FDA Proposes Delay to Some Provisions of Rule on Regulation of Tobacco as Drug or Device

The Food and Drug Administration is proposing to delay until further notice certain provisions of its final rule on when products made or derived from tobacco are subject to regulation as a drug, device or combination product. Under the final rule, 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 would apply 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 the final rule is already delayed until March 19, 2018 (see 1703170030). Comments are due Feb. 5.