How does the US' MoCRA regulatory reform affect you?

Published: 6-Mar-2023

Amendments have been made to Section VI of the Federal Food, Drug, and Cosmetic Act. Sharon Blinkoff, Senior Counsel at Locke Lord LLP, details the likely impact on cosmetics makers

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On 30 December 2022, President Biden signed into law the Food and Drug Omnibus Reform Act of 2022 (FDORA), which included the Modernization of Cosmetic Regulations Act of 2022 (MoCRA).

It is an Act that significantly expands the US Food and Drug Administration’s (FDA’s) oversight authority over the cosmetics industry and provides increased funding for the FDA’s Cosmetic Program.

Perhaps the most insightful characterisation of MoCRA was that of The Wall Street Journal, which described the Act as “giving your mascara a headache”.

With the FDA’s new authority and funding, industry should prepare not only for a more active FDA, which will have increased records access and enhanced administrative enforcement tools, but also for required reporting and record keeping responsibility for serious and non-serious adverse events of product use.

Congress and NGOs will be watching the FDA’s performance; the Act contains an interesting exemption for cosmetic products marketed by NGOs.

MoCRA did benefit the professional segment of the industry. The hair dye exemption, which exempts hair dyes from review under Color Additive Amendments, was retained. MoCRA also addressed the diversion of professional products that are unsafe for consumer use.

The Act significantly expands the FDA’s oversight over the cosmetics industry without addressing  encroaching state activity in the regulation of cosmetic ingredients, or state-created laws that encroach on the FDA’s authority to enforce its own laws.

Years ago, the industry looked to the FDA’s warning letters for guidance on product compliance.

Today, we look to see what new actions the plaintiffs’ bar is mounting that are predicated on violation of the Federal Food, Drug, and Cosmetic Act (FDCA), rather than classic product liability or advertising claims.

NGOs have been a driving force behind the passage of MoCRA and its aggressive administrative enforcement tools, which were adopted in the Food Safety bill.

In contrast to the food industry, cosmetics have generally had a good safety record.

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