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  1. Cosmetics Laws & Regulations

Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

The Modernization of Cosmetics Regulation Act of 2022

Background on the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

Most American consumers use cosmetic products every day. On average people use 6 to 12 cosmetics products daily. Examples of some of these products include makeup, nail polishes, shaving cream and other grooming products, perfumes, face and body cleansers, haircare products, moisturizers, and other skincare products.

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.

Key Terms

Adverse Event: any health-related event associated with the use of a cosmetic product that is adverse

Facility: any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States

Responsible Person: the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act

Serious Adverse Event: an adverse event that

  • (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; or
    • 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; or
  • (B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in (A) above.

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. The responsible person must include a copy of the label on or within the retail packaging of such cosmetic product. If the responsible person receives medical or other information about the adverse event within 1 year of the initial report to FDA, they must submit this new information to FDA within 15 business days. FDA will also have access to adverse event reports during an inspection.

FDA recommends that industry responsible persons submit serious adverse event reports for cosmetics by using the current Form 3500A that is downloadable and fillable at MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (PDF). Please submit the completed form along with information to support the report, such as scans of labels and images of the serious adverse event to FDA via email at: [email protected] or by mail to:

FDA CDER Mail Center
Attn: Cosmetics MedWatch reports
White Oak Campus, Building 22, G0207
10903 New Hampshire Ave.
Silver Spring, MD 20993

FDA is developing a process for submitting electronic mandatory adverse event reports for cosmetics.

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.
  • For more resources on cosmetics safety substantiation, please visit Product Testing of Cosmetics.

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

Exemptions

MoCRA exempts certain small businesses from GMP, registration, and product listing requirements.  

However, such exemptions do not apply to manufacturers or facilities that manufacture or process the following cosmetic products: 

  • Products that regularly come into contact with mucus membrane of the eye under customary or usual conditions of use.
  • Products that are injected.
  • Products that are intended for internal use.
  • Products that are 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 of use. 

Exemptions also exist for certain products and facilities that are subject to requirements for drugs and devices.

MoCRA Webinar

FDA hosted a webinar titled Modernization of Cosmetics Regulation Act of 2022 – Key Terms and Provisions in April 2023. This stakeholder webinar provides an overview of the Modernization of Cosmetics Regulation Act of 2022. It outlines the requirements mandated by the act and the current steps FDA is taking to implement the requirements, including an update on the Voluntary Cosmetic Reporting Program, and information about a public listening session on good manufacturing practices (GMPs).

  

Meetings


Inquiries about MoCRA can be directed to [email protected]



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