Avoiding Common Pitfalls: Tips for Complying with FDA Cosmetics Regulations

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.

Most American consumers use cosmetic products every day. On average people use 6 to 12 cosmetics products daily. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938. This new law will help ensure the safety of cosmetic products many consumers use daily.

MoCRA provides new authorities to FDA including:

Records Access

If certain conditions are met, FDA can access and copy certain records related to a cosmetic product, including safety records.

Mandatory Recall Authority

If the agency determines that there is a reasonable probability that a cosmetic is adulterated or misbranded and the use of or exposure to the cosmetic will cause serious adverse health consequences or death, FDA has the authority to order a mandatory recall if the responsible person refuses to do so voluntarily.

MoCRA establishes the following new requirements for industry:

Adverse Event Reporting

A responsible person is required to report serious adverse events associated with the use of cosmetic products in the United States to FDA within 15 business days, along with a copy of the label on or within the retail packaging of such cosmetic product, after receiving the report and certain additional information, such as new medical information, within 1 year of the initial report. FDA will also have access to adverse event reports during an inspection.

FDA is developing a process for submitting mandatory adverse event reports for cosmetics. Currently, we encourage electronic reporting through the Safety Reporting Portal (SRP). 

Facility Registration

Manufacturers and processors must register their facilities with FDA and renew their registration every two years.

• FDA has the authority to suspend a facility’s registration if the agency determines that a cosmetic product manufactured or processed by the registered facility and distributed in the United States has a reasonable probability of causing serious adverse health consequences or death to humans, and the agency has a reasonable belief that other products manufactured or processed by the facility may be similarly affected because of a failure that cannot be isolated to a product or products, or is sufficiently pervasive to raise concerns about other products manufactured in the facility. If a facility’s registration is suspended, it is a prohibited act to distribute or sell (or otherwise introduce or deliver into commerce) in the United States cosmetic products from the facility.

Product Listing

A responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.

Safety Substantiation

Companies and individuals who manufacture or market cosmetics have a responsibility to ensure the safety of their products. Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients.

• A responsible person is required to ensure and maintain records supporting adequate safety substantiation of their cosmetic products. Manufacturers can use relevant safety data that is already available to support the safety of their products. Animal testing is not a requirement for marketing a cosmetic product.  It’s important, however, that all data used to support the safety are derived from scientifically robust methods.

MoCRA also requires that industry comply with regulations that FDA will establish for:

Good Manufacturing Practice (GMP) requirements for facilities that manufacture cosmetic products:

The Federal Food, Drug and Cosmetic Act (the FD&C Act) prohibits the introduction, or delivery for introduction, into interstate commerce of cosmetics that are adulterated or misbranded (Section 301 of the FD&C Act). If you manufacture cosmetics, you can reduce the risk of adulterating or misbranding cosmetics by following the GMP recommendations in this guidance. By following these recommendations, you can effectively conduct a self-inspection to rate your operations.

Federal Food, Drug, and Cosmetic Act of 1938, as amended

To protect consumers from unsafe or deceptively labeled or packaged products by prohibiting the movement in interstate commerce of adulterated or misbranded food, drugs, devices, and cosmetics.

The cosmetics marketed in the United States, whether they are manufactured here or are imported from abroad, must comply with the labeling requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act, the Fair Packaging and Labeling (FP&L) Act, and the regulations published by the Food and Drug Administration under the Authority of these two laws.

Fair Packaging and Labeling Act: To ensure that packages and their labels provide consumers with accurate information about the quantity of contents and facilitate value comparisons.

Federal Food, Drug, and Cosmetic Act: The FD&C Act prohibits the marketing of cosmetics that are adulterated or misbranded as well as their adulteration or misbranding while in interstate commerce.

The FD&C Act prohibits the marketing of cosmetics that are adulterated or misbranded as well as their adulteration or misbranding while in interstate commerce.

A cosmetic is considered misbranded if:

1. Labeling is false or misleading
2. Label does not state
   • The name and address of the manufacturer, packer, or distributor
   • The net quantity of contents
3. The required information is not stated prominently, with conspicuousness and in terms that it is read and understood by consumers under customary conditions of purchase and use
4. The container or its fill is misleading