Advertising Law Tool Kit - Ninth Edition | 2021

Venable / 39 38 / Venable Marketing FDA-Regulated Products When taking a product to market that is, or may be, regulated by the FDA, marketers should consider the following questions: • Are you certain of the regulatory classification of the product? • Does marketing for a cosmetic product claim that the product affects the structure or function of the body? (It should not.) • Do any claims for dietary supplements address a disease or disease condition? (They should not.) • Are the claims for OTC drug products consistent with the appropriate monograph? • For a medical device, is FDA clearance required prior to going to market? Have all claims been checked against the appropriate regulation or clearance? • Do your social media practices influence how your products are perceived by the FDA? 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