Here is something interesting:
Dear Josh,
Thank you for writing the Division of Drug Information, in the FDA's Center
for Drug Evaluation and Research.
The "electronic cigarettes" that FDA has 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, or proven to be safe and effective. Thus, the marketing of them in the
United States would be subject to enforcement action.
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:
Drug Approval Application Process. The sections
of the Act referenced above are also available on FDA's Internet web site at
U S Food and Drug Administration Home Page.
I hope this is helpful.
Best regards,
Drug Information CC
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
02-03-2009, 01:53 PM
