Reedhill Ventures LLC – FDA Warning Letter, Jan 10, 2025

The FDA issued a Warning Letter to Reedhill Ventures LLC, d/b/a Vape On, following a review of inspection records, determining the company manufactures, sells, and/or distributes e-liquid products in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act, subject to FDA jurisdiction and compliance requirements. The letter highlights that the definition of "tobacco product" was expanded on March 15, 2022, to include products with nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without required premarket authorization. Specifically, the product "River-Reserve X34 Strawberry Coconut 3MG/ML 60ML" was cited as a new tobacco product not commercially marketed before February 15, 2007, and lacking an FDA marketing authorization order. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice or information under section 905(j).

The FDA requires the company to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuation dates for violative sales and distribution, and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure,