Turning Point Brands, Inc. d/b/a VaporFi – FDA Warning Letter, Aug 27, 2024

The FDA's Center for Tobacco Products reviewed the website vaporfi.com and determined that e-liquid products, specifically Smoozie NTN Perfectly Peachy Ice- and MRKT PLCE Salts Thai Apple Melon Razz, are offered for sale in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act, especially following the 2022 amendment extending jurisdiction to nicotine from any source. The FDA found that these are "new tobacco products" that lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) because the necessary notice or information under section 905(j) was not provided. The firm is required to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing the violative sale and distribution, and outlining a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, product seizure, injunction, and detention of imported products.