-

-

E-Cig Technology Inc.

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health ServiceFood and Drug Administration Silver Spring, MD 20993-0002

*_WARNING LETTER_* September 8, 2010 Mr. Sihui (Sam) HanCixi E-Cig Technology Inc, Ltd.E-Cig Technology Inc.7488 Celosia St.Las Vegas, NV 89113 Dear Mr. Han: This letter concerns the E-Cig Technology brand of electroniccigarettes, cigars, and USB cigarettes, and the components thereof, thatare marketed by your firm (collectively "E-Cig Technology products"). Based on our review of the products' labeling, including your Internetwebsite for these products, (www.e-cig.com <http://www.e-cig.com>^ ),the E-Cig Technology electronic cigarettes, cigars, and USB cigarettesare constructed with a lithium ion rechargeable battery, amicroprocessor, a heating element, and a cartridge that contains, or isintended to contain, various chemicals, including nicotine (in varyingspecified levels). Nicotine and/or other chemicals are intended to bevolatilized when the user inhales through these electronic cigaretteproducts. These electronic products do not contain tobacco leaf or stem.Each E-Cig Technology product is intended to heat air as it is drawnthrough it by the user. This heated air purportedly volatilizes thechemicals contained in the replaceable cartridge component of theseproducts. The volatilized chemicals are then inhaled by the user.

The E-Cig Technology E-Liquid and Healthcare E-Liquid products, whichmay or may not contain nicotine, are intended and labeled for use withthe electronic smoking products described above to fill depleted orempty cartridges that are components of these electronic smokingproducts. Additionally, E-Cig Technology offers the components ofelectronic cigarettes, cigars, and USB cigarettes such as cartridges,inhalers, cores, atomizers, E-Cigarillo lid, batteries, and chargers forsale. E-Cig Technology also distributes various accessories for electroniccigarettes, cigars, and USB cigarettes, such as syringes with needles,plastic dropper bottles, and plastic bottles, which are intended andlabeled to aid users of these electronic smoking products whentransferring the E-Cig Technology E-liquid into depleted or emptycartridges of various brands/models of these products and/or into emptyE-Cig Technology cartridges. As presently labeled and promoted, these E-Cig Technology productsviolate provisions of the Federal Food, Drug, and Cosmetic Act (theAct). As described in more detail below, E-Cig Technology products areunapproved new drugs marketed in the United States in violation ofsection 505 of the Act (21 U.S.C. § 355), are misbranded under section502 of the Act (21 U.S.C. § 352), and adulterated under section 501 ofthe Act (21 U.S.C. § 351). 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 intendedeither to affect the structure or function of the body or to cure,mitigate, treat, or prevent disease. Based on our review of the productsand their associated labeling and promotional materials, these productsare drug-device combination products, with a drug primary mode of action. Statements in labeling and promotional materials, including yourInternet website at www.e-cig.com <http://www.e-cig.com/>^ , thatreflect the intended uses for the products you market, include, but arenot limited to, the following:* **Home* “Why choose E-Cig? . . . E-Cig can help you reduce or quit smoking habits.” *Instruction Manuals* “E-Cigarillo Instruction Manual "It can refresh the smokers and satisfy their smoking addiction, makingthem happy and relaxed, so as to relief [sic] the suffering of quittingsmoking. The essentially [sic] differences between the Electronic Cigarillo andthe ordinary Cigarette are as follows: . . . 5. According to thesmoke-quitting procedure, the target of quitting smoke can be reachednon-painfully within a certain period of time . . . Suitable User . . .

