Nico Choice LLC – FDA Warning Letter, Feb 1, 2024

On January 31, 2024, the FDA's Center for Tobacco Products issued a Warning Letter to Nicochoice.com after reviewing their website and determining they offer Electronic Nicotine Delivery System (ENDS) products for sale in the U.S. These products, including "ELF Bar Disposable Passionfruit Orange Guava BC5000" and "Lava Plus Disposable Dragon Flume 2000 Puffs," are considered tobacco products under the FD&C Act, as amended to include nicotine from any source.

The FDA found these ENDS products to be "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, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Nicochoice.com 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, seizure, or injunction. The letter also notes that tobacco products offered for import that appear adulterated or misbranded may be detained or refused