FDA and FTC Regulations & Enforcement Actions

Stan Soper has worked in the supplement, cosmetic and OTC space involving FDA and FTC regulations since 1997.  During that time, he has:

• Developed a depth of knowledge of the regulatory environment and issues that is carefully balanced with an understanding of the enforcement posture and history of relevant agencies

• Led or participated in numerous industry lobbying and PR efforts in Washington D.C., including interacting with members of Congress and regulators and their staff members as well as various trade associations

• Designed and developed a custom software solution to manage adverse event record keeping and reporting, including semi-automated reporting of serious adverse reactions to FDA

• Personally reviewed and advised on thousands of product labels and warnings and advertising claims

• Conducted due diligence on over 100 companies in the natural products industry

Stan Soper can help with label and ad review, due diligence in acquisitions, inspections and interactions or enforcement actions involving regulators.