Rule Clarifying Tobacco Product Regulation Raises Off-Label Issues

Industry experts say FDA's newly issued rule clarifying when tobacco products should be regulated as drugs, devices or combination products includes new language on “intended uses” that could be perceived by industry as an attempt to push back on recent court decisions that truthful, non-misleading, off-label promotion is legal. The rule, published Monday (Jan. 9), states that should a tobacco product be determined to have a drug or device intended use, it will be regulated as a medical product, then...