Title 21 published on 2014-04-01
The following are only the Rules published in the Federal Register after the published date of Title 21.
For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.
2014-12-10; vol. 79 # 237 - Wednesday, December 10, 2014 79 FR 73201 - Uniform Compliance Date for Food Labeling Regulations
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective December 10, 2014. Submit electronic or written comments by February 9, 2015. 21 CFR Part 101 Summary The Food and Drug Administration (FDA or we) is establishing January 1, 2018, as the uniform compliance date for food labeling regulations that are issued between January 1, 2015, and December 31, 2016. We periodically announce uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes. On November 28, 2012, we established January 1, 2016, as the uniform compliance date for food labeling regulations issued between January 1, 2013, and December 31, 2014.
2014-12-01; vol. 79 # 230 - Monday, December 1, 2014 79 FR 71156 - Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. Effective date: December 1, 2015. Compliance date: Covered establishments must comply with the rule by December 1, 2015. See section XXIII for more information on the effective and compliance dates. Comment Date: Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by December 31, 2014 (see section XXVI, the “Paperwork Reduction Act of 1995” section of this document). 21 CFR Parts 11 and 101 Summary To implement the nutrition labeling provisions of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act or ACA), the Food and Drug Administration (FDA or we) is requiring disclosure of certain nutrition information for standard menu items in certain restaurants and retail food establishments. The ACA, in part, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act), among other things, to require restaurants and similar retail food establishments that are part of a chain with 20 or more locations doing business under the same name and offering for sale substantially the same menu items to provide calorie and other nutrition information for standard menu items, including food on display and self-service food. Under provisions of the ACA, restaurants and similar retail food establishments not otherwise covered by the law may elect to become subject to these Federal requirements by registering every other year with FDA. Providing accurate, clear, and consistent nutrition information, including the calorie content of foods, in restaurants and similar retail food establishments will make such nutrition information available to consumers in a direct and accessible manner to enable consumers to make informed and healthful dietary choices.
79 FR 71259 - Food Labeling; Calorie Labeling of Articles of Food in Vending Machines
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. Effective Date: December 1, 2016. Compliance Date: Covered vending machine operators must comply with the rule by December 1, 2016. See section III.E for more information on the effective and compliance dates. Comment Date: Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by December 31, 2014 (see section V, the “Paperwork Reduction Act of 1995” section of this document). 21 CFR Parts 11 and 101 Summary To implement the vending machine food labeling provisions of the Patient Protection and Affordable Care Act of 2010 (ACA), the Food and Drug Administration (FDA or we) is establishing requirements for providing calorie declarations for food sold from certain vending machines. This final rule will ensure that calorie information is available for certain food sold from a vending machine that does not permit a prospective purchaser to examine the Nutrition Facts Panel before purchasing the article, or does not otherwise provide visible nutrition information at the point of purchase. The declaration of accurate and clear calorie information for food sold from vending machines will make calorie information available to consumers in a direct and accessible manner to enable consumers to make informed and healthful dietary choices. This final rule applies to certain food from vending machines operated by a person engaged in the business of owning or operating 20 or more vending machines. Vending machine operators not subject to the rules may elect to be subject to the Federal requirements by registering with FDA.
2014-04-28; vol. 79 # 81 - Monday, April 28, 2014 79 FR 23262 - Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective January 1, 2016. 21 CFR Part 101 Summary The Food and Drug Administration (FDA, the Agency, or we) is issuing this rule to prohibit certain nutrient content claims for foods, including conventional foods and dietary supplements, that contain omega-3 fatty acids, based on our determination that such nutrient content claims do not meet the requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). We are taking this action in response to three notifications submitted to us. One notification concerning nutrient content claims for alpha-linolenic acid (ALA), docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA) was submitted collectively by Alaska General Seafoods, Ocean Beauty Seafoods, Inc., and Trans-Ocean Products, Inc. (the seafood processors notification); a second notification concerning nutrient content claims for ALA, DHA, and EPA was submitted by Martek Biosciences Corp. (the Martek notification); and a third notification concerning nutrient content claims for DHA and EPA was submitted by Ocean Nutrition Canada, Ltd. (the Ocean Nutrition notification). The final rule prohibits the nutrient content claims for DHA and EPA set forth in the three notifications and the nutrient content claims for ALA set forth in the seafood processors notification. FDA is taking no regulatory action at this time with respect to the nutrient content claims for ALA set forth in the Martek notification and, therefore, these claims will be allowed to remain on the market.
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office] .
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
United States Code U.S. Code: Title 15 - COMMERCE AND TRADE U.S. Code: Title 21 - FOOD AND DRUGS U.S. Code: Title 42 - THE PUBLIC HEALTH AND WELFARE
Title 21 published on 2014-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 101 after this date.
2014-12-10; vol. 79 # 237 - Wednesday, December 10, 2014 79 FR 73201 - Uniform Compliance Date for Food Labeling Regulations
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective December 10, 2014. Submit electronic or written comments by February 9, 2015. 21 CFR Part 101 Summary The Food and Drug Administration (FDA or we) is establishing January 1, 2018, as the uniform compliance date for food labeling regulations that are issued between January 1, 2015, and December 31, 2016. We periodically announce uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes. On November 28, 2012, we established January 1, 2016, as the uniform compliance date for food labeling regulations issued between January 1, 2013, and December 31, 2014.
