U.S. cosmetic regulations get major updates

2023-02-02

After years of effort from the cosmetic industry, the Modernization of Cosmetics Regulations Act of 2022 (MoCRA) was signed into law on December 29, 2022 as part of the Consolidated Appropriations Act. MoCRA is the first major update to cosmetic regulations in the United States since the Federal Food, Drug, and Cosmetic Act became law in 1938.

The Modernization of Cosmetics Regulations Act of 2022 (MoCRA) includes a few new important definitions including:

Facility

“The term ‘facility’ includes any establishment (including an establishment of an importer) that manufacturers or processes cosmetic products distributed in the United States.”
Exemptions include, but are not limited to:
Cosmetic product retailers, including individual sales representatives, direct sellers (as defined in section 3508(b)(2) of the IRS Code of 1986), retail distribution facilities, and pharmacies, unless such establishment manufactures or processes cosmetic products that are not sold directly to consumers at that location
Entities (such as hotels and airlines) that provide complementary cosmetic products to customers incidental to other services
Trade shows and other venues where cosmetic product samples are provided free of charge
An establishment that solely performs one or more of the following with respect to cosmetic products: Labeling, Relabeling, Packaging, Repackaging, Holding, Distributing (note: ‘packaging’ and ‘repackaging’ do not include filling a product container with a cosmetic product)

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) [adverse event report labeling requirement] of this Act or section 4(a) of the Fair Packaging and Labeling Act.”

As part of the overhaul of the Cosmetic Regulations, MoCRA includes the following new requirements for cosmetic products:

1) Mandatory serious adverse event reporting (Sec. 605 Adverse Events)

The responsible person shall submit to the FDA any report received of a serious adverse event associated with the use, in the United States, of a cosmetic product manufactured, packed, or distributed by such person within 15 business days of receipt.

The responsible person shall receive reports of adverse events through the domestic address, domestic telephone number, or electronic contact information on the label (see new labeling requirements information below).

Additionally, the responsible person shall maintain records relating to each adverse event report received for a period of 6 years, except small businesses shall maintain records for 3 years.

If the FDA suspects that the serious adverse event was due to a fragrance or flavor ingredient, they may request a list of substances in the fragrance or flavor ingredient.

Bureau Veritas, 02-02-23
; https://www.cps.bureauveritas.com/newsroom/us-cosmetic-regulations-get-major-updates