lucky's convenience & tobacco, llc – FDA Warning Letter, Apr 16, 2021

The FDA issued a Warning Letter to Lucky's Convenience & Tobacco LLC, d/b/a Lucky’s Vape, LLC, for manufacturing and distributing unapproved new tobacco products. The FDA determined that the company's e-liquid products, specifically "Lucky’s Vape Lux w/ GC 9MG" and "Lucky’s Vape Marilyn 5NIC," are "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007.

These products lack the required FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt. Consequently, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because the required notice or information under section 905(j) was not provided. The failure to provide such reports and the sale of adulterated/misbranded products are prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

The FDA requires Lucky's Vape, LLC to submit a written response within 15 working days detailing corrective actions, including dates of discontinued sales and distribution, and a plan for maintaining compliance. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure