Vapor Springs LLC – FDA Warning Letter, Mar 12, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Matthew Guidry regarding e-liquid products sold on vapor-springs.com. The FDA determined that products like "Vapor Springs Black Honey" and "Vapor Springs Cigafull" are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA regulation.

These e-liquid products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that these products are being sold without the required premarket marketing 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 due to the lack of required notice or information under section 905(j).

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 11,000 listed products, to ensure compliance with the FD&C Act and FDA regulations. Failure to correct these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The firm must submit a written response within 15 working days detailing actions taken to address the violations, including discontinuation of