Adverse Event Contact for Dietary Supplements
U.S. FDA requires labels of most dietary supplements to include the contact information for an entity in the USA capable of receiving and documenting consumer reports of serious adverse events. Products that don’t meet this requirement are considered “misbranded” by FDA and subject to detention and refusal.
As your U.S. Contact, Registrar Corp will quickly forward consumer reports of serious adverse events to your business. For more information, simply complete the form below.
Serious Adverse Event Reporting Requirements for Dietary Supplements
The Dietary Supplement and Non-Prescription Drug Consumer Protection Act includes the following requirements for serious Adverse Event reporting for most Dietary Supplement products:
• Reports must include a copy of the label on or within the retail package
• The responsible person must submit the report no later than 15 business days after receiving the initial report
• Serious adverse event reports must be submitted via the MedWatch form. Reports can be submitted on paper or electronically (Form FDA 3500A or the FDA Safety Reporting Portal, respectively)
