| Public Health Service Food and Drug Administration |
| Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 334-4100 FAX: (612) 334-4142 |
Department of Health and Human Services
September 8, 2010
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 10-20
Christian Berkey, CEO
Johnson Creek Enterprises, LLC
320 N. Watertown Street, Suite F
Johnson Creek, Wisconsin 53038
Dear Mr. Berkey:
This letter concerns "Smoke Juice," which is manufactured by your firm, and cartridge replacement products marketed by your firm under the "Johnson Creek" name.
As discussed below and in your labeling, these products are intended for use with electronic smoking products that are popularly called electronic cigarettes (or e-cigarettes), cigars and pipes. The electronic smoking products are generally designed to look and feel like the conventional tobacco products (cigarettes, cigars, and pipes). They are typically constructed with a battery, a sensor, a vaporizer or atomizer, and a cartridge that contains various chemicals, often including nicotine at various specified levels. These electronic products do not contain tobacco leaf or stem. Air is heated by these products as it is drawn through them by the user. This heated air purportedly volatilizes the chemicals contained in the cartridge components of these products and produces a mist or vapor upon each inhalation by the user that resembles and tastes like the smoke produced by tobacco products. The volatilized chemicals are then inhaled by the user.
The labeling and promotional material for your products, which includes your Internet website (www.johnsoncreeksmoke;uice.com), offers the Johnson Creek Original Smoke Juice products in twelve flavors, which are available in four different levels of nicotine (0 mg, 11 mg, 18 mg, 24 mg) and two different levels of propylene glycol (normal and reduced): "J.C. Original," "Black Cherry," "French Vanilla," "Chocolate Truffle," "Arctic Menthol," "Tennessee Cured," "Espresso," "Mint Chocolate," "Simply Strawberry," and "Summer Peach." There is a propylene glycol-free line of Johnson Creek Smoke Juice products in six flavors, which are available in three different levels of nicotine (0 mg, 11 mg, 18 mg)'. "Domestic," "Marcado"" "Island" "Wisconsin Frost," "Swiss Dark," and "Valencia." Additionally, you offer "JC Bees" which are disposable packets of Smoke Juice that allow users to refill their cartridge and dispose of the empty packet. All of these products are collectively described in this document as "Johnson Creek Smoke Juice products."
The Johnson Creek cartridge replacements are offered in three different forms: the "e-cigarette mini cartridge (DSE901)," the "e-cigarette mini cartridge (DSE103)," and the "e-cigarette pen-style cartridge (DSE801)" collectively described in this document as "Johnson Creek empty cartridge products."
The Johnson Creek Smoke Juice products are intended and labeled for use with various brands of so-called electronic cigarettes, cigars, and pipes to fill depleted or empty cartridges that are components of these electronic smoking products. The Johnson Creek empty cartridges are intended to replace the disposable cartridges that accompany various brands and models of electronic cigarettes.
Johnson Creek also distributes various accessories for electronic cigarettes, cigars, and pipes, such as 10 mL syringes without needle, flex-tip cartridge needles, plastic dropper bottles, needle-tipped travel droppers, small plastic funnels, and tweezers which are intended and labeled to aid users of these electronic smoking products when transferring the Johnson Creek Smoke Juice into depleted or empty cartridges of various brands/models of these products and/or into empty Johnson Creek cartridges.
As presently labeled and promoted, these Johnson Creek Smoke Juice products violate provisions of the Federal Food, Drug, and Cosmetic Act (the Act). As described in more detail below, Johnson Creek Smoke Juice 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 Johnson Creek Smoke Juice 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.johnsoncreeksmokejuice.com. that reflect these intended uses for the products you market include, but are not limited to, the following:
www.johnsoncreeksmokejuice.com
"Applause ...
If i had to wait two weeks, most likely I would have been back on smoke within a few days and I don't ever want to go there again, with as good as I feel right now. Daniel L.
... I have been off tobacco cigarettes for a week. I have been using an NJOY. I just received my first of many orders from your company. Norman S."
"News from Johnson Creek ...
"Effect of an E-Cigarette on Cravings and Withdrawal, Acceptability and Nicotine Delivery: Randomised Cross-Over Trial" - The University of Auckland Faculty of Medical and Health Sciences ... Aim ... To measure the effects of the Ruyan e-cigarette (EC) on craving relief and withdrawal and explore its acceptability and pharmacokinetic properties in comparison to placebo EC (i.e. with cartridges containing no nicotine), Nicorette nicotine inhalator and factory made cigarettes ... Conclusion ... The EC shows promise as a device that might aid cessation."
Promotional materials [brochures]
"Welcome to E-Smoking! A beginner's guide to E-Smoking ...
