FDA WARNING_LETTER - myscsz3, llc - September 02, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Samuel Chamino, operating through bluebirdstheword.com, for manufacturing and selling unapproved e-liquid tobacco products. The FDA's review of the website revealed that products like "Bluebird- Berry Cheesecake Crunch," "Redbird- Strawberry Cheesecake Frosted Cereal," and "Yellowbird- Lemon Cheesecake Corn Puffs" are being marketed without the required premarket authorization.

These e-liquid products are deemed "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order. Consequently, these products are considered adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Although a Premarket Tobacco Product Application (PMTA) (STN PM0003903) was submitted on September 22, 2020, it received a Refuse to File determination on June 15, 2022, covering 32 products. The FDA emphasizes that all new tobacco products on the market without statutory premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and injunction.

The letter requires a written response within 15 working days