| Public Health Service Food and Drug Administration |
| Silver Spring, MD 20993-0002 |
Department of Health and Human ServicesWARNING LETTER
September 8, 2010
Ms. Shena Malave
President
Gamucci America
c/o Smokey Bayou, Inc.
9838 Old Bay Meadows Road, Suite 332
Jacksonville, Florida 32256
Dear Ms. Malave:
This letter concerns products marketed by your firm under the “Gamucci” name, including the components thereof. According to your Internet website, www.gamucci-america.com, Gamucci America is an authorized distributor of Gamucci Electronic Cigarettes and Cigars and is owned and operated by Smokey Bayou Inc.
Based on our review of the labeling for the “Gamucci products,” which includes your Internet website (www.gamucci-america.com), these products include two different forms of electronic smoking products: one product that mimics conventional cigarettes, and one that mimics conventional cigars. These products are often called “electronic cigarettes,” “e-cigarettes,” and “e-cigars.” The Gamucci products are constructed with a rechargeable battery, a microprocessor, a heating element, an atomizer, and a replaceable cartridge that contains certain chemicals, including nicotine (in varying specified levels). You also distribute the cartridge refill packs in various flavors such as cherry, coffee, peach, menthol, and apple that are available in different nicotine strengths. Nicotine and/or other chemicals are intended to be volatilized when the user inhales through these electronic cigarette products. These electronic products do not contain tobacco leaf or stem. Each product is intended to heat air as it is drawn through it by the user. This heated air purportedly volatilizes the chemicals contained in the replaceable cartridge component of these products. The volatilized chemicals are then inhaled by the user.
According to your website, these products are based on “a very sophisticated micro-electronic technology which provides a non flammable smoking experience” and that the nicotine and/or other chemicals (“less than 20 chemicals . . . including mostly nicotine [and] propylene glycol”) that are volatilized and inhaled from these products “can cause stimulation, a feeling of relaxation, calmness, and alertness [which] . . . can last from minutes to hours.” Your website explains that “[these products] provide all [the] same pleasures [the tactile, emotional and physical sensations], but without all the problems commonly associated with traditional smoking.”
Your website offers these products as an aid to help smokers quit smoking:
• “use the device to cut down, break the habit and ultimately quit smoking altogether . . .
• [o]ther quit smoking methods have little success with many smokers, so it is not surprizing [sic] that people who are trying to quit will try this too . . .
• [a]nd given the reports, it seems to be working for many.”
As presently labeled and promoted, these Gamucci products violate provisions of the Federal Food, Drug, and Cosmetic Act (the Act). As described in more detail below, Gamucci 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 Gamucci products and their associated labeling and promotional materials, these products are drug-device combination products, with a drug primary mode of action.
Statements in labeling and promotional materials, including your Internet website at www.gamucci-america.com, that reflect the intended uses for the products you market, include, but are not limited to, the following:
“Home . . .
“You won’t have to worry about smoking tobacco, tar or the other 4000 carcingenics traditional cigarettes have. E-Cigarettes look, feel, and taste like traditional cigarettes, yet they are far from it. They are a healthier alternative to smoking.”
“The Gamucci Electronic Cigarettes do not produce smoke, but rather a harmless water vapor. In addition to this there are no dangers of passive smoking.”
“FAQ . . .
Are Electronic Cigarettes safe?
Clinical trials have now been carried out in New Zealand by Dr Murray Laugeson of Health New Zealand that prove that Electronic Cigarettes are very safe. Please click on Report by Health New Zealand to view in full . . .”
“Media . . .
TobaccoHarmReduction.org
[T]he leading source of information of safer alternatives for smokers who cannot or do not wish to quit using nicotine.
Electronic Cigarettes . . .
Are they really safer than regular cigarettes? -Yes.
Are they as safe as using smokeless tobacco? -Maybe.
Could these help me quit all nicotine use? -Maybe.
They might. Switching away from smoking is the most important thing to do so even if you end up not quitting. At least it won't harm you the way smoking will. Some people have found that electronic cigarettes reduce their need to smoke somewhat. E-cigarette Direct has posted a collection of e-cig user comments [http://www.e-cigarettedirect.co.uk/research/comments.html] about their experiences with many reporting that they have reduced or quit traditional smoking. The products are available with varying levels of nicotine, from a lot to none, so they can be used as a weaning product.
It does not strictly qualify as scientific evidence but indications are that e-cigarettes are being used successfully by many to quit smoking, with many of the quitters having a history of trying other methods and failing . . . Every anecdote so far appears to tell the same story; a cigarette smoker is switching over, sometimes just part time but more often full time, to this safer alternative.
Other quit smoking methods have little success with many smokers, so it is not surprizing [sic] that people who are trying to quit will try this too. And given the reports, it seems to be working for many. In time we should see some formal studies but in the meanwhile, on a person to person basis, some smokers are rapidly reducing their health risks . . .
Electronic Cigarette News
Discover the E Cigarette And Stop Smoking Aid . . .
Electronic Cigarettes – Stop Smoking Aid Or Cigarette Substitute? . . .
July 2nd, 2009 . . . I think the electronic cigarette is a great stop smoking aid and definitely the best nicotine replacement therapy available on the market but should we really be treating them as a long term substitute for smoking or a stepping stone to a drug free existence? I used the e cigarette along with the “easy way to stop smoking” book by Allen Carr to rid myself of nicotine and wholeheartedly recommend them to any smoker who wants to quit. But, my belief is that our aim should be to work on becoming nicotine free as possible.
Don’t get me wrong, swapping tobacco for vaporized nicotine is going to do wonders for your health if you are a long term smoker but cutting out nicotine entirely should be the next step . . .
There’s no doubt in my mind that E Cigarettes are miles ahead of tobacco products as a way to deliver nicotine to the system in terms of their effect on your health but is your aim to find a healthier way to be a drug addict or to free yourself from the shackles of addiction for good?
My advice is to get a hold of the “Easy way to stop smoking” book and an E cigarette if you need it as a way to get off the smokes. In time wean yourself off nicotine altogether and you’ll find life to be an altogether more enjoyable experience.”
Nicotine Replacement Therapy Causes Cancer
April 22nd, 2009 . . . using an E Cigarette for a few months as a stepping stone to becoming nicotine free is infinitely preferable to continuing to smoke and is currently the best way to quit smoking we have.”
The above statements demonstrate that the Gamucci 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 claims noted above demonstrate that the Gamucci products 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 Gamucci 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 Gamucci 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 Gamucci 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 Gamucci 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 Gamucci 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,
/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 See WORLD HEALTH ORGANIZATION, 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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