FDA WARNING_LETTER - The Chubby Baker LLC - February 26, 2021

On February 26, 2021, the FDA issued a Warning Letter to Brandon Farnsworth, operating as Chubby Baker Juice, following a review of their website, chubbybakerjuice.com. The FDA determined that e-liquid products offered for sale, specifically "The Chubby Baker - Strawnana" and "The Chubby Baker - Bakers Islands," are tobacco products under section 201(rr) of the FD&C Act.

These 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 e-liquids lack the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise 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 absence of required information under section 905(j).

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 1,800 listed products, to ensure compliance with the FD&C Act and FDA regulations. Failure to correct these violations may result in regulatory actions such as civil money penalties, seizure, or injunction. The firm must submit a written response within 15