Cosmetics section

A、regulatory background

On August 7, 2023, the U.S. Food and Drug Administration (FDA) Issued Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products, which addresses the requirements for facility registration and product listing in the "Modernization of Cosmetics Regulation Act of 2022" (MoCRA) Explained. Cosmetics exported to the United States require facility registration and product listing.

*Facility registration: Facility registration can be simply understood as factory registration. In the following, factory registration will be used instead of facility registration. This is hereby explained.

B、Compliance process

1. Exemptions :

1) Small business are mainly judged by their cosmetics sales in the U.S. market in the past three years. Enterprises with average annual sales of less than US$1 million can be considered small business ;

(However, if the enterprise produces some cosmetics with special usage methods (which should be considered to be higher risk), this exemption rule does not apply, such as some cosmetics that may come into contact with the mucous membrane of the eyes during use);

2) If the products produced by the enterprise also need to comply with the management requirements of drugs or medical devices, factory registration is exempted ;

3) Small business, that is, responsible Person are small business, and the products do not belong to certain products with higher risks of use, so they are exempt from product listing;

4) The product also meets the regulatory requirements for drugs or medical devices. Then the product does not need to be listed as a cosmetic product.

2. Registration/listing time limit requirements:

1) Factory registration time limit

Existing factories must complete factory registration before July 1, 2024;

New cosmetics factory - engaged in cosmetics processing and production within 60 days .

Factory registration is updated (continued) once every two years;

2) Product listing time limit

Products already on sale: Complete product listing before July 1, 2024;

Newly Marketed Cosmetics - The responsible person must submit the product for listing within 120 days of the product being sold in interstate commerce.

Product listings are updated ( continued) once a year;

FDA does not charge official fees for ordinary cosmetics factory registration and product listing.

OTC monograph product section

A、 OTC product listing requirements

OTC is the abbreviation of over the counter, which refers to drugs that do not require a doctor's prescription and can be purchased directly by consumers in pharmacies or drug store. They are regulated by the U.S. Food and Drug Administration ( FDA ) . OTC products must meet FDA standards for product quality, effectiveness and safety.

If the active ingredients in cosmetics meet the requirements of the OTC monograph , and the labeling and other general safety requirements meet the product requirements of the OTC monograph , factory registration and product listing are required before the product is put on the market, and FDA approval is not required.

(The following is an introduction to the compliance of OTC cosmetics.)

B、 Compliance process

1、Business registration time limit and fee requirements:

1) Time limit

Products must be registered within 5 days after they are put on the market, and the validity period is one year.

Annual renewals (continuations) must be made between October 1 and December 31 of each year.

2) FDA charges

For OTC enterprise registration , FDA will charge enterprise annuity

OTC monograph drug enterprise (independent production enterprise registration): $ 34,166/ year

Contract production outsourcing enterprise ( i.e. foundry registration): $ 22,777/ year

2. Product listing time limit requirements:

The initial listing must be submitted within 3 days after the company is registered, and new products must be listed before going on the market.

If there is a product update, it will be updated no later than June or December . If there is no update, a "No Change Notice" will be submitted between October 1 and December 31 each year

FDA does not charge official fees for product listing.

Professional services provided by ZOOP

·Apply for a Dun & Bradstreet number (DUNS number)

·general cosmetics and FDA OTC monograph products

·Product formula and label review

·general cosmetics and OTC monograph products

·Business registration and product listing annual update services

·Testing required to demonstrate product safety and safety assessment services

·Assume local agency in the United States (as needed)

·Cosmetic classification definition service       

·U.S. Cosmetic Regulatory Compliance Training

·Other customized services      

ZOOP’s service advantages

Since its establishment in 2010, ZOOP focuses on product compliance-related services. The company's cosmetic division audit teachers are all from medium- to large-sized cosmetic manufacturers and have relevant professional backgrounds in biology, medicine, cosmetics and chemistry.

Our advantages are:

1. Professional and mature team, periodic service guarantee;

2. Reasonable prices, high-quality services throughout the process, and peace of mind;

3. With outlets in Shenzhen, Guangzhou, Shanghai and Beijing, communication is convenient;

4. One-stop service for makeup , disinfection and medical devices , efficient and cost-effective;

5. Can provide services in full English to meet the needs of domestic and foreign customers ;

Responsible for customers and quality service are the consistent business philosophy of ZOOP. We hope to serve more quality-focused customers and grow with you!