Cosmeceuticals

Fenton Nelson advises manufacturers and resellers of cosmeceuticals, the skin creams, lotions, and ointments that are a growing segment of the health care product marketplace at the intersection of cosmetics and pharmaceuticals. Physician practices, particularly in cosmetic medicine, have increasingly incorporated cosmeceuticals as an ancillary revenue source.

Fenton Nelson counsels manufacturers and resellers on legal and regulatory issues related to cosmeceuticals. Providers and regulators alike are often confused about the rules and regulatory requirements governing the manufacture and sale of cosmeceuticals. Legal and compliance issues that call for careful attention include required disclosures, ingredients, labeling and advertising claims and content, mandatory and voluntary submissions, and packaging.

Fenton Nelson assists clients in entering this business and, when necessary, defends clients whose manufacture or sale of cosmeceuticals is reviewed. Our objective, when possible, is to counsel clients proactively to avoid issues. Occasionally, we are called upon to defend investigations or assist clients in dealing with responding to adverse events. Clients regularly seek our assistance in responding to the FDA, the Medical Board of California, the Pharmacy Board of California audits and investigations. We have developed collaborative relationships with leading Washington, D.C. FDA boutiques for federal lobbying and submission purposes.

Recent examples of representative matters we have handled include:
-advising a physician practice on the launch of retail and Internet launch of a cosmeceuticals division
-representing a client in an FDA inspection of manufacturing plant
-defending a Medical Board investigation of physician marketing of cosmeceuticals

Compliance Planning & Cosmetic Medicine: A Tool for Minimizing Risk