FDA WARNING_LETTER - Trippyvapors LLC - June 25, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to Trippy Vapors (https://trippyvapors.com) on June 14, 2024, for offering unapproved electronic nicotine delivery system (ENDS) products for sale in the United States. The FDA reviewed the website and determined that products listed, specifically FUME Ultra 2500 Puff Disposable Vape – Hawaii Juice and HQD Cuvie Mars 8000 Puff Disposable Vape – Purple Rain, are tobacco products under section 201(rr) of the FD&C Act, as amended to include nicotine from any source.

These products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Trippy Vapors is required to submit a written response within 15 working days, detailing actions taken to address the violations, including discontinuing the sale and distribution of the violative products, and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure,