FDA WARNING_LETTER - ockstore.com - August 12, 2025

The U.S. Food and Drug Administration (FDA) issued a warning letter to the company operating the website https://ockstore.com, located at 5318 Brown Street, Milford, DE, for selling electronic nicotine delivery system (ENDS) products without proper authorization. The inspection, conducted by the FDA"s Center for Tobacco Products, identified that products such as Elf Bar TE6000 – Lemon Drop and Elf Bar TE6000 – Apple Peach were being marketed in the U.S. without the required premarket authorization. These products are classified as tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act) due to their nicotine content, which is now regulated regardless of its source following amendments in March 2022.

The FDA"s regulatory framework mandates that new tobacco products, defined as those not commercially marketed in the U.S. as of February 15, 2007, must obtain a marketing authorization order. The identified products lacked such authorization, rendering them adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act, respectively.

The FDA requires the company to take immediate corrective actions, including ceasing the sale and distribution of these unauthorized products and ensuring compliance with all applicable regulations. A written response detailing these actions must be submitted within 15 working days of receiving the letter. Failure to comply may result in enforcement actions such as civil penalties or product seizure. The company is advised to consult the FDA"s searchable tobacco products database for authorized products and ensure all marketing practices align with regulatory requirements.