FDA Seeks More Comments on Regulation of Tobacco as Drug or Device

The Food and Drug Administration seeks more comments on a final rule that clarifies 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, FDA recently delayed the effective date until March 19, 2018 (see 1703170030). Comments on the final rule, as well as a request FDA has received to reconsider the new regulation, are now due July 18.