With the introduction of the Modernization of Cosmetics Regulation Act (MoCRA), cosmetic businesses seeking to enter the U.S. market are now required to adhere to updated regulatory standards. Additionally, a key provision of this legislation mandates the listing of cosmetic products with the FDA. In this article, UCC will provide a detailed explanation of the FDA requirements for listing cosmetic products.
1. Overview of Listing Cosmetic Products
The implementation of MoCRA has changed the way cosmetic businesses interact with the U.S. market. Under this new law, manufacturers, packers, and distributors of cosmetic products are now required to list their products with the FDA. This process not only improves compliance but also enhances business credibility and consumer safety.
For businesses, the advantages include increased brand reputation, reduced legal risks, and better access to the U.S. market. Moreover, effective product management becomes easier. For consumers, product listings ensure safety, transparency, and quicker resolution of any health-related concerns.
2. General Regulations for Listing Cosmetic Products
2.1. Responsible Person
The responsible person for a cosmetic product is the manufacturer, packer, or distributor whose name appears on the product label, according to the FDA’s guidelines. This individual or entity must list each product marketed in the U.S. and include the product’s ingredients. Additionally, they are required to update this information annually.
2.2. Deadlines
FDA will not enforce the requirements related to cosmetic product facility registration and listing cosmetic products until six months after the statutory deadline of December 29, 2023. Therefore, businesses now have until July 1, 2024, to comply with these updated regulations. Additionally, this extension provides businesses with more time to ensure full compliance with the listing cosmetic product requirements.
3. Required Information for Listing Cosmetic Products
3.1. Mandatory Information
When listing cosmetic products, the following details must be submitted:
Responsible Person
- The responsible person’s name (as listed on the label).
- Contact phone number for the responsible person (including country/area code).
Product Information
- Product category code(s) (refer to the relevant categories).
- Product name as it appears on the label (if not unique, include distinguishing information such as the brand name or internal code).
- Confirmation of whether the product contains fragrance, flavor, or both.
Manufacturing Facility
- FDA Establishment Identifier (FEI) for each facility where the product is manufactured or processed. If the facility is exempt, provide the facility name and address.
Ingredients
- A full list of ingredients, identified by their common or usual names
- For multiple products, specify which ingredients apply to each one.
Confirmation Statement
- An attestation to the accuracy and veracity of the information provided.
3.2. Optional Information (Encouraged)
The following optional details can also be provided to help streamline the listing cosmetic products process:
Responsible Person
- Specify whether the business qualifies as a “small business.”.
- Specify the type of business: manufacturer, packer, distributor, or a combination of these.
- Provide the name of the parent company (if applicable).
- DUNS number for the responsible person’s listed address.
Product Information
- Upload images of the product label (front and back).
- Include the product’s webpage link.
- Confirm whether the product is for professional use only.
Manufacturing Facility
- If the FEI is not available, register through the FEI Search Portal.
Ingredients
- Include Unique Ingredient Identifiers (UNIIs) through the Global Substance Registration System.
Additional Contact Information
- Provide the name, email, and phone number of an authorized agent.
In summary, listing cosmetic products with the FDA is a necessary step for businesses entering the U.S. market. Additionally, it ensures compliance, builds brand credibility, and enhances consumer safety. If you have any questions or need assistance with your listing cosmetic products, feel free to contact UCC for expert guidance.
For more information: Cosmetic Product Labels: Ensuring Safety and Compliance
