The U.S. Food and Drug Administration (FDA) has issued warning letters to three companies for serious regulatory violations. Two manufacturers, PMS4PMS and Naturista Store, were cited for marketing drug products without proper FDA authorization, while compounding drug manufacturer Nubratori was flagged for failing to maintain sterility standards at its facility.

PMS4PMS, based in New York, marketed an over-the-counter menstrual cramp relief cream, Comforté, with claims that went beyond what’s permitted without FDA approval. Additionally, the company failed to meet critical good manufacturing practices (cGMP), including product testing, stability programs, and quality control oversight. Although PMS4PMS has ceased manufacturing the product, FDA emphasized that remaining inventory could still pose risks.

Naturista Store, an online retailer, was cited for selling Advance King, an herbal product marketed for pain and bone health, which was found to contain undeclared pharmaceutical ingredients like diclofenac and methocarbamol. These substances can cause serious health risks, including cardiovascular events, gastrointestinal damage, and impaired physical and mental abilities. The FDA expressed concern about other products sold by the company as well.

Meanwhile, California-based Nubratori faced warnings for sterility failures at its outsourcing facility. Investigators found products prepared in insanitary conditions, raising concerns about potential contamination. Although Nubratori addressed some of the FDA’s issues, others remain unresolved.

All three companies were given 15 business days to respond to the FDA’s warning letters and must take corrective actions to comply with federal regulations.