The International Agency for Research on Cancer (IARC), part of the World Health Organization (WHO), has updated its classification of talc and acrylonitrile, now labeling it as “probably carcinogenic to humans” (Group 2A) for all forms not containing asbestos or asbestiform fibers. This update, published in The Lancet Oncology, may significantly impact the chemical industry, especially under California’s Proposition 65 (Prop 65).

According to the regulations, the FDA was required to accept facility registrations and product listings by December 29, 2023. However, in November 2023, the FDA issued guidelines delaying the implementation of cosmetic facility registrations and product listings under MoCRA until July 1, 2024, to ensure the industry had sufficient time to submit the necessary information. Additionally, the FDA adjusted the requirements for registrations and product listings for facilities that first began manufacturing or processing cosmetic products after December 29, 2022, to be mandatorily enforced by July 1, 2024.

FDA Direct is a U.S. Food and Drug Administration's web-based and free structured product labeling (SPL) authoring tool. Previously CDER Direct, FDA Direct now includes CDER Direct and Cosmetics Direct. Users can create separate accounts, depending on drugs or cosmetics submissions, or a single account that includes both CDER Direct submissions as well as Cosmetics Direct submissions.

According to FDA regulations, if a product is intended to be applied to a person’s body to make the person more attractive, it’s a cosmetic under the law, for instance perfumes, colognes and aftershave should all be regulated as cosmetics. However, some products add fragrances for therapeutic purposes, such as aromatherapy products that could relieve muscle pain or headaches, and fragrance products that help sleep. These kind of fragrance products are generally regulated as pharmaceuticals. Other products that may contain fragrance ingredients, but are not applied to the body, including detergent, fabric softener and carpet freshenerare, are under the administration of the Consumer Product Safety Commission.

The US Food and Drug Administration has published a Structured Product Labeling (SPL) Implementation Guide with Validation Procedures. Cosmetic product facility registrations and product listings are now included within the SPL framework. The Implementation Guide can be used to develop SPL authoring tools. In the future, once FDA begins accepting data, users may transmit SPL-formatted submissions through FDA’s Electronic Submissions Gateway (ESG), or SPL authoring software including Xforms, for cosmetic product facility registrations and product listings, mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

The US FEI Portal allows a user to look up an FDA Establishment Identifier (FEI) based on a firm name and address, or validate the address of an FEI.

On August 7, 2023, the US Food and Drug Administration (FDA) published draft guidance on cosmetic product facility registrations and product listings, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). When finalized, the draft guidance will assist 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, and when to submit, as well as certain exemptions to the registration and listing requirements.

In December 2022, Hochul, governor of New York State, signed an amendment to the Environmental Protection Act (A8630A) to prohibit the use of 1,4-dioxane or mercury in cosmetics and personal care products. The bill will come into effect on June 1, 2023. From the effective date, cosmetics or personal care products containing 1,4-dioxane or mercury must not be sold in New York State.

On December 29, 2022, US President Biden signed into law the Food and Drug Omnibus Reform Act (FDORA Act), which included the Modernization of Cosmetics Regulation Act of 2022 (MOCRA Act). This is the first significant amendment to American cosmetics regulations since 1938. Compared with the current Federal Food, Drug and Cosmetic Act (FDC Act), MOCRA Act forces cosmetic enterprises to register their facilities and maintain records for their products.