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.
Question(s) For Expert Witness
1. Please describe your background in FDA product regulation.
2. What are the differences between over-the-counter product marketing/labeling regulations as opposed to cosmetic product marketing/labeling regulations?
Expert Witness Response E-219884
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. 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. 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.
About the author
Wendy Ketner, M.D.
Dr. Wendy Ketner is a distinguished medical professional with a comprehensive background in surgery and medical research. Currently serving as the Senior Vice President of Medical Affairs at the Expert Institute, she plays a pivotal role in overseeing the organization's most important client relationships. Dr. Ketner's extensive surgical training was completed at Mount Sinai Beth Israel, where she gained hands-on experience in various general surgery procedures, including hernia repairs, cholecystectomies, appendectomies, mastectomies for breast cancer, breast reconstruction, surgical oncology, vascular surgery, and colorectal surgery. She also provided care in the surgical intensive care unit.
Her research interests have focused on post-mastectomy reconstruction and the surgical treatment of gastric cancer, including co-authoring a textbook chapter on the subject. Additionally, she has contributed to research on the percutaneous delivery of stem cells following myocardial infarction.
Dr. Ketner's educational background includes a Bachelor's degree from Yale University in Latin American Studies and a Doctor of Medicine (M.D.) from SUNY Downstate College of Medicine. Moreover, she is a member of the Board of Advisors for Opollo Technologies, a fintech healthcare AI company, contributing her medical expertise to enhance healthcare technology solutions. Her role at Expert Institute involves leveraging her medical knowledge to provide insights into legal cases, underscoring her unique blend of medical and legal acumen.