The smokers who want [sic] to quit smoking. Painless smoking abstentioncan be realized gradually by decreasing nicotine content.” *Consumer Testimonials** *“Testimonials I have published my recommendations in one of the largest newspapers inIsrael and in many other forums I am a member of, and to all my closestfriends who ordered and stopped smoking also. - - A. Rahamim I have not had a real cigarette since Monday night . . . I feel thiscould be the first thing that really works to keep me off realcigarettes (have tried the gum, patch, zyban, etc ...).” . - - A.Bastarache”* *“Read Reviews James USA . . . I am extremely pleased with this product and I will bepurchasing more cartridges to move from dangerous cigarettes to yoursafer invention. Conrad CO . . . I LOVE your product and all my friends have orderedbecause I was able to quit smoking with your Ecig!” *Press* “Take Smoking To Next Level . . . One product called E-Rimonabant promises to help users lose weight andcombat their smoking addiction. This electronic cigarette producesvaporable Rimonabant, an anorectic anti-obesity drug. As an inverseagonist for the cannabinoid receptor CBI, Rimonabant helps reduceappetite by creating a full or satisfied feeling. ‘Rimonabant also reduces those strong cravings for smokers, which mayhelp users quit smoking completely or reduce their smokingdependency. E-Rimonabant has the same characteristics and effectivenessas the original Rimonabant’, states Sam Han, owner of E-Cig Technology,Inc. Ltd. Another innovative product that has recently come on the scene at E-Cigis called E-Cialis. This electronic cigarette helps improve sexualcapacity for men who suffer with ED (erectile dysfunction). More than 50percent of men between the ages of 40 and 70 years experience ED to somedegree. E-Cialis provides a simple solution by enhancing sexualperformance when smoking an electronic cigarette. ‘E-Cialis produces vaporable Cialis, an ED medication which is currentlymarketed in pill form and is more effective and longer lasting thanViagra.’” *News & Announcement *

“5 July 2009 - New Product E-Cialis has been released . . . we havedeveloped this new Vaporizable Cialis which have [sic] the samecharacteristic and the same effectiveness as the original Cialis. Nowyou can treat your ED or pulmonary arterial hypertension and improveyour sexual capacity by smoking. 8 July 2009 - New Product E-Rimonabant has been released . . . this newVaporizable Rimonabant which have [sic] the same characteristic and thesame effectiveness as the original Rimonabant. Now you can Loss [sic]Your Weight and Reduce Your Smoking Addiction! by smoking. 5 May 2008 - Healthcare Liquid released . . . Healthcare Liquid isavailable now. These new developped [sic] Electronic Smoking HealthcareLiquid products not only give you the same feeling as a tobacco cigar orcigarette without suffering any tar and carbon monoxide smoking damages,but also give you the personal health care for your body.” *Product Page* “Electronic Smoking Liquid Vitamins are a great way to increaseabsorpion [sic] into the blood stream and produce maximum efficacy. Itwill give you not only the same feeling as a tobacco cigar or cigarettewithout suffering any tar and carbon monoxide smoking damages, but alsogive you the highest possible bodily absorption, and keeps your immunesystem running in tip-top shape. . . You can use it with any brand andmodel of E-Cig products.” The above statements demonstrate that the E-Cig Technology productsmarketed by your firm are intended both to affect the structure orfunction of the body and to mitigate, treat, or prevent disease. /See/21 C.F.R. § 201.128 (describing the meaning of “intended use”). Inparticular, these statements suggest that these products are intendedfor use as smoking deterrents or to reduce dependence on traditionaltobacco products, and are also capable of delivering nicotine. Thescientific and medical communities have determined that nicotine is apharmacological agent,^1 that nicotine addiction is a disease,^2 andthat nicotine withdrawal is itself a recognized medical condition.^3 Itis well understood that people smoke for the pharmacologically rewardingeffects of nicotine, such as alleviation of stress and negative mood,enhancement of thinking, and increased alertness.^4 For an addictedsmoker, the body has adapted to nicotine, and abstinence produceswithdrawal and craving.^5 As a result, people also smoke to avoid thenegative effects of nicotine withdrawal, such as anxiety, difficultyconcentrating, negative mood, increased appetite, insomnia, andirritability.^6 Therefore, the claims noted above demonstrate that theE-Cig Technology products are intended to affect the structure orfunction of the body and to mitigate, treat, or prevent disease. Furthermore, the E-Cig Technology products and their components,described above, are also intended both to affect the structure orfunction of the body (e.g., by providing various vitamins for inhalationto supplement the diet, helping people lose weight, improving sexualcapacity, and improving the overall health of the user) and to mitigate,treat, or prevent disease (e.g., mitigate, treat, or prevent erectile

