FDA WARNING_LETTER - Nexus Smoke - October 30, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to Nexus Smoke on October 29, 2024, after reviewing their website, https://nexussmoke.com. The review determined that Electronic Nicotine Delivery System (ENDS) products were offered for sale or distribution in the U.S. without required premarket authorization.

Specifically, the "Craftbox V Touch 30000 Disposable Vape – Strawberry Delight" was identified as a "new tobacco product" that was not commercially marketed before February 15, 2007, and lacks an FDA marketing authorization order. This renders the product adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) for not providing required information under section 905(j).

The FDA expressed particular concern that the product's labeling and advertising imitate smartphones, with features like an "Interactive Touch Screen," "Social Media Integration," and "Call Functionality," which may appeal to youth and help conceal the product's nature as a tobacco product.

Nexus Smoke is required to submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and distribution of violative products, and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.