FDA WARNING_LETTER - Lynda’s Legacy LLC d/b/a Chaney’s Tobacco Station - May 03, 2022

The FDA issued a Warning Letter to Lynda’s Legacy LLC d/b/a Chaney’s Tobacco Station on May 3, 2022, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act.

The primary violation identified is the marketing of "Chaney’s Vape Station Marbo 1.8% Nicotine 120 ml e-liquid product" without the required premarket authorization. This product is considered a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption.

Consequently, this product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide a required report under section 905(j) is also a prohibited act under section 301(p).

The FDA noted that the firm is a registered manufacturer with over 3,100 listed products. The letter emphasizes that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction.

The company must submit a written response within 15 working days detailing actions taken to address violations, including