The U.S. Food and Drug Administration’s Human Foods Program (HFP) 2025 guidance agenda was released in mid-2025, shaping compliance priorities across the food and dietary supplement sectors—including those involving cannabinoids like CBD, CBN, and CBG. While the agenda does not specifically call out cannabinoids, several topics hold significant implications for brands formulating foods and supplements with hemp-derived ingredients. Additionally, the FDA’s move to integrate hemp cannabinoids into its adverse event reporting (AER) systems underscores expanded post-market scrutiny for consumer safety and risk.
FDA Human Foods Program CBD 2025: Overview of the Guidance Agenda
The 2025 HFP guidance agenda sets out the FDA’s regulatory priorities and the types of draft guidance it plans to release or update. Key topics this year relate directly to the frameworks and tools likely to be applied to CBD and cannabinoid-infused products, even in the absence of explicit CBD rulemaking.
Core Agenda Topics Affecting Cannabinoid Products
1. Claims Substantiation and Labeling
- The FDA continues to prioritize accuracy in food and supplement labeling, focusing on clearer ingredient disclosures and compliance with claims regulations. This will affect how brands can describe benefits or make wellness claims about CBD, CBN, or CBG.
2. Allergen Handling in Infused Foods
- The 2025 agenda emphasizes updates related to allergen disclosure and cross-contact prevention. CBD-infused baked goods, beverages, or snacks will increasingly fall under expected allergen controls and labeling standards for major food allergens.
3. Color Additive Approvals
- Draft guidance on food colors derived from natural sources (e.g., fruit and vegetable juices) could impact the types of colorants permitted in cannabinoid-infused foods and drinks, especially as the FDA moves to authorize more natural additives and phase out synthetic ones.
4. New Dietary Ingredient (NDI) Notifications
- While the status of CBD as a dietary ingredient remains unresolved, the guidance agenda reiterates the FDA’s commitment to clarifying the process and standards for NDIs—a critical issue for any cannabinoid brand seeking formal market entry via the dietary supplement route.
Hemp Cannabinoids in Adverse Event Reporting: Expanded Oversight
A major development for 2025 is the FDA’s inclusion of hemp-derived cannabinoids—such as CBD, CBN, and CBG—in its Adverse Event Reporting (AER) portals (source). Health care professionals, consumers, and manufacturers can now select cannabinoid product types directly when filing adverse event or complaint reports. This change signals:
- Heightened post-market surveillance for cannabinoid-infused foods, beverages, and supplements;
- The need for brands and retailers to proactively monitor, log, and respond to consumer complaints and health event reports;
- Likely future enforcement if significant safety signals emerge from AER database trends.
What Touchpoints Should CBD and Cannabinoid Brands Watch in 2025?
Based on the 2025 HFP guidance agenda and the FDA’s recent actions, the most relevant areas of near-term compliance and enforcement pressure for the cannabinoid sector include:
Labeling & Claims
- Ensure all cannabinoid product labeling follows FDA standards for conventional foods or dietary supplements, as relevant.
- Avoid claims about medical treatment, cure, or mitigation of disease unless supported by robust scientific evidence—and beware of emerging guidance on wellness and structure/function claims substantiation.
- Monitor for updates on how ingredients like CBD, CBN, or CBG should be declared on both principal display panels and ingredient statements.
Allergen Controls in Manufacturing
- Adopt allergen control practices equivalent to those for traditional food products, including segregation, cleaning protocols, and validated label reviews for infused products.
- Prepare for future audits and enforcement of undeclared allergens in cannabinoid-infused edibles, especially as FDA harmonizes allergen guidance for all manufacturers.
Color Additives in Infused Products
- Track guidance about natural colorants, as FDA’s review process for colors derived from fruits or vegetables may affect permissibility for infused beverages, candies, and edibles.
- Do not use unapproved synthetic dyes; maintain documentation for all color additives used, including supplier certificates and GRAS (Generally Recognized As Safe) status evidence.
Dietary Ingredient Notifications
- For any product positioned as a dietary supplement, review status under the NDI Notification requirements. While CBD remains in regulatory limbo, related cannabinoids may receive more explicit focus in future guidance, so documentation and safety dossiers should be ready for likely review.
Adverse Event and Complaint Intake Systems
- Set up internal systems for capturing, assessing, and retaining records of consumer complaints, side-effects, and adverse health events from cannabinoid products (see FDA Constituent Updates and latest compliance notices).
- Train staff on prompt reporting to FDA when required and develop investigation protocols.
- Consider trends in AER data as early warning signals for product recalls, reformulations, or communication with regulators.
Preparation Checklist: Protecting Your Cannabinoid Brand
In light of 2025’s agenda, compliance-minded brands should:
- Conduct Regular Label Audits – Proactively review labels for compliance with FDA guidance on ingredients, claims, allergens, and colors.
- Update Quality Assurance and Manufacturing SOPs – Integrate allergen controls, record-keeping, and ingredient traceability into operations for any product containing cannabinoids.
- Maintain Robust Complaint and AER Documentation – Implement systems to capture and respond to consumer complaints and adverse events; monitor for patterns or signals that may demand corrective action.
- Keep Scientific Substantiation Files – For any statement regarding benefits or safety, maintain a record of clinical studies, expert reviews, and technical data supporting your claims.
- Monitor Regulatory Developments – Subscribe to FDA’s HFP updates, and industry sites, and consult regularly with expert compliance resources like CannabisRegulations.ai.
Looking Ahead: High Alert for Policy Changes
The FDA’s 2025 Human Foods Program agenda is notable for what it signals more than what it mandates. For cannabinoid brands, it marks a continued migration of compliance expectations from the dietary supplement sector into the food and beverage world, with new enforcement levers poised to activate as hemp cannabinoids take center stage in the AER system.
Staying ahead means engaging now—ensuring your products withstand scrutiny on labeling, ingredient sourcing, color/additive approvals, and post-market complaint monitoring.
Stay connected with the latest in federal cannabis compliance! For tailored updates, compliance checklists, and regulatory alerts, trust CannabisRegulations.ai—your partner in navigating the evolving FDA Human Foods Program CBD 2025 landscape.
