FDA Guidance Clarifies Treatment of Consumer Health and Fitness Products

Issues relating to the dividing line between regulation by the U.S. Consumer Product Safety Commission (“CPSC”) and the Food and Drug Administration (“FDA”) have arisen more frequently in recent years as an increasingly wide range of consumer products, from athletic and recreational products to wearables and personal comfort products, advertise health and wellness benefits. Although the intended uses of these products typically fall within what customarily would be regarded as consumer products, how the products are advertised and promoted—specifically with respect to health-related claims—can raise troublesome questions regarding whether the product may be considered a device subject to FDA, rather ...