FDA WARNING_LETTER - StemStix, Inc. - June 16, 2020

The FDA issued a Warning Letter to StemStix, Inc. on June 5, 2020, following a review of their website (https://www.mystemjuice.com) and Instagram account (https://www.instagram.com/stemjuice). The FDA determined that StemStix, Inc. manufactures and sells e-liquid products, which are regulated as tobacco products under the FD&C Act.

The letter identified several violations:

1. **New Tobacco Products Without Required Marketing Authorization:** StemStix, Inc. is selling e-liquid products (STEMJUICE – Tobacco, STEMJUICE – Menthol, STEMJUICE - Tobacco Blend, and STEMJUICE - Tobacco Mix) that are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. These products lack the required FDA marketing authorization orders, making them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. Failure to provide required reports under section 905(j) is also a prohibited act under section 301(p).

2. **Misbranded Tobacco Products for False or Misleading Advertising:** The website includes false and misleading statements, such as "Our e-liquid has undergone tests with the Food and Drug Administration, ensuring its quality and