US FDA registration requirements for cosmetics - enterprise registration and product registration

Latest news, the FDA cosmetics registration system is officially open on December 16, 2023! ! ! The cosmetics FDA is officially launched. From the cosmetics registration that was suspended in March, the FDA cosmetics registration system was reopened on December 16.

01 Regulatory background

On December 29, 2022, the United States passed the highly anticipated "Cosmetic Regulation Modernization Act of 2022" (MOCRA). After MOCRA takes effect, all companies selling cosmetics in the United States will be required to register their factories with the FDA and submit cosmetics product filings. The Voluntary Registration Program (VCRP) for cosmetics factory registration and product filing has become history.

The "Cosmetic Regulatory Modernization Act of 2022" (MoCRA) is the most significant expansion of the FDA's power to regulate cosmetics since the passage of the Federal Food, Drug, and Cosmetic (FD&C) Act in 1938. This new law will help ensure the safety of cosmetics that many consumers use daily.

02 Major changes in cosmetic regulations

The main differences between the registration requirements of the MOCRA Act for cosmetic companies and products and the requirements of the VCRP include:

1) US agent

MOCRA requires non-US manufacturers to designate US agents and register in the system;

VCRP does not require US agent information.

2) Registration requirements

MOCRA's requirements for manufacturers to register are mandatory;

VCRP is voluntary.

3) Registration update requirements

MOCRA requires companies to update their registrations every two years and product listings every year;

VCRP does not have clear annual update requirements.

4) Enterprise size classification identification

MOCRA will identify the size of the enterprise and differentiate the requirements; (Dun & Bradstreet coding requirements)

VCRP does not have clear degree update requirements.

03 Other issues of concern to enterprises

1) Does the FDA charge official fees?

For cosmetics, the FDA does not charge official fees.

2) How long does the registration cycle take?

We estimate that it will take about 2 weeks from acceptance to completion