Stellalife, Inc. Warning Letter Details

Summary

Stellalife, Inc. was warned that its StellaLife VEGA Oral Care homeopathic drug products—including oral care kits, gels, and rinses—were unapproved new drugs introduced into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act. The FDA identified particular public health concerns because these products were marketed to vulnerable populations including children and patients at high risk for infection, such as those with open oral wounds or post-surgical status, and some products had previously been recalled due to microbial contamination that could cause bacteremia and sepsis if introduced to disrupted oral mucosa. The violations were identified through FDA review of the company's website and social media accounts in July 2025.