U.S. FDA Adverse Event Contact Requirement for Dietary Supplement Labels
U.S. FDA requires dietary supplement labels to bear a United States address or phone number to receive consumer reports of A serious adverse event is a health related event associated with the use of a Dietary Supplement that results in or requires medical intervention to prevent death or other serious injury.serious adverse events. Marketing a supplement in the U.S. without this contact information is a prohibited act that may result in civil penalties or other FDA enforcement action.
Registrar Corp can serve as your U.S. Contact for the timely forwarding of consumer reports to your business as required by FDA. For more information, simply complete the form below.