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. E-Cig Company - 507975 - 01/17/2017
  1. Warning Letters

WARNING LETTER

E-Cig Company MARCS-CMS 507975 —


Recipient:
E-Cig Company


United States

Issuing Office:
Center for Tobacco Products

United States


  

Department of Health and Human Services logo

 
 
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993 

 

JAN 17, 2017
VIA UPS and Email
 
E-Cig Company d.b.a. http://www.e-liq.com
1611 South Catalina Avenue
Suite # 105
Redondo Beach, CA 90277
sales@e-liq.com
 
WARNING LETTER
 
 
Dear Ms. Tracy:
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your website, http://www.e-liq.com/, and determined that you offer for sale or distribution e-liquid products that contain nicotine to consumers in the United States.  Specifically, your website advertises e-liquid products that contain “pure nicotine.” 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 are intended for human consumption. Certain tobacco products, including e-liquids that contain nicotine, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).[1]
 
Section 301(tt) Violation
FDA has determined that the statements or representations made on the website http://www.e-liq.com/ regarding your e-liquid products violate section 301(tt) of the FD&C Act (21 U.S.C. 331(tt)), which prohibits:
 
Making 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 products including, but not limited to, “pure nicotine.” These products are sold or distributed on your website, which includes the following statements: “Wholesale USP Kosher Grade PG/VG, FDA Approved Nicotine with the Manufacturers Prices!”; “FDA Approved Pure Nicotine”; and “The 100% pure nicotine is FDA approved product with FDA Registration No. 11488791158, NDC# 055742-0003.”
 
Because these statements or representations on your website are directed to consumers and convey, mislead, or would mislead consumers into believing that the above-listed tobacco products are approved by FDA, they are in violation of section 301(tt) of the FD&C Act.
 
Misbranding Violations 
 
FDA has also determined that your e-liquid products are 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)). Section 903(a)(1) of the FD&C Act provides that a tobacco product is misbranded if its “labeling is false or misleading in any particular.” Section 903(a)(7) of the FD&C Act provides that a tobacco product distributed or offered for sale in any State is misbranded if its “advertising is false or misleading in any particular.” These e-liquid products are misbranded under section 903(a)(1) of the FD&C Act and/or section 903(a)(7)(A) of the FD&C Act as their labeling or advertising is false or misleading because it makes the representation that the products are FDA approved.
 
Conclusion and Requested Actions
 
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should immediately correct these violations 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), 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, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Please note that 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. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
 
Please note your reference number, RW1700667, 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:
 
1 & 1 Internet
abuse@1and1.com
 
Bigcommerce, Inc.
abuse@bigcommerce.com
 
 

[1] FDA finalized a rule, effective August 8, 2016, deeming certain tobacco products, including e-liquids that contain nicotine, to be subject to Chapter IX of the FD&C Act. (Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 81 FR 28973 (May 10, 2016)).