FDA WARNING_LETTER - Stellalife, Inc. - July 31, 2025

The FDA issued a Warning Letter to Stellalife, Inc. on September 16, 2025, after reviewing their website and social media in July 2025. The Agency found that Stellalife is marketing several homeopathic drug products, including the "StellaLife VEGA Oral Care Recovery Kit," gels, and rinses, as unapproved new drugs. These products are promoted with therapeutic claims such as accelerating healing after dental surgeries, relieving pain and swelling, managing mucositis, and reducing bacteria that cause periodontal disease. The FDA determined these claims establish the products as drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), rendering their introduction into interstate commerce a violation of sections 505(a) and 301(d) of the FD&C Act. A significant public health concern highlighted is the marketing of these products for vulnerable populations, including children and patients with open oral wounds or post-oral surgery. This concern is heightened by previous recalls of some StellaLife products due to microbial contamination, which could lead to severe infections like bacteremia and sepsis. Stellalife, Inc. is required to cease marketing these products as unapproved new drugs and ensure all offerings comply with FDA regulations.