When the Modernization of Cosmetics Regulation Act (MoCRA) was enacted in 2022, US Congress and the Food and Drug Administration (FDA) lauded this sweeping federal legislation, which was designed to increase cosmetic safety and quality standards. And, yes, MoCRA significantly expanded the FDA’s authority to regulate cosmetic manufacturing practices and impose registration/listing and adverse event reporting requirements. It also provided a mandate for the agency to issue new rules related to fragrance allergen labelling, among other provisions.
But, fast-forward three years, the FDA has yet to implement many rules and regulations that give teeth to MoCRA. Indeed, the beauty industry is still waiting on good manufacturing practices (GMP) regulations and fragrance allergen labelling requirements, and a final rule for testing of talc in asbestos-containing products, among other mandates under this legislation.
The likelihood of those regulations is also now in question. The Trump administration’s regulatory freeze, which pauses any new or pending rules until they undergo further review, coupled with federal hiring freezes and mass departures from the FDA in recent months, further reduces the likelihood of imminent changes under MoCRA.
To the extent the cosmetic industry thinks only of MoCRA when it comes to cosmetic regulations, it is necessary to shift that mindset. Yes, sweeping change is here, but at the state level.
Step aside, FDA, states are taking their own approaches to cosmetic safety
Change is here: state toxic-free laws ban or restrict specific ingredients. Whether due to frustration at the pace of MoCRA’s implementation or simply a desire to take a different approach towards regulating cosmetic safety, at least 17 states have passed or introduced their own laws governing cosmetic and personal care product safety according to state toxic-free laws.
Each state law has its own nuances, but four key themes remain consistent with the states’ approach:
- Ingredient focus: In contrast to MoCRA’s focus on manufacturing practices and labelling disclosures, states are taking a more pointed approach by simply banning (or severely restricting) numerous substances used in cosmetics as well as personal care products. Not surprisingly, the ingredients at issue are largely those that have become increasingly familiar to consumers via the ‘clean beauty’ trend, including mercury and mercury compounds, formaldehyde and formaldehyde-releasing agents, certain phthalates, PFAS (per- and polyfluoroalkyl substances), lead compounds and other substances that the states assert are linked to cancer, reproductive harm or endocrine disruption. In this way, states are focused on reducing consumer exposure from the outset by deciding what is and isn’t ‘safe’ for consumers, rather than the FDA’s preference for ingredient disclosure and manufacturer recordkeeping/reporting.
- Scope: The state laws cover not only ‘cosmetics’ as defined by the FDA, but also broader personal care products (such as menstrual products and related wellness products) and, in some cases, household cleaning products. And, unlike the FDA’s approach to holding the entity whose name is on the label largely responsible for regulatory compliance, many state laws have broader enforcement for manufacturers, distributors and even retailers – particularly if they ‘knowingly’ distribute prohibited products to consumers.
- Enforcement: While the FDA generally enforces its regulations through warning letters, inspections, seizures and recalls, state regulators focus on the pocketbook. Violations of state laws generally carry civil penalties in addition to the authority to seize violative products.
- Impact on the industry: The state laws are crafted to generally avoid potential preemption by MoCRA. Also, states impose slight variances on the list of banned and/or restricted ingredients, the parties responsible for compliance and the penalties associated with a violation. This leaves industry grappling with a patchwork of state laws.
The time is now: brand strategy for compliance
In several states, toxic-free laws have already gone into effect. For example, California’s Toxic-Free Cosmetics Act, which bans 24 ingredients, went into effect on 1 January this year. Similarly, Oregon’s 2023 Toxic-Free Cosmetics Act, effective 1 January 2024, introduced similar bans and disclosure mandates. Colorado, for its part, has passed one of the most restrictive PFAS laws, that also went into effect on 1 January this year, restricting PFAS from personal care products that contain intentionally added PFAS, with a penalty of up to $5,000 per violation.
At the other end of the country, Maryland implemented a ban at the start of this year on dozens of intentionally added ‘banned’ ingredients, while Vermont and Maine are set to implement similar laws effective from the start of 2026 and 2027, respectively. Finally, New York has already implemented a restriction on mercury and dioxane (above de minimis levels) in personal care products. The New York state senate has introduced broader legislation under the Beauty Justice Act that, if passed, would ban or restrict dozens of chemicals from personal care products.
In terms of compliance, beauty brands should closely evaluate the nuances of each state law against their product formulations. While the patchwork of state laws presents a compliance burden, brands could consider conforming to the most restrictive state laws, or at a minimum, removing any substances that are consistently restricted across various state laws, while limiting sales in states with more rigorous requirements.
Brands should work closely with their supply chain to ensure that all entities in the supply chain are aware of, and adhere to, the state law restrictions. Finally, brands (and retailers) should ensure that vendor agreements require state cosmetic law compliance for any products distributed or sold by the brand or retailer.
Kristen Klesh is a partner in Loeb & Loeb’s Washington DC office, advising clients on a broad range of FDA, Federal Trade Commission and related state law regulatory compliance matters throughout all stages of the product life cycle. She can be reached at [email protected].
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