FDA WARNING_LETTER - MJS Medicals

The FDA issued a Warning Letter to MJS Medicals on November 3, 2025, after reviewing their website, www.mjsmedicals.com. The letter identifies significant violations related to the introduction of unapproved new drugs and misbranded drugs into U.S. interstate commerce. Specifically, MJS Medicals is offering injectable botulinum toxin drug products, such as "Innotox 100ui" and "Innotox 100u." These products are considered unapproved new drugs under sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they lack the necessary FDA approval to ensure safety and effectiveness. Furthermore, the products are deemed misbranded under sections 301(a) and 502(f)(1) of the FD&C Act. As prescription drugs intended for conditions not amenable to self-diagnosis, their labeling fails to provide adequate directions for use by a layperson. The FDA emphasizes the inherent risks associated with unapproved and misbranded injectable drugs, including potential contamination and serious health complications. MJS Medicals is required to immediately cease selling these unapproved and misbranded drugs to U.S. consumers and to notify the FDA within 15 working days, detailing the specific steps taken to correct all identified violations and prevent their recurrence, along with supporting documentation. Failure to comply may lead to further legal action.