dysfunction). As described in 21 C.F.R. § 310.544, any product that bears labelingclaims that it “helps stop or reduce the cigarette urge,” “helps stop orreduce smoking,” or similar claims is a smoking deterrent drugproduct.^7 Products that are labeled, represented, or promoted assmoking deterrents, such as the E-Cig Technology products marketed byyour 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 dataestablishing that they are generally recognized as safe and effectivefor such use. /See/ 21 C.F.R. § 310.544. These products are also “newdrugs” under the Act because we are not aware of any data establishingthat these E-Cig Technology products are generally recognized amongscientific experts as safe and effective for the other drug usesdescribed above and in the products’ labeling. “New drugs” requireapproval of an application filed in accordance with section 505 of theAct (21 U.S.C. § 355) to be legally marketed in the United States. Noneof the E-Cig Technology or any of their components marketed by your firmis so approved; therefore, marketing these products in the United Statesviolates section 505 of the Act. E-Cig Technology products are also misbranded under section502(e)(1)(A)(ii) of the Act (21 U.S.C. § 352(e)(1)(A)(ii)) because theirlabeling fails to declare the quantity of each active ingredients fortheir Cialis, Rimonabant, and E-liquid products. The E-Cig Technology products marketed by your firm are also misbrandedunder section 502 of the Act (21 U.S.C. § 352) because they are intendedfor use as smoking deterrents under 21 C.F.R. § 310.544 but are notcovered by an approved new drug application. The E-Cig Technologyproducts are further misbranded under section 502(f)(1) of the Act (21U.S.C. § 352(f)(1)) because they do not bear adequate directions fortheir intended drug uses, including smoking deterrence and treatment oferectile dysfunction. “Adequate directions for use” is defined in 21C.F.R. § 201.5 as “directions under which the layman can use a drugsafely and for the purposes for which it is intended.” FDA’s Division of Pharmaceutical Analysis (DPA) evaluated multiplesamples of your products and in a sample of the Vitamin C E-Liquid, wedetected DEG. The presence of DEG in the Vitamin C E-liquid drug productsuggests that DEG has been added to a component in this drug product. DEG is an unexpected contaminant in Vitamin C E-liquid, perhaps tracingto DEG contamination of one of the ingredients used to manufactureVitamin C E-liquid. The amount of this adulterant our lab found inVitamin C E-liquid is fivefold in excess of the USP upper limit for DEGin Propylene Glycol and Glycerin, which are currently listed on yourwebsite as possible product ingredients.^8 The USP monographs forGlycerin and Propylene Glycol have a DEG upper limit of 0.1% to preventand detect DEG intentionally added as an adulterant. In certaininstances outside the United States in which a drug manufacturer failedto detect DEG in an ingredient such as glycerin or propylene glycol, thehealth consequences from DEG poisoning have been serious andirreversible. According to section 801(a)(3) of the Act (21 U.S.C.§381(a)(3)), an imported drug that appears to be adulterated shall be

