Manufacturer Is Accused Of Mislabeling Over-The-Counter Products

Case Overview

This case involves a distribution rights dispute between a skincare products company and another member of their LLC. The defendant company had exclusive worldwide distribution rights for certain products supplied by the plaintiff entity. However, under their contract, the plaintiff entity could also distribute over-the-counter products and drugs, thus rendering the defendant company’s rights non-exclusive. It was alleged that the plaintiff entity manipulated their cosmetic products and repacked them as “over-the-counter” so they could distribute the products as well. An FDA regulatory expert was sought to review the products, their packaging and labeling, and their marketing and opine on whether or not the products would be considered over-the-counter products.

Questions to the Product Liability expert and their responses

Please describe your background in FDA product regulation.

I spent forty years in FDA, with 36 years at the FDA’s Center for Drug Evaluation and Research (CDER) Office of Compliance. I have eight years’ experience in the OTC drug branch, and I worked with to review and evaluate marketed OTC drugs. Most OTC drugs do not require FDA approval, but are required to meet the FDA OTC monographs once they are published. The vast majority of OTC drugs are not approved under an approved new drug application (NDA). Some OTC drugs have NDA approval. All OTC drugs must be manufactured under adequate cGMPs, and must be labeled correctly. During my forty years at FDA, I initiated several dozen cases against the illegal marketing of human drugs, dietary supplements, and drugs that were masquerading as either cosmetics or dietary supplements. I identified expert witnesses to testify for the government, and I also was an expert witness in both federal and state cases. I would be interested in and capable of working on this case.

What are the differences between over-the-counter product marketing/labeling regulations as opposed to cosmetic product marketing/labeling regulations?

The intended use of a product determines whether it is a drug. A drug is intended to treat, cure, mitigate, or prevent disease; or it is intended to affect the structure or any function of the body of man or other animals. Cosmetics, on the other hand, are intended for cleansing, beautifying, promoting attractiveness, or altering the appearance.

About the expert

This expert has over 40 years of experience as an FDA compliance expert. He serves in a wide range of roles and focuses explicitly on compliance issues. His main areas of expertise lie in the human drug, cosmetic, and dietary supplement industries. During his time at the FDA, he served in a number of roles, including as a compliance officer and the deputy director and acting director in the Division of New Drugs and Labeling Compliance, responsible for regulating marketed human Rx and OTC drugs. Additionally, he was a senior compliance officer of the Center for Drug Evaluation and Research. Currently, he serves as a senior regulatory advisor with an FDA compliance consultancy, assisting companies with FDA regulatory compliance for various goods.