New Reporting Category Strengthens National Adverse-Event Monitoring for CBD and Other Hemp-Derived Products
FOR IMMEDIATE RELEASE
November 5, 2025
Colorado Springs, CO – The U.S. Food & Drug Administration (FDA) recently expanded its MedWatch adverse-event reporting system to formally include “Cannabinoid hemp products (e.g., CBD)” as a selectable product type. The update, applied to both Form 3500 (for healthcare professionals) and Form 3500B (for consumers), marks the first time hemp-derived products have been explicitly recognized within the nation’s public-health reporting framework.
The S3 Collective, a national nonprofit advancing cannabis and botanical standardization through collaboration and education, welcomed the update as a significant step toward improving consumer safety, data transparency, and evidence-based regulation.
The change allows consumers and healthcare providers to directly report adverse reactions or product quality issues associated with hemp-derived cannabinoid products. Over time, this data will inform federal and state regulators, researchers, and manufacturers, supporting a stronger, evidence-based foundation for public-health policy and labeling practices.
“This update by FDA fills a critical gap in our national monitoring framework,” said David Vaillencourt, Board Chair of the S3 Collective. “Having a formal mechanism to capture adverse-event data on hemp and cannabinoid products brings us one step closer to the scientific accountability that consumers deserve.”
How to Report a Cannabinoid Product Issue
- Visit the FDA MedWatch website: https://www.fda.gov/medwatch
- Select “Report a Problem” and complete Form 3500B (Consumer/Patient form).
- Under Product Type, select ’Cannabinoid hemp products (such as products containing CBD).”
- Include product name, brand, lot number, event description, timing, and any other products used.
- Submit electronically or print and mail as directed.
By reporting product issues directly to the FDA, consumers help strengthen the scientific foundation for safe and effective cannabis products and contribute to public-health surveillance.
Through its role in the FDA’s Network of Experts, S3 Collective continues to bridge science, safety, and standards, advancing regulatory understanding and promoting public health through collaboration and transparency.
About S3 Collective
The S3 Collective is a 501(c)(3) nonprofit organization committed to advancing the cannabis, hemp, and botanical industries through collaboration, education, and standardization. By assisting in the development of robust standards, fostering strategic partnerships, and providing scientifically validated resources, S3 Collective empowers stakeholders to make informed decisions that promote public health and safety.
Media Contact
S3 Collective – Marketing