---
kind: "section"
citation: "21 U.S.C. § 360fff–3"
title: "21"
title_heading: "Food and Drugs"
number: "360fff–3"
heading: "GRASE determination"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360fff-3"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part I — Nonprescription Sunscreen and Other Active Ingredients"
---

# §360fff–3. GRASE determination

- (a) **Review of new request—**
  - (1) **Proposed sunscreen order—** In the case of a request under [section 360fff–1 of this title](/usc/21/360fff–1.md), not later than 300 calendar days after the date on which such request is filed under subsection (b)(2)(A) or (b)(3)(B)(ii)(III) of [section 360fff–2 of this title](/usc/21/360fff–2.md), the [Secretary](/usc/21/321.md?p=d)—
    - (A) may convene a meeting of the [Advisory Committee](/usc/21/360fff.md?p=1) to review such request; and
    - (B) shall complete the review of such request and issue a [proposed sunscreen order](/usc/21/360fff.md?p=7) with respect to such request.
  - (2) **Proposed sunscreen order by Commissioner—** If the [Secretary](/usc/21/321.md?p=d) does not issue a [proposed sunscreen order](/usc/21/360fff.md?p=7) under [paragraph (1)(B)](#a-1-B) within such 300-day period, the [sponsor](/usc/21/360fff.md?p=8) of such request may notify the Office of the [Commissioner](/usc/21/321.md?p=ee) of such request and request review by the Office of the [Commissioner](/usc/21/321.md?p=ee). If such [sponsor](/usc/21/360fff.md?p=8) so notifies the Office of the [Commissioner](/usc/21/321.md?p=ee), the [Commissioner](/usc/21/321.md?p=ee) shall, not later than 60 calendar days after the date of notification under this paragraph, issue a [proposed sunscreen order](/usc/21/360fff.md?p=7) with respect to such request.
  - (3) **Public comment period—** A [proposed sunscreen order](/usc/21/360fff.md?p=7) issued under paragraph [(1)(B)](#a-1-B) or [(2)](#a-2) with respect to a request shall provide for a period of 45 calendar days for public comment.
  - (4) **Meeting—** A [sponsor](/usc/21/360fff.md?p=8) may request, in writing, a meeting with respect to a [proposed sunscreen order](/usc/21/360fff.md?p=7) issued under this subsection and described in subparagraph (B) or (C) of [section 360fff(7) of this title](/usc/21/360fff.md?p=7), not later than 30 calendar days after the [Secretary](/usc/21/321.md?p=d) issues such order. The [Secretary](/usc/21/321.md?p=d) shall convene a meeting with such [sponsor](/usc/21/360fff.md?p=8) not later than 45 calendar days after such request for a meeting.
  - (5) **Final sunscreen order—** With respect to a [proposed sunscreen order](/usc/21/360fff.md?p=7) under paragraph [(1)(B)](#a-1-B) or [(2)](#a-2)—
    - (A) the [Secretary](/usc/21/321.md?p=d) shall issue a [final sunscreen order](/usc/21/360fff.md?p=2)—
      - (i) in the case of a [proposed sunscreen order](/usc/21/360fff.md?p=7) described in subparagraph (A) or (B) of [section 360fff(7) of this title](/usc/21/360fff.md?p=7), not later than 90 calendar days after the end of the public comment period under [paragraph (3)](#a-3); or
      - (ii) in the case of a [proposed sunscreen order](/usc/21/360fff.md?p=7) described in subparagraph (C) of [section 360fff(7) of this title](/usc/21/360fff.md?p=7), not later than 210 calendar days after the date on which the [sponsor](/usc/21/360fff.md?p=8) submits the additional information requested pursuant to such [proposed sunscreen order](/usc/21/360fff.md?p=7); or
    - (B) if the [Secretary](/usc/21/321.md?p=d) does not issue such [final sunscreen order](/usc/21/360fff.md?p=2) within such 90- or 210-calendar-day period, as applicable, the [sponsor](/usc/21/360fff.md?p=8) of such request may notify the Office of the [Commissioner](/usc/21/321.md?p=ee) of such request and request review by the Office of the [Commissioner](/usc/21/321.md?p=ee).
