Bootstrap Runners LLC – FDA Warning Letter, Sep 6, 2022

The FDA issued a Warning Letter to Bootstrap Runners LLC on September 1, 2022, following a review of submissions and inspection records. The FDA determined that Bootstrap Runners LLC manufactures and distributes e-liquid products, specifically "Sinister Marino Blend 3mg/ml 60ml" and "Sinister Marino Blend 12mg/ml 60ml," which are considered tobacco products under section 201(rr) of the FD&C Act, as amended to include products with nicotine from any source.

These e-liquid products are deemed "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that Bootstrap Runners LLC is manufacturing, selling, and/or distributing these products without the required premarket authorization orders under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required marketing authorization and failure to provide necessary information under section 905(j).

The letter states that the failure to provide a required report under section 905(j) is a prohibited act under section 301(p) of the FD&C Act, and any act