Cosmetic Regulatory Compliance Lawyer

Why an Integrated Program Matters

MoCRA's various requirements — facility registration, product listing, safety substantiation, adverse event reporting, and labeling — are interconnected, often relying on the same underlying product and ingredient data. Addressing them as an integrated program, rather than as isolated tasks, reduces duplication and closes compliance gaps.

Core Components of a Compliance Program

A well-built program addresses facility registration and renewal, timely product listing and updates, documented safety substantiation for each product, a functioning adverse event complaint-handling process, and labeling that reflects current requirements.

Safety Substantiation

Companies must maintain records supporting the safety of each cosmetic product, and building a defensible safety file — including relevant ingredient data and testing where applicable — is a central part of MoCRA compliance.

Adverse Event Reporting and Recordkeeping

Responsible persons must report serious adverse events to the FDA within a defined window after becoming aware, and must maintain related records for a set retention period, making a functioning complaint-intake process essential.

FDA Enforcement and Inspection

FDA can inspect facilities and request access to required records, and MoCRA grants the agency mandatory recall authority in appropriate circumstances. Companies with organized, accessible compliance documentation are better positioned to respond to these inquiries.

Scaling Compliance to Company Size

While MoCRA includes limited exemptions tied to business size, most cosmetic companies — from emerging brands to established manufacturers — have meaningful compliance obligations, and a program appropriately scaled to the company's size and risk profile is generally the most practical approach.

Working With Anthony Girand, Esq.

Anthony Girand, Esq. is a JD/MBA and Maryland attorney whose practice includes immigration, tax controversy, federal litigation, startup law, and regulatory compliance. He brings a business-minded legal perspective to matters involving federal agencies, founders, professionals, companies, and individuals facing consequential legal decisions.

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