FDA Clarifies Situations When Tobacco Considered Drug or Device

The Food and Drug Administration is issuing a final rule (here) to clarify when products made or derived from tobacco are subject to regulation as a drug, device or combination product, it said. Under the final rule, a product made or derived from tobacco is regulated as a drug, device or combination product: “(1) If the product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease; or (2) if the product is intended 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,” FDA said. “The final rule also clarifies remaining circumstances where a product is subject to regulation as a tobacco product,” it said.