Sec. 113. Enforcement

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Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ) is amended— in paragraph (e)— by striking 504, 564, and inserting 504, 564, 609, 610, ; and by striking 519, 564, and inserting 519, 564, 609, ; in paragraph (j), by inserting 606, 607, 608, before 704 ; in paragraph (ii)— by striking 760 or 761) or and inserting 604, 760, or 761) or ; and by striking 761) submitted and inserting 761 or as described in section 609) submitted ; in paragraph

(xx)by inserting or 611 after 423 ; and by adding at the end the following: The failure to register in accordance with section 605, the failure to provide any information required by section 605, or the failure to update the information required by section 605, as required. . Section 601 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 ) is amended by adding at the end the following: If the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to current good manufacturing practice, as prescribed by the Food and Drug Administration in accordance with section 608. If it contains, after the date prescribed under section 607(e), an ingredient that the Food and Drug Administration has determined under section 607(d)(4) to be not safe, or not safe under the conditions of use recommended or suggested in the label or a non-functional constituent that the Food and Drug Administration has determined under section 607(d)(4) to be not safe or not safe in the amount present in the cosmetic. If it is a cosmetic product for which assurances regarding safety substantiation have not been supplied under section 605(e)(2)(A)(xii). . Section 602 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 362 ) is amended— in paragraph (b)— by striking and

(2)and inserting

(2); and by inserting ; and

(3)a domestic address or a domestic telephone number, and it is encouraged that the label include both a domestic address and a domestic telephone number, through which the responsible person may receive a report of an adverse event associated with the use of such cosmetic product after numerical count ; and by adding at the end the following: If it has been manufactured or processed in any factory, warehouse, or establishment and the responsible person, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection. If its labeling does not conform with a requirement under section 612. . Not later than 1 year after the date of enactment of this Act, the Food and Drug Administration shall issue guidance that defines the circumstances that would constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection, for purposes of section 602(g) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (c)(2). Section 801(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381(a) ) is amended— by striking section 760 or 761 the first, third, and fourth place such term appears and inserting section 609, 760, or 761 ; and by striking 760 or 761) and inserting 604, 760, or 761) . Section 704(a)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374(a)(1) ) is amended by inserting after the third sentence the following: In the case of any person who manufactures, processes, distributes, or imports a cosmetic product, or distributes a cosmetic product and affixes its name on the cosmetic label, the inspection shall extend to all records and other information described in section 610 (regarding inspection of cosmetic records), when the standard for records inspections under paragraph

(1)or

(2)of subsection

(a)of such section applies, subject to the limitations under subsections

(d)and

(e)of such section. .

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Sec. 113

Enforcement