Sunshine Vape MARCS-CMS 535033 — August 16, 2017

WARNING LETTER

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• Delivery Method: UPS and Electronic Mail

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• Recipient: Keith Cohen-Skali; Sunshine Vape; 2699 Post Rd, unit 2; Warwick, RI 02886; United States

• Issuing Office: Center for Tobacco Products; United States

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

 

AUG 16, 2017

VIA UPS and Electronic Mail

 

Sunshine Vape, LLC

Attn: Keith Cohen-Skali

2699 Post Rd, unit 2

Warwick, RI 02886

info@sunshinevape.com

matt@sunshinevape.com

 

 

WARNING LETTER

 

Dear Keith Cohen-Skali:

 

The Center for Tobacco Products of   the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.sunshinevape.com 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 (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. 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 thatyour Sunshine Vape Cowboy e-liquid ismisbranded 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.  

 

Sales to Minors Violation

 

FDA’s investigation of the website http://www.sunshinevape.com revealed that you sold an e-liquid product to a minor. Specifically, during our investigation of http://www.sunshinevape.com, a person younger than 18 years of age purchased Sunshine Vape Cowboy 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 of21 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)).

 

Conclusion and Requested Actions

 

The violation discussed in this letter does not necessarily constitute an exhaustive list. You should immediately correct the violation that is referenced above, as well as violations that are the same as or similar to the one 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),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, 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, RW1700761, 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 UPS and Electronic Mail

 

cc:

                                                          

Sunshine Vape, LLC

35 South County Commons Way

South Kingstown, RI 02879

 

Keith Cohen-Skali

19 Colvintown Road

Coventry, RI 02816

 

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