THE WHAT? The US Food & Drugs Administration (FDA) has issued final guidance for the industry on the requirement for cosmetic product facility registrations and product listings ushered in under the Modernization of Cosmetics Regulation Act, 2022 (MoCRA).
THE DETAILS The regulatory body has also unveiled an electronic registration and listing submission portal. Cosmetics Direct, as the portal has been dubbed, is now available for manufacturers to use. Paper forms as an alternative submission tool are in development.
THE WHY? The guidance assists stakeholders with cosmetic product facility registration and product listing submissions to FDA, by describing who is responsible for making the registration and listing submissions, what information to include, how to submit, when to submit, and certain exemptions to the registration and listing requirements.
Aesthetic supplies USA refers to products and equipment used in the field of aesthetic medicine and cosmetic treatments that are available for purchase in the United States. These supplies encompass a wide range of items necessary for various aesthetic procedures and treatments conducted by professionals such as dermatologists, plastic surgeons, aestheticians, and other qualified practitioners.
Examples of aesthetic supplies include:
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Dermal Fillers: Injectable substances used to restore volume and reduce wrinkles.
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Botulinum Toxin (Botox): Injectables used to temporarily relax facial muscles and reduce wrinkles.
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Laser Devices: Equipment used for hair removal, skin rejuvenation, tattoo removal, and other laser treatments.
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Chemical Peels: Solutions applied to the skin to exfoliate and improve texture.
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Microdermabrasion Devices: Tools used for mechanical exfoliation to rejuvenate skin.
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Microneedling Devices: Devices that create tiny punctures in the skin to stimulate collagen production.
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Cosmeceuticals: Skincare products that contain biologically active ingredients with pharmaceutical-like benefits.
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Sterilization and Disinfection Products: Essential for maintaining hygiene and preventing infections in clinical settings.
