FDA WARNING_LETTER - NSE Products, Inc. - March 01, 2026

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to NSE Products, Inc. DBA Nu Skin Enterprises, Inc. on March 2, 2026, citing significant drug listing violations. This letter followed multiple prior communications to the firm regarding these deficiencies. Nu Skin failed to fulfill its drug listing obligations under section 510(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR Part 207. A key violation involved drug listings for products such as "AP-24 Fluoride," "AP-24," and "AP-24 Whitening." These listings inaccurately referenced a manufacturing establishment that had not produced these drugs for over five years, without including an appropriate end marketing date. Additionally, the FDA identified that 61 of the company"s other drug listings had not been updated or certified as required, leading to their inactivation by the agency. The FDA underscored that complete and accurate drug listing information is crucial for promoting patient safety, enabling effective drug establishment inspections, ensuring supply chain security, and supporting post-market surveillance efforts. Nu Skin is required to respond to the FDA in writing within 15 working days of receiving the letter. This response must detail the specific steps taken to correct the identified violations and outline measures implemented to prevent their recurrence. The company must also update all inactivated listings, providing end marketing dates if those products are no longer distributed. Failure to adequately address these issues may lead to further legal and regulatory actions.