  - (6) **Final sunscreen order by Commissioner—** The [Commissioner](/usc/21/321.md?p=ee) shall issue a [final sunscreen order](/usc/21/360fff.md?p=2) with respect to a [proposed sunscreen order](/usc/21/360fff.md?p=7) subject to [paragraph (5)(B)](#a-5-B) not later than 60 calendar days after the date of notification under such paragraph.
- (b) **Review of pending requests—**
  - (1) **In general—** The review of a [pending request](/usc/21/360fff.md?p=6) shall be carried out by the [Secretary](/usc/21/321.md?p=d) in accordance with this subsection.
  - (2) **Inapplicability of sections 360fff–1 and 360fff–2 of this title—** Sections [360fff–1](/usc/21/360fff–1.md) and [360fff–2](/usc/21/360fff–2.md) of this title shall not apply with respect to any [pending request](/usc/21/360fff.md?p=6).
  - (3) **Feedback letters as proposed sunscreen order—** Notwithstanding the requirements of [section 360fff(7) of this title](/usc/21/360fff.md?p=7), a letter issued pursuant to section 330.14(g) of title 21, Code of Federal Regulations before November 26, 2014, with respect to a [pending request](/usc/21/360fff.md?p=6), shall be deemed to be a [proposed sunscreen order](/usc/21/360fff.md?p=7) and displayed on the Internet website of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration. Notification of the availability of such letter shall be published in the Federal Register not later than 45 calendar days after November 26, 2014.
  - (4) **Proposed sunscreen order—** In the case of a [pending request](/usc/21/360fff.md?p=6) for which the [Secretary](/usc/21/321.md?p=d) has not issued a letter pursuant to section 330.14(g) of title 21, Code of Federal Regulations before November 26, 2014, the [Secretary](/usc/21/321.md?p=d) shall complete review of such request and, not later than 90 calendar days after November 26, 2014, issue a [proposed sunscreen order](/usc/21/360fff.md?p=7) with respect to such request.
  - (5) **Proposed sunscreen order by Commissioner—** If the [Secretary](/usc/21/321.md?p=d) does not issue a [proposed sunscreen order](/usc/21/360fff.md?p=7) under [paragraph (4)](#b-4), or the [Secretary](/usc/21/321.md?p=d) does not publish a notification of the availability of a letter under [paragraph (3)](#b-3), as applicable, the [sponsor](/usc/21/360fff.md?p=8) of such request may notify the Office of the [Commissioner](/usc/21/321.md?p=ee) of such request and request review by the Office of the [Commissioner](/usc/21/321.md?p=ee). The [Commissioner](/usc/21/321.md?p=ee) shall, not later than 60 calendar days after the date of notification under this paragraph, issue a proposed order with respect to such request.
  - (6) **Public comment period—** A [proposed sunscreen order](/usc/21/360fff.md?p=7) issued under paragraph [(4)](#b-4) or [(5)](#b-5), or a notification of the availability of a letter under [paragraph (3)](#b-3), with respect to a [pending request](/usc/21/360fff.md?p=6) shall provide for a period of 45 calendar days for public comment.
  - (7) **Meeting—**
    - (A) **In general—** A [sponsor](/usc/21/360fff.md?p=8) may request, in writing, a meeting with respect to a [proposed sunscreen order](/usc/21/360fff.md?p=7) issued under this subsection, including a letter deemed to be a [proposed sunscreen order](/usc/21/360fff.md?p=7) under [paragraph (3)](#b-3), not later than 30 calendar days after the [Secretary](/usc/21/321.md?p=d) issues such order or the date upon which such feedback letter is deemed to be a [proposed sunscreen order](/usc/21/360fff.md?p=7), as applicable. The [Secretary](/usc/21/321.md?p=d) shall convene a meeting with such [sponsor](/usc/21/360fff.md?p=8) not later than 45 calendar days after the date of such request for a meeting.
