FDA WARNING_LETTER - vapordna.com - May 27, 2025

On May 16, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to VaporDNA (vapordna.com) after reviewing their website and determining they offer electronic nicotine delivery system (ENDS) products for sale in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act, as amended on March 15, 2022, to include nicotine from any source.

The FDA identified two specific ENDS products lacking required premarket authorization: "Flum Pebble 6000 Puffs Rechargeable Disposable Vape – Mighty Grapefruit" and "Geek Bar Pulse 15000 Puffs Dual Mesh Disposable Vape – StoneMintz." These are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions.

Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required premarket authorization and failure to provide necessary information under section 905(j).

VaporDNA is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing sales and distribution of the viol