On July 5, 2024, the Office of Information and Regulatory Affairs (OIRA) published the "Spring 2024 Unified Agenda of Regulatory and Deregulatory Actions," which provides updates on various proposed rules affecting cosmetics in the U.S. Two key proposed rules under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) have been delayed, with further delays possible:

• Disclosure of Fragrance Allergens in Cosmetic Labeling: MoCRA initially required the FDA to issue a proposed rule by June 29, 2024, mandating the disclosure of fragrance allergens on cosmetic labels. The Unified Agenda now indicates that this rule will be issued in October 2024.
• Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetics: The FDA was expected to propose standardized testing methods for detecting asbestos in talc-containing cosmetics by December 29, 2023. This proposal has been delayed to July 2024, but no rule has yet been released.

The Unified Agenda also updated the timeline for a proposed rule to ban formaldehyde and formaldehyde-releasing ingredients in hair straightening and smoothing products. Originally expected in October 2023, the proposal is now expected to be released in September 2024.

FDA Announces Enhancements to Cosmetics Direct Submission Portal

On July 29, 2024, the U.S. Food and Drug Administration (FDA) introduced updates aimed at helping the cosmetics industry maintain its registration and listing submissions. The most significant updates include two new features in Cosmetics Direct, the electronic submission portal established by MoCRA.

The new features allow for the discontinuation and relisting of cosmetic product listings. The discontinuation feature enables responsible persons - manufacturers, packers, or distributors of cosmetic products - to discontinue products that are no longer on the market. The relisting feature allows previously discontinued products to be reintroduced to the market.

Discontinuation is different from deletion in Cosmetics Direct. Discontinued products remain in the Structured Product Labeling (SPL) file and can be relisted, whereas deleted products are permanently removed and cannot be retrieved. For more details, please refer to the updated User's Guide to Cosmetics Direct.

Maine, New Hampshire, and Massachusetts have recently advanced their efforts to phase out PFAS (per- and polyfluoroalkyl substances). PFAS are a group of synthetic chemicals widely used in consumer products for their water- and stain-resistant properties. Known as "forever chemicals," PFAS persist in the environment and are linked to various health risks, including cancer.

Maine delays most prohibitions on non-essential PFAS

Maine’s Department of Environmental Protection (DEP) issued a preliminary draft rule on August 5 to implement the state’s revised PFAS phase-out law. The update reflects legislative changes to the 2021 PFAS in products statute, delaying most prohibitions on non-essential PFAS to 2032 and narrowing reporting requirements to “currently unavoidable uses” (CUUs). The draft also exempts items such as semiconductors and motor vehicles.

The draft outlines regulations for goods and businesses, including disclosure requirements, phased-in sales restrictions, and CUU designations for products that need more time to replace PFAS. Manufacturers with CUU-designated products must provide detailed PFAS notifications and pay a $5,000 fee per notification; small businesses with 100 or fewer employees are exempt from these notifications.

The DEP plans to proceed with the rulemaking this autumn, aiming for completion early next year. Comments on the draft are due by August 30.

New Hampshire bans PFAS in 8 product categories

On August 2, New Hampshire’s Governor Chris Sununu signed a law prohibiting PFAS (per- and polyfluoroalkyl substances) in eight product categories. This law represents an ongoing effort at state level to eliminate these persistent chemicals from consumer goods.

Effective January 1, 2027, New Hampshire will ban the sale of products containing intentionally added PFAS including food packaging and containers, carpets or rugs, fabric treatments, upholstered furniture, textile furnishings, other than industrial or medical ones, juvenile products, cosmetics, and feminine hygiene products.

Unlike other states, New Hampshire's law uses the PFAS definition from the U.S. EPA's TSCA reporting rule, which covers around 1,400 compounds.

The law exempts certain products, including those with at least 85% recycled content or that were manufactured before the restrictions take effect. Manufacturers must provide certificates of compliance within 30 days if requested by the New Hampshire Department of Environmental Services (NHDES). Failure to comply could lead to misdemeanors, felonies, fines of up to $25,000 per offense, and additional penalties of up to $2,000 per violation.

Massachusetts phases out PFAS in turnout gears:

On August 15, Massachusetts Governor Maura Healey signed a law banning PFAS (per- and polyfluoroalkyl substances) in firefighter turnout gear, making Massachusetts the first state in the U.S. to phase out these chemicals in firefighting PPE by 2027. This legislation aims to protect firefighters from harmful exposures to PFAS, which are linked to serious health issues.

Starting January 1, 2025, sellers must inform buyers about the presence of PFAS in firefighting gear and provide details about the specific compounds used. Sellers and buyers must also submit these notices and related documents to state regulators within 60 days, if requested.

The law defines PFAS as "fluorinated organic chemicals containing at least one fully fluorinated carbon atom" and covers all PFAS that are intentionally added or result from manufacturing processes. The ban applies to all firefighter PPE, including jackets, trousers, helmets, gloves and respiratory equipment.