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All dietary supplement labels must list a U.S. address or phone number to receive adverse event reports. We serve as your U.S. Agent — our domestic contact goes on your label, we receive consumer reports 24/7, log them, and notify you within one business day so you can fulfill FDA reporting obligations.
What’s included:
U.S. address and toll-free phone number for your label
24/7 receipt of consumer adverse event reports
Documented logging of every report
Notification to you within one business day
Annual renewal reminders for FDA reporting deadlines
Who it’s for:
Dietary supplement brands selling in the U.S. — especially foreign brands and Amazon sellers without a U.S. office.
FAQ:
Is this legally required? Yes. FDA regulations requires every dietary supplement label to display a U.S. address or domestic phone number for adverse event reports.
What’s a “serious adverse event”? Death, life-threatening condition, hospitalization, persistent disability, congenital anomaly, or any event requiring medical intervention.
Who reports to FDA — you or me? You. We log the reports and notify you within one business day. FDA reporting (Form 3500A) is your responsibility, but we provide everything you need to file.
This is an annual subscription. Your card will be charged $499 today and automatically renewed every 12 months at the same price unless you cancel. You can cancel anytime from your account at usimports.us/account. We'll email you a reminder 7 days before each renewal.
All dietary supplement labels must list a U.S. address or phone number to receive adverse event reports. We serve as your U.S. Agent — our domestic contact goes on your label, we receive consumer reports 24/7, log them, and notify you within one business day so you can fulfill FDA reporting obligations.
What’s included:
U.S. address and toll-free phone number for your label
24/7 receipt of consumer adverse event reports
Documented logging of every report
Notification to you within one business day
Annual renewal reminders for FDA reporting deadlines
Who it’s for:
Dietary supplement brands selling in the U.S. — especially foreign brands and Amazon sellers without a U.S. office.
FAQ:
Is this legally required? Yes. FDA regulations requires every dietary supplement label to display a U.S. address or domestic phone number for adverse event reports.
What’s a “serious adverse event”? Death, life-threatening condition, hospitalization, persistent disability, congenital anomaly, or any event requiring medical intervention.
Who reports to FDA — you or me? You. We log the reports and notify you within one business day. FDA reporting (Form 3500A) is your responsibility, but we provide everything you need to file.
This is an annual subscription. Your card will be charged $499 today and automatically renewed every 12 months at the same price unless you cancel. You can cancel anytime from your account at usimports.us/account. We'll email you a reminder 7 days before each renewal.