    - (B) **Confidential meetings—** A [sponsor](/usc/21/360fff.md?p=8) may request one or more confidential meetings with respect to a [proposed sunscreen order](/usc/21/360fff.md?p=7), including a letter deemed to be a [proposed sunscreen order](/usc/21/360fff.md?p=7) under [paragraph (3)](#b-3), to discuss matters relating to data requirements to support a general recognition of safety and effectiveness involving confidential information and public information related to such [proposed sunscreen order](/usc/21/360fff.md?p=7), as appropriate. The [Secretary](/usc/21/321.md?p=d) shall convene a confidential meeting with such [sponsor](/usc/21/360fff.md?p=8) in a reasonable time period. If a [sponsor](/usc/21/360fff.md?p=8) requests more than one confidential meeting for the same [proposed sunscreen order](/usc/21/360fff.md?p=7), the [Secretary](/usc/21/321.md?p=d) may refuse to grant an additional confidential meeting request if the [Secretary](/usc/21/321.md?p=d) determines that such additional confidential meeting is not reasonably necessary for the [sponsor](/usc/21/360fff.md?p=8) to advance its [proposed sunscreen order](/usc/21/360fff.md?p=7), or if the request for a confidential meeting fails to include sufficient information upon which to base a substantive discussion. The [Secretary](/usc/21/321.md?p=d) shall publish a post-meeting summary of each confidential meeting under this subparagraph that does not disclose confidential commercial information or trade secrets. This subparagraph does not authorize the disclosure of confidential commercial information or trade secrets subject to 552(b)(4)[^1] of title 5 or [section 1905 of title 18](/usc/18/1905.md).
  - (8) **Advisory Committee—** In the case of a [proposed sunscreen order](/usc/21/360fff.md?p=7) under paragraph [(3)](#b-3), [(4)](#b-4), or [(5)](#b-5), an [Advisory Committee](/usc/21/360fff.md?p=1) meeting may be convened for the purpose of reviewing and providing recommendations regarding the [pending request](/usc/21/360fff.md?p=6).
  - (9) **Final sunscreen order—** In the case of a [proposed sunscreen order](/usc/21/360fff.md?p=7) under paragraph [(3)](#b-3), [(4)](#b-4), or [(5)](#b-5)—
    - (A) the [Secretary](/usc/21/321.md?p=d) shall issue a [final sunscreen order](/usc/21/360fff.md?p=2) with respect to the request—
      - (i) in the case of a [proposed sunscreen order](/usc/21/360fff.md?p=7) described in subparagraph (A) or (B) of [section 360fff(7) of this title](/usc/21/360fff.md?p=7), not later than 90 calendar days after the end of the public comment period under [paragraph (6)](#b-6); or
      - (ii) in the case of a [proposed sunscreen order](/usc/21/360fff.md?p=7) described in subparagraph (C) of [section 360fff(7) of this title](/usc/21/360fff.md?p=7)—
        - (I) if the [Advisory Committee](/usc/21/360fff.md?p=1) is not convened under [paragraph (8)](#b-8), not later than 210 calendar days after the date on which the [sponsor](/usc/21/360fff.md?p=8) submits the additional information requested pursuant to such [proposed sunscreen order](/usc/21/360fff.md?p=7), which shall include a rationale for not convening such [Advisory Committee](/usc/21/360fff.md?p=1); or
        - (II) if the [Advisory Committee](/usc/21/360fff.md?p=1) is convened under [paragraph (8)](#b-8), not later than 270 calendar days after the date on which the [sponsor](/usc/21/360fff.md?p=8) submits such additional information; or
    - (B) if the [Secretary](/usc/21/321.md?p=d) does not issue such [final sunscreen order](/usc/21/360fff.md?p=2) within such 90-, 210-, or 270-calendar-day period, as applicable, the [sponsor](/usc/21/360fff.md?p=8) of such request may notify the Office of the [Commissioner](/usc/21/321.md?p=ee) about such request and request review by the Office of the [Commissioner](/usc/21/321.md?p=ee).
