Cosmetics and Personal Care
Beauty is 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. And 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 be aware of a new cosmetics directive (Cosmetic Products Regulation 1223/2009) that went into effect July 2013.
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. The Acta Group’s (Acta®) professionals, located in the United States, Europe, and Asia, have the regulatory and scientific knowledge-base as well as the strategic skills to help companies streamline the regulatory process within their desired markets.
Acta 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 Bultena has over 20 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).
Dr. Jane Vergnes, 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 U.S., 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.
Dr. Brian Xu, M.D., Ph.D., DABT®, has over 15 years of industry experience as a senior toxicologist and scientist at major chemical companies. He assists clients in designing safety testing, risk assessment, product safety, and regulatory compliance programs. Dr. Xu’s significant experience with FDA regulations and with the Orders and Decrees of the Chinese regulatory system helps him anticipate potential hurdles for clients registering or marketing cosmetic products in either jurisdiction.
Dr. David Peveler, holding a Ph.D. in organic chemistry, is expert in product regulatory compliance. Dr. Peveler joins Acta from Evonik Degussa Corporation, where he managed a variety of regulatory matters under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Jason Johnston, M.S., holds two Master of Science degrees in Chemical Engineering and in Technology and Policy from the Massachusetts Institute of Technology, and has more than 25 years in the field of risk assessment. Mr. Johnston has served as the project manager/senior scientist for a diverse range of risk assessments and is well-versed in the preparation of screening assessments and consumer product exposure assessments.
What We Do:
Acta 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 the U.S. Consumer Product Safety Commission (CPSC) and FTC, for products with multi-jurisdictional issues
- Acta professionals routinely review and counsel on advertising for cosmetic products marketed in Europe and the United States.
- In connection with GMPs, Acta professionals review client practices to ensure alignment and compliance.
- Acta professionals assist clients with implementing the provisions of the Cosmetics Directive (EC) No. 1223/2009, which is effective in July 2013.