Modernization of Cosmetics Regulation Act

By Ferraiuoli LLC

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of the Food and Drug Administration 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.

MoCRA provides new authorities to FDA including:

-Facility Registration: Cosmetic product manufacturers and processors must register their facilities with FDA, update content within 60 days of any changes, and renew their registration every two years.

-Product Listing: A responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.

Responsible person means 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.

Exemptions:

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

However, such exemptions do not apply to facilities that manufacture or process, or responsible persons for, 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.

Ferraiuoli LLC

Ferraiuoli LLC (FLLC) was founded in 2003 by the late Blas Ferraiuoli-Martínez, Eugenio Torres-Oyola and María Marchand-Sánchez. This group was then joined in 2004 by Fernando J. Rovira-Rullán, thus forming the founding core of FLLC. FLLC has grown exponentially since its founding from a law firm with three attorneys and a support staff of three to its current size of 54 attorneys with a support staff of 38. Also, FLLC has grown from initially being known as an intellectual property and corporate law boutique law firm to a multiservice law firm that handles most matters relevant to a business while continuing to earn praise for its leading intellectual property and corporate practices.

FLLC has been ranked as a leading law firm in Puerto Rico by the professional publication Chambers Latin America in intellectual property, corporate, bankruptcy, labor & employment, real estate, and tax law. Moreover, 17 FLLC partners have been ranked as leaders in their field by the same publication. 4 FLLC partners are ranked as leaders in Intellectual Property, no other firm has more than 2. This recognition in such a short period of time is a tribute to FLLC’s business model.

FLLC prides itself in doing its work faster and more cost-efficiently yet with the same quality as that of its main competitors. The founding name partners are available at all times to attend to client matters. Their work ethic sets the tone for the rest of the firm. FLLC’s founders’ goal has been steady from the outset: become one of the premier multiservice law firms in Puerto Rico.

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