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WARNING LETTER

The-Vape-Place LLC MARCS-CMS 572058 —

Product:
Tobacco

Recipient:
Recipient Name
Gordon Tinsley and Angie Tinsley
The-Vape-Place LLC

112 N. Snead Street, Suite B

Boaz, AL 35957
United States

Issuing Office:
Center for Tobacco Products

United States


MARCH 4, 2019 

VIA UPS and Electronic Mail

                       

Gordon Tinsley and Angie Tinsley

The-Vape-Place LLC                                        

112 N. Snead Street, Suite B

Boaz, AL 35957

thevapeplace101@gmail.com 

WARNING LETTER

Dear Gordon Tinsley and Angie Tinsley:

The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website, https://the-vape-place.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 the e-liquid products sold on your website are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) and 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)) because your website regarding e-liquid products fails to include the required nicotine warning statement for these e-liquid products.

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

Our review of the website, https://the-vape-place.com, revealed that the labeling and/or advertising for the following e-liquid products that you manufacture, advertise, and offer for sale or distribution in the United States, does not include the required nicotine warning statement: AM Red, Analog Lite, Apple Freeze, Arctic Wolf, Bear Poo, Bear Poo Max, Black Label Bama’s Nectar, Black Label Uncharted, Black Label Kaos Theory, BlackRazz, Blueberry, Bounty Dew, Bug Juice, Bug Juice Max, Crazy Ape, Cream Saver V2, Cream Saver Max V2, Drunk Punch, Frozen Breeze, Gladiator, Gladiator Max, Granny’s Green Apple, Grape Code, Grape Freeze, Hi Berry, Hi Berry Max, Knott Adam’s Apple, Luck of the Irish, Mad Modder King, Mad Modder Queen, Magic City Custard, Magic City Custard Max, Maw Maw’s Candy Cane, Melon Freeze, Midnight Love, Mystic Melon, Nana’s Nuts, Peach Paradise, Pineapple, Purple Cow Max, Reptile Killer, RY4, Smooth, Smurf P, Strawberry, StrawMelon, Strawmelon max, StrawNado, Tropical Dream, Twi-Lite, and Watermelon. Under 21 C.F.R. § 1143.3, labeling and 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 person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution in the United States such product unless such tobacco product package bears the following required warning statement on the package label: “WARNING: This product contains nicotine. Nicotine is an addictive chemical” (21 C.F.R. § 1143.3(a)). It also is unlawful for 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. § 1140.3, 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 regarding e-liquid products does not include the required nicotine warning statement for these products, in violation of 21 C.F.R. § 1143.3(a) and/or 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)).

In addition, a tobacco product is misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) if its labeling is false or misleading in any particular. A tobacco product is misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) if, in the case of any tobacco product distributed or offered for sale in any State, its advertising is false or misleading in any particular.  Under section 201(n) of the FD&C Act (21 U.S.C. § 321(n)), in determining whether labeling and/or advertising is misleading, the agency considers, among other things, the failure to reveal material facts concerning the consequences that may result from the customary or usual use of the product. Because your website regarding e-liquid products does not include the required nicotine warning statement for these products, 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)).   

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 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 labeling, 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, RW1901028, 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:

 

Gordon Tinsley and Angie Tinsley

The-Vape-Place, LLC
406 North Main Street

Boaz, AL 35957

 

Gordon Tinsley and Angie Tinsley

The-Vape-Place, LLC

108 Pell Street

Albertville, AL 35951

 

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