To: Jay Taylor, MeritCare Health System, Fargo, ND:
This responds to your recent telephone inquiry regarding "electronic" cigarettes, cigars, and pipes.
The "electronic" cigarettes, cigars, and pipes that we have reviewed are drug-device combinations under section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 353(g)(1)) with their "drug" uses, as defined by section 201(g) of the Act (21 U.S.C. § 321(g)), as the primary mode of action. These products contain no tobacco leaf or stem material, but are designed to look like conventional cigarettes, cigars, and pipes, and to produce a mist or vapor upon each inhalation by the user that resembles and tastes like the smoke produced by conventional tobacco products. They are intended to be manipulated and used (inhaled) in ways similar to how a smoker manipulates and uses conventional tobacco products. And, like the conventional tobacco products, they are intended primarily for the delivery of volatilized chemical substances to affect the body's structures and functions and/or to mitigate or treat the symptoms of nicotine addiction. These products are designed with a re-chargeable battery-operated heating element that volatilizes the chemical constituents contained within replaceable cartridges. These cartridges may or may not include nicotine. Thus, these "electronic" cigarettes, cigars, pipes, AND their components are intended to affect the body's structures and functions and/or to treat or prevent withdrawal symptoms of nicotine addiction. (See 21 C.F.R. 201.128 for the meaning of "intended uses.")
Since we are not aware of any data establishing that such products are generally recognized among scientific experts as safe and effective for these "drug" uses, they are "new drugs," as defined by section 201(p) of the Act (21 U.S.C. § 321(p)) requiring approval of an application filed with FDA in accordance with section 505 of the Act (21 U.S.C. § 355) to be legally marketed in the United States. None of these so-called "electronic" cigarettes, cigars, pipes, OR their components, is covered by an approved NDA. Nor are any of these products covered by an approved application for premarket approval (PMA) in accordance with section 515(a) of the Act (21 U.S.C. 360e(a)), or by an approved application for an investigational device exemption (IDE) under section 520(g) of the Act (21 U.S.C. 360j(g)).
Therefore, the marketing of the "electronic" cigarettes, cigars, pipes, AND their components, as described above, in the United States violates sections 505 and 501(f)(1)(B) of the Act (21 U.S.C. 355 and 351(f)(1)(B)) and they are subject to enforcement action.
Furthermore, the "electronic" cigarettes, cigars, and pipes, AND their components, that we have reviewed are not subject to the Federal Cigarette Labeling and Advertising Act (FCLAA), Pub. L. No. 89-92, (15 U.S.C. §§ 1331 et seq), nor are they subject to the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA), Pub. L. No. 98-474 (1986), (15 U.S.C. §§ 4401 et seq). Thus, they do not fit within the regulatory scheme that Congress has established for tobacco products.
FDA has detained and refused several importations of various brands of these "electronic" cigarettes, cigars, and pipes, AND their components.
A detailed discussion of the new drug application (NDA) process is available on FDA's Internet Web site at: http://www.fda.gov/cder/regulatory/applications/default.htm. The sections of the Act referenced above are also available on FDA's Internet web site at www.fda.gov.
I hope this is helpful.
Kevin M. Budich
Compliance Officer
Food and Drug Administration
CDER/Office of Compliance
Division of New Drugs & Labeling Compliance
OTC Drugs Team
10903 New Hampshire Ave.
WO51-5174
Silver Spring, MD 20993
301-796-3304
kevin.budich@fda.hhs.gov
