Tobacco Product Regulation: Sottera Court Decision
What is a “tobacco product”?
In general, a “tobacco product” is any product that is made or derived from tobacco that is intended for human consumption.
What tobacco products does FDA regulate?
FDA regulates all tobacco products, including cigarettes, smokeless tobacco, e-cigarettes and other Electronic Nicotine Delivery Systems (ENDS), hookah (waterpipe) tobacco, pipe tobacco, cigars, nicotine gels, and dissolvables.
The relationship between FDA’s tobacco product authorities and its drug/device authorities was addressed in a 2010 court decision: Sottera, Inc. v. FDA, 627 F.3d 891 (D.C. Cir. 2010). The court stated that products made or derived from tobacco can be regulated under the FD&C Act’s “tobacco product” authorities unless they are "marketed for therapeutic purposes," in which case they are regulated as drugs and/or devices (by FDA’s Center for Drug Evaluation and Research (CDER)).
Please note that the above comments are general in nature. You must comply with all applicable requirements of the FD&C Act and FDA regulations when marketing a tobacco product. Manufacturers and other interested parties may wish to consult the relevant provisions of the statute and regulations to determine whether a particular product made or derived from tobacco is subject to regulation under the tobacco authorities or the drug/device authorities of the FDCA.
Please contact us with questions regarding the regulatory authorities applicable to a particular product at NicotineInquiries@fda.hhs.gov.