| Public Health Service Food and Drug Administration |
| Silver Spring, MD 20993-0002 |
Department of Health and Human ServicesWARNING LETTER
September 8, 2010
Ms. Sabina King
Registered Agent
E-CigaretteDirect, LLC
18695 Pony Express Drive
Parker, Colorado 80134
Dear Ms. King:
This letter concerns various brands of electronic cigarettes and cigars (e.g., “Gamucci,”“Smoking Everywhere,” and “Veppo”), and the components thereof (e.g., batteries and cartridges), that are marketed by your firm.
Based on our review of the products’ labeling and promotional materials, including your Internet website (www.e-cigarettedirect.com), each of these products, often called “e-cigarettes” and “ecigars,” is constructed with a lithium ion battery, a microprocessor, a heating element, and a replaceable cartridge that contains certain chemicals, including nicotine (in varying specified levels). These products do not contain tobacco leaf or stem.
According to your website, “drawing” on an electronic cigarette or cigar causes the product to produce heated air that volatilizes the chemicals contained in the product’s cartridge, thereby producing “a cloud of nicotine-carrying vapor” that, “when inhaled, satisfies a smoker's craving for nicotine” and “produces the physiological effect that a smoker seeks” when one cannot or chooses not to smoke conventional tobacco products. In addition, you specifically offer these products as an aid to deter or cease smoking conventional tobacco products.
As presently labeled and promoted, these electronic cigarette and cigar products, and their components marketed by your firm violate provisions of the Federal Food, Drug, and Cosmetic Act (the Act). As described in more detail below, these products are unapproved new drugs marketed in the United States in violation of section 505 of the Act (21 U.S.C. § 355) and are misbranded under section 502 of the Act (21 U.S.C. § 352).
Both the “drug” and “device” definitions in sections 201(g) and 201(h) of the Act (21 U.S.C. §§ 321(g) and (h), encompass products intended either to affect the structure or function of the body or to cure, mitigate, treat, or prevent disease. Based on our review of the electronic cigarette and cigar products and their components marketed by your firm, as well as their associated labeling and promotional materials, these products are drug/device combination products, with the primary mode of action being that of a drug.
Statements in the labeling, promotional materials, and website (www.e-cigarettedirect.com), that reflect the intended uses for the products you market, include, but are not limited to, the following:
“Why should I quit smoking and how? . . . That’s an easy question. You should stop smoking because of the carcinogenic properties of cigarettes. The only [nicotine] delivery system that is remotely close to smoking a traditional cigarette is an electronic cigarette.”
“If you’ve tried the patch, gum and other methods that haven’t worked for you, try the electronic cigarette.”
“[W]ean yourself off of nicotine and quit smoking for good! . . . Our new program is designed to naturally and slowly wean your body off of the nicotine cravings by slowly decreasing them. . . . The Nicotine Withdrawal System consists of everything you need to decrease your nicotine cravings over a period of 3-6 months, depending on how quickly you'd like to accomplish your goal. . . . Included with the Nicotine Withdrawal Program is: . . . Veppo Complete Starter Kit . . . Blank refill cartridges . . . 4 bottles of e-liquid: 1 HIGH, 1 MED, 1 LOW, 1 NO nicotine. . . . Each bottle is used to refill the cartridges and is equivalent to 30 packs of cigarettes. . . . The point is to start with the high (or whatever level) you are used to and gradually shift to the med, low, and no nicotine levels. You do this at your pace. Most of our customers are completely off of nicotine in 3-6 months.”
“E-cigarettes Reducing 400,000 American Deaths per year to 10,000.”
“Experience better health without the toxins, tar and other poisons traditional cigarettes contain. Your body will notice the relief of cutting out all of those added poisons. Our customers tell us that they feel better, their skin is better looking and they breathe better.”
“The Electronic Cigarette or e-cigarette, is a patented sophisticated electronic device that atomizes purified liquid nicotine and produces a vapor that, when inhaled, satisfies a smoker's craving for nicotine . . . .”
“When using the E-cigarette, drawing on it produces the physiological effect that a smoker seeks . . . .”
“Electronic cigarettes allow you to puff where ever you are so you can get your nicotine fix in places where smoking is not permitted. Now you can calm your cravings at work, in the restaurant, at the bar, or airport without having to step out for a ‘smoking break.’”
“One electronic cigarette cartridge is equal to nearly a full pack [of regular cigarettes].”
“Joyce Bunker, Strasburg, CO (testimonial):
‘I have been smoking for over 20 years. I truly enjoy the experience of smoking a cigarette and knew a patch or gum would not help me kick the habit. . . . After doing research on the internet, I knew [the e-cigarette] was my solution to quitting smoking. . . . [It] tastes and functions like a real cigarette.’”
“Becca Crowder, Frankfield, MO (testimonial):
‘I smoke around 2 pks as well, and have been wanting to quit, or at least cut down for a long time. Now, I finally think it is going to work! . . . Thank you Ms. King, for finally making my nasty cigarette habit go away!’”
