FDA WARNING_LETTER - vaporhatch.com - May 27, 2025

On May 16, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to Vapor Hatch, LLC, following a review of their website, vaporhatch.com. The FDA determined that the company was offering for sale or distribution in the United States electronic nicotine delivery system (ENDS) products, specifically "ElfBar BC5000 Disposable 5000 Puffs – Honeydew Pineapple Orange" and "ElfBar BC5000 Disposable 5000 Puffs – Strawberry Pear Orange Ice."

These products are classified as "tobacco products" under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they contain nicotine from any source and are intended for human consumption. The FDA asserts that these are "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007.

The primary violation cited is the marketing of these new tobacco products without 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, as no notice or information was provided as required by section 905(j