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WARNING LETTER
•vapecityusa.com•October 1, 2025

vapecityusa.com – FDA Warning Letter, Oct 1, 2025

Record Details

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to vapecityusa.com on October 9, 2025, following a review of their website. The letter identifies that the company is offering electronic nicotine delivery system (ENDS) products, specifically "Humo Case 30000 Phone Case Vape" models, for sale to customers in the United States without the required premarket authorization. Under the Federal Food, Drug, and Cosmetic (FD&C) Act, these products are considered "new tobacco products" and must receive FDA authorization before being marketed. The FDA determined these products are unlawfully marketed because they lack the necessary clearance and were not commercially available before February 15, 2007, or subsequently approved. Furthermore, the FDA expressed significant concern regarding the product design, which mimics cell phone cases. This design feature is believed to entice youth and conceal the products" identity as tobacco products from adults, contributing to public health and safety concerns related to youth ENDS use. Vapecityusa.com is required to immediately cease the sale and distribution of all unauthorized tobacco products and ensure that all its products, labeling, and advertising comply with the FD&C Act and FDA"s implementing regulations. Failure to promptly correct these violations may result in further regulatory actions, including civil money penalties, product seizure, or legal injunctions.

Company
vapecityusa.com
Inspection date
October 1, 2025
Product type
Tobacco
Office
Office of Compliance and Enforcement
People
  • John E. Verbeten (Director)
  • Javier A. Del Pino
  • Arlen Lagueruela
View Company Profile

ID · ae65dd4c-47ed-4021-9f06-1798ab3f32fe

Violation Codes10
FD&C Act 201(rr)21 U.S.C. 321(rr)FD&C Act 901(b)21 U.S.C. 387a(b)21 CFR 1100.1FD&C Act 910(a21 U.S.C. 387j(a)FD&C Act 910(c}(1)(A)(i)21 U.S.C. 387j(c)(1)(A)(i)FD&C Act 905(j)

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