21 USC 364g - Mandatory recall authority

U.S Code last checked for updates: Nov 22, 2024

§ 364g.

Mandatory recall authority

(a)

In general

(b)

Hearing

(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

(e)

Notice to persons affected

(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

(h)

Effect

(June 25, 1938, ch. 675, § 611, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5855.)

cite as: 21 USC 364g