FDA Delays Effective Date of Final Rule on When Tobacco Considered Drug or Device

The Food and Drug Administration is delaying the effective date of a final rule that clarified when products made or derived from tobacco are subject to regulation as a drug, device or combination product, it said (here). Under the final rule, issued Jan. 9, 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" (see 1701060011). Originally effective March 21, 2017, the final rule will now take effect March 19, 2018, FDA said. The agency will take the extra time to consider a petition from industry, including by seeking more comments on the final rule, it said.