Modernization of Cosmetics Regulation Act (MoCRA) Services

The Modernization of Cosmetics Regulation Act (MoCRA) 2022 was signed into law on December 29, 2022, enhancing the FDA’s regulatory jurisdiction and enforcement of cosmetics.

MoCRA is the first major update to US cosmetics law since the Federal Food, Drug and Cosmetic Act (FDCA) 1938. Its unified framework for cosmetic regulations allows the FDA mandatory recall authority and authorizes new requirements, such as facility registration, allergen labeling, product listing standards, adverse event reporting and safety substantiation.

Manufacturers or processors should:

1. Get a US agent if your facility is based outside the US
2. Register your facility with the FDA
3. Identify the responsible person(s) for your products
4. The responsible person(s) must complete the required tasks for product listing, safety substantiation and adverse events

We can support you through these steps.

Any harmful health-related event associated with using a cosmetic product.

Any establishment, including an establishment of an importer, that manufactures or processes cosmetic products distributed in the US.

The FDA published draft GMP guidance for the cosmetics industry in 2013. This compliance standard incorporates many ISO 22716 requirements for global harmonization. Complying with MoCRA’s GMP requirements should be seamless for facilities already compliant with the 2013 guidance and/or ISO 22716 certified.

The cosmetic product manufacturer, packer or distributor whose name appears on the product label, according to FDCA Act Section 609(a) or Fair Packaging and Labeling Act Section 4(a).

Their main obligations include:

• Listing products on the FDA portal
• Ensuring the compliance of each product formula and label
• Completing safety substantiation
• Implementing an adequate adverse event recording system
• Reporting any serious adverse events to the FDA

A serious adverse event:

• A, results in:


• Death
• A life-threatening experience
• Inpatient hospitalization
• A persistent or significant disability or incapacity
• A congenital anomaly or birth defect
• An infection
• Significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended under conditions of use that are customary or usual

• B, based on reasonable medical judgment, the requirement of a medical or surgical intervention to prevent an outcome described in A

The regulation provides new authorities to the FDA including:

Records access

The FDA can access and copy certain cosmetic product records, including its safety records, if certain conditions are met.

Mandatory recall

If the FDA determines a reasonable probability that a cosmetic is adulterated or misbranded, and using or being exposed to it will cause serious adverse health issues or death, the agency can order a mandatory recall if the responsible person refuses to do so voluntarily.

Adverse event reporting

A responsible person must report serious adverse events associated with using the cosmetic product in the US to the FDA within 15 business days. They must include the label on or within the retail packaging.

If the responsible person receives medical or other information about the adverse event within one year of the initial report to the FDA, they must submit this new information to the agency within 15 business days. The FDA can access adverse event reports during an inspection.

Facility registration

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

The FDA can suspend a facility’s registration if it:

• Determines that a cosmetic product, manufactured or processed by the registered facility and distributed in the US, has a reasonable probability of causing serious adverse health consequences or death
• Reasonably believes 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 cannot distribute or sell (or otherwise introduce or deliver into commerce) in the US cosmetic products from the facility.

Product listing

A responsible person must list each marketed cosmetic product to the FDA, including its ingredients, and provide updates annually.

Safety substantiation

Organizations and individuals manufacturing or marketing cosmetics must ensure product safety. Neither the law nor FDA regulations require specific tests to demonstrate product or ingredient safety.

A reasonable person must ensure and maintain records supporting adequate safety substantiation of their products. Manufacturers can use relevant safety data already available to support this. Animal testing is not a requirement for marketing a cosmetic product. All data used to support safety claims must be from scientifically robust methods.

MoCRA requires relevant organizations to comply with regulations the FDA will establish for:

• GMP for facilities manufacturing cosmetic products
• Fragrance allergen labeling
• Standardized testing methods for detecting and identifying asbestos in talc-containing products

Certain small businesses are exempt from GMP, registration and product listing requirements. Such exemptions do not apply to manufacturers or facilities that manufacture or process cosmetic products that are:

• In regular contact with the eye’s mucus membrane under customary or usual conditions of use
• Injected
• Intended for internal use
• Intended to alter appearance for more than 24 hours under customary or usual conditions of use, and removal by the consumer is not part of such conditions

Certain products and facilities subject to drug and device requirements could also be exempt.