Page 140 - FDCC_InsightsSpecialIssue_Published

Products Liability Law
A Facelift for Cosmetics: Modernization of Cosmetics
Regulations Act of 2022
By Michael Walsh
As 2022 came to an end so too did the cosmetic industry’s comfortable position largely outside FDA regulation. The federal Food Drug and Cosmetics Act (FDCA) is the foundational law governing everything that goes on or in or comes in contact with anything that goes on or in humans or animals, and for decades cosmetic products have been largely outside of FDA’s regulatory scheme – until now.
While the law may be new, the issue has been brewing for decades. FDA Commissioner, Robert Califf put it this way:
The debate about regulation of the cosmetics industry to protect the public health has gone unresolved for more than a century. Unlike drugs and devices used for diagnosis and treatment, Congress has never required cosmetic manufacturers to obtain premarket approval before selling a new product.... Nor does any regulatory body evaluate claims about the safety or effectiveness of these products. The FDA’s role with regard to cosmetics is thus similar to that of police, who can act only if they become aware of something that gives them “probable cause” to investigate. The challenge for regulators is daunting... JAMA June 26, 2017
Michael Walsh
Buried in the middle of the 4155-page Consolidated Appropriations Act of 2023 is the “Modernization of Cosmetics Regulation Act of 2022” (MOCRA), requiring registration and providing enhanced FDA oversight for cosmetic products.
Definitions
• Cosmetic: The term ‘cosmetic product’ was already defined under the FDCA as (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap (21 U.S.C. 321(I)). MOCRA focuses the definition on finished products defining cosmetic as “a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.”
130
FDCC ANNUAL INSIGHTS 2023