US FDA Cosmetic Product Facility Registration and Cosmetic Product Listing

On December 29, 2022, US President Biden signed and passed the "Modernization of Cosmetics Regulation Act of 2022" (MoCRA). This bill will make significant revisions to the current Federal Food, Drug, and Cosmetic Act (FD&C Act).

Previously, the Food and Drug Administration (FDA) regulated cosmetics through the Voluntary Cosmetic Registration Program (VCRP). However, the FDA has stopped accepting submissions to the Voluntary Cosmetic Registration Program (VCRP) effective March 27, 2023, as a result of the FDA's plans to develop a program for submission of the facility registrations and product listings mandated by the "Modernization of Cosmetics Regulation Act of 2022" (MoCRA).

FDA will launch a new Cosmetics Direct portal in November 2023 to handle mandatory facility registration and product listing required by MoCRA. FDA strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency. FDA is also developing a paper form as an alternative submission tool to the electronic submission portal.

The definition of cosmetics

The 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" (FD&C Act, sec. 201(i)). Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product. It does not include soap.

But, if the product is intended for therapeutic use, such as treating or preventing disease, or to affect the structure or function of the body, it's a drug (FD&C Act, 201(g)), or in some cases a medical device (FD&C Act, 201(h)), even if it affects the appearance.

FDA Registration Process of Cosmetic Product Facility in the United States

FDA Cosmetic Product Listing in the United States

Our services

• US agent;
• FDA Cosmetic Product Facility Registration in the United States;
• FDA Cosmetic Product Listing in the United States;
• FDA OTC Drug Registration in the United States;
• Batch certification of color additives in the United States;
• Cosmetic/OTC drug label review in the United States; and
• Application for INCI name of cosmetic ingredients.