FDA WARNING_LETTER - nastyworldwide.com - November 03, 2025

The U.S. Food and Drug Administration (FDA) Center for Tobacco Products issued a Warning Letter to nastyworldwide.com on November 07, 2025. This action followed a review of their website, which revealed the illegal sale and distribution of Electronic Nicotine Delivery System (ENDS) products, specifically DRG:ON 25K – Phantom and NASTY BAR D16Ki – Pineapple Ice, to customers in the United States.

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), these ENDS products are classified as "new tobacco products" because they were not commercially marketed in the U.S. before February 15, 2007. To be legally marketed, such products require a premarket authorization order from the FDA. Nastyworldwide.com"s products lack this mandatory authorization, rendering them "adulterated" and "misbranded" according to sections 902(6)(A) and 903(a)(6) of the FD&C Act, respectively.

The FDA requires nastyworldwide.com to promptly address these violations and ensure all its tobacco products comply with the FD&C Act. The company must submit a written response within 15 working days from receipt of the letter, detailing the actions taken to cease the illegal sale and distribution of these products and outlining its plan for ongoing compliance. Failure to comply may lead to further regulatory enforcement, including civil penalties or injunctions.