FDA WARNING_LETTER - Vapor Boss - September 07, 2021

The FDA issued a Warning Letter to Robert Garcia of Vapor Boss on September 1, 2021, following a review of their website, vaporboss.com. The FDA determined that Vapor Boss manufactures and sells Electronic Nicotine Delivery System (ENDS) products, specifically "Boss Bar I Love Licorice" and "Boss Bar Mango," which are considered "new tobacco products" under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

These products are deemed "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that Vapor Boss is marketing these ENDS products without the required premarket authorization order, as mandated by section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are considered adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Although Vapor Boss is a registered manufacturer with over 200 products listed with the FDA and submitted a Premarket Tobacco Product Application (PMTA) (STN PM0001802) for 20 products, this application received a "refuse to accept" determination on January 8, 2021.

Vapor Boss is required to submit a written response within 15 working days