FDA WARNING_LETTER - mikuvape.com - August 03, 2026
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On August 7, 2026, the FDA issued a warning letter to the online retailer mikuvape.com after an investigation revealed that the company sold electronic nicotine delivery system (ENDS) products to a person under the age of 21. Specifically, the agency documented the sale of a "MiKU Abu Pro 20000 Puffs Mung Bean" nicotine product to a minor via the company’s website. This action violates the Federal Food, Drug, and Cosmetic Act, which mandates a minimum age of 21 for all tobacco product purchases, including those containing nicotine from any source. Under this regulatory framework, selling tobacco products to underage individuals constitutes misbranding. The FDA also highlighted that new tobacco products must receive premarket authorization before being marketed in the United States. To resolve these issues, mikuvape.com is required to submit a written response within 15 working days. This response must outline the specific actions taken to stop current violations, the dates those actions were implemented, and a comprehensive plan to ensure future compliance across all digital and physical sales platforms. The agency warned that failure to correct these violations promptly could lead to further regulatory enforcement, such as civil monetary penalties, product seizures, or permanent injunctions against the business.
ID · ea44d3e5-272e-4544-a43f-1ae11c375c25
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