FDA Issues a Proposed Rule for Regulating Devices, Drugs, or Combination Derived from Tobacco

This proposed rule issued this week is in hopes of clarifying the circumstances under which tobacco products may be regulated as a drug or device. Under this rule, the product would be regulated if (1) the product is intended for used in diagnoses, treatment, or prevention of a disease, or (2) if the product is intended to affect the body in a way different differently than legally claimed in the marketing. This proposal could impact the importations of e-cigarettes and liquids. The complete proposal can be read in the Federal Register.