Countdown to compliance: Navigating upcoming cosmetic facility registration & product listing deadline

Countdown to compliance Navigating upcoming cosmetic facility registration product listing deadline

As the July 1 deadline for the registration and listing of cosmetic product facilities and products under MoCRA rapidly approaches, it is crucial for manufacturers and suppliers in the cosmetics and personal care industry to be well-prepared. The U.S. Food and Drug Administration (FDA) has outlined essential requirements and provided guidelines​ to ensure compliance.

We reviewed FDA’s recently published Cosmetics Constituent Update and spoke with industry attorney Rachel Raphael, Partner at Morgan Lewis, to compile our key takeaways that every stakeholder needs to know in advance of next week’s deadline:

Mandatory registration & listings

FDA requires all facilities involved in the manufacturing, packaging, and distribution of cosmetic products in the United States to register and list their products, including domestic and foreign establishments. Failure to comply with these regulations could result in enforcement actions, including but not limited to product seizures, injunctions, and other legal penalties, according to FDA.

Raphael emphasized the gravity of non-compliance: “Failing to properly register a cosmetics manufacturing or processing facility or submit product listing information to the FDA are ‘prohibited acts’ under the Federal Food, Drug, and Cosmetic Act, and can lead to criminal and/or civil penalties,” she said.

“Other possible consequences can include seizures, injunctions, and product recalls,” she added, and “failing to comply with the facility registration and product listing requirements also increases litigation risk, and in turn, potential harm to a brand’s reputation.”

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