§364g — Title 21 Food and Drugs | U.S. Code

Summary

The Secretary can order a cosmetic to stop being sold or to be recalled when there is a reasonable chance the product is unsafe or mislabeled and could cause serious health harm or death. The company or person responsible for the product must be offered a chance to voluntarily stop distribution and recall it. If they refuse, the Secretary may order them to stop immediately. The responsible party must get a short informal hearing no later than 10 days after the order. After that hearing, the Secretary will either cancel the order, keep the stop-sale order in effect until a set date, or change the order to require a formal recall with required notices, a timetable, and regular updates to the Secretary. Anyone under such an order must immediately stop distribution or carry out the recall and send the notices the order requires. The Secretary can also make the responsible party notify other people, such as makers, importers, distributors, sellers, and the public. For any recall, the Secretary will make sure a press release, alerts, and public notices go out to warn consumers and retailers. The notices must say the product name, describe the risk, and, when possible, tell consumers about similar products that are not affected. If available, an image of the recalled cosmetic should be shown on the FDA website. Only the Commissioner may be given the power to order or cancel these recalls, and this rule does not limit other recall or stop-sale powers the Secretary already has.

Title 21, §364g

Food and Drugs — Source: USLM XML via OLRC

(a)If the Secretary determines that there is a reasonable probability that a cosmetic is adulterated under section 361 of this title or misbranded under section 362 of this title 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)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)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)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)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)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)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)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.

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Construction

ConfidentialityNothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure 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

Summary

Title 21, §364g

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Construction

Citations & Metadata