U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. khahan LLC - 05/18/2016
  1. Compliance Actions and Activities

WARNING LETTER

khahan LLC 18/05/2016

khahan LLC - 05/18/2016


Delivery Method:
UPS and Electronic Mail

Recipient:
khahan LLC

1449 Columbus Dr.

Elkhart, IN 46514
United States

Issuing Office:
Center for Tobacco Products

United States


  

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

 

VIA UPS and Electronic Mail
MAY 18, 2016
 
Khahan LLC                                                                 
Attn: Carolyn Dickson
1449 Columbus Dr.
Elkhart, IN 46514
 
 
WARNING LETTER
 
Dear Ms. Dickson:
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.khahan.com and determined that the e-liquids listed there, containing varying amounts of nicotine, are offered for sale or distribution to consumers 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 (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 statements or representations on the website http://www.khahan.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, certain e-liquid products, which contain varying amounts of nicotine (e.g. 6mg, 12mg, 18mg, or 24mg), are sold or distributed on the website to customers in the United States with an image of the FDA logo with the word “APPROVED” directly underneath, including the following: Rich Tobacco, 555 Tobacco, Triple Berry, Caramel Apple, Desert Sands Tobacco, N. Port Tobacco, Royal Tobacco, Hot Cocoa, and RY4.   Because these statements or representations on the website are directed to consumers and convey, mislead, or would mislead consumers into believing that the above-listed tobacco products are approved or endorsed 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 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, criminal prosecution, seizure, 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 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, RW1600471, 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:
 
Domain.com, LLC

iPage Hosting
support@ipage.com
 
The Endurance International Group, Inc.
 


[1]Certain tobacco products, including e-liquids that contain nicotine, are not yet 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.  Please also note that, effective August 8, 2016, additional tobacco products meeting the definition in section 201(rr) of the FD&C Act, including e-liquids that contain nicotine, will be deemed subject to the tobacco product authorities under Chapter IX of the FD&C Act (81 FR 28974).