Import Alert
An import alert is an FDA instruction to field staff to detain specified imported goods without physical examination, shifting the burden onto the importer to prove the shipment complies.
Section 801 of the Act lets FDA refuse admission to an imported article that appears to violate it, and appearance is the whole standard: nothing has to be tested. An import alert operationalises this by instructing field staff to detain named products, firms or countries without physical examination. Once a firm is listed the burden inverts, and removal requires the importer to present evidence, typically independent laboratory analyses and a run of compliant entries.
Alerts are numbered by subject. Import Alert 66-41 covers drugs that appear to be unapproved new drugs and catches most peptides; others cover unregistered firms, refused inspections and manufacturing failures. Each carries a red list of entries subject to detention and sometimes a green list of exempted firms. FDA's separate personal importation guidance is enforcement discretion, not an entitlement, and does not extend to listed products. These lists are edited continuously, so any specific entry should be confirmed against FDA's import alert database.
The signal is asymmetric. A listing means the agency has decided a firm or product is presumptively violative, which is meaningful. Absence of a listing means very little, since coverage depends on what has crossed a port and been noticed. It also explains logistics that otherwise look strange, such as repackaging and transhipment through third countries.
The common misreading is that detention implies goods were tested and found contaminated. Detention without physical examination means precisely that nobody looked. The other frequent error treats establishment registration as protection: registration is a filing obligation conferring no approval, and a registered firm can sit on a red list, which is what marketing copy offering an FDA-registered facility trades on.