Pursuant to Section 201(rr) of the Food, Drug and Cosmetic Act , as amended by the Tobacco Control Act , a “tobacco product” is any product made or derived from tobacco intended for human consumption, but excludes drugs, devices, and combination (drug-device) products. A product is a drug, device, or combination product if it is intended to diagnose, cure, mitigate, treat or prevent disease, or if it affects the structure or function of the body (and is not a food).

On January 9, 2017, FDA published a final rule entitled, Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses.” The rule reiterates that a product made or derived from tobacco will be subject to FDA’s drug authority, and not its tobacco authority, if it is intended (a) for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, including use in the cure or treatment of nicotine addiction (e.g., smoking cessation), relapse prevention, or relief of nicotine withdrawal symptoms; or (b) to affect the structure or any function of the body in any way that is different from effects related to nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000.