FDA WARNING_LETTER - Vape Element LLC, d/b/a BLVK

The FDA issued a Warning Letter to Vape Element LLC, operating as BLVK, on September 25, 2025, following an inspection by the Center for Tobacco Products. The inspection revealed that the company sells and distributes e-liquid products in the U.S. without the necessary marketing authorization, specifically citing the BLVK ORIGINAL CREAMY STRAWBERRY 3MG 60ML product. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), these products are classified as tobacco products because they contain nicotine, regardless of its source. The FD&C Act mandates that new tobacco products, which were not marketed before February 15, 2007, must have a premarket authorization order to be legally sold in the U.S.

The FDA determined that the aforementioned product is adulterated and misbranded due to the absence of a marketing authorization order and failure to provide required notifications. The letter emphasizes that all tobacco products must comply with the FD&C Act and related regulations. Non-compliance may lead to enforcement actions, including penalties, seizure, or injunction.

Vape Element LLC is required to respond within 15 working days, detailing actions taken to rectify the violations and ensure compliance. The company must cease the sale and distribution of the violative products and submit a plan for maintaining compliance. The FDA provides contact information for further inquiries and emphasizes the importance of addressing these issues promptly.