StemStix, Inc. – FDA Warning Letter, Jun 5, 2020

The FDA issued a Warning Letter to StemStix, Inc. on June 5, 2020, following a review of their website (mystemjuice.com) and Instagram account (@stemjuice). The FDA determined that StemStix's e-liquid products are tobacco products subject to FDA regulation.

The letter identifies several violations: 1. **New Tobacco Products Without Required Marketing Authorization:** StemStix's e-liquid products (STEMJUICE – Tobacco, STEMJUICE – Menthol, STEMJUICE - Tobacco Blend, and STEMJUICE - Tobacco Mix) are considered "new tobacco products" as they were not commercially marketed before February 15, 2007. They lack the required FDA marketing authorization, rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. Failure to provide a required report under section 905(j) is also a prohibited act under section 301(p). 2. **Misbranded Tobacco Products for False or Misleading Advertising:** The website falsely claims products "have undergone tests with the Food and Drug Administration" and implies FDA has ensured their quality and safety. It also misleadingly suggests that beginning the PMTA process means products are safe. This misbranding violates section 903(a)(7)(A) of the FD&C