FDA Proposes New Cosmetic Rules on Formaldehyde and Fragrance Allergens

The U.S. Food and Drug Administration (FDA) has included two long-awaited cosmetic regulations in its 2026 regulatory agenda, signalling renewed progress on measures that could significantly affect cosmetic manufacturers, importers, and consumers. The planned proposals address the use of formaldehyde in hair straightening products and the mandatory declaration of fragrance allergens on cosmetic labels.

Although neither measure is yet legally binding, both are expected to enter the formal rulemaking process later this year, marking an important step in the implementation of the Modernization of Cosmetics Regulation Act (MoCRA).

Two cosmetic rules move into the proposal stage

According to the FDA’s 2026 Regulatory Plan and Unified Agenda, the agency intends to publish two Notices of Proposed Rulemaking (NPRMs) in November 2026.

The first proposal would prohibit the use of formaldehyde and formaldehyde-releasing substances in hair smoothing and hair straightening products. The second would introduce mandatory labelling requirements for specific fragrance allergens in cosmetic products.

The publication of an NPRM does not immediately create new legal obligations. Instead, it launches the formal regulatory process, allowing stakeholders to review the proposal and submit comments before a final rule is adopted.

Why the regulatory agenda matters

The FDA’s Regulatory Plan and Unified Agenda provides an overview of the agency’s planned regulatory actions and priorities. Inclusion of a topic in the agenda indicates that the FDA intends to advance work on that regulation, although publication dates may change as the rulemaking process develops.

For the cosmetics sector, these initiatives are closely linked to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which expanded the FDA’s authority over cosmetic safety, manufacturing practices and product labelling. Since its adoption, MoCRA has served as the legal foundation for several ongoing regulatory initiatives.

Proposed restrictions on formaldehyde in hair treatments

One of the most closely watched proposals concerns professional hair smoothing and straightening products that contain formaldehyde or ingredients capable of releasing formaldehyde during use, such as methylene glycol.

These products may emit formaldehyde gas when heat is applied during styling procedures, increasing the potential for inhalation exposure by both salon professionals and consumers. Scientific studies have associated repeated exposure to formaldehyde with a range of health concerns, prompting regulators to reassess its use in cosmetic applications.

The FDA has previously announced plans to regulate these products but postponed publication several times. Their inclusion in the 2026 agenda suggests that the agency intends to move the proposal forward later this year.

Fragrance allergen labelling could become mandatory

A second proposal focuses on improving transparency for consumers with fragrance sensitivities or allergies.

The FDA plans to identify a list of substances considered fragrance allergens and require their disclosure on cosmetic product labels. Currently, fragrance ingredients are generally declared under collective terms such as “fragrance” or “parfum”, which can make it difficult for sensitive consumers to identify specific allergenic substances.

If adopted, the new requirements would align cosmetic labelling more closely with the objective of enabling consumers to make informed purchasing decisions and avoid ingredients that may trigger allergic reactions.

What manufacturers should expect

At this stage, neither proposal has entered into force. Once published as NPRMs, both measures will be subject to a public consultation period during which industry stakeholders, trade associations, scientists and consumers will be able to provide feedback.

Only after reviewing those comments will the FDA decide whether to adopt, modify or withdraw the proposed rules. Companies marketing cosmetic products in the United States should nevertheless monitor these developments closely, as both initiatives could require future reformulation, updated ingredient assessments and changes to product labelling.