FDA WARNING_LETTER - Vape Corp LLC d/b/a Blue Diamond Vapors - June 22, 2023

The FDA issued a Warning Letter to Jamie Homampour of Blue Diamond Vapors on June 16, 2023, following a review of their website, bluediamondvapors.com. The FDA determined that the company offers for sale or distribution in the U.S. electronic nicotine delivery system (ENDS) products, specifically "ELF BAR" ENDS products like Elf Bar BC5000 Disposable Vape – Gumi and Elf Bar BC5000 Disposable Vape – Honeydew Pineapple Orange.

These products are considered "new tobacco products" under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that these products lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, nor are they exempt. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The Warning Letter requires Blue Diamond Vapors to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the non-compliant products and a plan for maintaining compliance. Failure to comply may result in regulatory or legal actions such as