FDA WARNING_LETTER - Global Source Distribution, LLC - November 06, 2024

On November 4, 2024, the FDA's Center for Tobacco Products issued a Warning Letter to Global Source Distribution, LLC, following a review of inspection records. The letter states that Global Source Distribution, LLC sells and/or distributes Electronic Nicotine Delivery System (ENDS) products, which are classified as tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is the marketing of a "new tobacco product" without the required premarket authorization order. Specifically, the product "Geek Bar Pulse Disposable 5% Berry Bliss" was found to be a new tobacco product, as it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. 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 Global Source Distribution, LLC to submit a written response within 15 working days from receipt of the letter. The response must detail actions taken to address the violations, including dates of discontinued sale/distribution of the non-compliant products, and a plan for maintaining future compliance with the FD&C Act. Failure to comply may result in regulatory actions such as civil money penalties