Cosmetic market in USA

In the USA, two tiers of regulation must be considered: Federal Law and State Law, the last one depending on the state where the product will be available.

Legal frameworks apply to cosmetic products at a federal level include The Food, Drug, and Cosmetic Act (FD&C Act), The Fair Packaging and Labeling Act (FP&L Act), and more recently, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

MoCRA represents the most substantial extension of the FDA's jurisdiction over cosmetics since the enactment of the Federal Food, Drug, and Cosmetic (FD&C) Act in 1938 and aims to bolster the safety of the cosmetic products that countless consumers incorporate into their daily routines.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics as "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."

The MoCRA amended the FD&C Act to include “cosmetic product” which is defined as “a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.”

With MoCRA additional authorities are conferred to the FDA, which include:

Mandatory reporting of serious adverse events

- The Responsible Person* is required to report serious adverse events linked to the use of cosmetic products in the United States to the FDA.

Facility registration

- Manufacturers and processors are obligated to register their facilities with the FDA.

- The initial registration must be performed by July 1, 2024, or 60 days after first engaging in the manufacturing or processing of a cosmetic product for distribution in the US.

Product Listing

- A Responsible Person* is required to register each marketed cosmetic product with the FDA, disclosing product ingredients, and submit any updates annually.

- The initial listing must be performed until July 1, 2024, or within 120 days of marketing the product.

Good manufacturing processes

- MoCRA bestows upon the FDA the authority to establish standards for cosmetic facilities, with a focus on ensuring quality control and maintaining sanitary conditions. Sec.606 of MoCRA imposes the requirement to adhere to Good Manufacturing Practices (GMPs).

- In December 29. 2024 a proposed rule of GMP requirements must be published.

- In December 29, 2025, it should be released the final publication.

Safety substantiation

- As per Sec.608 of MoCRA, the Responsible Person* must have evidence and maintain records for safety substantiation.

Label Requirements

- Professional Cosmetic Products - Specific labeling is mandatory to ensure that both professionals and consumers have all essential information readily available.

- Starting December 29, 2024, product labels must incorporate domestic contact details for reporting adverse events.

- Fragrance allergens in personal care products should be displayed on the label – The FDA has until October, 2024, to publish a draft list of required fragrance allergens for labeling.

As mentioned above, every cosmetic product must appoint a designated Responsible Person, as outlined in Section 604 (4), who could be the manufacturer, packager, or distributor, whose name must be displayed on the product label. Although it's not mandatory for the Responsible Person to be situated within US territory, Responsible Persons must appoint a contact based in the USA.

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