FDA WARNING_LETTER - Vaporama - November 09, 2023

On November 8, 2023, the FDA's Center for Tobacco Products issued a Warning Letter to Vaporama.store after reviewing their website, vaporama.store. The FDA determined that the website offers electronic nicotine delivery system (ENDS) products for sale or distribution in the United States, which are classified as tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the FDA cited "ElfBar BC5000 Rechargeable Disposable 5000 Puffs – Strawberry Watermelon" and "ElfBar BC5000 Rechargeable Disposable 5000 Puffs – Peach Berry." These products are considered new tobacco products because they were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order or exemption.

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 notification. Vaporama.store is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties,