| Public Health Service Food and Drug Administration |
| Silver Spring, MD 20993-0002 |
Department of Health and Human ServicesWARNING LETTER
September 8, 2010
Mr. William P. Bartkowski
President
Ruyan America, Inc.
5550 Nicollet Avenue
Minneapolis, MN 55419
Dear Mr. Bartkowski:
This letter concerns the RUYAN brand of products marketed by your firm, Ruyan America, Inc. (Ruyan America), your joint venture partner Ruyan Holdings Ltd. of Hong Kong, and Nathan & James Group LLC, with which you have a distribution agreement to sell your products in the United States.
Based on our review of the products’ labeling and promotional materials, including the Internet websites www.ruyanamerica.com, www.getruyanusa.com, and www.ruyan.com.cn,1 RUYAN products include six different forms of electronic smoking products: two that mimic conventional cigarettes (identified as RUYAN V-8 and RUYAN RAPP E-Mystick), two that mimic conventional cigars (identified as RUYAN Vegas and RUYAN e-Gar), and two that mimic conventional tobacco pipes (identified as Rosewood E-Pipe and Agate E-Pipe) (collectively “RUYAN products”). According to the labeling and promotional materials, these products are “sophisticated electronic devices that use modern microelectronic technology” and “consist of a stainless steel shell, various lithium battery components, [a] microcomputer circuit, a vaporization chamber and a . . . cartridge.” Furthermore, “drawing on [these devices] will produce a water-like vapor” that “allow[s] smokers to satisfy their cravings” to, among other uses, “ratchet down nicotine consumption.” The RUYAN products do not contain tobacco leaf or stem.
The RUYAN RAPP E-Mystick is similar in design and function to the other RUYAN products, but instead of containing nicotine, it “contains the active ingredient lobelia . . . an herbal remedy/dietary supplement.” RUYAN RAPP E-Mystick is “marketed exclusively to smoking adults as a tonic” whereby “[t]he product provides smokers quick and effective relief for a number of conditions commonly attributed to tobacco use.” The RUYAN products are offered, among other things, as aids to deter or cease smoking when one cannot or chooses not to smoke conventional tobacco products.
As presently labeled and promoted, these RUYAN products and their components violate provisions of the Federal Food, Drug, and Cosmetic Act (the Act). As described in more detail below, these RUYAN 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 RUYAN 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 labeling and promotional materials that further reflect the intended uses for these RUYAN products include, but are not limited to, the following:
All RUYAN products
“[RUYAN products] could be used to ratchet down nicotine consumption.”
“Ruyan America Inc. of Minneapolis is distributing electronic cigarettes, cigars and pipes that . . . satisfy a smoker’s nicotine craving.”
Customer Feedback from “kate”:
“RUYAN decreases my daily cigarette usage. I mainly use it at home, it helps me reduce 4 - 8 cigarettes per day.”
Customer Feedback from “Wu Jiesi”:
“I started smoking when I was sixteen years old and I am fifty four now, so I have smoked for 38 years. I have attempted to stop smoking for many times, but failed. I am very anxious about my health. Fortunately, the appearance of ‘RUYAN’ solves my problem.”
Customer Feedback from “Mr. Cui”:
“My grandmother smoked like a chimney. After I bought her the Ruyan products, she reduced her cigarette smoking remarkably.”
www.getruyanusa.com (as of November 24, 2009):
“Ruyan smoking substitutes use liquids that can contain nicotine . . . .” Each product “gives the user the sensation of smoking, without producing the harmful tar, carbon monoxide and other chemicals found in the second hand smoke of traditional tobacco products.”
“When using these products, drawing on them will produce a water-like vapor that smokers find satisfying. . . . [T]he products provide the physiological and psychological effects that many smokers require for a satisfying experience.”
User manual for RUYAN V-8 electronic cigarettes
“Who Should Use This Product . . . Smokers over the age of twenty-one who wish to satisfy their craving and need for nicotine . . . .”
“The REC [RUYAN Electronic Cigarette] Device's cartridge contains nicotine. Nicotine is a natural alkaloid substance extracted from the tobacco leaf and certain other plants. It is the substance that causes smokers to become addicted.”
“The REC Device is a kind of non-flammable electronic cigarette with efficacies similar to those of the common cigarette. It has been demonstrated to refresh and satisfy smokers . . . .”
User manual for RUYAN e-GAR electronic cigars
“The cartridge in the RUYAN e-Gar contains nicotine . . . the substance that causes smokers to become addicted.”
“Who Should Use This Product: Smokers over the age of twenty-one who wish to satisfy their craving and need for nicotine . . . .”
Rapp E-Mystick
“The RAPP E-Mystick is designed for adult smokers who want the look, feel and experience of a cigarette.”
“[T]he Ruyan E-Mystick . . . contain[s] the recognized herbal remedy and dietary supplement lobelia and [is] marketed exclusively to smoking adults as a tonic. The product provides smokers quick and effective relief for a number of conditions commonly attributed to tobacco use.”
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 pharmacological agent,2 that nicotine addiction is a disease,3 and that nicotine withdrawal is itself a recognized medical condition.4 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.5 For an addicted smoker, the body has adapted to nicotine, and abstinence produces withdrawal and craving.6 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.7 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.8 Products that are labeled, represented, or promoted as smoking deterrents, such as the RUYAN 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 the RUYAN 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 RUYAN 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.
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 of delivering nicotine. 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 The website for Ruyan Holdings Ltd. of Hong Kong, www.ruyan.com.cn, directs potential customers in North America to Ruyan America, Inc., at www.ruyanamerica.com. The website www.ruyan.com.cn also features a press release consisting of an article in the Los Angeles Times that discusses Ruyan America and how Ruyan is “planning a big push in the United States.” In addition, the website www.ruyan.com.cn contains user manuals that state: “The maintenance and repair of this product must be conducted by RUYAN America.” The www.ruyanamerica.com website includes statements such as, “Ruyan America, Inc. is a U.S.-based joint venture partner of Ruyan Holdings Ltd. of Hong Kong,” which further demonstrates the close relationship between Ruyan America, Inc. and Ruyan Holdings Ltd. of Hong Kong. Thus, it is appropriate to include your joint venture partner's website in our review. Additionally, as of November 24, 2009, the website for Nathan & James Group LLC, www.getruyanusa.com, stated: “the Company executed a Distribution Agreement with Ruyan America to market and sell its Ruyan Nicotine Delivery Products”; therefore, we also included this website in our review.
2 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).
3 WORLD HEALTH ORGANIZATION, ICD-10 INTERNATIONAL STATISTICAL CLASSIFICATION OF DISEASES, 10TH REVISION (2nd ed. 2007).
4 AMERICAN PSYCHIATRIC ASSOCIATION, DIAGNOSTIC AND STATISTICAL MANUAL -- TEXT REVISION 192 (2000).
5 E.g., N.L. Benowitz, Drug Therapy. Pharmacologic Aspects of Cigarette Smoking and Nicotine, 319 NEW ENG. J. MED. 1318 (1988).
6 Supra note 3.
7 E.g. T.B. Baker, T.H. Brandon & L. Chassin, Motivational Influences on Cigarette Smoking, 55 ANN. REV. PSYCHOL. 463 (2004).
8 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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