FDA Regulation: Cosmetic or Drug Product?
Webinar: 1 CCS Credit
Over the years, the regulatory lines between cosmetics and drugs have been blurred as companies have created innovative products with inventive claims and ingredients. This webinar will discuss the various regulatory classifications and explore circumstances in which a product can be considered a drug, medical device, dietary supplement, or consumer product. It will also analyze how a personal care product comes to market and identify FDA requirements while exploring applicable regulatory hurdles.
- requirements for marketing personal care products
- when cosmetics must also meet FDA OTC drug requirements
- the role of ingredients in determining the legal status of cosmetic or personal care products
- the risks involved when a cosmetic’s claims shift the product into the drug category
- enforcement activity
- best practices
Shelly Garg is an attorney with Sandler, Travis & Rosenberg’s FDA Practice Group. She represents clients across a broad range of FDA-regulated product categories, including food, beverages and dietary supplements, over-the-counter drugs, medical devices, and cosmetics. She advises in strategic business planning, product development, testing and approval, labeling, advertisement and promotion, liability risk, inspections, responding to regulatory enforcement matters, and related issues. Her keen insights into FDA and its inner workings have proved to be of significant value to her clients in successfully resolving matters before the agency.