FDA WARNING_LETTER - Sir Vapes-A-Lot LLC - October 07, 2021

The FDA issued a Warning Letter to Sir Vapes-A-Lot LLC, identifying that the company manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act. The letter states that three specific e-liquid products—SIR VAPES-A-LOT TROPIC THUNDA 12 MG, SIR VAPES-A-LOT CRYSTAL BLUE 6 MG, and THE ESSENTIAL BLACK ICE 12 MG—are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007.

These products are being sold without the required FDA marketing authorization, making them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide a required report under section 905(j) is also a prohibited act.

The FDA noted that Sir Vapes-A-Lot LLC is a registered manufacturer with over 500 listed products. While Premarket Tobacco Product Applications (PMTAs) were submitted for some products, one (STN PM0003463, covering 214 products) received a Marketing Denial Order on September 2, 2021. The FDA emphasizes that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement actions,