We counsel cosmetic and over-the-counter (OTC) drug companies on a comprehensive range of Food and Drug Administration (FDA)-related issues. We assist clients with:
- Regulatory compliance, including clinical research, formulation development, and current good manufacturing practices (cGMPs) and quality programs
- Product logistics, including distribution, state licensing, and FDA registration and listing requirements
- Labeling and claims, including product labeling and compliance for imports and exports
- Enforcement management, including avoiding and responding to FDA enforcement actions (e.g., 483s, warning letters, recalls, import alerts and detentions, and consent decrees)
- Cosmetic-drug product compliance with the FDA’s OTC drug administrative orders under the CARES Act
- OTC monograph order requests to help ensure products meet FDA standards
Beyond this work, we help ensure compliance with the Modernization of Cosmetics Regulation Act (MoCRA) by guiding clients through new facility registration, product listing, and cGMP requirements—including counsel on ingredient reviews, color additive approvals, and adverse event reporting as well as product safety substantiation and ongoing regulatory compliance.
Our team also advises companies on Consumer Product Safety Commission (CPSC) compliance for child-resistant packaging, hazard reports, recalls or corrective action programs, and other CPSC-related issues.