FDA cosmetic facility registration is the mandatory registration required for many facilities that manufacture or process cosmetic products for distribution in the United States. The requirement comes from the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

Generally, domestic and foreign facilities that manufacture or process cosmetic products for U.S. distribution must register unless a statutory exemption applies. Certain small businesses may be exempt, but the exemption does not apply to specified higher-risk product categories.

FDA requires cosmetic facility registration to be renewed every two years from the date of initial registration. Facility registration information also must be updated within 60 days of certain changes. See FDA's current instructions.

The FDA filing cycle and the professional U.S. Agent service term are separate. FDA cosmetic facility registration is renewed every two years, but FDA Registration Assistance provides ongoing U.S. Agent representation and compliance support as an annual service, so the $849 professional service renews each year.

Yes. Foreign cosmetic facilities that are required to register must provide U.S. Agent contact information as part of Form FDA 5066. FDA Registration Assistance offers annual U.S. Agent representation for foreign cosmetic facilities.

No. FDA currently lists the facility DUNS number as optional on Form FDA 5066. The required facility registration number is the FDA Establishment Identifier (FEI), which should be obtained before the facility registration is submitted.

The FDA Establishment Identifier (FEI) is the facility registration number FDA uses for cosmetic product facility registration. FDA states that the owner or operator should obtain an FEI before submitting the facility registration.

A Responsible Person must provide updates to each cosmetic product listing annually. FDA Form 5067 includes annual update and abbreviated renewal options.

FDA Registration Assistance charges $849 per year for its professional MoCRA facility registration and compliance service. For foreign facilities, the annual service includes ongoing U.S. Agent representation. FDA does not charge a government filing fee for MoCRA cosmetic facility registration.

FDA Registration Assistance charges $200 per cosmetic product listing. FDA does not currently charge a government filing fee for the MoCRA product listing submission itself.

No. Facility registration, product listing, an FEI, or a listing confirmation does not mean FDA has approved, endorsed, or certified the cosmetic product. Cosmetics generally are not preapproved by FDA, except that certain color additives require approval for their intended uses.

Some small businesses may qualify for an exemption based on average U.S. cosmetic sales, adjusted for inflation, but the exemption does not apply to specified product categories such as certain products used around the eye, injected products, internal-use products, or products intended to alter appearance for more than 24 hours under the statutory conditions.

Facility registration identifies the manufacturing or processing facility. Product listing identifies each marketed cosmetic product and is submitted by the Responsible Person. A company may have obligations under both requirements, but they are separate filings.

The Responsible Person is the manufacturer, packer, or distributor whose name appears on the cosmetic product label in accordance with applicable U.S. labeling law. The Responsible Person is responsible for cosmetic product listing and other MoCRA duties tied to the product.

Cosmetics Direct is FDA's electronic submission portal for cosmetic facility registration and cosmetic product listing. FDA also permits other submission methods described in its current registration and listing materials.

Common required information includes the facility's legal name, physical address, FEI number, phone and email, owner or operator information, cosmetic product brand names, Responsible Person information, product category codes, and U.S. Agent contact information for a foreign facility.

Yes. FDA provides Cosmetics Direct and other submission methods for businesses that choose to self-file. Professional assistance can be useful when you want help reviewing facility information, FEI details, U.S. Agent information for a foreign facility, product categories, and submission records before filing.

Timing depends on whether the required facility information and FEI are already available and on FDA processing. Once we have complete information, we prepare and submit the filing promptly, but FDA processing time is outside our control and we do not represent a filing as approved until the applicable FDA confirmation is available.

The Responsible Person must report a serious adverse event associated with use of a cosmetic product in the United States to FDA within 15 business days. The report must include a copy of the label on or within the retail packaging. Certain follow-up information received within one year must also be submitted to FDA within 15 business days.

The Responsible Person must ensure and maintain records supporting adequate substantiation of safety for each cosmetic product. FDA does not prescribe one specific test for every cosmetic; scientifically robust existing data, studies, analyses, and other appropriate evidence may be used to support safety.

Cosmetic labeling must comply with applicable U.S. requirements, including an identity statement, net quantity of contents, the name and place of business, and an ingredient declaration where required. Required label information generally must appear in English and be prominent and conspicuous. Products that are also drugs have additional requirements.

Yes. Imported cosmetics must comply with the same U.S. laws and regulations that apply to domestically produced cosmetics. Depending on the business and product, that can include MoCRA facility registration, product listing, U.S. Agent information for a foreign facility, labeling, ingredient, and safety requirements.

Selling online does not by itself make a company a cosmetic manufacturing facility. Facility registration obligations depend on whether the business manufactures or processes cosmetics, while product listing obligations generally fall on the Responsible Person whose name appears on the label. We can review the roles in your supply chain before determining which filings apply.

FDA classification depends on intended use. Products intended to cleanse, beautify, promote attractiveness, or alter appearance are generally cosmetics; products intended to diagnose, treat, mitigate, or prevent disease or affect the structure or function of the body are drugs. A product can be both. The term “cosmeceutical” has no legal meaning under the FD&C Act.