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Health claims not authorized for foods in conventional food form or for dietary supplements of vitamins, minerals, herbs, or other similar substances:
(a) Dietary fiber and cardiovascular disease.
(b) Zinc and immune function in the elderly.
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.
§ 1453 - Requirements of labeling; placement, form, and contents of statement of quantity; supplemental statement of quantity
§ 1454 - Rules and regulations
§ 1455 - Procedure for promulgation of regulations
§ 321 - Definitions; generally
§ 331 - Prohibited acts
§ 342 - Adulterated food
§ 343 - Misbranded food
§ 348 - Food additives
§ 371 - Regulations and hearings
§ 243 - General grant of authority for cooperation
§ 264 - Regulations to control communicable diseases
§ 271 - Penalties for violation of quarantine laws
Title 21 published on 2015-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 101 after this date.
The Food and Drug Administration (FDA or we) is proposing to establish requirements concerning “gluten-free” labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. These additional requirements for the “gluten-free” labeling rule are needed to help ensure that individuals with celiac disease are not misled and receive truthful and accurate information with respect to fermented or hydrolyzed foods labeled as “gluten-free.” There is uncertainty in interpreting the results of current gluten test methods for fermented and hydrolyzed foods on a quantitative basis that equates the test results in terms of intact gluten. Thus, we propose to evaluate compliance of such fermented and hydrolyzed foods that bear a “gluten-free” claim with the gluten-free labeling rule based on records that are made and kept by the manufacturer of the food bearing the “gluten-free” claim and made available to us for inspection and copying. The records would need to provide adequate assurance that the food is “gluten-free” in compliance with the gluten-free food labeling final rule before fermentation or hydrolysis. In addition, the proposed rule would require the manufacturer of fermented or hydrolyzed foods bearing the “gluten-free” claim to document that it has adequately evaluated the potential for gluten cross-contact and, if identified, that the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process. Likewise, manufacturers of foods that contain fermented or hydrolyzed ingredients and bear the “gluten-free” claim would be required to make and keep records that demonstrate with adequate assurance that the fermented or hydrolyzed ingredients are “gluten-free” in compliance with the gluten-free food labeling final rule. Finally, the proposed rule would state that we would evaluate compliance of distilled foods by verifying the absence of protein using scientifically valid analytical methods that can reliably detect the presence of protein or protein fragments in the distilled food.
The Food and Drug Administration (FDA or we) is announcing the establishment of a docket to receive information and comments on the use of the term “natural” in the labeling of human food products, including foods that are genetically engineered or contain ingredients produced through the use of genetic engineering. We are taking this action in part because we received three citizen petitions asking that we define the term “natural” for use in food labeling and one citizen petition asking that we prohibit the term “natural” on food labels. We also note that some Federal courts, as a result of litigation between private parties, have requested administrative determinations from FDA regarding whether food products containing ingredients produced using genetic engineering or foods containing high fructose corn syrup may be labeled as “natural.” We are working with the United States Department of Agriculture (USDA) Agricultural Marketing Service and Food Safety and Inspection Service to also examine the use of the term “natural” in meat, poultry, and egg products, and are considering areas for coordination between FDA and USDA. We invite public comment on the term “natural” in the context of food labeling and on specific questions contained in this document.
The Food and Drug Administration (FDA or we) is announcing the reopening of the comment period for certain documents associated with the proposed rule to amend FDA's labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the Nutrition Facts and Supplement Facts labels to assist consumers in maintaining healthy dietary practices. We also are reopening the comment period for a supplemental proposed rule to revise the Nutrition Facts and Supplement Facts labels. We are taking this action due to technical difficulties at the Federal eRulemaking Portal.
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods—Part II (Menu Labeling Requirements in Accordance with 21 CFR 101.11); Draft Guidance for Industry.” The draft guidance, when finalized, will help certain restaurants and similar retail food establishments comply with the menu labeling requirements, including the requirements to provide calorie and other nutrition information for standard menu items, including food on display and self-service food.
The Food and Drug Administration (FDA or we) is announcing the availability of certain documents to update the administrative docket of the proposed rule to amend FDA's labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the Nutrition Facts and Supplement Facts labels to assist consumers in maintaining healthy dietary practices.
The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a draft guidance for industry entitled “FDA's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels: Guidance for Industry.” The draft guidance, when finalized, will explain to manufacturers of conventional foods and dietary supplements our policy on determining the amount to declare on the nutrition label for certain nutrients and dietary ingredients that are present in a small amount.
The Food and Drug Administration (FDA or we) is revising certain provisions of the proposed rule, issued in March 2014, that would amend FDA's labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the Nutrition Facts and Supplement Facts labels to assist consumers in maintaining healthy dietary practices (“the NFL/SFL proposed rule”). We are proposing text for the footnotes to be used on the Nutrition Facts label. We are taking this action after completing our consumer research in which we tested various footnote text options for the label. We are also proposing to establish a Daily Reference Value (DRV) of 10 percent of total energy intake from added sugars, proposing to require the declaration of the percent Daily Value (DV) for added sugars on the label, and are providing additional rationale for the declaration of added sugars on the label. We are taking these actions based, in part, on the science underlying a new report released by the 2015 Dietary Guidelines Advisory Committee.
The Food and Drug Administration (FDA or we) is reopening, as to specific documents, the comment period regarding our proposed rule to revise the Nutrition Facts and Supplement Facts labels. We are reopening the comment period for 60 days for the sole purpose of inviting public comments on two consumer studies being added to the administrative record. The consumer studies pertained to proposed changes to the Nutrition Facts label formats.
The Food and Drug Administration (FDA or we) is extending the compliance date for the final rule requiring disclosure of certain nutrition information for standard menu items in certain restaurants and retail food establishments. The final rule appeared in the Federal Register of December 1, 2014. We are taking this action in response to requests for an extension and for further clarification of the rule's requirements.