MoCRA movement: Should industry seek counsel when navigating regulatory challenges?

31 Aug 2023 --- The Modernization of Cosmetics Regulation Act (MoCRA) is said to be the most significant change to the US policy for personal care products in decades. The revamp of regulations poses uncertain challenges to industry players, with questions of whether they can maneuver hurdles alone.

The act was passed last December, providing the US FDA with new authorities. The law is expected to ensure the safety of cosmetic products on the market.

“It is difficult to understate MoCRA’s impact on the personal care products industry. This is a significant new level of federal oversight for an industry that, up to now, has been relatively self-policed,” Kelly Bonner, an associate at Duane Morris, tells Personal Care Insights.

Before MoCRA, the federal government had not made compelling changes to the way it regulated cosmetics since the passage of the Food Drug and Cosmetics Act (FDCA) in 1938 and the Fair Packaging and Labeling Act in 1966.

The FDA will require any facility that manufactures or processes cosmetic products intended for sale in the US – irrespective of whether the facility is in the US – to register with the FDA and list products and ingredient information for any cosmetics intended for US distribution.

MoCRA will also require the FDA to enact regulations addressing good manufacturing practices and grant the administration greater enforcement authority over potentially adulterated cosmetics.

Kelly Bonner, an associate at Duane Morris.Impact on cosmetic safety
Bonner from Duane Morris specializes in litigation risk and regulatory issues affecting businesses in the cosmetics and personal care industries and cross-jurisdictional and complex commercial disputes involving FDA-regulated and consumer-branded products.

“Under the FDCA, companies had a legal duty to ensure that their products weren’t adulterated and were safe for use when used as intended. Under MoCRA, the FDA has expanded enforcement authority, including facility inspection and records access rights, and mandatory recall authority over cosmetics it believes to be adulterated or misbranded and would result in serious adverse health consequences,” says Bonner.

“MoCRA also poses greater recordkeeping obligations regarding product safety and reporting, documenting and following up on serious adverse events – with an expanded definition of what constitutes a ‘serious adverse event.’”

MoCRA imposes new obligations for personal care product manufacturers, with rolling deadlines for when companies should be prepared to meet these obligations.

The first of these deadlines is December 29, 2023. By then, anyone who owns or operates a facility must register it with the FDA and submit cosmetic product listings for any marketed products.

Looking forward Duane Morris’ associate Bonner says MoCRA brings the biggest change to personal care products since 1966.
Last week, the FDA issued Draft Guidance regarding facility registration and product listing requirements and announced that it expected its portal to go live in October.

“To prepare for these deadlines, companies should carefully review MoCRA and any relevant Draft Guidance, determine what, if any, facilities or products they would need to register and or list, begin compiling the required information for submission and raise any questions or issues with counsel,” explains Bonner.

Bonner believes MoCRA represents a “sea change” in how the FDA regulates the cosmetics industry while closing several gaps in the existing regulatory framework.

“That said, MoCRA raises new questions, like to what extent information disclosed under the new regulations will remain confidential. MoCRA also provides comparatively little guidance on the kinds of marketing or promotional claims brands can make about product safety.”

“Finally, MoCRA does not preempt state consumer protection or liability claims, and it is unclear whether MoCRA’s obligations will give rise to new opportunities for an emboldened plaintiffs’ bar.

Bonner says the personal care industry is at the start of a years-long process of fundamentally changing how cosmetic products are regulated in the US.

“These are challenging times, and companies should proceed cautiously and involve counsel whenever possible rather than trying to navigate these changes solo,” she concludes.

By Sabine Waldeck

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