FDA WARNING_LETTER - naturevapeshop.com - October 01, 2025
Discuss this record with AI
The FDA issued a Warning Letter to naturevapeshop.com on October 9, 2025, following a review of its website. The agency determined that the company is unlawfully offering "new tobacco products," specifically Electronic Nicotine Delivery Systems (ENDS), without the required premarket authorization. Products cited include "Humo iPhone 15 Case 30000 Puffs Disposable Vape – Mi Amor" and "Humo iPhone 15 Case 30000 Puffs Disposable Vape – Love 66." Under the Federal Food, Drug, and Cosmetic Act, these items are considered adulterated and misbranded because they were not commercially marketed before February 15, 2007, and lack necessary FDA marketing authorization orders. The FDA also highlighted concerns about the products" design, which mimics an iPhone case, potentially enticing youth and facilitating concealment from adults, thus contributing to public health risks. Naturevapeshop.com is required to take prompt action to resolve these violations and ensure all tobacco products comply with the FD&C Act and FDA regulations. A detailed written response outlining corrective measures must be submitted within 15 working days, with potential enforcement actions like civil penalties or product seizure for continued non-compliance.
ID · e9fd815a-60d5-4980-913c-43d077cb12bd
Full citation text and observation details available on the Dashboard.