Green Circle Talks Cross-border] - Interpretation of U.S. Cosmetic Compliance Policies

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The U.S. Federal Food, Drug, and Cosmetic Act (FD&C Act) is designed to ensure the safety and compliance of food, drugs, and cosmetics in the marketplace. The FD&C Act authorizes the U.S. Food and Drug Administration (FDA) to regulate cosmetics and provides for definitions, labeling requirements, ingredient safety evaluations, and prohibitions on inappropriate advertising. Through its regulation of the cosmetics industry, the FDA is committed to protecting the health and interests of consumers and ensuring the safety and compliance of cosmetics. Therefore, cosmetic manufacturers are responsible for complying with these regulations and ensuring that their products meet the relevant requirements.

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Merchants need to be aware of and comply with the relevant FD&C Act regulations for cosmetics to ensure that their products are compliant in the U.S. market and to protect the health and rights of consumers.

Compliance Guide

  Under the FD&C Act, cosmetic manufacturers are required to register their facilities with the U.S. Food and Drug Administration (FDA) and register each marketed cosmetic with the FDA. These registration processes allow the FDA to track and monitor the production and sale of cosmetics and ensure compliance.

1. Registration of facilities (enterprises)
The registration needs to be renewed every two years and an FEI (business registration number) is issued. Manufacturers of their own products and commissioned cosmetic products only need to register once. The information required for registration is as follows:
①Required information:

• Name of the facility owner and/or operator;
• The name, physical address, e-mail address and telephone number of the facility;
• For foreign facilities, provide the facility's U.S. agent contact information (name and phone number) and, if applicable, electronic contact information (email);
• The factory registration number, if any, previously assigned by the FDA to all brand names used in cosmetics manufactured or processed at the facility.
• The product category and responsible person for each cosmetic manufactured or processed at the facility;
• Type of Submission (Initial, Amendment, Two Year Renewal or Short Renewal).
  ② Optional information:
• Name of the parent company (if applicable);
• Facility (Business) DUNS no;
• Other contact information of the individual associated with the registration.
  2、Product Registration
  The responsible party must list each listed cosmetic, including product ingredients, with the FDA and provide any updates annually. The registration requirements are listed below:
  ①Required information:
• The factory registration number of each factory that manufactures or processes the cosmetic;
• The name and contact number of the person in charge, and the name of the cosmetic product (based on the name on the label);
• The category of cosmetics to which the cosmetic applies (see Appendix A of the Modernization of Cosmetic Regulation Act (MoCRA) of 2022 for details);
• A list of cosmetic ingredients, including any flavors, fragrances, or colors, each of which is identified by name as required by section 701.3 of Title 21 of the Code of Federal Regulations (or any successor regulation), or by the common or usual name of the ingredient;
• Product List Number (if any);
• Submission Type (Initial, Content Update (Annual), Short Renewal).
  ②Optional Information
• Name of the parent company (if applicable);
• Type of business (as listed on the label), i.e., manufacturer, packer, or distributor;
• Label image (currently accepts JPG files);
• Links to product pages;
• Whether the cosmetics are for professional use only;
• DUNS number of the address listed on the product label;
• Unique Ingredient Identifiers (UNIIs);
• The responsible person is required to obtain a facility registration number for each facility that produces or processes cosmetics, or provide the name/address of the facility if there is no facility registration number.