Session Supply Co. – FDA Warning Letter, Jan 15, 2021

The FDA issued a Warning Letter to Dutch Knudson of Session Supply Company on January 15, 2021, following a review of their website, sessionsupply.com. The FDA determined that e-liquid products, specifically "Sesh Sauce 30ml" and "Sesh Sauce 60ml," 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 (21 U.S.C. § 321(rr)) and are subject to FDA jurisdiction. The FDA found that these products are "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is that these e-liquid products lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)). Consequently, the 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 company, registered with over