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HHS/FDA | RIN: 0910-AH00 | Publication ID: Fall 2017 |
Title: Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods | |
Abstract:
FDA was required by statute to establish criteria for the voluntary labeling of food as "gluten-free” to assist consumers with celiac disease who must avoid gluten in their diet. In 2013, FDA issued a final rule on gluten-free” labeling that established criteria for when food may be labeled "gluten-free.” The final rule included methods that FDA would use for testing for the presence of gluten, which are appropriate for many food types, but not for fermented and hydrolyzed foods. FDA then issued a proposed rule entitled "Gluten-Free Labeling of Fermented or Hydrolyzed Foods” to propose requirements for maintenance of certain records that provide alternative means for the agency to verify that manufacturers of fermented and hydrolyzed foods have complied with the federal criteria for foods voluntarily labeled "gluten-free.” |
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Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: No | Unfunded Mandates: No |
EO 13771 Designation: Regulatory | |
CFR Citation: 21 CFR 101.91(c) | |
Legal Authority: sec. 206 of the Food Allergen Labeling and Consumer Protection Act 21 U.S.C. 343(a)(1) 21 U.S.C. 321(n) 21 U.S.C. 371(a) |
Legal Deadline:
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Timetable:
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Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: Undetermined |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: Yes | |
Agency Contact: Carol D'Lima Staff Fellow Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition, Room 4D022, HFS 820, 5001 Campus Drive, College Park, MD 20740 Phone:240 402-2371 Fax:301 436-2636 Email: carol.dlima@fda.hhs.gov |