FDA Delays Some Provisions of Rule on Regulation of Tobacco as Drug or Device

The Food and Drug Administration will delay until further notice certain provisions of its new regulations on when products made or derived from tobacco are subject to regulation as a drug, device or combination product, it said in a final rule. Under regulations issued Jan. 9, 2017, 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). FDA's indefinite delay applies to provisions describing the types of evidence that may be considered in determining a medical product’s intended uses, it said. The overall effective date of all other provisions of the regulations continues to be March 19, 2018 (see 1703170030).