The U.S. cosmetics industry is undergoing its most significant regulatory transformation in nearly a century.
With the Modernization of Cosmetics Regulation Act (MoCRA) now rolling out, beauty companies face new requirements to enhance product safety and transparency. For both established and emerging brands, understanding current and upcoming MoCRA legislation is crucial to compliance and maintaining consumer trust.
What is MoCRA?
MoCRA represents the first major update to U.S. cosmetics regulations since 1938. Signed into law in December 2022, the legislation introduces new requirements for beauty brands to ensure greater product safety and traceability.
The Act modernises how the beauty sector operates by implementing stricter safety standards, mandatory reporting requirements, and enhanced FDA oversight – all aimed at protecting consumers while creating a more accountable industry.
For more background on MoCRA, check out our blog post: The FDA is overhauling cosmetics regulation. What does it mean for beauty brands?
Which MoCRA changes are already in force?
Since MoCRA was signed off in 2022, the FDA has introduced a number of significant legislative requirements. These include:
1. Safety substantiation
Since December 2023, all cosmetic products require adequate safety substantiation. This means maintaining comprehensive documentation that proves product safety through tests, studies, research and analysis.
Cosmetic brands need qualified experts to evaluate their products and ingredients, ensuring there's sufficient evidence to support their safety claims.
2. Serious adverse event reporting
Also effective from December 2023, manufacturers, packers and distributors must report serious adverse events to the FDA within 15 business days. These include incidents resulting in death, hospitalisation, significant disfigurement or other serious health impacts.
Companies must also submit any new medical information received within a year of the initial report.
3. Product listing
In July 2024, the FDA introduced a mandate requiring beauty companies to list all marketed cosmetic products with their organisation. Each listing must include:
- Complete ingredient information
- Facility registration numbers
- Regular updates to reflect any changes
Small businesses may qualify for exemption, except those producing goods that come into contact with eye mucus membranes, injectable products, or products intended for internal use or extended appearance alteration.
4. Professional use labelling
Since December 2023, products intended for professionals require specific labelling that states this fact. The FDA defined professionals as an individual licensed by an Official State authority to practice in the field of cosmetology, barbing, nail care or an aesthetician.
Which MoCRA policies are yet to roll out?
While significant changes have already come into force, there are still some new regulations that haven’t been finalised. These include:
1. Responsible Person (RP) information
MoCRA legislation requires a Responsible Person to be included on the labelling for beauty products sold in the USA by the end of 2024. This can be a manufacturer, packer or distributor, and it can be a company or brand name – there is no need to list an individual person.
The U.S. RP must have a physical address, phone number or digital contact information (e.g. email or website address) listed on product labels. Virtual addresses are not permitted.
2. Fragrance allergen labelling
The FDA is also developing guidelines for fragrance allergen disclosure on product labels. Brands will be required to label EU fragrance allergens on the US INCI. The timeline and detail of this legislation remains uncertain, but greater clarity has been promised in December 2024.
In the meantime, some states have started to develop their own guidelines. For example, California has declared that any fragrance containing ingredients that are allergens in the EU should be reported under The Cosmetics Fragrance and Flavor Ingredient Right to Know Act, which came into effect at the start of 2024.
But since this information is listed on a government website rather than product labels, consumers must take the extra step of researching allergens online instead of finding this information directly on their products
3. Product records and recalls
The FDA is set to release guidance by the end of 2024 regarding record access and mandatory recalls. This will clarify when and how the FDA can exercise its new authority to access product records and order recalls.
4. Good Manufacturing Practices (GMPs)
December 2025 will bring the FDA's final rule on current Good Manufacturing Practices (cGMPs) for cosmetic production facilities. The ruling will establish standard quality control measures across the industry.
5. Research on PFAS
By December 2025, the FDA must report on per- and polyfluoroalkyl substances (PFAS) in cosmetics, including safety assessments and potential risks. Several U.S. states have already moved to ban PFAS in cosmetic products.
Prepare your business for the next MoCRA updates
Although there are several months until new MoCRA updates become law, the time to act is now. These regulatory changes require careful planning and implementation to ensure your brand remains compliant when selling beauty products in the USA.
Working with a specialist beauty compliance agency like Hooley Brown has never been more crucial. We can help you understand how MoCRA legislation will affect your business and guide you through the necessary adaptations.
Our MoCRA support services include:
- Developing action plans for upcoming requirements
- Managing documentation and reporting
- Ensuring your labelling meets new standards
- Providing Responsible Person services
- Preparing for facility registrations
- Implementing safety substantiation protocols
Don't let regulatory changes catch you off guard. Book a call to find out more about MoCRA legislation.
