FDA WARNING_LETTER - You Suck Vapes Altus - May 11, 2022

The FDA issued a Warning Letter to You Suck Vapes Altus on May 11, 2022, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, specifically "Berry Crunch e-liquid," which are deemed tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction.

The primary violation is the marketing of "Berry Crunch e-liquid" as a "new tobacco product" without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. These products were not commercially marketed in the U.S. as of February 15, 2007, and lack the necessary FDA authorization or exemption. Consequently, the products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required information under section 905(j).

The FDA cited prohibited acts under sections 301(k) and 301(p) of the FD&C Act for holding for sale and failing to provide required reports for adulterated and misbranded products. The company, a registered manufacturer with over 72,000 listed products, is responsible for ensuring compliance. Failure to address these violations may result in regulatory actions