- Delivery Method:
- VIA UPS and Electronic Mail
- MadTown Vapor LLC
3839 West Sahara Avenue, Suite 5
Las Vegas, NV 89102-0506
- Issuing Office:
- Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
April, 14, 2020
Dear Mr. Spinelli:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) has reviewed your submissions to the FDA and our inspection records, and determined that MadTown Vapor LLC, manufactures and distributes e-liquid products for commercial distribution in the United States, and that the e-liquid products are manufactured 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)), these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including e-liquid products, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)) and 21 C.F.R. § 1100.1.
Please be aware that, effective August 8, 2016, FDA deemed additional products meeting the definition of a tobacco product, except accessories to these newly deemed products, to be subject to regulation under the Act. These products include, but are not limited to, electronic nicotine delivery systems (including e-cigarettes), e-liquids, cigars, and pipe tobacco. See Final Rule, 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 Fed. Reg. 28,974 (May 10, 2016), available at https://federalregister.gov/a/2016-10685.
A Tobacco Product Without Required Ingredient Listing Submissions Is Misbranded
FDA has determined that you have not provided an ingredient listing to FDA as required by section 904(a)(1). Section 904(a)(1) requires each tobacco product manufacturer or importer, or agents thereof to provide “a listing of all ingredients, including tobacco, substances, compounds, and additives that are… added by the manufacturer to the tobacco, paper filter, or other part of each tobacco product by brand and by quantity in each brand and sub-brand.”
Because you have not provided FDA with an ingredient listing, FDA has determined that Berry Splash e-liquid product, which MadTown Vapor LLC manufactures, sells, and/or distributes to customers in the United States, is misbranded under section 903(a)(10)(A) of the FD&C Act (21 U.S.C. § 387d(a)(1) because you failed to comply with requirements prescribed under section 904 of the FD&C Act (21 U.S.C. §387d). The doing of any act with respect to a tobacco product while such article is held for sale after shipment in interstate commerce which results in such product being misbranded is a prohibited act under section 301(k) of the FD&C Act (21 U.S.C. § 331(k)). In addition, the failure to provide any information required by section 904 is a prohibited act under section 301(q)(1)(B) of the FD&C Act (21 U.S.C. § 331(q)(1)(B)).
A Tobacco Product Packaging Without the Required Nicotine Warning Statement Is Misbranded
FDA’s inspection of your establishment revealed that packages for your Berry Splash e-liquid product, which you manufacture, package, sell, offer to sell, distribute, and/or import for sale or distribution into the United States, do not include the nicotine warning statement required by 21 C.F.R. § 1143.3(a). Under 21 C.F.R. § 1143.3(a), packages 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 required warning statement on the package label (21 C.F.R. § 1143.3(a)(1)). 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. The e-liquid product whose packages do not contain the required nicotine warning statement 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 1143. Because your Berry Splash e-liquid product does not include the required nicotine warning statement on its packages, in violation of 21 C.F.R. § 1143.3(a), it is 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. 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 the product packages for your Berry Splash e-liquid product do not include the required nicotine warning statement, it is misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)). The doing of any act with respect to a tobacco product while such article is held for sale after shipment in interstate commerce which results in such product being misbranded is a prohibited act under section 301(k) of the FD&C Act (21 U.S.C. § 331(k)).
Conclusion and Requested Actions
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should take prompt action to address any 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 comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to address any violations of the types described above may result in FDA’s taking regulatory action. These actions may include but are not limited to, civil money penalties, seizure, and/or injunction. However, this Warning Letter does not constitute “written notice” for purposes of section 303(f)(9)(B)(i)(II) of the FD&C Act. Please note that any adulterated and/or 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 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, ER2000042, in your response and direct your response to the following address:
DEM-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 Lillian Ortega at (240) 402-9041 or Lillian.Ortega@fda.hhs.gov.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products