Hello all, the supplier in question has asked to remain anonymous but has given me permission to reprint in full the email he received from the FDA.
Included is his response - I will update as soon as he receives a reply.
Included is his response - I will update as soon as he receives a reply.
From: "Budich, Kevin M" <Kevin.Budich@fda.hhs.gov>
Cc: "Wollscheid, Kristine" <Kristine.wollscheid@fda.hhs..gov>
Sent: Tuesday, March 31, 2009 2:05:15 PM
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 my office 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, and any other information 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.
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. They are intended to be manipulated and used in ways similar to how a smoker manipulates and uses the 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 through a chemical or metabolic action on the body. The "electronic" cigarettes, cigars, and pipes 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. Thus, the "electronic" cigarettes, cigars, and pipes, AND their components, that we have reviewed are intended to affect the body's structures and functions and, in some cases, 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, and 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, and pipes, described above, in the United States without an approved NDA 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, and the agency is continuing to evaluate them on a case-by-case basis.
Your e-mail does not change our position on the regulatory status of these products, i.e., they are still intended to affect the body's structures and functions and to treat, mitigate or prevent nicotine addiction symptoms when one can't or chooses not to smoke conventional tobacco products. As noted in my previous e-mail, such products are drug-device combinations that require premarket clearance through the new drug application procedures of the Federal Food, Drug, and Cosmetic Act (the Act).
Regarding the regulatory status of these products and their components, as explained in my original e-mail to you, a claim/representation for smoking cessation is not the only element FDA evaluates in making these determinations. We focus on the product's "intended uses." FDA considers ALL of the circumstances surrounding the marketing of a product in determining its "intended uses." See 21 C.F.R. 201.128. The key elements in evaluating these products is whether they are intended to affect the body's structures and functions and/or to treat, mitigate, or prevent disease (e.g., nicotine addiction). See section 201(g) of the Act (21 U.S.C. § 321(g)).
For your information and guidance, I am attaching a copy of a Regulatory Letter FDA issued concerning products marketed under the name "Favor." Like the "electronic" cigarettes, cigars, and pipes we have reviewed, those products were nicotine-delivery systems, and they were offered, among other things, as alternatives to conventional cigarettes to provide the same smoking and/or satisfaction derived from conventional tobacco products. As I noted in my previous e-mail, FDA has detained and refused all of the "electronic cigarettes" (and "electronic" cigars and pipes) and their components offered for importation into the United States that we have reviewed. FDA has not allowed the importation of any of these products.
Also noted in my previous e-mail, 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.
Please note that it is the responsibility of each person marketing drug products in the United States to comply with all of the requirements of the Act and its implementing regulations. Should you have further questions concerning the manufacturing and labeling of drug-device combinations or drug products, I recommend that you retain the services of a consultant with specific expertise in these matters.
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
Sent: Wednesday, April 01, 2009 4:11 PM
To: Budich, Kevin M
Subject: Re: Electronic Cigarettes
Hi Kevin,
I appreciate your prompt and informative response. My intention was to market this device as an alternative to smoking, not a quit-smoking aid. Does this change anything regarding the necessity for approval? Also, the liquid used in the e-cigarette we were looking into is comprised of 3 ingredients: Propylene Glycol (approved by the FDA for use as an additive in food), tobacco-derived nicotine solution, and natural flavor. Do any of these ingredients require FDA approval?
Also, where can I find the proper forms to apply for FDA approval of our e-cigarette products should your response indicate that I will, in fact, need approval to sell these products in the US? Please do let me know.
