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21 U.S.C. § 364g — Mandatory recall authority
Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** If the Secretary determines that there is a reasonable probability that a cosmetic is adulterated under [section 361 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section361&num=0&edition=prelim) or misbranded under [section 362 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section362&num=0&edition=prelim) and the use of or exposure to such cosmetic will cause serious adverse health consequences or death, the Secretary shall provide the responsible person with an opportunity to voluntarily cease distribution and recall such article. If the responsible person refuses to or does not voluntarily cease distribution or recall such cosmetic within the time and manner prescribed by the Secretary (if so prescribed), the Secretary may, by order, require, as the Secretary determines necessary, such person to immediately cease distribution of such article.
**(b) Hearing** The Secretary shall provide the responsible person who is subject to an order under subsection (a) with an opportunity for an informal hearing, to be held not later than 10 days after the date of issuance of the order, on whether adequate evidence exists to justify the order.
**(c) Order resolution** After an order is issued according to the process under subsections (a) and (b), the Secretary shall, except as provided in subsection (d)—
(1) vacate the order, if the Secretary determines that inadequate grounds exist to support the actions required by the order;
(2) continue the order ceasing distribution of the cosmetic until a date specified in such order; or
(3) amend the order to require a recall of the cosmetic, including any requirements to notify appropriate persons, a timetable for the recall to occur, and a
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Stable record: federal_law:legal_authorities:record_usc_e2fdbd63b881b3699bbaf9b0
Source file: Laws/federal/codes/united-states-code/title-21/section-364g-mandatory-recall-authority--9a630cc3ce.md
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Source location: Title 21, Chapter 9, § 364g; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(a) In general** If the Secretary determines that there is a reasonable probability that a cosmetic is adulterated under [section 361 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section361&num=0&edition=prelim) or misbranded under [section 362 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section362&num=0&edition=prelim) and the use of or exposure to such cosmetic will cause serious adverse health consequences or death, the Secretary shall provide the responsible person with an opportunity to voluntarily cease distribution and recall such article. If the responsible person refuses to or does not voluntarily cease distribution or recall such cosmetic within the time and manner prescribed by the Secretary (if so prescribed), the Secretary may, by order, require, as the Secretary determines necessary, such person to immediately cease distribution of such article.
**(b) Hearing** The Secretary shall provide the responsible person who is subject to an order under subsection (a) with an opportunity for an informal hearing, to be held not later than 10 days after the date of issuance of the order, on whether adequate evidence exists to justify the order.
**(c) Order resolution** After an order is issued according to the process under subsections (a) and (b), the Secretary shall, except as provided in subsection (d)—
(1) vacate the order, if the Secretary determines that inadequate grounds exist to support the actions required by the order;
(2) continue the order ceasing distribution of the cosmetic until a date specified in such order; or
(3) amend the order to require a recall of the cosmetic, including any requirements to notify appropriate persons, a timetable for the recall to occur, and a schedule for updates to be provided to the Secretary regarding such recall.
**(d) Action following order** Any person who is subject to an order pursuant to paragraph (2) or (3) of subsection (c) shall immediately cease distribution of or recall, as applicable, the cosmetic and provide notification as required by such order.
**(e) Notice to persons affected** If the Secretary determines necessary, the Secretary may require the person subject to an order pursuant to subsection (a) or an amended order pursuant to paragraph (2) or (3) of subsection (c) to provide either a notice of a recall order for, or an order to cease distribution of, such cosmetic, as applicable, under this section to appropriate persons, including persons who manufacture, distribute, import, or offer for sale such product that is the subject of an order and to the public.
