Your recent inquiry directed to the Division of Drug Information in
FDA's Center for Drug Evaluation and Research, regarding the regulatory status of so-called "electronic cigarettes," was forwarded to me for reply. Please note that in order to make a definitive determination of the regulatory status of any product it is necessary that we review a complete description of the product's design, function, its formulation, labeling and promotion (including statements and representations on the Internet), and any other information (e.g., patents) that describe the product's intended uses. In addition, as a matter of policy, we limit communications about the regulatory status of specific marketed products to those responsible for them, and we do not discuss our enforcement actions except with the targets of those actions. Nonetheless, we can make the following general comments:
The "electronic cigarettes" 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. In this regard, these products contain no tobacco leaf or stem material, but are designed to look like conventional cigarettes. They are intended to be manipulated and used (inhaled) in ways similar to how a smoker manipulates and uses conventional cigarettes. And, like conventional cigarettes, 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 through a chemical or metabolic action on the body. The "electronic cigarettes" that we have reviewed 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. 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 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" is covered by an approved NDA.
Furthermore, the "electronic cigarettes" 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.
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/a...ns/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
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FDA IS MAKING WAVES! Read my e-mail from one agent.
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