  - (10) **Final sunscreen order by Commissioner—** The [Commissioner](/usc/21/321.md?p=ee) shall issue a [final sunscreen order](/usc/21/360fff.md?p=2) with respect to a [proposed sunscreen order](/usc/21/360fff.md?p=7) subject to [paragraph (9)(B)](#b-9-B) not later than 60 calendar days after the date of notification under such paragraph.
- (c) **Advisory Committee—** The [Secretary](/usc/21/321.md?p=d) shall not be required to—
  - (1) convene the [Advisory Committee](/usc/21/360fff.md?p=1)—
    - (A) more than once with respect to any request under [section 360fff–1 of this title](/usc/21/360fff–1.md) or any [pending request](/usc/21/360fff.md?p=6); or
    - (B) more than twice in any calendar year with respect to the review under this section; or
  - (2) submit more than a total of 3 requests under [section 360fff–1 of this title](/usc/21/360fff–1.md) or [pending requests](/usc/21/360fff.md?p=6) to the [Advisory Committee](/usc/21/360fff.md?p=1) per meeting.
- (d) **No delegation—** Any responsibility vested in the [Commissioner](/usc/21/321.md?p=ee) by subsection [(a)(2)](#a-2), [(a)(6)](#a-6), [(b)(5)](#b-5), or [(b)(10)](#b-10) shall not be delegated.
- (e) **Effect of final sunscreen order—**
  - (1) **In general—**
    - (A) **Sunscreen active ingredients determined to be GRASE—** Upon issuance of a [final sunscreen order](/usc/21/360fff.md?p=2) determining that a [nonprescription](/usc/21/360fff.md?p=5) [sunscreen active ingredient](/usc/21/360fff.md?p=10) or combination of [nonprescription](/usc/21/360fff.md?p=5) [sunscreen active ingredients](/usc/21/360fff.md?p=10) is [GRASE](/usc/21/360fff.md?p=3) and is not misbranded, a [sunscreen](/usc/21/360fff.md?p=9) containing such ingredient or combination of ingredients shall be permitted to be introduced or delivered into [interstate commerce](/usc/21/321.md?p=b) for use under the conditions described in such [final sunscreen order](/usc/21/360fff.md?p=2), in accordance with all requirements applicable to [drugs](/usc/21/321.md?p=g-1) not subject to [section 353(b)(1) of this title](/usc/21/353.md?p=b-1), for so long as such [final sunscreen order](/usc/21/360fff.md?p=2) remains in effect.
    - (B) **Sunscreen active ingredients determined not to be GRASE—** Upon issuance of a [final sunscreen order](/usc/21/360fff.md?p=2) determining that a [nonprescription](/usc/21/360fff.md?p=5) [sunscreen active ingredient](/usc/21/360fff.md?p=10) or combination of [nonprescription](/usc/21/360fff.md?p=5) [sunscreen active ingredients](/usc/21/360fff.md?p=10) is not [GRASE](/usc/21/360fff.md?p=3) and is misbranded, a [sunscreen](/usc/21/360fff.md?p=9) containing such ingredient or combination of ingredients shall not be introduced or delivered into [interstate commerce](/usc/21/321.md?p=b), for use under the conditions described in such [final sunscreen order](/usc/21/360fff.md?p=2), unless an application is approved pursuant to [section 355 of this title](/usc/21/355.md) with respect to a [sunscreen](/usc/21/360fff.md?p=9) containing such ingredient or combination of ingredients, or unless conditions are later established under which such ingredient or combination of ingredients is later determined to be [GRASE](/usc/21/360fff.md?p=3) and not misbranded under the over-the-counter [drug](/usc/21/321.md?p=g-1) monograph system.
  - (2) **Amendments to final sunscreen orders—**
    - (A) **Amendments at initiative of Secretary—** In the event that information relevant to a [nonprescription](/usc/21/360fff.md?p=5) [sunscreen active ingredient](/usc/21/360fff.md?p=10) or combination of [nonprescription](/usc/21/360fff.md?p=5) [sunscreen active ingredients](/usc/21/360fff.md?p=10) becomes available to the [Secretary](/usc/21/321.md?p=d) after issuance of a [final sunscreen order](/usc/21/360fff.md?p=2), the [Secretary](/usc/21/321.md?p=d) may amend such [final sunscreen order](/usc/21/360fff.md?p=2) by issuing a new [proposed sunscreen order](/usc/21/360fff.md?p=7) under [subsection (a)(1)](#a-1) and following the procedures set forth in this section.
