FDA WARNING_LETTER - gethyppe.com - May 01, 2026

The U.S. Food and Drug Administration (FDA) issued a Warning Letter dated May 19, 2026, to gethyppe.com for the unauthorized sale and distribution of dissolvable tobacco products. Following a website review, the FDA identified several products, including Hyppe Nicotine Lozenges in various flavors, as being marketed without the necessary legal approvals. Under the Federal Food, Drug, and Cosmetic Act, these items are classified as "new tobacco products" because they were not commercially available before February 15, 2007. As the company lacks the required premarket authorization orders, these products are considered both adulterated and misbranded. The FDA highlighted significant safety concerns regarding the product design and labeling, which imitate candy and cough drops. Such features make the products particularly attractive to youth and increase the risk of accidental nicotine poisoning in small children. The agency also noted that the discreet packaging could allow minors to conceal tobacco use from parents and teachers. The company is required to submit a written response within 15 working days detailing the specific actions taken to address these violations and their plan for maintaining future compliance. Failure to discontinue the sale of these unauthorized products may result in regulatory enforcement, including civil money penalties, product seizures, or legal injunctions.