FDA WARNING_LETTER - Soul Vapor - May 27, 2021

The FDA issued a Warning Letter to Aurelius Jeffery of Soul Vapor, identifying violations related to the marketing of e-liquid products. The FDA's Center for Tobacco Products reviewed the website https://www.soulvaporejuice.com and determined that e-liquid products, specifically "Soul Vapor Honey Pot" and "Soul Vapor Peach Rings," are manufactured and offered for sale or distribution in the United States.

These e-liquids are classified as "tobacco products" under section 201(rr) of the FD&C Act (21 U.S.C. § 321(rr)) and are subject to FDA jurisdiction. The FDA asserts that these products are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. Consequently, they require a premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)), which they lack.

Therefore, 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 notice or information under section 905(j). The letter emphasizes the firm'