Sec. 3. Adulterated and misbranded cosmetics
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/bill/116/hr/4296/ih/section-3A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 601 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 ) is amended— in paragraph (a), by striking , except that this provision shall not apply to coal-tar hair dye and all that follows through or eyebrow dyes ; and by adding at the end the following: If it is manufactured in a manner that fails to comply with section 617(a). If it is imported, distributed, or marketed and— it contains an ingredient on the list under section 616(b)(1)(A), and the manufacturer has not complied with section 616(b)(5) with respect to such ingredient and such cosmetic; or it contains an ingredient on the list under section 616(b)(1)(B), such ingredient is being used in a manner that violates the limit on use or concentration of such ingredient under section 616(b)(3), and the manufacturer has not complied with section 616(b)(5) with respect to such ingredient and such cosmetic.
If it is marketed by a brand owner that, with respect to such cosmetic, is required to demonstrate, under section 617(b)(2), that the cosmetic meets the safety standard and the brand owner has not yet submitted the required data under section 617(b)(3). . Section 602 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 362 ) is amended— in paragraph (a), by inserting or fails to meet the requirements of section 613 or 618(b) before the period; and by adding at the end the following:
If it— was brought to market by a brand owner that failed to register and pay the applicable fee as required under section 612; is brought to market, manufactured, packaged, distributed, or sold in retail by a brand owner, manufacturer, packager, distributor, or retailer, respectively, who fails to notify the Secretary as required under section 620(a)(1); is distributed in violation of an order under section 620(c); is not recalled as required by an order under section 620(d); is manufactured in a manner that fails to comply with good manufacturing practices prescribed by the Secretary under section 614(b); or is brought to market by a brand owner who fails— to submit the statement required under section 619; or notify the Secretary of changes to information contained in such report, as required by such section. .
Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ) is amended— in paragraph (e), by inserting 612, after 564, each place it appears; and by adding at the end the following: The failure of a brand owner, manufacturer, or supplier of a cosmetic or an ingredient for use in a cosmetic to submit and update data and information as required under section 615(a). The manufacture, importation, distribution, or marketing of an ingredient for use in a cosmetic that is on the list under section 616(b)(1)(A).
The failure of a supplier of an ingredient for use in a cosmetic— to provide data and information as required by section 615(a)(4)(B); or to comply with the testing requirements under section 618(d). The failure of a manufacturer to comply with the requirements of section 618(e). The failure of a brand owner of a cosmetic to comply with the requirement of reporting serious adverse events under section 622. The conduct of animal testing in violation of section 624. .
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