Advertising Law Tool Kit - Tenth Edition | 2022

38 / Venable Marketing FDA-Regulated Products The Food and Drug Administration (FDA) regulates the marketing of dietary supplements, over-the-counter (OTC) drugs, cosmetics, medical devices, foods, infant formula, pet foods/supplements, and even e-cigarettes. However, the regulatory classification of a product may not always be clear. For instance, is a face wash an OTC drug or a cosmetic? (It can be either one.) Is an energy drink a dietary supplement or a conventional food? Is that compression garment a consumer product or a medical device? A product’s regulatory classification will determine both the claims that may be made for that product and any requirement for FDA premarket review. The FDA’s regulations governing these types of products, in combination with misunderstandings about those regulations, are a frequent source of trouble for marketers. Claudia A. Lewis calewis@Venable.com +1 202.344.4359 Todd A. Harrison taharrison@Venable.com +1 202.344.4724