FDA WARNING_LETTER - Biz Pump LLC d/b/a Puffin Enterprises - June 13, 2024

The FDA issued a Warning Letter to Zackary J Muller regarding the sale and distribution of unauthorized electronic nicotine delivery system (ENDS) and e-liquid products on the website https://www.puffinvapeshop.com. The FDA determined that products like "Cereal Trip by Bad Drip Series 60mL," "Don’t Care Bear by Bad Drip Series 60mL," and "Funky Republic Fi3000 Disposable 3000 Puff 5mL 40-50mg - Apple Watermelon" are "new tobacco products" as they were not commercially marketed in the U.S. before February 15, 2007, and lack required premarket authorization orders under section 910(c)(1)(A)(i) of the FD&C Act.

These products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required marketing authorization and failure to provide necessary information under section 905(j). The FDA also expressed concern that the design of some Bad Drip Labs e-liquid products, imitating prescription pill bottles, is likely to appeal to youth and could lead to accidental ingestion, contributing to public health concerns.

The letter mandates a written response within 15 working days detailing actions taken to address violations, including discontinuing sales