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. Dr. K - 04/02/2015
  1. Compliance Actions and Activities

WARNING LETTER

Dr. K Apr 02, 2015

Dr. K - 04/02/2015


Delivery Method:
UPS andElectronic Mail

Recipient:
Recipient Name
Sue J Hyung
Dr. K

1955 Raymond Dr. Ste. 106

Northbrook, IL 60062
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

 

APR 2, 2015

 
VIA UPS andElectronic Mail
 
Dr. K
Attn: Sue J Hyung
1955 Raymond Dr. Ste. 106
Northbrook, IL 60062
drkeliquid@hotmail.com
 
 
 
WARNING LETTER
 
Dear Ms. Hyung:
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your website, http://www.drkeliquid.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., 0.8%, 1.6%, or 2.4%). 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 considered tobacco products because they are “made or derived from tobacco” and are “intended for human consumption.”
 
Section 301(tt) Violation[1]
FDA has determined that the statements or representations made on the website http://www.drkeliquid.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
      1. its regulation or inspection by the Food and Drug Administration; or
      2. 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., 0.8%, 1.6% or 2.4%), including, but not limited to: Apple (15 ML), Banana (15 ML), Blackberry (15 ML), Blueberry (15 ML), Cherry (15 ML), Grape (15 ML), Ice Mint (15 ML), Kiwi (15 ML), Lemon (15 ML), and Mango (15 ML). These products are sold or distributed on your website, which includes the following statements: “FDA Registered Lab” and “Formulas FDA Registered.”
 
Because these statements on your website are directed to consumers and convey, 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.
 
In addition, it has come to our attention that one of the retail outlets appears to be selling your e-liquids from a display case marked with your firm’s name and the claim “FDA approved,” which conveys or would mislead consumers into believing that your products are approved by FDA. 
 
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), and 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, RW1500260, 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:
ENOM, Inc.
abuse@enom.com
 
Bigcommerce, Inc.
abuse@bigcommerce.com
 

[1] There are certain tobacco products, including e-liquids that contain nicotine, which are not currently subject to the tobacco product authorities under Chapter IX of the FD&C Act. However, because e-liquids meet the definition of a “tobacco product,” such products must comply with applicable provisions that are outside of Chapter IX of the FD&C Act, such as, section 301(tt) of the FD&C Act. 
                                                 

Close Out Letter