Cosmetics Regulatory Services
Congress passed the Modernization of Cosmetics Regulation Act (MoCRA) in December 2022, to shift the FDA’s cosmetics oversight further towards safety and quality in the cosmetics space. As a result, new regulatory requirements and FDA guidance for cosmetics manufacturers are forthcoming, giving companies and stakeholders a meaningful opportunity over the next several years to provide input.
Greenleaf Health serves as a trusted partner to both large and small clients developing and commercializing cosmetics as they navigate the complex landscape of FDA regulations and policies.
Cosmetics Regulatory Services Team
Greenleaf experts draw on decades of FDA and industry experience to provide best-in-class insight on all aspects of the FDA’s regulation of cosmetics.
John TaylorPresident and Principal, Compliance and Regulatory Affairs
Cynthia SchnedarPrincipal, Regulatory Compliance
Maura M. Norden, J.D.Executive Vice President, Medical Devices and Combination Products & General Counsel
Kalah Auchincloss, J.D., M.P.H.Executive Vice President, Regulatory Compliance & Deputy General Counsel
Elizabeth OestreichSenior Vice President, Regulatory Compliance
Madeleine Giaquinto, J.D.Director, Regulatory Affairs
Samantha EakesVice President, Regulatory Affairs
Our Cosmetics Regulatory Services
Strategic & Technical Guidance
Greenleaf provides guidance to cosmetics and aesthetic product manufacturers, beauty and personal care product companies, trade associations, and other stakeholders implementing and complying with FDA regulations and policies under the FD&C Act, including new MoCRA requirements, the Federal Fair Packaging and Labeling Act, and related statutes and regulations.
Areas of Expertise
Greenleaf’s cosmetic clients vary greatly in nature, scope, and levels of experience with FDA regulation. With our wide-ranging expertise, we can advise companies:
- Entering the cosmetics space with limited FDA regulatory experience and/or knowledge
- With existing products in the cosmetics space that now need to interpret and comply with new FDA regulatory requirements under MoCRA
- Marketing cannabis-derived consumer products (e.g., CBD-containing products) in the cosmetics space
- Marketing novel products, such as innovative products or combination products that include a cosmetic along with an over-the-counter drug or device, that are seeking assistance in complying with the most appropriate regulatory framework
Greenleaf experts work cross-functionally as teams specializing in medical devices and combination products; product quality, manufacturing, and compliance; and drug and biological products. Clients seeking guidance in the cosmetics and personal care products space receive Greenleaf’s comprehensive support on complex regulatory challenges spanning the product lifecycle.
Connect With an Expert
Greenleaf’s Cosmetics Regulatory Services Team is ready to help your company comply with the latest FDA requirements. Please provide the information below and a team member will be in contact.