**(f) Public notification** In conducting a recall under this section, the Secretary shall—
(1) ensure that a press release is published regarding the recall, and that alerts and public notices are issued, as appropriate, in order to provide notification—
(A) of the recall to consumers and retailers to whom such cosmetic was, or may have been, distributed; and
(B) that includes, at a minimum—
(i) the name of the cosmetic subject to the recall;
(ii) a description of the risk associated with such article; and
(iii) to the extent practicable, information for consumers about similar cosmetics that are not affected by the recall; and
(2) ensure publication, as appropriate, on the website of the Food and Drug Administration of an image of the cosmetic that is the subject of the press release described in paragraph (1), if available.
**(g) No delegation** The authority conferred by this section to order a recall or vacate a recall order shall not be delegated to any officer or employee other than the Commissioner.
**(h) Effect** Nothing in this section shall affect the authority of the Secretary to request or participate in a voluntary recall, or to issue an order to cease distribution or to recall under any other provision of this subchapter.
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Federal law — U.S. Code and appendices · legal_authorities
In this subchapter:
(1) **Adverse event** — The term “adverse event” means any health-related event associated with the use of a cosmetic product that is adverse.
(2) **Cosmetic product** — The term “cosmetic product” means a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.
(3) **Facility**
(A) *In general.—* — The term “facility” includes any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States.
(B) Such term does not include any of the following:
(i) Beauty shops and salons, unless such establishment manufactures or processes cosmetic products at that location.
(ii) Cosmetic product retailers, including individual sales representatives, direct sellers (as defined in [section 3508(b)(2) of title 26](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title26-section3508/b/2&num=0&edition=prelim)), retail distribution facilities, and pharmacies, unless such establishment manufactures or processes cosmetic products that are not sold directly to consumers at that location.
(iii) Hospitals, physicians’ offices, and health care clinics.
(iv) Public health agencies and other nonprofit entities that provide cosmetic products directly to the consumer.
(v) Entities (such as hotels and airlines) that provide complimentary cosmetic products to customers incidental to other services.
(vi) Trade shows and other venues where cosmetic product samples are provided free of charge.
(vii) An establishment that manufactures or processes cosmetic products that are solely for use in research or evaluation, including for production testing and not offered for retail sale.
(vii
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 364
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Federal law — U.S. Code and appendices · legal_authorities
A cosmetic shall be deemed to be adulterated—
**(a)** If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual, except that this provision shall not apply to coal-tar hair dye, the label of which bears the following legend conspicuously displayed thereon: “Caution—This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.”, and the labeling of which bears adequate directions for such preliminary testing. For the purposes of this paragraph and paragraph (e) the term “hair dye” shall not include eyelash dyes or eyebrow dyes.
**(b)** If it consists in whole or in part of any filthy, putrid, or decomposed substance.
**(c)** If it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
**(d)** If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health.
**(e)** If it is not a hair dye and it is, or it bears or contains, a color additive which is unsafe within the meaning of [section 379e(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379e/a&num=0&edition=prelim).
**(f)** If it has been manufactured or processed under conditions that do not meet the good manufacturing practice requirements of [section 364b of this title](https://uscode.house.gov/view.xhtml?r
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 361
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Federal law — U.S. Code and appendices · legal_authorities
Whoever, being an officer or employee of the United States or of any department or agency thereof, any person acting on behalf of the Federal Housing Finance Agency, or agent of the Department of Justice as defined in the Antitrust Civil Process Act ([15 U.S.C. 1311–131](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1311–131&num=0&edition=prelim)4), or being an employee of a private sector organization who is or was assigned to an agency under chapter 37 of title 5, publishes, divulges, discloses, or makes known in any manner or to any extent not authorized by law any information coming to him in the course of his employment or official duties or by reason of any examination or investigation made by, or return, report or record made to or filed with, such department or agency or officer or employee thereof, which information concerns or relates to the trade secrets, processes, operations, style of work, or apparatus, or to the identity, confidential statistical data, amount or source of any income, profits, losses, or expenditures of any person, firm, partnership, corporation, or association; or permits any income return or copy thereof or any book containing any abstract or particulars thereof to be seen or examined by any person except as provided by law; shall be fined under this title, or imprisoned not more than one year, or both; and shall be removed from office or employment.
