21 U.S.C. § 364g — Mandatory recall authority
submitted 88 years ago by Pub. L. 117-328 to r/title-21-FOOD-AND-DRUGS · 602 words · no verdicts yet
If the FDA finds a cosmetic is likely adulterated or misbranded and dangerous, it must first ask the maker to voluntarily stop selling and recall it. If they refuse, the FDA can order an immediate stop, hold a hearing, and then vacate, continue, or expand the order into a mandatory recall. The FDA must also publicize any recall.
(a) In general: If the Secretary* determines there is a reasonable probability that a cosmetic* is adulterated under section 361 or misbranded under section 362, and that using or being exposed to it will cause serious health harm or death, the Secretary must first give the responsible person* a chance to voluntarily stop distributing and recall it. If the responsible person* refuses, or does not act within the time and manner the Secretary sets, the Secretary may order that person to immediately stop distributing the product.
(b) Hearing: The responsible person subject to that order gets an informal hearing*, held no later than 10 days after the order issues, on whether there is enough evidence to justify it.
(c) Order resolution: After that hearing process, the Secretary must, unless (d) applies: (1) vacate the order if the grounds for it turn out to be inadequate; (2) keep the stop-distribution order in place until a specified date; or (3) amend the order into a recall, including requirements to notify the right people, a recall timetable, and a schedule of updates to the Secretary.
(d) Action following order: Anyone subject to an order under (c)(2) or (c)(3) must immediately stop distributing, or recall, the cosmetic, and provide the notifications the order requires.
(e) Notice to persons affected: If the Secretary decides it is necessary, the Secretary can require the person under the order to send a recall notice or stop-distribution notice to the right people, including manufacturers, distributors, importers, and sellers of the product, and to the public.
(f) Public notification: While running a recall, the Secretary must (1) make sure a press release goes out and appropriate alerts and public notices are issued, telling consumers and retailers who received, or may have received, the cosmetic about the recall, including at minimum the product's name, a description of its risk, and, where practical, information about similar, unaffected products; and (2) make sure an image of the recalled product is published on the FDA's website alongside the press release, if available.
(g) No delegation: Only the Commissioner* personally, not any other officer or employee, can order a recall or vacate a recall order under this section.
(h) Effect: This section does not limit the Secretary's authority to request or take part in a voluntary recall, or to issue a stop-distribution or recall order under any other part of this subchapter.
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.
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.
After an order is issued according to the process under subsections (a) and (b), the Secretary shall, except as provided in subsection (d)—
vacate the order, if the Secretary determines that inadequate grounds exist to support the actions required by the order;
continue the order ceasing distribution of the cosmetic until a date specified in such order; or
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.
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.
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.
In conducting a recall under this section, the Secretary shall—
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—
of the recall to consumers and retailers to whom such cosmetic was, or may have been, distributed; and
that includes, at a minimum—
the name of the cosmetic subject to the recall;
a description of the risk associated with such article; and
to the extent practicable, information for consumers about similar cosmetics that are not affected by the recall; and
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.
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*.
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.
Source credit: (June 25, 1938, ch. 675, § 611, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5855.)
- 1938Enacted · Pub. L. 117-328 · 136 Stat. 5855
A history note hasn’t been published yet. The record shows enactment by Pub. L. 117-328 on 1938-06-25.
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