FDA Adds Hemp Cannabinoids to Adverse Event Reporting: What Compliance Teams Must Do Now

Focus keyword: FDA adverse event reporting hemp 2025

The U.S. Food and Drug Administration (FDA) is significantly enhancing its oversight of hemp-derived cannabinoids like CBD, CBG, and others by incorporating them into federal adverse health event reporting systems. In June 2025, the FDA submitted a proposed update for White House/OMB review to add hemp cannabinoids as selectable product categories in official health event tracking systems—an action with broad implications for cannabis compliance and business operations nationwide (see Marijuana Moment, June 26, 2025; FDA Docket FDA-2024-N-5468 at Regulations.gov). The public comment period closed on July 25, 2025, signaling that these changes could take effect imminently.

For compliance teams, regulatory affairs officers, and cannabis industry executives, preparedness is critical. This transition doesn’t change the legal status of CBD in foods or supplements but creates new regulatory risks and intensifies oversight, especially for brands already marketing hemp cannabinoid products. Here’s what you need to know and how your business should respond.

What Is Changing? FDA’s New Approach to Hemp Adverse Event Reporting

Background: From Market Exclusion to Data Inclusion

Since the 2018 Farm Bill, hemp and its derivatives—including CBD—have been federally legal but remain problematic under FDA rules for use in foods and dietary supplements. While the FDA has warned companies not to market hemp cannabinoids as conventional ingestibles, widespread consumer use continues. However, to date, adverse event reporting for hemp cannabinoids has been fragmented and difficult to track.

In June 2025, the FDA advanced a plan to update its adverse event reporting portals—including the Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System (CAERS) and the FDA Adverse Event Reporting System (FAERS)—by adding hemp-derived cannabinoids as explicit product categories. This was transmitted for review (Docket FDA-2024-N-5468) and is expected to go live after the required federal review process.

Key Takeaways:

• Hemp-derived cannabinoids will soon be selectable in U.S. adverse health event portals.
• The FDA expects this to sharpen “signal detection”—the rapid identification of safety concerns by product type, brand, or batch.
• Consumer and healthcare provider reports of adverse health events will be more easily categorized, tracked, and actioned.

Implications for Cannabis Businesses

This action does not legalize new uses of CBD or other cannabinoids, but it will sharply increase scrutiny—from FDA and possibly state partners—on reported product safety issues. Expect new visibility if adverse event clusters arise linked to a brand or category.

FDA Adverse Event Reporting for Hemp: What’s Required?

1. No New Mandatory Reports—Yet, but Duties May Expand

For most food and cosmetic companies, serious adverse event reporting is not yet mandatory for hemp cannabinoid products unless they are labeled as dietary supplements (which is still technically not allowed federally for CBD). However, the Dietary Supplement and Nonprescription Drug Consumer Protection Act requires dietary supplement manufacturers to report certain serious adverse events within 15 business days.

If and when FDA formally allows cannabinoids as dietary supplements or expands CAERS/FAERS mandates, companies could face new direct reporting requirements. In the interim, increased data transparency means:

• More consumer-reported events will be flagged directly to FDA for your products.
• FDA will likely reach out if clusters of complaints or safety signals emerge.

2. CAERS and FAERS: Two Overlapping Reporting Systems

• CAERS: Primarily for foods, dietary supplements, and cosmetics; receives both voluntary (consumer/provider) and required (manufacturer, for supplements only) reports.
• FAERS: For drugs and biologics; includes mandatory and voluntary reporting.
• New hemp-derived cannabinoid fields will likely harmonize with these taxonomies—track updates at FDA’s Adverse Event Reporting Resource Page.

Steps Cannabis Compliance Teams Must Take Now

1. Strengthen Complaint Intake and Recordkeeping SOPs

With the new reporting categories, even voluntary or minor complaints may result in FDA scrutiny or requests for follow-up information. Review and upgrade your adverse event and complaint intake SOPs immediately:

• Capture thorough product and lot data from every complaint.
• Document consumer or clinical details—even for non-serious complaints.
• Assign trained staff to monitor and respond to adverse events promptly and consistently.