E-Smoking vs. Cigarette Smoking ... To many who take up e-smoking, it completely takes over for regular cigarette smoking. In fact many report never picking up a cigarette again after starting to e-smoke ...
Why E-Smoke? . .. Most people who smoke, do so because they enjoy the tactile, emotional and physical sensations. E-smoking provides pleasures similar to those commonly associated with traditional smoking ...
Nicotine ... Nicotine is an alkaloid found in certain plants, predominantly tobacco ... When absorbed in small amounts, whether from cigarettes, cigars or e-cigarettes, nicotine can cause stimulation, a feeling of relaxation, calmness, and alertness. The effects of nicotine can last from minutes to hours, Although addictive, nicotine is widely considered far less dangerous than the ingredients in regular cigarettes."
"Archive for the 'News' Category ...
Response to the FDA - Why Johnson Creek is Different ... There's no diethylene glycol, there's no tobacco, no known carcinogens ... Comments ... Rick Hageman ... July 31, 2009 at 12:05 pm ... I've tried to quit several times by many methods - always went back because nothing addressed the physical addiction to the act of smoking. I was miserable as a non smoker 'cause I constantly craved the act of smoking. I've successfully abandoned tobacco thanks to the e-cig and Johnson Creek.
A Letter From the Founder ... For the past six months, we've been working tirelessly creating a formula that actually produces more vapor, more throat hit ... yet also happens to use fewer ingredients and is 100% tobacco-free! ... Comments ... August 2, 2009 at 3:22 pm . .. I smoked for 40 years and was unable to quit until I purchased my first e-cigarette. I have not had a tobacco cigarette for over 3 months, and I no longer have any desire to have one!"
The above statements demonstrate that the Johnson Creek Smoke Juice 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 Johnson Creek Smoke Juice 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 Johnson Creek Smoke Juice 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 Johnson Creek Smoke Juice 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 Johnson Creek Smoke Juice products or any of their components marketed by your firm are so approved; therefore, marketing these products in the United States violates section 505 of the Act.
The Johnson Creek Smoke Juice 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 Johnson Creek Smoke Juice products are further misbranded under section 502(t)(1) of the Act (21 U.S.C. § 352(t)(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."
Additionally, during our September 1-25, 2009, inspection of your manufacturing facility, Johnson Creek Enterprises, LLC, located at 320 N. Watertown Street, Suite F, Johnson Creek, Wisconsin, investigator(s) from the FDA identified significant violations of Current Good Manufacturing Practice (cGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug product(s), as described above, to be adulterated within the meaning of section 501(a)(2)(B) of the Act (21 U.S.C. § 351 (a)(2)(B)) in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, cGMP. Specific violations observed during the inspection include, but are not limited, to the following:
CGMP Violations
Your firm has not established a quality control unit having the responsibility and authority to approve and reject all components, drug product containers, closure, in-process materials, packaging materials, labeling and drug products, and the authority to review production records to assure that no errors have occurred (21 C.F.R. § 211.22(a)). For example, your firm has not established a quality control unit. Personnel with quality control unit responsibility have not been designated.
1. Your firm does not test each batch of drug product to determine conformance with final specifications (21 C.F.R. § 211.165(a)). Specifically, your firm does not test each batch of drug product prior to release.
2. Your firm has not established written procedures designed to prevent microbiological contamination of drug products not required to be sterile (21 C.F.R. § 211.1 13(a)). For example, your firm has not set microbial limits for your firm's oral liquid drug products, nor have you demonstrated preservative effectiveness.
3. Your firm has not conducted specific identification testing when components are accepted based on the supplier's report of analysis (21 C.F.R. § 211.84(d)(2)). For example, your firm accepts a Certificate of Analysis (COA) from the supplier of components. However, your firm does not conduct identity testing on your components or appropriate verification of the supplier's test results.
4. Your firm does not have a written testing program designed to assess the stability characteristics of drug products in order to determine appropriate storage conditions and expirations dates (21 C.F.R. § 211.166(a)). For example, your firm does not have a stability testing program for your firm's components and finished drug products.
5. Your firm's drug products do not bear an expiration date determined by appropriate stability data to ensure they meet applicable standards of identity, strength, quality and purity at the time of use (21 C.F.R. § 211.137(a)). For example, your firm does not have the stability data to support expiration dating for these products.
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 the Minneapolis District Office at 612-334-4100.
Sincerely,
/s/
Gerald J. Berg
Director
Minneapolis District
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-l 0 INTERNATIONAL STATISTICAL CLASSIFICATION OF DISEASES, 10TH REVISION (2nd ed. 2007).
3 AMERICAN PSYCHIATRlC 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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