Cosmetics -Who Must Register and List?

If you market cosmetic products, you probably have heard that with the passage of the Modernization of Cosmetics Regulation Act, or “MoCRA”, the FDA is now enforcing mandatory registration and listing requirements for the cosmetics industry.

So who exactly must register and who must list under these new requirements?

First, let’s talk about registration.

People often ask, “How do I register my cosmetics?”

But the registration requirement applies to the cosmetic facilities, not to products. FDA requires cosmetic facilities to register, and those facilities must renew their registration every two years.

So, what does FDA consider a cosmetic facility? The law defines a cosmetic facility as any establishment, including foreign establishments, that manufactures or processes cosmetic products distributed in the United States. So for remainder of this discussion, we will simply refer to cosmetic manufacturers and processors as “cosmetic facilities.”

It doesn’t matter how many cosmetic products a facility manufactures or processes. The facility only needs one registration as a cosmetic facility!

Now if the facility also manufactures or processes drugs, medical devices, foods, or other FDA-regulated commodities, the facility is subject to separate registration requirements. For example, if a cosmetic facility also manufactures sunscreens, it may have to register as both a cosmetic facility as well as a drug establishment.

Note that establishments that do not manufacture or process cosmetics do not register with the FDA as cosmetic facilities. For example, if you import finished cosmetics and you do not manufacture or process any cosmetics, then you do not register with the FDA as a cosmetic facility.

Also, brand owners of cosmetics do not register if they contract a facility to manufacture their cosmetics. The contract manufacturer, rather than the brand owner, would need to register with the FDA.

A lot of times, companies we’ll say that their facilities are “FDA approved.” But the FDA does not approve facilities. What those companies usually mean is that their facility is “registered.” Registration places the facility’s information into the FDA’s firm inventory, allowing the FDA to track the firm for routine or emergency inspections. Registration does not represent the FDA’s approval or endorsement of a facility!

You may have heard of the Voluntary Cosmetic Registration Program, or “VCRP”, under which cosmetic facilities could voluntarily register with the FDA. However, the FDA has discontinued the VCRP as registration is now mandatory for cosmetic facilities. Any facilities that registered under the VCRP must register again under the mandatory registration requirements.

Now let’s discuss cosmetic product listing.

Cosmetic products must be listed with the FDA. It’s easy to confuse the terms, “listing” and “registration.” But remember, you do not register products with the FDA. “Registration” applies to the cosmetic facility whereas “listing” applies to the product.

The FDA requires the “responsible person” to list the cosmetic. For cosmetics, the law defines the responsible person as the manufacturer, packer, or distributor that is declared on the product’s label. The responsible person must provide any updates to the cosmetic listing annually.

Note that the cosmetic facility registration and cosmetic product listing requirements are different than the registration and listing requirements in other areas of FDA regulation. If you also market medical devices, drugs, foods, tobacco, or biologics, be sure to adhere to the appropriate registration and listing requirements associated with those products.

The FDA has required cosmetic firms to comply with the registration and listing requirements since July 1 of 2024.

There are some exemptions which you can find on our website!

FDA Specialist offers registration and listing services, so if you have not met these requirements yet, contact us right away!