firms to Make Gluten-Free Claims on Foods Containing 20 ppm or More Gluten, Regardless of the Ingredients They Use to Make Them, and Restrict the Wording of Gluten-Free Claims on Foods That Inherently Do Not Contain Gluten
5. Option Five: Take the Proposed Action, Except Delete Wording Requirements for Gluten-Free Claims on Foods That Inherently Do Not Contain Gluten
6. Option Six: Take the Proposed Action, but Also Define the Food Labeling Claim ``Low Gluten''
7. Option Seven: Take Proposed Action, but Include Oats in the List of Grains That We Propose to Prohibit in Foods That Firms Label a Gluten-Free
V. Unfunded Mandates
VI. Executive Order 13132: Federalism
VII. Environmental Impact Analysis
VIII. Paperwork Reduction Act of 1995
IX. Comments
X. References
