FDA WARNING_LETTER - Lynda's Legacy LLC - December 16, 2021

The FDA issued a Warning Letter to Lynda’s Legacy LLC on December 16, 2021, 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 and subject to FDA regulation.

The primary violation identified is the manufacturing, sale, and/or distribution of "Chaney’s Vape Station Redbull 6mg 30ml" e-liquid without the required premarket marketing 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, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as the required notice or information under section 905(j) was not provided.

These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The FDA noted that the firm is a registered manufacturer with over 3,100 listed products, and all new tobacco products without premarket authorization are unlawfully marketed.

Lynda’s Legacy LLC is required to submit a written response within 15 working days detailing actions taken to address the violations,