The US Fragmented Market

Written By Bloom Regulatory
 

How US State Laws are Reshaping Cosmetic Compliance

 

For a long time, cosmetic companies formulating products for the US have primarily had one regulatory landscape to navigate: the Federal Food, Drug and Cosmetic Act (FD&C Act), enforced by the FDA. Compared to the EU, the ingredient prohibitions and restrictions listed were fewer but the framework was largely uniform nationwide.  This  situation is now evolving and with quite some pace!

 

A patchwork of regulation

While the FDA continues to hold overarching authority, several states have begun to introduce their own restrictions on the cosmetic ingredients that can be used in finished products. California is a key player in this campaign to strengthen control in the face of perceived relaxed national laws, introducing its Toxic-Free Cosmetics Act, which came into effect in 2025 and banned a range of substances (further prohibitions to come in 2027).

Other states have also followed by adopting or proposing similar controls.  Some states have adopted California’s prohibited list outright whilst others are developing their own unique prohibitions. For example, New York and Washington have both introduced or proposed legislation addressing ingredients deemed hazardous to human health or the environment, similar to those prohibited in California but some notable challenges arise.

For EU-compliant brands, there is some good news as the prohibitions are often similar to those in place in the EU but, unfortunately, it is not automatic that compliance in the EU will lead to compliance in the US.

Key issues seen so far

Washington:

  • Restriction of lead to 1ppm (including as an impurity)

  • Proposal to prohibit named formaldehyde releasers (including many used as preservatives in the EU)

  • Prohibition of Triclosan, used in some EU products

New York:

  • Potential prohibition of talc

  • Potential prohibition of parabens

  • Potential prohibition of benzophenone-3 (oxybenzone)

 

How we can help?

At Bloom we are tracking laws introduced at state level and can offer a comprehensive formula review for those brands looking to market in the US.  Our comprehensive formula review includes: 

  • Review of the formula under national cosmetic legislation

  • Drug borderline considerations triggered by ingredient inclusion

  • State requirements/proposals in California, Maryland, New York, Oregon, Vermont and Washington (and additional states as the situation evolves)

Additionally, we offer a number of other US-specific services to support US launches or ongoing compliance. For example:

  • Comprehensive label review which includes screening and advice on the warnings required under Proposition 65

  • Product category screening in relation to California’s VOC laws

  • Screening and notification under the California Safe Cosmetics Act

  • Cosmetics Direct (FDA) product listings

Get in touch if you’d like to learn more about these or any of our services.

 

Amanda Isom

Bloom Regulatory
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