Unapproved New Drugs Promoted In The U.S.

Why FDA issued it

NOTE: The revision of this Import Alert, dated 05/19/2026, updates the guidance section, including Agency contacts. Changes to the import alert are bracketed by asterisks (***). Unapproved new drugs present public health and safety risks because they have not been reviewed by FDA for safety or effectiveness. Without FDA review, there is no way to know if these drugs are safe and effective for their intended use, whether they are manufactured in a way that ensures consistent drug quality, or whether their labels are complete and accurate. Unapproved new drugs have resulted in patient harm, and the agency works to protect patients from the risks posed by these drugs. In part, the Federal Food, Drug, and Cosmetic Act (FD&C Act) defines "drug" as (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (ot

Quoted from the “Reason for Alert” section of the FDA page for 66-41, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.