FDA WARNING_LETTER - Shoplet - November 04, 2025

The FDA issued a Warning Letter to Shoplet on November 13, 2025, following a review of their website. The agency found that Shoplet was offering unapproved and misbranded drug products, specifically "Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan." These products are considered drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) due to their intended antimicrobial use, such as "Kills bacteria on contact." The primary violations stem from the fact that triclosan-containing antiseptic products are not generally recognized as safe and effective by the FDA. Consequently, these products are deemed "unapproved new drugs," violating sections 505(a) and 301(d) of the FD&C Act. Furthermore, they are "misbranded" under sections 502(ee) and 301(a) of the FD&C Act because they do not comply with the regulatory requirements for marketing nonprescription drugs without an approved application. Shoplet is required to respond to the FDA within 15 working days, detailing specific corrective actions taken to address these violations, including steps to prevent their recurrence, and providing supporting documentation. Failure to adequately address these issues may lead to legal actions such as seizure or injunction.