FDA WARNING_LETTER - Vape Crusaders Premium E-Liquid LLC - April 05, 2022

The FDA issued a Warning Letter to Elizabeth and Jason Weber, owners of vapecrusaderseliquid.com, on March 10, 2022, after reviewing their website and determining that their e-liquid products are manufactured and offered for sale in the U.S. These products are classified as tobacco products under the FD&C Act.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order. Specifically, the e-liquid products "Pebbled" and "Onoki" were found to be new tobacco products, as they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Although the firm is a registered manufacturer with over 6,900 products listed, their Premarket Tobacco Product Application (PMTA) (STN PM0002951) for 237 products received a Marketing Denial Order on September 8, 2021. 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/or injunction.

The company is required to submit a written response within