Source: Supplied U.S. Code snapshot — release unconfirmed · 18 U.S.C. § 1905
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Federal law — U.S. Code and appendices · legal_authorities
A cosmetic shall be deemed to be misbranded—
**(a)** If its labeling is false or misleading in any particular.
**(b)** If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; and (3) the information required under [section 364e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section364e&num=0&edition=prelim): Provided, That under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary.
**(c)** If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
**(d)** If its container is so made, formed, or filled as to be misleading.
**(e)** If it is a color additive, unless its packaging and labeling are in conformity with such packaging and labeling requirements, applicable to such color additive, as may be contained in regulations issued under [section 379e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379e&num=0&edition=prelim). This paragraph shall not apply to packages of color additives which, with respect to their use for cosmetics, are marketed and intended for use only in or on hair dyes (as defined in the last sentence of [section 361(a) of th
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 362
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Federal law — U.S. Code and appendices · legal_authorities
The following acts and the causing thereof are prohibited:
**(a)** The introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.
**(b)** The adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce.
**(c)** The receipt in interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.
**(d)** The introduction or delivery for introduction into interstate commerce of any article in violation of section 344, 350d, 355,,11 So in original. 360bbb–3, or 364c of this title.
**(e)** The refusal to permit access to or copying of any record as required by section 350a, 350c, 350f(j), 350e, 354, 360bbb–3, 364a, 373, 374(a), 379aa, or 379aa–1 of this title; or the failure to establish or maintain any record, or make any report, required under section 350a, 350c(b), 350f, 350e, 354, 355(i) or (k), 360b(a)(4)(C), 360b(j), (l) or (m), 360ccc–1(i), 360e(f), 360i, 360bbb–3, 364a, 364g, 379aa, 379aa–1, 387i, or 387t of this title or the refusal to permit access to or verification or copying of any such required record; or the violation of any recordkeeping requirement under section 2223 22 See References in Text note below. of this title (except when such violation is committed by a farm).
**(f)** The refusal to permit entry or inspection as authorized by [section 374 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section374&num=0&edition=prelim).
**(g)** The manufacture within any Territory of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.
*
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 331
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Federal law — U.S. Code and appendices · legal_authorities
Page 488
TITLE 21—FOOD AND DRUGS
§ 364g
the Secretary reasonably believes is likely to be
affected in a similar manner, that are needed to
assist the Secretary in determining whether the
cosmetic product is adulterated and presents a
threat of serious adverse health consequences or
death to humans. This subsection shall not be
construed to extend to recipes or formulas for
cosmetics, financial data, pricing data, per-
sonnel data (other than data as to qualification
of technical and professional personnel per-
forming functions subject to this chapter), re-
search data (other than safety substantiation
data for cosmetic products and their ingredi-
ents), or sales data (other than shipment data
regarding sales).
(b) Rule of construction
Nothing in this section shall be construed to
limit the authority of the Secretary to inspect
records or require establishment and mainte-
nance of records under any other provision of
this chapter, including section 364a or 364b of
this title.
(June 25, 1938, ch. 675, § 610, as added Pub. L.
117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136
Stat. 5855.)
Statutory Notes and Related Subsidiaries
CONSTRUCTION; CONFIDENTIALITY
Nothing in section 3502 of Pub. L. 117–328, which en-
acted this section, to be construed to authorize the dis-
closure of information that is prohibited from disclo-
sure under section 331(j) of this title or section 1905 of
title 18 or that is subject to withholding under section
552(b)(4) of title 5, see section 3503(c)(2) of Pub. L.
117–328, set out as a note under section 364 of this title.
§ 364g. Mandatory recall authority
(a) In general
If the Secretary determines that there is a
reasonable probability that a cosmetic is adul-
terated under section 361 of this title or mis-
br
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 364g
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