KNOWLEDGE ALONE ≠ INTENT: FDA Proposes to Trim One Basis for Determining “Intended Use” of Drugs and Devices

Last week, the U.S. Food and Drug Administration (FDA) published a proposed rule, 80 Fed. Reg. 57756 (Sept. 25, 2015), that at first blush is devoted to clarifying when a tobacco product may be subject to FDA’s regulation as a drug, device, or combination product vs. a tobacco product.