Cosmetics are big business, with annual worldwide sales for the cosmetic industry estimated at more than $170 billion. Countries across the globe have instituted stringent regulations for cosmetics, which vary dramatically from market to market. Companies that wish to access U.S.-based markets need to be mindful not only of U.S. federal laws and regulations, but also of state-based laws and regulations. Companies that wish to access markets in European Union (EU) Member States need also to be aware of stringent requirements for cosmetics under the Cosmetic Products Regulation (EC) No 1223/2009, as well as potential obligations for ingredients under Regulation (EC) No 1907/2006.
The web of regulations impacting cosmetic companies can be simplified significantly through strategic planning by professionals who know the ins and outs of the relevant laws and regulations. Bergeson & Campbell, P.C. (B&C®) professionals have the regulatory and scientific knowledge base as well as the strategic skills to help companies streamline the regulatory process within their desired markets.
What We Do
B&C professionals have extensive experience assisting clients in obtaining appropriate authority to market their health and beauty products. Our client counsel includes the following:
- Regulatory Matters —
- Assess available regulatory options and advise clients on appropriate pathway
- Assist in filings with the Voluntary Cosmetic Registration Program for U.S. markets
- Assist in obtaining GMP (Good Manufacturing Practices) Certification
- Prepare cosmetic safety assessments, including Product Information Files (PIF)
- Labeling and Claims Development —
- Assess scientific substantiation and work with clients to develop appropriate labeling and claims
- Marketing and Response —
- Coordinate press and media relations
- Advise clients on development of promotional materials
- Enforcement —
- Manage compliance risks and promotional violations, including FDA inspections
- Respond to deficiencies, warning letters, and other regulatory inquiries
- Represent clients before other agencies, including CPSC and FTC, for products with multi-jurisdictional issues
B&C professionals offer clients a combination of regulatory, strategic, and scientific expertise. That combination is key to assisting clients in bringing their products to market, staying on top of regulatory issues, and responding effectively to matters that may arise over the course of a product’s life.
Jayne P. Bultena has over 30 years of experience in food and drug regulatory matters, including labeling, compliance, and promotion. She has counseled Fortune 100 companies, start-ups, and venture capital investors across issues impacting the cosmetic and consumer healthcare industries, from claims development to labeling and promotional materials. She has represented clients before the U.S. Food and Drug Administration (FDA), the U.S. Consumer Product Safety Commission (CPSC), and the U.S. Federal Trade Commission (FTC).
Jane S. Vergnes, Ph.D., DABT®, an experienced research scientist and scientific study director with a Ph.D. in Human Genetics, helps companies assess cosmetic ingredient safety and comply with cosmetic regulations in the United States, the EU, and China. Her strong links with the Personal Care Products Council, Cosmetics Europe, and the European Federation for Cosmetic Ingredients (EFfCI) are invaluable resources for clients.
Karin F. Baron, MSPH has more than 20 years’ experience developing, implementing, and managing complex regulatory compliance matters for some of the largest industrial and specialty chemical companies in the world. Ms. Baron provides clients with expert advice and guidance with matters involving FDA, the Modernization of Cosmetics Regulation Act (MoCRA), the EU’s Regulation (EC) No 1223/2009, and Regulation EC (No) 1907/2006 on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH).
- B&C professionals routinely review and counsel on advertising for cosmetic products marketed in the United States and Europe.
- In connection with GMPs, B&C professionals review client practices to ensure alignment and compliance.
- B&C professionals assist clients with implementing the provisions of the Cosmetics Directive (EC) No. 1223/2009, which became effective in July 2013.