New FDA Rules on Importing Cosmetics into the US: What Does It Mean for Manufacturers

The FDA has established new requirements for the import of cosmetic products into the United States, which must be met by July 1, 2024. Let’s take a look at all the nuances of the new regulation.

General Overview

Today, the United States has several restrictions on the composition of cosmetic products. Eleven ingredients and their compounds are prohibited for use in cosmetics, and most others require certification from the FDA. These restrictions apply to both colorants and fragrances used in cosmetic products. Therefore, cosmetics manufacturers must comply with the established rules to be able to sell their products on the US market.

To successfully import cosmetic products into the United States, two important steps must be taken. The first step is to determine whether the product and its manufacturer are subject to registration with the FDA. The second step is to ensure that the product complies with the FDA’s labeling requirements.

Background Information on MoCRA and Cosmetics Direct

MoCRA (Cosmetic Regulatory Modernization Act) implements new standards for the regulation of cosmetics in the United States. The program requires owners or responsible persons of businesses engaged in the manufacture or processing of cosmetic products to register their businesses and all cosmetics they manufacture for sale in the United States.

With the new Cosmetics Direct portal, cosmetics manufacturers will have a user-friendly interface for registering MoCRA-compliant facilities and products. 

Explanation of the New Rules

With the adoption of the MoCRA in 2022, the FDA gained significantly more authority to regulate cosmetic products. According to MoCRA, owners or operators of facilities that manufacture or process cosmetic products for distribution in the United States must register their facilities and cosmetic products.

If a company has a contract manufacturer that produces the products on its behalf, only the contract manufacturer needs to be registered. The company will be listed as the responsible person and will be solely accountable for the products.

However, it is important to note that there are exceptions. Small businesses with average annual gross sales of cosmetic products in the U.S. for the preceding three-year period of less than $1,000,000, adjusted for inflation, may be exempt from FDA manufacturer and cosmetic product registration. Nevertheless, their product labeling must meet certain standards.

Regardless of average annual gross sales, all businesses engaged in the manufacture or processing of the following products are not exempt from manufacturer and product registration:

• Cosmetics that usually come into contact with the mucous membrane of the eye (e.g., eye makeup removers, liquid eyeliner, glue for false eyelashes).
• Cosmetics that are injected (e.g., tattooing).
• Cosmetics intended for internal use.
• Cosmetics intended to change appearance for more than 24 hours (e.g., certain nail polishes like gel polishes, certain hair products like dyes and colorants, certain eyebrow dyes, and certain leave-on skincare products like SPF).

If a company manufactures one or more of the above products, it is required to register the manufacturer and all products it plans to sell in the United States under any circumstances.

Compliance with the new rules is critical for cosmetics manufacturers, as failure to comply can have serious consequences, including fines and even a ban on importing products into the US market.

Responsible Person of the FDA Cosmetic Product

The Responsible Entity (i.e., the entity named on the product label) must register all cosmetic products with the FDA and submit comprehensive information about each product. This includes the product name, brand, responsible person on the label, product manufacturer, ingredient list, and label file, which includes product ingredients. It is also necessary to update the information about the company annually and in case of data changes. Additionally, the relevance of the manufacturer and product data must be confirmed at the end of each year by December 31, though updates can be made at any time.

A responsible person may be a manufacturer, packager, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with Section 609(a) of the FD&C Act or Section 4(a) of the Fair Packaging and Labeling Act.

Source: https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products

Conclusions

The new rules for importing cosmetics into the United States are designed to ensure control over manufacturers and the safety of cosmetic products for consumers. According to these rules, manufacturers or responsible persons must comply with FDA and MoCRA requirements regarding product registration and labeling. Adhering to these requirements will ensure the quality and safety of cosmetic products for consumers in the United States.

If you have any questions regarding compliance with FDA and MoCRA requirements or the cosmetic registration process, please contact our experts.