Simply Vapour LLC – FDA Warning Letter, Nov 16, 2021
The FDA Center for Tobacco Products issued a Warning Letter to Simply Vapour LLC on November 5, 2021, after reviewing their website, https://www.simplyvapour.com. The FDA determined that Simply Vapour manufactures and sells e-liquid products, including "Original Blend Orange Cream" and "Platinum Series Boston Cream Pie," which are considered tobacco products under section 201(rr) of the FD&C Act.
These e-liquid products are deemed "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that these products are being marketed without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, nor are they exempt from this requirement. Consequently, these products are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.
Simply Vapour is a registered manufacturer with over 440 products listed with the FDA. Their Premarket Tobacco Product Application (PMTA) STN PM0003803, submitted on September 9, 2020, received a Marketing Denial Order on September 10, 2021, covering 442 products.
The FDA emphasizes that all new tobacco
ID · 9a28ced3-e9a4-4845-9696-edde8032f5a0
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.