FDA WARNING_LETTER - Bootstrap Runners LLC d/b/a Sinister Liquids - October 12, 2021

The FDA issued a Warning Letter to Bootstrap Runners LLC, d/b/a Sinister Liquids, on October 12, 2021, following a review of submissions and inspection records. The FDA determined that the company manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act and subject to FDA regulation.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the products "Sinister Green Apple - 24mg 30ml," "Sinister The Duke - 24mg 30ml," "Sinister Fresh Strawberries - 6mg 60ml," "Misty Mountain Vapors MMV New Blackberry - 6mg 30ml," and "Misty Mountain Vapors MMV Strawberry Watermelon - 24mg 30ml" were found to be new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization orders.

These products are cited as adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) for failure to provide required information under section 905(j). The failure to provide such reports is also a prohibited act under section 301(p).

The FDA requires a written response within 15 working