WARNING LETTER
Cloud 9 Systems, LLC d/b/a Cloud 9 Vapor
MARCS-CMS 565001 —
September 21, 2018
Delivery Method:
VIA UPS and Electronic Mail
Product:
Tobacco
Recipient:
Recipient Name
Brendon J Gunn
Cloud 9 Systems, LLC d/b/a Cloud 9 Vapor
1055 W Red Cliffs Drive Unit B
Washington
,
UT
84780
United States
cloud9vaporsystems@gmail.com
cloud9vapororders@g mail.com
brendongunn@gmail.com
Issuing Office:
Center for Tobacco Products
United States
SEP 21, 2018
WARNING LETTER
Dear Brendon J Gunn:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://cloud9vapor.biz and determined that the e-liquid products listed there are manufactured and offered for sale or distribution to customers in the United States. Under section 201 (rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 321 (rr)), as amended by the Family Smoking Prevention and Tobacco Control Act, these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including e-liquids, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
FDA has determined that your Cloud 9 Vapor Fruit Strips e-liquid is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because you sold this product to a person younger than 18 years of age.
Sales to Minors Violation
FDA's investigation of the website https://cloud9vapor.biz revealed that you sold an e-liquid product to a minor. Specifically, during our investigation of https://cloud9vapor.biz, a person younger than 18 years of age purchased Cloud 9 Vapor Fruit Strips e-liquid from your website. No retailer may sell covered tobacco products, including e-liquid, cigar, pipe tobacco, waterpipe tobacco, and dissolvable tobacco products, as well as electronic nicotine delivery system (ENDS) products that contain any tobacco derivative, to a person younger than 18 years of age under 21 C.F.R. § 1140.14(b). Under 21 C.F.R. § 1140.3, a "covered tobacco product" is defined as any tobacco product deemed to be subject to chapter IX of the FD&C Act by 21 C. F. R. § 1100.2, excluding components or parts not made or derived from tobacco. Before 21 C.F.R. § 1100.2 became effective, only cigarettes, smokeless tobacco, roll-your-own tobacco, and cigarette tobacco were subject to chapter IX of the FD&C Act. 21 C.F.R. § 1100.2 deems all other tobacco products, except accessories of such tobacco products, subject to chapter IX and its implementing regulations. The product cited in this violation is a "covered tobacco product." Under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), tobacco products are misbranded if sold or distributed in violation of regulations prescribed under section 906(d) of the FD&C Act, including those within 21 C.F.R. Part 1140. Because this product is sold or distributed to persons younger than 18 years of age in violation of 21 C.F. R. § 1140.14(b), this product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).
Conclusion and Requested Actions
The violation discussed in this letter does not necessarily constitute an exhaustive list. You should immediately correct the violation that is referenced above, as well as violations that are the same as or similar to the one stated above, and take any necessary actions to bring your tobacco products into compliance with the FD&C Act.
It is your responsibility to ensure that your tobacco products and all related labeling and/or advertising on this website, on any other websites (including e-commerce, social networking, or search engine websites), in any other media in which you advertise, and in any retail establishments comply with each applicable provision of the FD&C Act and FDA's implementing regulations. Failure to ensure full compliance with the FD&C Act may result in FDA initiating further action without notice, including, but not limited to, civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Please note that adulterated and misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.
Please submit a written response to this letter within 15 working days from the date of receipt describing your corrective actions, including the dates on which you discontinued the violative labeling, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. You can find the FD&C Act through links on FDA's homepage at http://www.fda.gov.
Please note your reference number, RW1800992, in your response and direct your response to the following address:
DPAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
c/o Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
If you have any questions about the content of this letter, please contact Ele Ibarra-Pratt at
(301) 796-9235
or via email at CTPCompliance@fda.hhs.gov.
Sincerely,
/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
VIA UPS and Electronic Mail
cc:
Cloud 9 Systems, LLC
d/b/a Cloud 9 Vapor
Attn: Tysen K Johnsen
2458 S Camino Real
Washington, UT 84780
OLWM, LLC
1240 East 1 00 South #5
Saint George UT 84790
OLWM, LLC
555 S Bluff Street Ste 301
Attn: Steven W. Beckstrom
St George, UT 84770
SourceDNS
abuse@sourcedns.com
GoDaddy.com, LLC
abuse@godaddy.com
Liquid Web L.L.C
abuse@liquidweb.com
Content current as of:
10/02/2018
Regulated Product(s)
Tobacco