FDA WARNING_LETTER - The Vapor Island Inc. - September 22, 2020

The FDA issued a Warning Letter to David Kobel and Tanja Thompson, operating The Vapor Island (thevaporisland.com), on August 27, 2020. The FDA's Center for Tobacco Products reviewed the website and determined that Electronic Nicotine Delivery System (ENDS) products, specifically JUUL Pod Flavor Cartridges (Creme Brulee, Cool Cucumber, Fruit Medley, Cool Mint, and Mango), were offered for sale or distribution in the United States.

These ENDS products are classified as "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that these products lacked the required premarket marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act and were not otherwise exempt.

Consequently, these products are deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notices or information under section 905(j). The letter emphasizes the responsibility of the recipients to ensure compliance with the FD&C Act and FDA regulations for all tobacco products, labeling, and advertising across all sales channels. Failure to correct these violations may result in regulatory