Tobacco Product Regulation
In general, a “tobacco product” is any product that is made or derived from tobacco that is intended for human consumption. FDA currently has the authority to regulate certain tobacco products, including cigarettes, cigarette tobacco, smokeless tobacco, and roll-your-own tobacco, under the “tobacco product” authorities in Chapter IX of the Food, Drug, and Cosmetic Act (FDCA). The FDCA also permits FDA to issue regulations to subject other products that meet the definition of “tobacco product” to the Agency’s “tobacco product” authorities under the FDCA. FDA has issued a proposed rule that would extend the Agency's "tobacco product" authorities in Chapter IX of the FDCA to cover additional products that meet the statutory definition of "tobacco product" in Section 201(rr) of the FDCA.
The relationship between FDA’s tobacco product authorities and its drug/device authorities was addressed in a recent court decision. In 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 FDCA’s “tobacco product” authorities unless they are "marketed for therapeutic purposes," in which case they are regulated as drugs and/or devices.
Please note that the above comments are general in nature. It is the responsibility of each person marketing a product to comply with all applicable requirements of the FDCA and FDA regulations. 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. Questions regarding the regulatory authorities applicable to a particular product can also be sent to FDA at NicotineInquiries@fda.hhs.gov.