Title 21 CFR reference

Scope and purpose.(a) (1) This subpart applies to the submission and consideration of petitions under section 403A(b) of the Federal Food, Drug, and Cosmetic Act (the act), by a State or a political subdivision of a State, requesting exemption of a State requirement from preemption under section 403A(a) of the act. (2) Section 403A(b) of the act provides that where a State requirement has been preempted under section 403A(a) of the act, the State may petition the agency for an exemption. The agency may grant the exemption, under such conditions as it may prescribe by regulation, if the agency finds that the State requirement will not cause any food to be in violation of any applicable requirement under Federal law, will not unduly burden interstate commerce, and is designed to address a particular need for information that is not met by the preemptive Federal requirement. Definitions.Actet seq.(b) (1) means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 ). Agency(2) means the Food and Drug Administration. Commissioner(3) means the Commissioner of Food and Drugs. State(4) means a State as defined in section 201(a)(1) of the act (which includes a territory of the…

In accordance with section 403(d) of the act, a food shall be deemed to be misbranded if its container is so made, formed, or filled as to be misleading. (a) A container that does not allow the consumer to fully view its contents shall be considered to be filled as to be misleading if it contains nonfunctional slack-fill. Slack-fill is the difference between the actual capacity of a container and the volume of product contained therein. Nonfunctional slack-fill is the empty space in a package that is filled to less than its capacity for reasons other than: (1) Protection of the contents of the package; (2) The requirements of the machines used for enclosing the contents in such package; (3) Unavoidable product settling during shipping and handling; (4) The need for the package to perform a specific function (e.g., where packaging plays a role in the preparation or consumption of a food), where such function is inherent to the nature of the food and is clearly communicated to consumers; (5) The fact that the product consists of a food packaged in a reusable container where the container is part of the presentation of the food and has value which is both significant in…

iodized saltiodized table salt(a) For the purposes of this section, the term or is designated as the name of salt for human food use to which iodide has been added in the form of cuprous iodide or potassium iodide permitted by §§ 184.1265 and 184.1634 of this chapter. In the labeling of such products, all words in the name shall be equal in prominence and type size. The statement “This salt supplies iodide, a necessary nutrient” shall appear on the label immediately following the name and shall be in letters which are not less in height than those required for the declaration of the net quantity of contents as specified in § 101.7 of this chapter. (b) Salt or table salt for human food use to which iodide has not been added shall bear the statement, “This salt does not supply iodide, a necessary nutrient.” This statement shall appear immediately following the name of the food and shall be in letters which are not less in height than those required for the declaration of the net quantity of contents as specified in § 101.7 of this chapter. (c) Salt, table salt, iodized salt, or iodized table salt to which anticaking agents have been added may bear in addition to the ingredient…

(a) Under section 307 of the Federal Food, Drug, and Cosmetic Act (the act), a State may bring, in its own name and within its own jurisdiction, proceedings for the civil enforcement, or to restrain violations, of sections 401, 403(b), 403(c), 403(d), 403(e), 403(f), 403(g), 403(h), 403(i), 403(k), 403(q), or 403(r) of the act if the food that is the subject of the proceedings is located in the State. (b) No proceeding may be commenced by a State under paragraph (a) of this section: (1) Before 30 days after the State has given notice to the Food and Drug Administration (FDA) that the State intends to bring such proceeding. (2) Before 90 days after the State has given notice to FDA of such intent if FDA has, within such 30 days, commenced an informal or formal enforcement action pertaining to the food which would be the subject of such proceeding. (3) If FDA is diligently prosecuting a proceeding in court pertaining to such food, has settled such proceeding, or has settled the informal or formal enforcement action pertaining to such food. (c) A State may intervene as a matter of right, in any court proceeding described in paragraph (b)(3) of this section. (d) The notification…