FDA WARNING_LETTER - VapeHub Incorporated d/b/a VapeHub - February 22, 2024

On February 22, 2024, the FDA issued a Warning Letter to VapeHub Incorporated d/b/a VapeHub for manufacturing and distributing e-liquid products, specifically "Fusion," without required marketing authorization. The FDA determined these e-liquid products are "new tobacco products" under section 201(rr) of the FD&C Act because they contain nicotine and were not commercially marketed in the U.S. as of February 15, 2007.

The violations cited include: - **Adulteration:** The products are adulterated under section 902(6)(A) of the FD&C Act because they lack FDA marketing authorization orders under section 910(c)(1)(A)(i) and are not otherwise exempt. - **Misbranding:** The products are misbranded under section 903(a)(6) of the FD&C Act because required notice or information under section 905(j) was not provided. - **Prohibited Acts:** The sale of adulterated/misbranded products (section 301(k)) and failure to provide required reports (section 301(p)) are prohibited.

VapeHub is required to submit a written response within 15 working days detailing actions taken to address violations, including discontinuation of violative sales/distribution and a plan for maintaining compliance. Failure to comply may result