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WARNING LETTER

CueCig MARCS-CMS 592362 —


Delivery Method:
VIA UPS and Electronic Mail
Product:
Tobacco

Recipient:
CueCig

1400 Market Place Blvd. Suite 103
Cumming, GA 30041
United States

cuecigmerchant@gmail.com
Issuing Office:
Center for Tobacco Products

10903 New Hampshire Avenue
Silver Spring, MD 20993
United States


OCT 24, 2019

                       

 

WARNING LETTER

 

 

The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the  social media accounts of CueCig on Twitter (https://www.twitter.com/cuecig), Instagram (https://www.instagram.com/cuecig), and Facebook (https://www.facebook.com/cuecig) containing social media posts with advertising for several e-liquid products, as well as the website, https://cuecig.com, and determined that the e-liquid products listed there are manufactured, advertised, and 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, 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 your e-liquid products (i.e., Nic Salts Grape Soda Shake and Vape e-Juice by Airship, Nic Salts 555 Gold Shake and Vape e-Juice by Airship, and Nic Salts Watermelon Ninja e-Juice by Airship) are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because the website advertising and social media posts regarding your e-liquid products fail to include the required nicotine warning statement.

 

E-Liquid Products with Advertising that Fails to Include the Required Nicotine Warning Statement are Misbranded

 

Our review of the website, https://cuecig.com, revealed that you sell, offer for sale, distribute, and/or advertise in the United States several e-liquid products with  advertising that does not include the required nicotine warning statement, for example: Nic Salts Grape Soda Shake and Vape e-Juice by Airship, Nic Salts 555 Gold Shake and Vape e-Juice by Airship, and Nic Salts Watermelon Ninja e-Juice by Airship.

 

Our review of your website, Twitter account, https://www.twitter.com/cuecig, Instagram account, https://www.instagram.com/cuecig, and Facebook account, https://www.facebook.com/CueCig, revealed they contain advertising posted on behalf of CueCig for e-liquid products that does not include the required nicotine warning statement in the manner required under 21 CFR 1143.3, for example: Nic Salts Grape Soda Shake and Vape e-Juice by Airship, Nic Salts 555 Gold Shake and Vape e-Juice by Airship, and Nic Salts Watermelon Ninja e-Juice by Airship.

 

Specifically, these social media accounts of CueCig contain posts dated June 19, 2019, June 21, 2019, and June 22, 2019 with advertising for Nic Salts Grape Soda Shake and Vape e-Juice by Airship, Nic Salts 555 Gold Shake and Vape e-Juice by Airship, and Nic Salts Watermelon Ninja e-Juice by Airship.

 

Under 21 C.F.R. § 1143.3, advertising for cigarette tobacco, roll-your-own tobacco, and covered tobacco products (other than cigars), such as e-liquid products, must bear the following warning statement:

 

WARNING:  This product contains nicotine.  Nicotine is an addictive chemical.

 

For cigarette tobacco, roll-your-own tobacco, and covered tobacco products other than cigars, it is unlawful for any such tobacco product manufacturer, packager, importer, distributor, or retailer of the tobacco product to advertise or cause to be advertised within the United States any tobacco product unless each advertisement bears the required warning statement (21 C.F.R. § 1143.3(b)). Under 21 C.F.R. § 1143.1, a “covered tobacco product” is defined as any tobacco product deemed to be subject to the FD&C Act under 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 products cited in this violation are “covered tobacco products.” 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 1143. Because your website and social media accounts regarding e-liquid products do not include the required nicotine warning statement, in violation of 21 C.F.R. § 1143.3(b), your e-liquid products are 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 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 any 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 advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act.  If you do not believe that your products are in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.  You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.

 

Please note your reference number, RW1901174, 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:

 

CueCig

3505 Summit Trl.

Cumming, GA 30041-6697

 

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