If you’re a beauty brand selling products in the USA, pay close attention.

The FDA has made its biggest update to cosmetics regulations in almost 100 years – and it’s going to impact how personal care companies manage product compliance and packaging/labelling.

To help you get to grips with U.S. cosmetics regulation changes, Hooley Brown has looked at how the laws are being modernised and what it may mean for your business:

How are U.S. Cosmetics Regulations changing?

On 29th December 2022, President Biden signed two pieces of beauty industry legislation: the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), and amendments to Chapter VI of the Federal Food, Drug, and Cosmetic Act (FD&C).

It’s the first federal update to cosmetics laws since 1938.

The new legislation is designed to increase traceability and accountability in the beauty industry, to make products safer for consumers. Key updates include:

• Operators of facilities that manufacture/produce cosmetics must register with the FDA and renew their registration every two years – any new entrants have 60 days to register their business
• A full list of existing cosmetics products, their ingredients and manufacturing details must be submitted to the FDA by 29th December 2023
• Ingredient listings for new cosmetics products must be submitted to the FDA within 120 days of going on sale in the U.S.
• Any ‘serious adverse events’ that happen as a result of using a cosmetic product must be reported to the FDA within 15 days of the event. Scenarios could include a death, life-threatening experience, serious infection, significant disfigurement or hospitalisation. Any new updates and evidence must be collected up until a year after the incident, and records of all adverse events should be kept for six years.
• All cosmetics products must have a designated ‘responsible person’ (manufacturer, packer or distributor) who compiles the list of products, ingredients and manufacturing information required by the FDA and reports serious incidents
• Responsible persons will also be required to maintain records ‘adequately substantiating’ that a cosmetic product is safe to use – any products without adequate safety substantiation will be considered adulterated
• The FDA provides an opportunity for the responsible person to voluntarily cease distribution or recall a product in the event of a serious adverse event, in case it determines that product is adulterated or misbranded
• Product labels must be updated to include contact details for the responsible person so that consumers can report adverse events

This new ‘federal baseline’ will standardise cosmetics regulation across the USA. It supersedes existing state laws, but states can add their own supplementary rules – like banning the use of certain ingredients.  

Further cosmetics legislation to follow in the coming years

In addition to the finalised policies we’ve already mentioned, Congress has also directed the FDA to:

• Create a list of mandatory fragrance allergens – these allergens will need to be identified on cosmetics labelling/packaging.
• Standardise testing methods for detecting asbestos in cosmetics that contain talc
  
• Establish good manufacturing practices (GMPs) that companies should follow to maintain product quality, consistency and safety in line with national and international laws
• Work towards phasing out unnecessary animal testing

The FDA will also prepare an official report on the safety of using perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetics within the next three years.

Which cosmetics brands will be affected by MOCRA?

The new laws impact any company that manufactures and processes cosmetics for distribution in the USA – but not firms that exclusively perform labelling, packaging, holding and distribution services. Retailers and beauty salons are also excluded unless they manufacture products.

It’s important to note that the FDA’s definition of cosmetics is much broader than many people’s understanding of the term. The FD&C Act classifies cosmetics as: “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance”. This definition includes personal care products such as shampoo, deodorant, moisturisers and perfumes, not just traditional makeup.

What should beauty brands do next?

If your company is affected by changes to U.S. cosmetics regulation, there are some key action points to cover during 2023:

• Register your business/facility with the FDA
• Provide a full list of your current products, their ingredients and how they were manufactured
• Appoint responsible persons for all your products and add their contact details to your product labels

Once you’ve ticked these boxes, the next step to ensuring your business remains compliant is to review your operational processes – answering questions such as:

• How will you collate ingredient lists and manufacturing information for future products?
• Can you easily report significant product safety breaches within the new 15-day deadline?
• Have you set reminders to re-register your company with the FDA every two years?

For many cosmetics brands selling in the USA, the modernisation of personal care laws creates a strong business case for putting more investment into product compliance.  

Hooley Brown is a specialist compliance agency helping cosmetics companies sell worldwide. Our team of legal experts keep pace with the latest personal care legislation to ensure your product and its packaging/labelling meet market requirements.

If you’d like help adapting to the FDA’s new cosmetics regulations, book a free phone consultation with one of our legal experts.

‍This blog post was written in January 2023. Facts were correct at the time of writing.