Chapter 1 Registration Background

1. FDA Regulatory Information Brief

The U.S. FOOD & DRUG Administration (FDA) is the U.S. cosmetic agency. The FDA works closely with U.S. Customs and Border Protection (CBP) to inspect imported cosmetics for compliance at the point of entry.

2. Supervision and regulation

Modernization of Cosmetics Regulation Act of 2022 (MoCRA);

21 CFR of Federal Food, Drug, and Cosmetic Act;

Fair Packaging and Labeling Act.

3. Definition and classification of American cosmetics

21 The CFR of Federal Food, Drug, and Cosmetic Act defines a cosmetic product as "an article intended to be applied, poured, sprayed, or applied to, or otherwise applied to, the human body to cleanse, beautify, enhance attractiveness, or alter appearance." Section 201(i) of Bill C].

Cosmetic claims should not relate to the efficacy of drugs. Products that meet the claims of OTC monographs will be regulated as drugs and cosmetics and will need to meet the regulatory requirements of both.

4. Entry requirement

① Cosmetics registration requires factory registration and product listing;

② Manufacturers should meet the GMP requirements for cosmetics in the United States;

③ Adverse reaction contact information needs to be determined.

5. Registration language

 English

6. U.S. Agent

For imported cosmetics, a U.S. agent is required to act as a bridge between FDA and the product owner.

A U.S. agent is an individual or business entity that resides in the United States or has a place of business in the United States and actually conducts business in the United States.

Chapter 2 Registration process, cycle & Government fee

1. Registration flow chart

2. Registration period and official fees

FDA cosmetics registration, the authority currently does not charge official fees. The registration period is 1-2 weeks.

Chapter 3 FAQ 

Q：Who is the head of American cosmetics?

A：Responsible person means according to FD& C Act, Section 609 (a) or Section 4 (a) of the Fair Packaging and Labeling Act, a manufacturer, packer, or distributor of cosmetics whose name appears on a cosmetic label.

Q：How long is the validity of the American cosmetics listing?

A：It is valid for one year.

Q：Can the US cosmetics list be renewed after expiration?

A：Agreed. The FDA requires that the list be updated once a year, and the factory registration be updated once every two years.