FAQ: How do I report adverse events and safety concerns to the FDA about hemp derived products?

How do I report adverse events and safety concerns to the FDA about hemp derived products?

There are four different ways to report safety concerns to the FDA about unregulated hemp products. 

1) Online: www.fda.gov/medwatch

2) Download your form below and Mail it in.

3) Fax: 1–800–332–0178

4)Call FDA: 1-800-FDA-1088. Monday - Friday 8AM – 4:30 PM EST

Remember there are different forms for HCPs vs consumers.

• • -  Health professional: Form 3500
  • - Consumer: Form 3500B
  • Both can be found here: FDA 3500 and 3500B form link

The FDA needs 4 primary pieces of information when filling out the paperwork: Patient, product, event, reporter.