2. Tighten Lot Traceability and Recall Readiness

If a cluster of adverse events surfaces for a particular product or batch, the FDA may request manufacturing and distribution records in detail. Best practices include:

• Implement or enhance electronic lot traceability, linking finished goods to raw material intake and distribution.
• Keep batch records easily accessible for rapid response.
• Conduct mock recall drills to ensure readiness if a recall is demanded.

3. Verify Labeling and Marketing Controls

With increased FDA scrutiny, companies must ensure that all product claims are accurate and compliant. This includes avoiding unapproved health, disease, or drug claims on packaging, websites, or marketing materials. Typical pitfalls include:

• Claims to cure or treat disease, which can trigger drug classification.
• Dosage recommendations inconsistent with labeling or safety guidance.
• Noncompliance with basic federal labeling rules, such as ingredient and allergen disclosures.

Audit your labeling process regularly and correct discrepancies proactively.

4. Ensure Coordination with State-Level Regulations

States like California, Colorado, and New York maintain their own hemp cannabinoid product and reporting rules. State inspectors may reference FDA adverse event data during compliance audits. Businesses should:

• Harmonize federal and state adverse event documentation protocols.
• Stay alert for state announcements referencing or mirroring FDA reporting category updates.

See California's DCC, Colorado MED, and New York OCM for state resources.

5. Monitor for Post-Launch FDA Directions

The final version of the new adverse event category fields will come after OMB review and possible public feedback from the summer 2025 docket period. Stay current on:

• FDA guidance and FAQs about hemp adverse event reporting (published at FDA Cannabis and Cannabis-Derived Products).
• Updates to the CAERS/FAERS online portals and taxonomy.

What Could Trigger an FDA Data Request or Product Recall?

FDA’s signal detection focus means they are actively seeking clusters or novel safety risks. Event triggers may include:

• Multiple similar complaints traced to a single lot or SKU.
• Reports involving unexpected serious effects—hospitalization, death, or product tampering claims.
• Patterns that suggest mislabeling, contamination, or non-approved ingredients.

Be prepared for prompt traceability documentation, incident investigation, and, if warranted, voluntary or mandatory recall procedures.

Serious Adverse Event Reporting in the Hemp Sector: Existing Requirements

For dietary supplements (though hemp cannabinoids are not yet formally allowed), the serious adverse event reporting requirement is already established under 21 U.S.C. §379aa. Companies must report within 15 business days if a serious health event linked to use arises. This may serve as a template for future regulatory expansion to all hemp cannabinoid products.

For now, voluntary reporting is strongly encouraged, especially if credible health risks are tied to retail products.

Best Compliance Practices for the Remainder of 2025

Given the FDA’s heightened attention and new surveillance tools, compliance teams should:

• Educate staff and authorized sellers about the importance of thorough adverse event documentation.
• Update training on lot traceability, labeling accuracy, and recall procedures.
• Establish clear communication lines for FDA and state regulator requests.

Remember, these changes are about consumer safety and market credibility. Companies that are proactive can reduce enforcement risk and maintain reputational trust.

For Consumers: What Does This Mean?

If you experience an adverse health event you associate with a hemp derivative (such as CBD), you can now submit a detailed report directly to FDA’s CAERS or MedWatch portal. With new product categories, your complaints will travel directly to the correct review team. This may enhance safety outcomes and speed regulatory response.

• Learn more at FDA Consumer Complaint System.
• Track the latest at FDA’s Hemp and Cannabis Information.

Final Takeaways for Businesses and Stakeholders

The FDA’s move to include hemp-derived cannabinoids in the official adverse event reporting system is a watershed for regulatory oversight. For cannabis businesses and compliance teams, now is the time to revisit and reinforce your product safety, labeling, and recall systems.

While this doesn’t legalize new CBD pathways or change federal dietary supplement restrictions, it does make visibility—and enforcement—more likely. Prioritize preparedness now to weather any storm of increased attention or regulatory scrutiny.

Stay up to date with federal and state cannabis compliance trends, enforcement actions, and policy updates at CannabisRegulations.ai. Our resources and alerts can help your business remain audit-ready in this rapidly evolving space.