Are You Ready for the Modernization of Cosmetics Regulation Act of 2022?

The Act, which was signed into law on December 29 2022, will affect all cosmetic products marketed in the US. It uses a broad definition of cosmetics and encompasses all companies marketing personal care products. The Act brings many of the regulations which you are familiar with from OTC drugs and applies them to personal care. These include - registration of facilities, and products, including ingredients, serious adverse event reporting, safety testing, fragrance allergens, FDA mandated recalls and Good Manufacturing Practices.

Definitions Included in the Act

Responsible Person

The Act applies to - “manufacturer, packer, or distributor of a cosmetic whose name appears on the label”

Facility

The Act covers - “any establishment (including that of an importer) that manufactures or processes cosmetic products distributed in the United States”

Cosmetic

The products affected - “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.”

Key Requirements of the Act

All existing facilities (domestic and foreign) that engage in the manufacturing or processing of a cosmetic product for distribution in the United States must register with the FDA not later than December 29, 2023. A contract manufacturer “shall require only a single registration for such facility even if such facility is manufacturing or processing its own cosmetic products or cosmetic products on behalf of more than one responsible person”. Registrations are to be renewed every two years.

Submit cosmetic product listings to the FDA no later than December 29, 2023. Submit “a list of ingredients in the cosmetic product, including any fragrances, flavors, or colors with each ingredient identified by the name”.

Reporting requirement for “serious adverse events […] that 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 a significant disfigurement”. Examples of significant disfigurement include “serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance”. MOCRA considers an adverse event to be serious if it “requires, based on reasonable medical judgement, a medical or surgical intervention to prevent an outcome described” in the list above. Reporting is to be done “no later than 15 business days after the report is received by the responsible person.”

“A responsible person for a cosmetic product shall ensure, and maintain records supporting, that there is adequate substantiation of safety of such cosmetic product.” “The term ‘adequate substantiation of safety’ means tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.”

FDA is directed to issue draft regulations designating substances which are “fragrance allergens” and threshold levels by June 29, 2023 and finalize them after 180 days of consultation. Fragrance allergens to be included on the product label.

FDA is given stronger mandatory recall authority over cosmetic products, and there is a requirements for the content of alerts and public notices to be issued.

FDA is required to issue a notice of proposed rulemaking covering Good Manufacturing Practices (GMP) not later than December 29, 2024, and a final such rule not later than December 29, 2025.

”No State or political subdivision of a State may establish or continue in effect any law, regulation, order or other requirement for cosmetics that is different from or in addition to, or otherwise not identical with, any requirement […] with respect to registration and product listing, good manufacturing practices, records, adverse event reporting, or safety substantiation.”