FDA Proposes Rule on Tobacco-Derived Drugs and Devices
The Food and Drug Administration on Sept. 25 issued a proposed rule to clarify the circumstances under which tobacco products may be regulated as a drug or device (here). Under the proposed rule, a product made from or derived from…
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tobacco and intended for human consumption would be regulated as a drug, device or combination product if (1) 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 of nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000. FDA said the proposed rule will “increase clarity regarding the types of claims and other evidence that make a product made or derived from tobacco subject to regulation as a drug, device or combination product”. Comments on the proposed rule are due Nov. 24.