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Products Liability Law
• Facility: The term “facility’ is defined to include any establishment (including an establishment of an importer) that manufactures, or processes cosmetic products distributed in the United States.”
• Responsible Person: The term ‘responsible person’ means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product under the Act of the Fair Packaging and Labeling Act. Under MOCRA, the designated Responsible Person is the point person for the FDA.
MOCRA excludes beauty shops, retailers, medical providers, hotels, labelers, packagers, and distributors. The Act further provides small business exemption from certain registration and good manufacturing requirements, except for injectables, ocular products, internally applied or products that alter the appearance for more than 24 hours.
When?
• 1 year - Registration: By December 31, 2023, existing “Facilities” must register and every 2 years thereafter. For contract manufactured products, a single registration may be submitted by either the contract manufacturer or the “Responsible Person” for the “manufacturer” (i.e., the entity whose name is on the product). The registration must include brands, product categories and Product Listing, including ingredients, fragrances and colors, but not formulas or recipes.
• 2 years - GMP: By December 31, 2024, FDA is required to publish Good Manufacturing Practice regulations generally conforming to international standards. Whether FDA will meet this deadline is unknown but, with history as a guide, the regulations will not likely be issued any sooner.
• 18 months - allergens: The FDA is required to issue a proposed rule within 18 months identifying fragrance allergens.
• 1 year - asbestos: FDA has until January 2024 to propose regulations for testing to detect asbestos in talc- containing cosmetics. Asbestos is naturally found in or near talc and may be present in body powders, facial powders, eye shadow. FDA has issued consumer advisories in the past regarding certain cosmetic products for the presence of asbestos.
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FDCC ANNUAL FIVES 2023