FDA WARNING_LETTER - Great American Vapes Bossier City - October 07, 2021

The FDA issued a Warning Letter to Great American Ventures LLC d/b/a Great American Vapes for manufacturing and distributing e-liquid products without required marketing authorization. The FDA determined that products like "Great American VAPES Ambrosia 6mg 120ml," "Great American VAPES Apple Pie 6mg 120ml," and "Great American VAPES Cucumber 6mg 120ml" are "new tobacco products" as they were not commercially marketed before February 15, 2007.

These products are deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) because they lack FDA marketing authorization orders or substantial equivalence exemptions. The failure to provide required reports under section 905(j) is also a prohibited act.

The firm's Premarket Tobacco Product Application (PMTA), STN PM0003726, submitted September 9, 2020, received a Marketing Denial Order on August 26, 2021, covering 8,607 products. The FDA considers products with Marketing Denial Orders or no applications as high enforcement priorities.

Great American Ventures LLC must submit a written response within 15 working days detailing actions taken to address violations, including discontinuation dates for violative sales/distribution, and a plan for