WARNING LETTER
13th Floor Elevapors, LLC
MARCS-CMS 553136 —
May 10, 2018
Recipient:
Recipient Name
Chris Warkenton and Randall Dalby
13th Floor Elevapors, LLC
3303 Harbor Blvd Suite F5
Costa Mesa
,
CA
92626
United States
Issuing Office:
Center for Tobacco Products
United States
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
May 10, 2018
VIA UPS and Electronic Mail
Breanne Warkenton
13th Floor Elevapors, LLC
3303 Harbor Blvd Suite F5
Costa Mesa, CA 92626
breanne@elevapors.com
info@Elevapors.com
sales@Elevapors.com
WARNING LETTER
Dear Breanne Warkenton:
This is to advise you that the Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.13thfloorelevapors.com 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)).
Misbranding Violation
FDA has determined that your Frank ‘N Vape 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.
FDA’s investigation of the website http://www.13thfloorelevapors.com revealed that it sells or distributes Frank ‘N Vape 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 looks very similar to Franken Berry cereal, which is a product that is primarily marketed toward, and/or appealing to, children (see Exhibit B). For example, the labeling and/or advertising for Frank ‘N Vape e-liquid includes the statement “Spooky marshmallows in scary berry cereal drenched in milk.”  In addition, the labeling and/or advertising of Frank ‘N Vape e-liquid prominently features the term “Frank N Vape” and includes an illustrated cartoon character that resembles both a strawberry and popular depictions of Frankenstein’s monster, which are substantially similar to the cereal in Exhibit B. Further, Frank ‘N Vape e-liquid has a strong scent like Franken Berry cereal. This labeling and/or advertising causes the product to imitate food products, particularly ones that are marketed toward, and/or appealing to, children, and is therefore misleading. In addition, the use of a cartoon character further enhances its appeal to children and increases the likelihood that the children will ingest the product as a food.
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 Frank ‘N Vape e-liquid describes its nicotine content as 6mg/mL, with a total volume of 60mL, an accidental ingestion of about 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 Frank ‘N Vape e-liquid is misleading because it causes the product to imitate food products, particularly ones that are marketed toward, and/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.
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), and in any other media in which you advertise 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, 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, RW1800861, 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 andElectronic Mail
cc:
Randall Darby and Christopher Warkenton
13th Floor Elevapors, LLC
1900 Wright Place, Ste 200
Carlsbad, CA 92008
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13thfloorelevapors.com@domainsbyproxy.com
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Close Out Letter
13th Floor Elevapors - Close Out Letters 7/31/18
Content current as of:
04/30/2018