Unapproved finished new animal drugs

Why FDA issued it

Note: The revision of this Import Alert (IA) dated 08/31/2022 updates the guidance section and agency contacts. Changes to the import alert are bracketed by asterisks (***). Unapproved new animal drugs may present serious safety and effectiveness concerns. When evidence exists that finished new animal drugs offered for import into the United States for commercial distribution are unapproved, such products would appear to be adulterated. Accordingly, the products should be considered for detention without physical examination. Evidence of marketing or promotion may consist of information contained in: unapproved product being offered for import and distribution; solicitations for mail orders; press releases; internet websites; advertising materials; labeling indications of US patents or patent applications; or other public announcements directed to persons residing in the U.S. New animal

Quoted from the “Reason for Alert” section of the FDA page for 68-19, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.