The article describes a case in which a US federal prosecutor used the Food, Drug, and Cosmetic Act (FDA Act) to send a letter to the head of a medical facility warning that certain professional treatment recommendations may violate federal law. The authors explain that the FDA law is primarily aimed at regulating the manufacturers and marketing of drugs and medical devices, not at punishing the individual clinical decisions of physicians. The article states that the prosecutor's letter contained a threat of possible criminal sanctions in connection with the use of the drug outside the approved indication (off-label). The authors point out that the use of off-label drugs is a common and often necessary part of medical practice and is not in itself a violation of FDA law. At the same time, the text emphasizes that a similar way of applying the law can have a deterrent effect on doctors when providing individual care to patients. The article notes that the case has raised concerns in the professional community and explains the legal context why such an interpretation of FDA law is unusual in the context of medical practice.