The above statements demonstrate that the electronic cigarette and cigar products marketed by your firm are intended both to affect the structure or function of the body and to mitigate, treat, or prevent disease. See 21 C.F.R. § 201.128 (describing the meaning of “intended use”). In particular, these statements suggest that these products are intended for use as smoking deterrents or to reduce dependence on traditional tobacco products, and are also capable of delivering nicotine. The scientific and medical communities have determined that nicotine is a pharmacological agent,1 that nicotine addiction is a disease,2 and that nicotine withdrawal is itself a recognized medical condition.3 It is well understood that people smoke for the pharmacologically rewarding effects of nicotine, such as alleviation of stress and negative mood, enhancement of thinking, and increased alertness.4 For an addicted smoker, the body has adapted to nicotine, and abstinence produces withdrawal and craving.5 As a result, people also smoke to avoid the negative effects of nicotine withdrawal, such as anxiety, difficulty concentrating, negative mood, increased appetite, insomnia, and irritability.6 Therefore, the statements noted above demonstrate that the electronic cigarette and cigar products marketed by your firm are intended to affect the structure or function of the body and to mitigate, treat, or prevent disease.
As described in 21 C.F.R. § 310.544, any product that bears labeling claims that it “helps stop or reduce the cigarette urge,” “helps stop or reduce smoking,” or similar claims is a smoking deterrent drug product.7 Products that are labeled, represented, or promoted as smoking deterrents, such as the electronic cigarette and cigar products marketed by your firm, are regarded as “new drugs” under section 201(p) of the Act (21 U.S.C. § 321(p)) because there is a lack of adequate data establishing that they are generally recognized as safe and effective for such use. See 21 C.F.R. § 310.544. These products are also “new drugs” under the Act because we are not aware of any data establishing that these electronic cigarette and cigar products are generally recognized among scientific experts as safe and effective for the other drug uses described above and in the products’ labeling. “New drugs” require 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 the electronic cigarette or cigar products or any of their components marketed by your firm is so approved; therefore, marketing these products in the United States violates section 505 of the Act.
The electronic cigarette and cigar products marketed by your firm are also misbranded under section 502 of the Act (21 U.S.C. § 352) because they are intended for use as smoking deterrents under 21 C.F.R. § 310.544 but are not covered by an approved new drug application. The electronic cigarette and cigar products are further misbranded under section 502(f)(1) of the Act (21 U.S.C. § 352(f)(1)) because they do not bear adequate directions for their intended drug uses, including smoking deterrence. “Adequate directions for use” is defined in 21 C.F.R. § 201.5 as “directions under which the layman can use a drug safely and for the purposes for which it is intended.”
Please be aware that the FDA has issued a letter addressed to the Electronic Cigarette Association (ECA) which explains in detail how the electronic cigarette industry can begin the drug approval process. For your convenience, we have enclosed a copy of that letter and encourage you to follow through with the recommendations.
The violations cited in this letter are not intended to be an all-inclusive list of deficiencies regarding your products, nor are the arguments raised here regarding them exhaustive. You are responsible for investigating and determining the causes of these violations and for preventing their recurrence and the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the referenced violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Furthermore, please state what actions you will take to address products that you have already distributed. If another firm manufactures the products identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the products is not the manufacturer, please include the name of your supplier in addition to the manufacturer. Please direct your response to FDA's Electronic Cigarette Mailbox at FDAElectronicCigaretteMailboxCDER@fda.hhs.gov or (301) 796-3110.
Sincerely,
/s/
/Michael M. Levy, Jr./
Michael M. Levy, Jr., Esq.
Director, Division of New Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
1 E.g., P. Taylor, Agents Acting at the Neuromuscular Junction and Autonomic Ganglia, in GOODMAN & GILMAN’S THE PHARMACOLOGICAL BASIS OF THERAPEUTICS 193, 193-218 (J.G. Hardman, L.E. Limbird & A.G. Gilman eds., 2001).
2 WORLD HEALTH ORGANIZATION, ICD-10 INTERNATIONAL STATISTICAL CLASSIFICATION OF DISEASES, 10TH REVISION (2nd ed. 2007).
3 AMERICAN PSYCHIATRIC ASSOCIATION, DIAGNOSTIC AND STATISTICAL MANUAL -- TEXT REVISION 192 (2000).
4 E.g., N.L. Benowitz, Drug Therapy. Pharmacologic Aspects of Cigarette Smoking and Nicotine, 319 NEW ENG. J. MED. 1318 (1988).
5 Supra note 2.
6 E.g. T.B. Baker, T.H. Brandon & L. Chassin, Motivational Influences on Cigarette Smoking, 55 ANN. REV. PSYCHOL. 463 (2004).
7 We note that the determination as to whether e-cigarette products would be considered Rx or OTC will be made during the review of an NDA submission
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