Title 21 published on 2013-04-01
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.
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).
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
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 101 after this date.