    - (B) **Petition to amend final order—** Any interested [person](/usc/21/321.md?p=e) may petition the [Secretary](/usc/21/321.md?p=d) to amend a [final sunscreen order](/usc/21/360fff.md?p=2) under section 10.30, [title 21](/usc/21.md) Code of Federal Regulations (or any successor regulations). If the [Secretary](/usc/21/321.md?p=d) grants any petition under such section, the [Secretary](/usc/21/321.md?p=d) shall initiate the process for amending a [final sunscreen order](/usc/21/360fff.md?p=2) by issuing a new [proposed sunscreen order](/usc/21/360fff.md?p=7) under [subsection (a)(1)](#a-1) and following the procedures set forth in this section.
    - (C) **Applicability of final orders—** Once the [Secretary](/usc/21/321.md?p=d) issues a new [proposed sunscreen order](/usc/21/360fff.md?p=7) to amend a [final sunscreen order](/usc/21/360fff.md?p=2) under subparagraph [(A)](#e-2-A) or [(B)](#e-2-B), such [final sunscreen order](/usc/21/360fff.md?p=2) shall remain in effect and [paragraph (3)](#e-3) shall not apply to such [final sunscreen order](/usc/21/360fff.md?p=2) until the [Secretary](/usc/21/321.md?p=d) has issued a new [final sunscreen order](/usc/21/360fff.md?p=2) or has determined not to amend the [final sunscreen order](/usc/21/360fff.md?p=2).
  - (3) **Relationship to orders under section 355h of this title—** A [final sunscreen order](/usc/21/360fff.md?p=2) shall be deemed to be a final order under [section 355h of this title](/usc/21/355h.md).
- (f) **Exclusivity—**
  - (1) **In general—** A [final sunscreen order](/usc/21/360fff.md?p=2) shall have the effect of authorizing solely the order requestor (or the licensees, assignees, or successors in interest of such requestor with respect to the subject of such request and listed under [paragraph (5)](#f-5)) for a period of 18 months, to market a [sunscreen](/usc/21/360fff.md?p=9) ingredient under this section incorporating changes described in [paragraph (2)](#f-2) subject to the limitations under [paragraph (4)](#f-4), beginning on the date the requestor (or any licensees, assignees, or successors in interest of such requestor with respect to the subject of such request and listed under [paragraph (5)](#f-5)) may lawfully market such [sunscreen](/usc/21/360fff.md?p=9) ingredient pursuant to the order.
  - (2) **Changes described—** A change described in this paragraph is a change subject to an order specified in [paragraph (1)](#f-1) that permits a [sunscreen](/usc/21/360fff.md?p=9) to contain an active [sunscreen](/usc/21/360fff.md?p=9) ingredient not previously incorporated in a marketed [sunscreen](/usc/21/360fff.md?p=9) listed in [paragraph (3)](#f-3).
  - (3) **Marketed sunscreen—** The marketed [sunscreen](/usc/21/360fff.md?p=9) ingredients described in this paragraph are [sunscreen](/usc/21/360fff.md?p=9) ingredients—
    - (A) marketed in accordance with a final monograph for [sunscreen](/usc/21/360fff.md?p=9) [drug products](/usc/21/321.md?p=dd) set forth at part [352](/usc/21/352.md) of title 21, Code of Federal Regulations (as published at 64 Fed. Reg. 27687); or
    - (B) marketed in accordance with a final order issued under this section.
  - (4) **Limitations on exclusivity—** Only one 18-month period may be granted per ingredient under [paragraph (1)](#f-1).
  - (5) **Listing of licensees, assignees, or successors in interest—** Requestors shall submit to the [Secretary](/usc/21/321.md?p=d) at the time when a [drug](/usc/21/321.md?p=g-1) subject to such request is introduced or delivered for introduction into [interstate commerce](/usc/21/321.md?p=b), a list of licensees, assignees, or successors in interest under [paragraph (1)](#f-1).

