New FDA Cosmetics Regulations to Impact Manufacturers of Children’s Makeup & Fragrance Kits, Face Paints, & More

January 17, 2023 | The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) — a major change to the Food and Drug Administration’s (FDA) current regulatory framework for cosmetics — was included in the Consolidated Appropriations Act 2023, which President Biden signed into law on December 29, 2022.

MoCRA amends Chapter VI of the Federal Food, Drug, and Cosmetics Act (FDCA), with key provisions taking effect on or by December 29, 2023, a year from the enactment date. The FDCA broadly defines “cosmetics” as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body ... for cleansing, beautifying, promoting attractiveness, or altering the appearance.” As such, the new regulations will affect any toymakers that produce, import, or sell items such as DIY makeup and fragrance kits, temporary tattoos, face paint, play cosmetics, and more.

“The Modernization of Cosmetics Regulation Act is a significant update to cosmetics regulations and strengthens the FDA’s oversight for these products,” said Jos Huxley, senior vice president of technical affairs at The Toy Association. “Due to the broad definition, members who have products that are determined to be cosmetics will need to act swiftly to ensure that they meet the new registration and listing requirements.”

Key provisions affecting toymakers include the following:

• All domestic and foreign facilities that manufacture or process cosmetics distributed in the U.S. must be registered with the FDA by December 29, 2023 and biannually afterward.
• All cosmetic products currently distributed in the U.S. as of the date of enactment (December 29, 2022) must be listed with the FDA no later than one year after enactment. The listing includes product-specific information, such as the ingredients and where it is manufactured. In addition, for new products, manufacturers must submit a product listing to the FDA within 120 days of the cosmetic being introduced to the market. All product listings are required to be updated annually thereafter.
• Manufacturers will be required to submit a report to the FDA within 15 business days of a “serious adverse event,” which is defined as a health-related effect associated with the use of the cosmetic product.
• The FDA will now have the authority to recall a cosmetic if the organization determines it to be adulterated or misbranded. Manufacturers will have a chance to voluntarily recall the cosmetic first.
• Manufacturers will need to maintain safety substantiation records for all cosmetics. Cosmetic products that do not have “adequate substantiation” will be considered to be adulterated under a revision to the FDCA.
• The FDA will work on regulations for asbestos in talc-containing cosmetics (deadline of one year), fragrance allergens (deadline of 18 months), good manufacturing practices (deadline of two years), and the use of PFAS in cosmetics (deadline of three years).

Members may reach out to The Toy Association’s Jos Huxley, senior vice president of technical affairs, with any questions on this topic.