Sec. 111. Foreign supplier verification
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Chapter VIII of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381 et seq.) is amended by adding at the end the following: Except as provided under subsection (e), each importer shall perform risk-based foreign supplier verification activities for the purpose of verifying that the cosmetic product or cosmetic ingredient imported by the importer (or agent thereof)— has been manufactured according to the cosmetic product good manufacturing practices established under section 610; and is not adulterated under section 601 or misbranded under section 602.
For purposes of this section, the term importer means, with respect to a cosmetic product or cosmetic ingredient— the United States owner or consignee of the cosmetic product or cosmetic ingredient at the time of entry of such cosmetic product or cosmetic ingredient into the United States; or in the case when there is no United States owner or consignee as described in subparagraph (A), the United States agent or representative of a foreign owner or consignee of the cosmetic product or cosmetic ingredient at the time of entry of such article into the United States.
Not later than 1 year after the date of enactment of the Cosmetic Safety Enhancement Act of 2019 , the Secretary shall issue guidance to assist importers in developing foreign supplier verification programs. Not later than 1 year after the date of enactment of Cosmetic Safety Enhancement Act of 2019 , the Secretary shall promulgate regulations to provide for the content of the foreign supplier verification program established under subsection (a). The regulations promulgated under paragraph (1)— shall require that the foreign supplier verification program of each importer be adequate to provide assurances that each foreign supplier to the importer produces the imported cosmetic product or cosmetic ingredient in compliance with— with cosmetic good manufacturing practices established under section 610; and sections 601 and 602; and shall include such other requirements as the Secretary deems necessary and appropriate to verify that cosmetic products and cosmetic ingredients imported into the United States are as safe as cosmetic products and cosmetic ingredients produced and sold within the United States.
In promulgating regulations under this subsection, the Secretary shall, as appropriate, take into account differences among importers and types of imported cosmetic products and cosmetic ingredients, including based on the level of risk posed by the imported cosmetic product or cosmetic ingredient. Verification activities under a foreign supplier verification program under this section may include monitoring records for shipments, lot-by-lot certification of compliance, annual on-site inspections, compliance with cosmetic good manufacturing practices and other safety processes, and periodically testing and sampling shipments.
Records of an importer related to a foreign supplier verification program shall— be maintained for a period of not less than 2 years; and be made available promptly to a duly authorized representative of the Secretary upon request. The Secretary, by notice published in the Federal Register, shall establish an exemption from the requirements of this section for cosmetic products or cosmetic ingredients imported in small quantities for research and evaluation purposes or for personal consumption, provided that such cosmetic products or cosmetic ingredients are not intended for retail sale and are not sold or distributed to the public.
The Secretary shall publish and maintain on the internet website of the Food and Drug Administration a current list that includes the name of, location of, and other information deemed necessary by the Secretary about, importers participating under this section. . Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ), as amended by section 113, is further amended by adding at the end the following: The importation or offering for importation of a cosmetic product or cosmetic ingredient if the importer (as defined in section 810) does not have in place a foreign supplier verification program in compliance with such section 810. .
Section 801(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381(a) ) is amended by striking or the importer (as defined in section 805) is in violation of such section 805 and inserting , or being imported or offered for import into the United States by an importer (as defined in section 805 or 810, as applicable) that is in violation of section 805 or 810, respectively . The amendments made by this section shall take effect 2 years after the date of enactment of this Act.
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