refused admission into the United States. It appears that the DEGcontamination renders your product adulterated under section501(a)(2)(B) of the Act (21 U.S.C. 351(a)(2)(B)) and may not be importedinto this country. In addition, testing by FDA’s DPA revealed that several samples of yourproduct were tested and revealed that the amount of active ingredient inthe product did not correspond with that amount represented on thelabeling. Specifically, the Rimonabant prefilled cartridges, theRimonabant Healthcare E-Liquid, and the nicotine containing prefilledcartridges and E-Liquids did not contain the amount of activeingredients as represented on your labeling. The failure of yourproducts to contain the amount of ingredients they purport to containrenders the products adulterated under section 501(c) of the Act. (21U.S.C 351(c)). ^9 Testing by FDA's DPA also revealed that the Cialis prefilled cartridgesand the Cialis Healthcare E-Liquid contained amino-tadalafil, nottadalafil, the reference listed drug in Cialis. The substitution of thisingredient renders the products adulterated under section 501(d) of theAct. (21 U.S.C 351(d)). Please be aware that the FDA has issued a letter addressed to theElectronic Cigarette Association (ECA) which explains, in detail, howthe electronic cigarette industry can begin the drug approvalprocess. For your convenience, we have enclosed a copy of that letterand encourage you to follow through with the recommendations. The violations cited in this letterare not intended to be anall-inclusive list of deficiencies regarding your products, nor are thearguments raised here regarding them exhaustive. You are responsible forinvestigating and determining the causes of these violations and forpreventing their recurrence and the occurrence of other violations. Itis your responsibility to assure that your firm complies with allrequirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in thisletter. Failure to promptly correct these violations may result in legalaction without further notice, including, without limitation, seizureand injunction. Other federal agencies may take this Warning Letter intoaccount when considering the award of contracts. Within fifteen working days of receipt of this letter, please notifythis office in writing of the specific steps that you have taken tocorrect the referenced violations. Include an explanation of each stepbeing taken to prevent the recurrence of violations, as well as copiesof related documentation. If you cannot complete corrective actionwithin fifteen working days, state the reason for the delay and the timewithin which you will complete the correction. Furthermore, pleasestate what actions you will take to address products that you havealready distributed. If another firm manufactures the productsidentified above, your reply should include the name and address of themanufacturer. If the firm from which you receive the products is notthe manufacturer, please include the name of your supplier in addition

to the manufacturer. Please direct your response to FDA's ElectronicCigarette Mailbox at FDAElectronicCigaretteMailboxCDER@fda.hhs.govor(301) 796-3110 begin_of_the_skype_highlighting (301)796-3110 end_of_the_skype_highlighting.<mailto:FDAElectronicCigaretteMailboxCDER@fda.hhs.gov> Sincerely,/S/Michael M. Levy, Jr., Esq.Director, Division of New Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and Research

^1 /E.g./, P. Taylor, /Agents Acting at the Neuromuscular Junction andAutonomic Ganglia/,/ in/ Goodman & Gilman’s The Pharmacological Basis ofTherapeutics 193, 193-218 (J.G. Hardman, L.E. Limbird & A.G. Gilmaneds., 2001).^2 World Health Organization, ICD-10 International StatisticalClassification of Diseases, 10th Revision (2nd ed. 2007).^3 American Psychiatric Association, Diagnostic and Statistical Manual-- Text Revision 192 (2000).^4 /E.g./Pharmacologic Aspects of Cigarette Smoking and Nicotine/, 319New Eng. J. Med. 1318 (1988)/, N.L. Benowitz, /Drug Therapy. /^5 /See /World Health Organization,/ supra/ note 2.^6 /E.g. /T.B. Baker, T.H. Brandon & L. Chassin, /MotivationalInfluences on Cigarette Smoking/, 55 Ann. Rev. Psychol. 463 (2004).^7 We note that the determination as to whether e-cigarette productswould be considered Rx or OTC will be made during the review of an NDAsubmission.^8 The website provides a choice of either the “propylene glycol” or“vegetable glycerin” base for the Vitamin C E-liquid.^9 The actual ingredient content found in the E-Liquids and prefilledcartridges were inconsistent in many cases with the amounts specified onthe manufacturer’s website. Also, there were several incidences in whichwe detected nicotine in products represented as nicotine-free.