Advertising Law Tool Kit - Tenth Edition | 2022

Venable / 39 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?