## Footnotes

[^1]: So in original. Probably should be preceded by “section”.

## Source credit

(June 25, 1938, ch. 675, § 586C, as added Pub. L. 113–195, § 2(a), Nov. 26, 2014, 128 Stat. 2039; amended Pub. L. 116–136, div. A, title III, § 3854(b)(1)–(3), Mar. 27, 2020, 134 Stat. 455, 456.)

## Notes

### Editorial Notes

### Amendments

2020—Subsec. (b)(7). Pub. L. 116–136, § 3854(b)(2), designated existing provisions as subpar. (A), inserted heading, and added subpar. (B).

Subsec. (e)(3). Pub. L. 116–136, § 3854(b)(1), amended par. (3) generally. Prior to amendment, par. (3) related to inclusion of ingredients that are subjects of final orders in the sunscreen monograph.

Subsec. (f). Pub. L. 116–136, § 3854(b)(3), added subsec. (f).

### Statutory Notes and Related Subsidiaries

### Sunscreen Final Administrative Order

Pub. L. 119–37, div. F, title V, § 6506(b), Nov. 12, 2025, 139 Stat. 645, provided that: “A final administrative order on nonprescription sunscreen active ingredients issued under section 3854 of the Coronavirus Aid, Relief, and Economic Security Act (Public Law 116–136; 21 U.S.C. 360fff–3 note) shall— account for historical data regarding the safety of sunscreen active ingredients that have previously been accepted for marketing in the United States; account for the role of broad spectrum sunscreens with a Sun Protection Factor of 15 or higher in effective skin cancer prevention; and incorporate the evidence and testing standards for sunscreen active ingredients detailed in section 505G(r) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355h) (as added by subsection (a)).”

### Review of Nonprescription Sunscreen Active Ingredients

Pub. L. 116–136, div. A, title III, § 3854(a), Mar. 27, 2020, 134 Stat. 454, provided that:Applicability of section 505g for pending submissions.— In general.—A sponsor of a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients that, as of the date of enactment of this Act [Mar. 27, 2020], is subject to a proposed sunscreen order under section 586C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff–3) may elect, by means of giving written notification to the Secretary of Health and Human Services within 180 calendar days of the enactment of this Act, to transition into the review of such ingredient or combination of ingredients pursuant to the process set out in section 505G of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355h], as added by section 3851 of this subtitle. Election exercised.—Upon receipt by the Secretary of Health and Human Services of a timely notification under subparagraph (A)— the proposed sunscreen order involved is deemed to be a request for an order under subsection (b) of section 505G of the Federal Food, Drug, and Cosmetic Act, as added by section 3851 of this subtitle; and such order is deemed to have been accepted for filing under subsection (b)(6)(A)(i) of such section 505G. Election not exercised.—If a notification under subparagraph (A) is not received by the Secretary of Health and Human Services within 180 calendar days of the date of enactment of this Act, the review of the proposed sunscreen order described in subparagraph (A)— shall continue under section 586C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff–3); and shall not be eligible for review under section 505G, added by section 3851 of this subtitle. Definitions.—In this subsection, the terms ‘sponsor’, ‘nonprescription’, ‘sunscreen active ingredient’, and ‘proposed sunscreen order’ have the meanings given to those terms in section 586 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff).”