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July 15, 2022

WARNING LETTER

The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://blackoutvapors.com and determined that the electronic nicotine delivery system (ENDS) listed there are 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 ENDS, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).

FDA has determined that ENDS products that are advertised and offered for sale or distribution on your website are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because your website advertising ENDS products fails to include the required nicotine warning statement.

ENDS Products with Advertising that Fails to Include the Required Nicotine Warning Statement are Misbranded

Our review of the website https://blackoutvapors.com revealed that the advertising for several ENDS products that you sell, offer for sale or distribute in the United States does not include the required nicotine warning statement in the manner required by 21 CFR 1143.3(b). Examples include: Hush Max Disposable – Strawberry Kiwi and Lucid Air Disposable Vape – Aloe Grape Ice. Under 21 C.F.R. § 1143.3(b), advertising for ENDS products containing nicotine made or derived from tobacco must bear the following warning statement:

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

It is unlawful for a manufacturer, packager, importer, distributor, or retailer of ENDS products containing nicotine made or derived from tobacco to advertise or cause to be advertised within the United States any such tobacco product unless each advertisement bears the required warning statement (21 C.F.R. § 1143.3(b)(1)). Further, the required warning statement must meet the requirements of 21 C.F.R. § 1143.3(b)(2).

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 promulgated under section 906(d) of the FD&C Act, including those within 21 C.F.R. Part 1143. Because your website regarding ENDS products does not include the required nicotine warning statement for these products, in violation of 21 C.F.R. § 1143.3(b), your ENDS 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

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 address any violations of the FD&C Act, 21 U.S.C. § 301 et seq., Chapter IX, relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, and 1143, may result in FDA taking regulatory action. Please note that adulterated and misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.

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.

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, RW2201790, in your response and direct your response via email at [email protected] and 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 Bryan Hills at (301) 796-9367 or via email at [email protected].

Sincerely,
/S/

Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products

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