FDA WARNING_LETTER - Adrenaline Vapors LLC - August 23, 2022

The FDA's Center for Tobacco Products issued a Warning Letter to Michael Friday of Adrenaline Vapors on August 19, 2022, following a review of their website, https://www.adrenalinevapors.com. The review determined that e-liquid products, specifically "Freak," "Shock," and "Overdose," were manufactured and offered for sale or distribution in the United States.

These e-liquid products are classified as "tobacco products" under section 201(rr) of the FD&C Act, being derived from tobacco and intended for human consumption. As such, they are subject to FDA jurisdiction and regulation under section 901(b) of the FD&C Act and 21 C.F.R. § 1100.1.

The primary violation identified is that these e-liquid products are "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007. They lack the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notices or information under section