Inspections, Compliance, Enforcement, and Criminal Investigations

Knoxville Vapor LLC 4/2/15

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993

 

APR 2, 2015
 
VIA UPS and Electronic Mail 
 
Teresa Livezey 
Knoxville Vapor
5201 Kingston Pike Unit #4                                           
Knoxville TN 37919
knoxvillevapor@gmail.com
 
 
WARNING LETTER
 
 
Dear Ms. Livezey:
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your website, http://knoxvillevaporshop.com, and determined that you sell or distribute e-liquids that contain nicotine to consumers in the United States. Specifically, your website advertises e-liquids that contain varying amounts of nicotine (e.g., 3mg, 8mg, 18mg or 24mg). 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 (Tobacco Control Act), these products are tobacco products because they are made or derived from tobacco and intended for human consumption.
 
Section 301(tt) Violation[1]
 
FDA has determined that a statement made on the website, http://knoxvillevaporshop.com, regarding your e-liquids violate section 301(tt) of the FD&C Act (21 U.S.C. 331(tt)) which prohibits, in pertinent part:
 
“[m]aking any express or implied statement or representation directed to consumers with respect to a tobacco product, in a label or labeling or through the media or advertising, that either conveys, or misleads or would mislead consumers into believing, that—
 
(1)   the product is approved by the Food and Drug Administration;
(2)   the Food and Drug Administration deems the product to be safe for use by consumers;
(3)   the product is endorsed by the Food and Drug Administration for use by consumers; or
(4)   the product is safe or less harmful by virtue of—
(A)    its regulation or inspection by the Food and Drug Administration; or
(B)    its compliance with regulatory requirements set by the Food and Drug Administration…”
 
Specifically, your website advertises the following e-liquids that are sold or distributed in varying amounts of nicotine (e.g., 3mg, 8mg, 18mg or 24mg), including but not limited to: 555, Absolute Pin (30mL), Ambrosia, American Tobacco, Apple Brandy (15mL), Apple Pie Moonshine (15mL) and Appletini. These products are sold or distributed on your website, which includes the statement that your e-liquids are, “tested, created and bottled in an FDA and/or AEMSA certified lab.” 
 
Because this statement on your website is directed toward consumers and conveys, or would mislead consumers into believing, that the above-listed tobacco products are endorsed by the FDA or that the products are safe or less harmful by virtue of regulation by FDA, they are in violation of section 301(tt) of the FD&C Act.
 
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 those stated above, and take any necessary actions to bring your tobacco products into compliance with the applicable provisions of the FD&C Act. 
 
It is your responsibility to ensure that your tobacco products and all related promotional materials 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 retail establishment(s) comply with each applicable provision of the FD&C Act and FDA’s implementing regulations.  Failure to ensure full compliance with the applicable provisions of the FD&C Act may result in FDA initiating further action without notice, including, but not limited to, civil money penalties, criminal prosecution, and/or injunction. 
 
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 promotion, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act.
 
Please note your reference number, RW1500287, 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 Electronic Mail
 
cc:
 
DotBlock.com
http://abuse@dotblock.com


[1]Certain tobacco products, including e-liquids that contain nicotine, are not yet deemed subject to the tobacco product authorities under Chapter IX of the FD&C Act. However, because your products meet the definition of a tobacco product, they must comply with applicable provisions that are outside of Chapter IX of the FD&C Act, including section 301(tt) of the FD&C Act.

 

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