Under MoCRA a brand reports a serious adverse event to FDA within 15 business days of hearing of it - death, a life-threatening event, hospitalisation, lasting disability, a birth defect, significant disfigurement (a serious or persistent rash, a second- or third-degree burn, significant hair loss), or medical intervention to prevent one. New medical information within a year goes in within 15 business days too. Records are kept six years, three for a small business. Small brands are excused registration and listing - not this. Salve keeps no customer's name or health record: a reference, the product and what happened in plain words.
A product goes on sale only with safety substantiation on file - tests, studies or analyses a qualified expert would accept - and a U.S. address, phone or web contact on its label for adverse event reports.