FDA WARNING_LETTER - Alien Vape LLC - July 09, 2024

The FDA issued a Warning Letter to Mike Sarieddine and Carol Sarieddine of Alien Vape on June 28, 2024, following a review of their website, https://alienvape.com. The FDA determined that e-liquid products listed on the website are manufactured and offered for sale or distribution in the United States. These products, including "Alien Vape – Area 51 – 60ML," "Alien Vape – Catalina – 60ML," and "Alien Vape – Roswell – 60ML," are classified as tobacco products under section 201(rr) of the FD&C Act, as amended to include products containing nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. These products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization. Consequently, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because the required notice or information under section 905(j) was not provided.

The FDA requires Alien Vape to submit a written response within 15 working days detailing actions taken to address the violations, including dates of