FDA WARNING_LETTER - The Vapor Studio LLC - September 15, 2022

On September 15, 2022, the FDA issued a Warning Letter to The Vapor Studio LLC for manufacturing and distributing e-liquid products, specifically "The Vapor Studio Waterberry e-liquid products," without required marketing authorization. These products are classified as tobacco products under section 201(rr) of the FD&C Act, as amended on March 15, 2022, to include products containing nicotine from any source.

The FDA determined that these e-liquid products are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the necessary premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. 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 failure to provide required information under section 905(j).

The letter states that manufacturing, selling, or distributing such products is a prohibited act under sections 301(k) and 301(p) of the FD&C Act. The FDA has not received a marketing authorization application from the firm for these products. The company is required to submit a written response within 15 working days detailing actions taken to address violations