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.