2014-12-01; vol. 79 # 230 - Monday, December 1, 2014 79 FR 71156 - Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. Effective date: December 1, 2015. Compliance date: Covered establishments must comply with the rule by December 1, 2015. See section XXIII for more information on the effective and compliance dates. Comment Date: Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by December 31, 2014 (see section XXVI, the “Paperwork Reduction Act of 1995” section of this document). 21 CFR Parts 11 and 101 Summary To implement the nutrition labeling provisions of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act or ACA), the Food and Drug Administration (FDA or we) is requiring disclosure of certain nutrition information for standard menu items in certain restaurants and retail food establishments. The ACA, in part, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act), among other things, to require restaurants and similar retail food establishments that are part of a chain with 20 or more locations doing business under the same name and offering for sale substantially the same menu items to provide calorie and other nutrition information for standard menu items, including food on display and self-service food. Under provisions of the ACA, restaurants and similar retail food establishments not otherwise covered by the law may elect to become subject to these Federal requirements by registering every other year with FDA. Providing accurate, clear, and consistent nutrition information, including the calorie content of foods, in restaurants and similar retail food establishments will make such nutrition information available to consumers in a direct and accessible manner to enable consumers to make informed and healthful dietary choices.
79 FR 71259 - Food Labeling; Calorie Labeling of Articles of Food in Vending Machines
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. Effective Date: December 1, 2016. Compliance Date: Covered vending machine operators must comply with the rule by December 1, 2016. See section III.E for more information on the effective and compliance dates. Comment Date: Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by December 31, 2014 (see section V, the “Paperwork Reduction Act of 1995” section of this document). 21 CFR Parts 11 and 101 Summary To implement the vending machine food labeling provisions of the Patient Protection and Affordable Care Act of 2010 (ACA), the Food and Drug Administration (FDA or we) is establishing requirements for providing calorie declarations for food sold from certain vending machines. This final rule will ensure that calorie information is available for certain food sold from a vending machine that does not permit a prospective purchaser to examine the Nutrition Facts Panel before purchasing the article, or does not otherwise provide visible nutrition information at the point of purchase. The declaration of accurate and clear calorie information for food sold from vending machines will make calorie information available to consumers in a direct and accessible manner to enable consumers to make informed and healthful dietary choices. This final rule applies to certain food from vending machines operated by a person engaged in the business of owning or operating 20 or more vending machines. Vending machine operators not subject to the rules may elect to be subject to the Federal requirements by registering with FDA.
2014-05-29; vol. 79 # 103 - Thursday, May 29, 2014 79 FR 30763 - Proposed Rules on Food Labeling: Revision of the Nutrition and Supplement Facts Labels and Serving Sizes of Foods That Can Reasonably Be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments; Public Meeting
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of public meeting. See “How to Participate in the Public Meeting” in the SUPPLEMENTARY INFORMATION section of this document for dates and times of the public meeting, closing dates for advance registration, requesting special accommodations due to disability, and information on deadlines for submitting either electronic or written comments to FDA's Division of Dockets Management. 21 CFR Part 101 Summary The Food and Drug Administration (FDA or we) is announcing a public meeting to discuss two proposed rules aimed at updating nutrition information and serving size requirements on the nutrition facts labels to provide consumers with information that could be used to maintain healthy dietary practices. The purpose of the public meeting is to inform the public of the provisions of the proposed rules and the rulemaking process (including how to submit comments, data, and other information to both dockets) as well as solicit oral stakeholder and public comments on the proposed rules and to respond to questions about the proposed rules.
2014-05-27; vol. 79 # 101 - Tuesday, May 27, 2014 79 FR 30055 - Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Extension of Comment Period
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule; extension of comment period. FDA is extending the comment period on the proposed rule published on March 3, 2014 (79 FR 11880). Submit either electronic or written comments by August 1, 2014. 21 CFR Part 101 Summary The Food and Drug Administration (FDA, the Agency, or we) is extending the comment period for the proposed rule that appeared in the Federal Register of March 3, 2014. In the proposed rule, FDA requested comments on FDA's revision of the Nutrition and Supplement Facts Labels. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
79 FR 30056 - Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments; Extension of Comment Period
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule; extension of comment period. FDA is extending the comment period on the proposed rule published on March 3, 2014 (79 FR 11990). Submit either electronic or written comments by August 1, 2014. 21 CFR Part 101 Summary The Food and Drug Administration (FDA, the Agency, or we) is extending the comment period for the proposed rule that appeared in the Federal Register of March 3, 2014. In the proposed rule, FDA requested comments on FDA's regulations for serving sizes for the Nutrition Facts Label. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
2014-04-28; vol. 79 # 81 - Monday, April 28, 2014 79 FR 23262 - Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective January 1, 2016. 21 CFR Part 101 Summary The Food and Drug Administration (FDA, the Agency, or we) is issuing this rule to prohibit certain nutrient content claims for foods, including conventional foods and dietary supplements, that contain omega-3 fatty acids, based on our determination that such nutrient content claims do not meet the requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). We are taking this action in response to three notifications submitted to us. One notification concerning nutrient content claims for alpha-linolenic acid (ALA), docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA) was submitted collectively by Alaska General Seafoods, Ocean Beauty Seafoods, Inc., and Trans-Ocean Products, Inc. (the seafood processors notification); a second notification concerning nutrient content claims for ALA, DHA, and EPA was submitted by Martek Biosciences Corp. (the Martek notification); and a third notification concerning nutrient content claims for DHA and EPA was submitted by Ocean Nutrition Canada, Ltd. (the Ocean Nutrition notification). The final rule prohibits the nutrient content claims for DHA and EPA set forth in the three notifications and the nutrient content claims for ALA set forth in the seafood processors notification. FDA is taking no regulatory action at this time with respect to the nutrient content claims for ALA set forth in the Martek notification and, therefore, these claims will be allowed to remain on the market.
