Accordingly, the enforcement date, in line with the Modernization of Cosmetics Regulations Act (MoCRA), is now set for July 1, 2024.
MoCRA represents the most significant expansion of the FDA’s cosmetics regulation efforts since the Federal Food, Drug, and Cosmetic Act of 1938. It grants the FDA new authority to access and copy specific records related to cosmetic products under certain conditions and to issue mandatory recalls on products that violate health and safety standards.
Additionally, MoCRA establishes new requirements for the cosmetics industry.
- Facility Registration: Cosmetic product manufacturers and processors must register their facilities with FDA, update content within 60 days of any changes, and renew their registration every two years.
- Product Listing: A “responsible person” (the manufacturer, packer, or distributor) must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.
- Adverse Event Reporting: A responsible person is required to report serious adverse events (such as hospitalization) associated with the use of cosmetic products in the United States to the FDA within 15 business days
- Safety Substantiation: Companies and individuals who manufacture or market cosmetics have a responsibility to ensure the safety of their products.
The requirements will apply to the following cosmetics categories:
- Baby products, including shampoo, lotion, oil, creams, and toallitas para bebé
- Bath products, including bubble bath, bath oils, tablets, and salts, bath wipes
- Eye makeup, including eyebrow pencils, eye shadow, and mascara. Toallitas desmaquillantes
- Childrens’ eye makeup
- Fragrances, including perfume and cologne
- Hair preparations, including conditioner, hair spray, and shampoo
- Hair coloring preparations, including hair dye, tints, and coloring rinses
- Non-eye makeup, including blush and rouge, face powder, foundation, and lipstick
- Children’s makeup (non-eye), including face paint and lip gloss
- Manicuring preparations, including nail polish, nail extenders, and cuticle softeners
- Oral products, including mouthwash and toothpaste
- Personal cleanliness products, including deodorant, soap, and body wash
- Shaving preparations, including shaving cream and aftershave
- Skin care preparations, including creams, lotions, powders, and sprays
- Suntan lotions, creams, gels, etc.
- Tattoo preparations, including permanent and temporary tattoo ink
The FDA hosted a webinar that provided an overview of the Modernization of Cosmetics Regulation Act of 2022, detailing the requirements mandated by the act and the current steps the FDA is taking to implement these requirements. The webinar also included an update on the Voluntary Cosmetic Reporting Program and information about an upcoming public listening session on good manufacturing practices (GMPs).
