Caplet Supplement Adverse Event File Kept in this browser Demo
Home
Complaints
Products
Setup
Every complaint logged, the serious ones to FDA in 15 business days, a year of follow-ups, six years of records
Complaints
Each health complaint about a supplement: serious or not and why, the MedWatch report and its deadline, and new medical information for a year after.
 
Products
Each supplement and the U.S. address or phone on its label where a customer reports a reaction.
 
These Records
Six years of them, ready for an FDA inspector, and how to take them with you.
 
Complaints×

Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, the company named on the label reports a serious adverse event to FDA on MedWatch form 3500A, with a copy of the label, within 15 business days of hearing of it. Serious means death, a life-threatening event, a hospital stay, lasting or significant disability, a birth defect, or medical or surgical treatment to prevent one of these. New medical information received within a year of the report goes in within 15 business days too. Every complaint, serious or not, is kept six years and shown to FDA on request. There is no small-business exception. Caplet keeps no customer's name or health record: a reference, the product and what happened in plain words.

Products×

A supplement goes on sale only with a U.S. address or U.S. phone number on its label through which the company receives adverse event reports.

Setup×
These Records×
Confirm×