FDA WARNING_LETTER - electronicpuffs.com - October 01, 2025

The FDA issued a Warning Letter to electronicpuffs.com on October 17, 2025, after reviewing its website and identifying significant violations related to the sale of unauthorized tobacco products. The primary concern is the marketing and distribution of electronic nicotine delivery system (ENDS) products, specifically "StarMax Disposables 30K Puffs 5% - Box of 5 – Naked Clear" and "StarMax Disposables 30K Puffs 5% - Box of 5 – Fresh Tobacco." These products are classified as "new tobacco products" under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the mandatory premarket authorization from the FDA. Under the FD&C Act, as amended to include nicotine from any source, these unauthorized products are deemed adulterated and misbranded. electronicpuffs.com is required to submit a written response within 15 working days from receipt of the letter. This response must detail actions taken to discontinue the sale and distribution of the violative products, outline a plan for maintaining future compliance, and provide reasoning if the company disputes the violations. Failure to comply could lead to further regulatory actions, including civil money penalties or product seizure.