FDA WARNING_LETTER - Sabor Vapors LLC - October 07, 2021

The FDA issued a Warning Letter to Sabor Vapors LLC for manufacturing and distributing unapproved new tobacco products. The Center for Tobacco Products determined that Sabor Vapors' e-liquid products, specifically SABOR VAPORS BUBBLE GUM 60ML 6MG, SABOR VAPORS POMBERRY 60ML 6MG, and SABOR VAPORS ROAR 60ML 6MG, are "new tobacco products" as they were not commercially marketed in the U.S. before February 15, 2007.

These products lack the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, making them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) due to the absence of required premarket notification. The firm is a registered manufacturer with over 27,400 listed products. While Premarket Tobacco Product Applications (PMTAs) were submitted for some products, including STN PM0003536 (covering 8,219 products), a Marketing Denial Order was issued for it on September 1, 2021.

The FDA considers products without pending applications or those with Marketing Denial Orders as high enforcement priorities. Sabor Vapors LLC must submit a written response within