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.

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. 

Greenleaf works with clients to clarify and support compliance with the regulatory requirements for consumer products marketed in the cosmetics space by:

  • Providing guidance on FDA regulatory policies, programs, and procedures, including advising on the anticipated FDA jurisdictional determination for the product
  • Advising on all aspects of MoCRA, including:
    • New marketing, facility registration, and product listing requirements
    • Small business accommodations under MoCRA
    • FDA’s expanded enforcement authorities under MoCRA, and relevant FDA enforcement trends
  • Providing compliance services, such as:
    • Helping clients understand applicable FDA manufacturing and quality controls, including GXP regulations for cosmetics
    • Conducting compliance assessments and gap analyses of manufacturing and quality practices and systems, and providing inspection readiness services
    • Assistance evaluating and responding to FDA communications related to enforcement actions and other regulatory correspondence
  • Advising on FDA labeling requirements and product claims made on packaging and marketing materials
  • Counseling on postmarket safety and reporting requirements

Greenleaf helps clients keep pace with, and better navigate, the emerging regulatory landscape by: 

  • Advising clients on new FDA rules and reports mandated by MoCRA and their underlying impact on the broader regulatory framework
  • Providing regulatory intelligence gathering and supporting clients in developing and implementing regulatory policy capabilities and strategies to effectively advance their priorities
  • Identifying opportunities for clients to engage with the FDA and other stakeholders and leverage alliances to influence regulatory policy

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

Full-Service Support

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.

Greenleaf guides medical technology clients through the complete regulatory process, from the earliest stages of product development, through the FDA review process, to marketing authorization and compliance with postmarket requirements and quality systems.

Greenleaf supports clients as they navigate the evolving process of bringing new therapeutics to market. Experts specialize in providing strategic and technical guidance on medical product development, regulatory review, and postmarket requirements.

Greenleaf provides expertise to companies seeking to strengthen their quality management systems. Experts specialize in corporate quality and compliance systems; FDA inspections, communication, and enforcement processes; and the complete spectrum of compliance and enforcement-related actions.

Greenleaf applies vast FDA institutional knowledge to equip investors with the thorough and focused due diligence needed to ensure that decisions and transactions reflect regulatory risk.

Cosmetics Regulatory Services Resources

View or download the PDFs below to learn more about Greenleaf’s cosmetics services and our comprehensive regulatory consulting capabilities.

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.

Connect with an Expert - Cosmetics Regulatory Services