§360fff — Title 21 Food and Drugs | U.S. Code

Summary

Defines key words used in the FDA’s sunscreen rules. Advisory Committee is the Nonprescription Drug Advisory Committee of the FDA or any group that replaces it. Final sunscreen order is an order the Secretary publishes saying an over‑the‑counter sunscreen ingredient (or combo) is either GRASE and not misbranded if used as ordered, or not GRASE and misbranded. GRASE means experts trained in science agree an ingredient is safe and works for the uses on the label. GRASE determination is the decision about whether an ingredient or combo is GRASE. Nonprescription means not subject to section 353(b)(1) of this title. Pending request is a request about a nonprescription sunscreen ingredient sent under section 330.14 of title 21, Code of Federal Regulations (as in effect on November 26, 2014) that had a notice of eligibility in the Federal Register before November 26, 2014 and had safety and effectiveness data submitted to the Secretary before November 26, 2014. Proposed sunscreen order is a published tentative finding that an ingredient is GRASE and not misbranded, or is not GRASE and misbranded, or is not GRASE because more data are needed. Sponsor is the person who submitted a request under section 360fff–1, a pending request, or any other application under this part. Sunscreen is a drug with one or more sunscreen active ingredients. Sunscreen active ingredient is an ingredient meant to be put on human skin to absorb, reflect, or scatter ultraviolet radiation.

Title 21, §360fff

Food and Drugs — Source: USLM XML via OLRC

In this part—

(1)the term “Advisory Committee” means the Nonprescription Drug Advisory Committee of the Food and Drug Administration or any successor to such Committee;

(2)the term “final sunscreen order” means an order published by the Secretary in the Federal Register containing information stating that a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients—

(A)is GRASE and is not misbranded if marketed in accordance with such order; or

(B)is not GRASE and is misbranded;

(3)the term “GRASE” means generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling of a drug as described in section 321(p) of this title;

(4)the term “GRASE determination” means, with respect to a nonprescription active ingredient or a combination of nonprescription active ingredients, a determination of whether such ingredient or combination of ingredients is GRASE;

(5)the term “nonprescription” means not subject to section 353(b)(1) of this title;

(6)the term “pending request” means each request with respect to a nonprescription sunscreen active ingredient submitted under section 330.14 of title 21, Code of Federal Regulations (as in effect on November 26, 2014) for consideration for inclusion in the over-the-counter drug monograph system—

(A)that was determined to be eligible for such review by publication of a notice of eligibility in the Federal Register prior to November 26, 2014; and

(B)for which safety and effectiveness data have been submitted to the Secretary prior to November 26, 2014;

(7)the term “proposed sunscreen order” means an order containing a tentative determination published by the Secretary in the Federal Register containing information proposing that a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients—

(A)is GRASE and is not misbranded if marketed in accordance with such order;

(B)is not GRASE and is misbranded; or

(C)is not GRASE and is misbranded because the data are insufficient to classify such ingredient or combination of ingredients as GRASE and not misbranded and additional information is necessary to allow the Secretary to determine otherwise;

(8)the term “sponsor” means the person that submitted—

(A)a request under section 360fff–1 of this title;

(B)a pending request; or

(C)any other application subject to this part;

(9)the term “sunscreen” means a drug containing one or more sunscreen active ingredients; and

(10)the term “sunscreen active ingredient” means an active ingredient that is intended for application to the skin of humans for purposes of absorbing, reflecting, or scattering ultraviolet radiation.

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Construction

Pub. L. 113–195, § 2(b), Nov. 26, 2014, 128 Stat. 2045, provided that: “Nothing in the amendment made by this section [enacting this section and section 360fff–1 to [former] 360fff–5 of this title] shall be construed to— “(1) limit the right of a sponsor (as defined in section 586(8) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360fff(8)], as added by subsection (a)) to request that the Secretary of Health and Human Services convene an advisory committee; or “(2) limit the authority of the Secretary of Health and Human Services to meet with a sponsor (as defined in section 586(8) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a)).”

§360fff Definitions

Summary

Title 21, §360fff

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Construction

Citations & Metadata