FDA WARNING_LETTER - prilla.com/us - March 17, 2026

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to prilla.com/us on March 6, 2026, following a review of their website. The FDA found that the company is illegally marketing new tobacco products, specifically nicotine pouch products like VITO Watermelon 6mg and VITO Mango Fusion 6mg, to consumers in the United States. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), all "new tobacco products"—defined as those not commercially available in the U.S. before February 15, 2007—require premarket authorization from the FDA to be legally sold. Prilla.com/us"s nicotine pouch products lack this mandatory marketing authorization. Consequently, these products are considered adulterated and misbranded under the FD&C Act because they were introduced to the market without the required regulatory approval or submission of necessary information. The FDA mandates that prilla.com/us immediately cease the unlawful sale and distribution of these unauthorized tobacco products. The company must submit a written response within 15 working days of receiving the letter. This response should detail the specific actions taken to rectify the violations, including the dates when the violative sales ceased, and outline a plan to ensure ongoing compliance with all applicable FDA regulations under the FD&C Act. Failure to comply may lead to further enforcement actions.