WARNING LETTER
Clouds Vapors LLC
MARCS-CMS 562959 —
September 26, 2018
Delivery Method:
VIA UPS and Electronic Mail
Product:
Tobacco
Recipient:
Recipient Name
Yakov Danino
Clouds Vapors LLC
11252 Harry Hines Blvd Suite 308
Dallas
,
TX
75229
United States
Issuing Office:
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
VIA UPS and Electronic Mail
SEPT 26, 2018
Yakov Danino
Clouds Vapors LLC
11252 Harry Hines Blvd
Suite 308
Dallas, TX  75229
info@cloudsvapors.com
WARNING LETTER
Dear Yakov Danino:
This is to advise you that the Center for Tobacco Products of
the U.S.
Food and Drug Administration (FDA) recently reviewed the websites
https://vaporloungeboca.com
and
https://cloudsvapors.com
and determined that the e-liquid products listed there are 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 Candy King Sour Worms e-liquid is misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) and/or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because its labeling and/or advertising is false or misleading.  Additionally, FDA has determined that
the JUUL Cool Cucumber pods e-liquid product 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.
False or Misleading Violation
FDA’s investigation of the website
https://vaporloungeboca.com
revealed that it sells or distributes Candy King Sour Worms e-liquid with labeling and/or advertising that causes it to imitate food products, particularly ones that are marketed toward, and/or appealing to, children (see Exhibit A).  Specifically, the labeling and/or advertising of the product imitates the labeling and/or advertising for candy that is commonly marketed toward, and/or appealing to, children, such as Trolli Sour Brite Crawlers sour gummy worms candy (see Exhibit B).  For example, the labeling and/or advertising for this e-liquid includes the terms “Candy King” and “Sour Worms,” prominently placed on the front of the product.  In addition, the labeling and/or advertising of Candy King Sour Worms e-liquid includes representations of the product name and color scheme that are substantially similar to the Trolli Sour Brite Crawlers sour gummy worms candy in Exhibit B.  Further, Candy King Sour Worms e-liquid has a strong scent like candy.  This labeling and/or advertising causes the product to imitate candy, particularly ones that are marketed toward, and/or appealing to, children and is therefore misleading.
Children are at particular risk for ingesting e-liquid products with labeling and/or advertising that causes the product to imitate a food or beverage, particularly a food or beverage that is typically marketed toward, and/or appealing to, children.  Moreover, children are at particular risk because exposure to the nicotine in the e-liquid product, even in relatively small amounts, could result in acute toxicity.  Child poisonings due to the ingestion of liquid nicotine have recently increased substantially.  Severe harms can occur in small children from ingestion of liquid nicotine, including death from cardiac arrest, as well as seizure, coma, and respiratory arrest.
Given that the labeling and/or advertising on Candy King Sour Worms e-liquid describes its nicotine content as 6mg/mL, with a total volume of 100mL, an accidental ingestion of approximately half a teaspoon would reach the lower end of the fatal dose range for an average two-year-old.  Additionally, an accidental ingestion of approximately 2% of a teaspoon would reach the lower end of the non-fatal acute toxicity range for an average two-year-old.
The FD&C Act provides, in part, that a tobacco product shall be deemed to be misbranded (1) if its labeling is false or misleading in any particular (section 903(a)(1)), or (2) if the tobacco product is distributed or offered for sale in any State and its advertising is false or misleading in any particular (section 903(a)(7)(A)).  The labeling and/or advertising for Candy King Sour Worms e-liquid is misleading because it causes the product to imitate candy, particularly ones that are marketed toward, or appealing to, children.  Therefore, the product is misbranded under section 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act.
Sales to Minors Violation
FDA’s investigation of
the website
https://cloudsvapors.com
revealed that you sold an e-liquid product to a minor.  Specifically,
during our investigation of
https://cloudsvapors.com
, a person younger than 18 years of age purchased the JUUL Cool Cucumber pods e-liquid product
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 violations discussed in this letter do not necessarily constitute an exhaustive list.  You should immediately correct the violations that are referenced above, as well as violations that are the same as or similar to the ones 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 these websites, 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 any 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.  If you do not believe that your products are in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.  You can find the FD&C Act through links on FDA’s homepage at
http://www.fda.gov
.
Please note your reference number, RW1800938, 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, 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:
Yakov Danino
Smart Vapor LLC d/b/a Vapor Lounge Boca
222 Yamato Rd
Boca Raton, FL  33431
orders@vaporloungeboca.com
Yakov Danino
7905 Habersham Ln
Dallas, TX  75248
kplm@walla.com
GoDaddy.com, LLC
abuse@godaddy.com
Websitewelcome.com
ipadmin@websitewelcome.com
1&1 Internet Inc.
abuse@1and1.com
Content current as of:
10/02/2018
Regulated Product(s)
Tobacco