Manufacturer Is Accused Of Mislabeling Over-The-Counter Products

FDA Regulatory ExpertThis 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.

Expert Witness Response E-065690

Expert-ID: E-065690

In my 29 years of experience at the FDA, I was involved with determining whether a product met regulatory requirements such as labeling, compliance with GMPs, etc. With regards to OTC drugs, the majority are based upon published OTC monographs, meaning that if they meet criteria for ingredients and labeling, they can be marketed without having any drug application submitted. The firm marketing such drug products would have to register and list their products with the FDA, however. The requirements for OTC drugs are much lower than for prescription drugs. In order for a product to be considered a drug (either prescription or OTC) it has to make what are known as structure/function claims through its labeling. In other words, the product would somehow affect the function or structure of a person’s (or animal, in the case of vet drugs) body chemically. Cosmetics do not make such claims, and are only allowed to suggest in their labeling that they somehow enhance one’s appearance. During my career I evaluated various products to determine whether or not they should be considered drugs, even if they were being promoted as cosmetics. I would be interested in working on this case.


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