Elemental Vapor Bar – FDA Warning Letter, Feb 12, 2021

On February 12, 2021, the FDA issued a Warning Letter to Elemental Vapor Bar LLC, identifying violations related to the manufacture and distribution of e-liquid products. The FDA determined that Elemental Vapor Bar LLC manufactures and distributes e-liquid products, which are deemed tobacco products under section 201(rr) of the FD&C Act.

The primary violations concern the marketing of "new tobacco products" without required premarket authorization. Specifically, the products "Elemental Vapor Bar Saturday Morning Seasonal Select 3mg 30ml" and "Elemental Vapor Bar Mooooo Seasonal Select 3mg 30ml" were found to be new tobacco products because they were not commercially marketed in the U.S. as of February 15, 2007, and lacked FDA marketing authorization orders or exemptions.

Consequently, these products are deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required notice or information under section 905(j). The sale or distribution of such products constitutes prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

Elemental Vapor Bar LLC, a registered manufacturer with over 132,200 listed products, is required to ensure compliance.