Chuckin’ Clouds Vape Shop Inc. – FDA Warning Letter, Feb 26, 2021

On February 26, 2021, the FDA issued a Warning Letter to Ronald and Trishcia Braden regarding e-liquid products sold on chuckinclouds.com. The FDA determined that products like "Oasis Chuckin’ Clouds Vape Shop & Custom E-Juice 120ml" and "Boardwalk Chuckin’ Clouds Vape Shop & Custom E-Juice 120ml" are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

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 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, as no notice or information was provided as required by section 905(j).

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 2,800 listed products, to ensure compliance with the FD&C Act and FDA regulations. Failure to address these violations may result in regulatory actions,