FDA WARNING_LETTER - Sema International Inc. - May 18, 2021

The FDA issued a Warning Letter to Anan Barbarawi of SemaVape.com on May 7, 2021, following a review of their website, which revealed the manufacture and sale of e-liquid products in the U.S. These products, including "Vapotech Strawberry" and "Vapotech Mango Xtreme," are classified as tobacco products under section 201(rr) of the FD&C Act.

The primary violation is that these e-liquid products are "new tobacco products" (not commercially marketed before February 15, 2007) and are being sold without the required premarket marketing 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 because the necessary notice or information under section 905(j) was not provided.

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 500 listed products, to ensure compliance with all applicable provisions of the FD&C Act and FDA regulations. Failure to correct these violations may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The company must submit a written response within 15 working days detailing actions taken to address the violations