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WARNING LETTER

http://www.ecigmates.co.uk MARCS-CMS 533939 —


Recipient:
http://www.ecigmates.co.uk

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 

 

 
SEP 26, 2017
VIA Electronic Mail
 
Ecigmates.co.uk   
info@ecigmates.co.uk
 
 
WARNING LETTER
 
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website FD&C Act http://www.ecigmates.co.uk and determined that the e-liquid products listed there are offered for sale or distribution to customers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic 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. 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)).
                                                                                                                                    
FDA has determined that the Hangsen Cheesecake e-liquid is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because you sold this productto a person younger than 18 years of age.  Additionally, FDA has determined a statement or representation made on the website http://www.ecigmates.co.uk regarding your e-liquids violates section 301(tt) of the FD&C Act (21 U.S.C. 331(tt)) because it is directed to consumers and conveys, misleads, or would mislead consumers into believing that the tobacco products are approved by FDA.
 
Sales to Minors Violation
 
FDA’s investigation of the website http://www.ecigmates.co.uk revealed that you sold an e-liquid productto a minor. Specifically, during our investigation of http://www.ecigmates.co.uk, a person younger than 18 years of age purchased Hangsen Cheesecake e-liquid from the website. No retailer may sell covered tobacco products, including e-liquid, cigar, pipe tobacco, waterpipe tobacco, and dissolvable tobacco products, as well as electronic nicotine delivery system (ENDS) products that contain any tobacco derivative, to a person younger than 18 years of age under 21 C.F.R. § 1140.14(b). Under 21 C.F.R. § 1140.3, a “covered tobacco product” is defined as any tobacco product deemed to be subject to chapter IX of the FD&C Act by 21 C.F.R. § 1100.2, excluding components or parts not made or derived from tobacco. Before 21 C.F.R. § 1100.2 became effective, only cigarettes, smokeless tobacco, roll-your-own tobacco, and cigarette tobacco were subject to chapter IX of the FD&C Act. 21 C.F.R. § 1100.2 deems all other tobacco products, except accessories of such tobacco products, subject to chapter IX and its implementing regulations. The product cited in this violation is a “covered tobacco product.” Under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), tobacco products are misbranded if sold or distributed in violation of regulations prescribed under section 906(d) of the FD&C Act, including those within 21 C.F.R. Part 1140.  Because this product is sold or distributed to persons younger than 18 years of age in violation of 21 C.F.R. § 1140.14(b), this product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).
 
Section 301(tt) Violation
 
FDA has determined that a statement or representation made on the website http://www.ecigmates.co.uk regarding your e-liquid products violates section 301(tt) of the FD&C Act (21 U.S.C. 331(tt)), which prohibits:
 
“[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., 12 mg, 18 mg, and 24 mg), are sold or distributed on the website to customers in the United States with the statement “FDA (USA Approved),” including, for example: Hangsen Cheesecake, Hangsen Menthol, Hangsen Mojito, Hangsen Strawberry, and Hangsen Vanilla.  Because this statement or representation on your website is directed to consumers and conveys, misleads, or would mislead consumers into believing that the  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 the violations that are referenced above, as well as violations that are the same as or similar to the ones 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, 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, RW1700753, 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
 
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