FDA Policy on CBD
The U.S. Food and Drug Administration (FDA) regulates how cannabidiol (CBD) can be marketed and sold in interstate commerce. This page explains the FDA’s current posture—what’s allowed, what isn’t, and where policy may evolve—specifically for THC-free CBD products.
While federal and state laws overlap, this page focuses on FDA policy and enforcement themes. For broader legal frameworks, see our overviews on Legality, USA State Laws (Overview), US State-by-State THC-Free CBD Laws, EU Laws (Overview), and EU Laws by Country.
Disclaimer: This content is for educational purposes only and not legal or medical advice. Policies and interpretations can change. Consult qualified counsel before making compliance decisions.
Where the FDA Stands Today
In short: the FDA treats CBD differently depending on the product category, and it has not created a broad, formal pathway for CBD in dietary supplements or conventional foods. The agency continues to monitor safety data, issue warning letters when companies make impermissible disease claims, and encourage a legislative path for CBD in certain categories.
Is CBD approved by FDA?
The FDA has approved one prescription drug that contains CBD (a highly purified form) for rare seizure disorders. This approval does not apply to over-the-counter CBD products. Nonprescription CBD products are not FDA-approved to diagnose, treat, cure, or prevent any disease.
What the FDA Regulates
Drugs
CBD products marketed with disease or therapeutic claims are considered drugs and require FDA approval based on adequate safety and efficacy data. Only the prescription CBD drug noted above is FDA-approved. Over-the-counter CBD products should avoid medical claims.
Dietary supplements
Under current FDA interpretation, CBD is not a lawful dietary ingredient in supplements because it has been approved as a drug and was the subject of substantial clinical investigations before being marketed as a supplement. As a result, the FDA has rejected New Dietary Ingredient (NDI) submissions and may take action against supplement-like CBD products, especially those making health claims. For claim wording and risk areas, see Labeling & Claims Compliance.
Conventional foods and beverages
The FDA’s position is that adding CBD to foods or beverages sold in interstate commerce is not permitted at this time. Some states have their own rules, but FDA policy governs interstate sales. Companies should closely track evolving policy discussions about a potential new pathway.
Cosmetics and topicals
Cosmetics do not require premarket approval, but they must be safe and properly labeled. CBD in a cosmetic cannot be marketed with medical claims (which would reclassify it as a drug). The product must be non-adulterated and comply with cosmetic regulations.
Animals (pet products and animal feed)
CBD is not approved for use in animal food or feed. The FDA has issued warning letters to firms marketing CBD for animals with disease claims. Pet products are a heightened area of scrutiny.
Enforcement themes and claims
The FDA has prioritized actions against products that: (1) make disease or therapeutic claims; (2) target vulnerable populations (e.g., children, pregnant individuals); (3) pose contamination risks; or (4) have egregious labeling. The agency also publishes testing and compliance updates highlighting mislabeling and variable cannabinoid content.
To reduce risk, brands commonly avoid explicit disease claims and ensure truthful, non-misleading labeling aligned with the product category. See Labeling & Claims Compliance for claim types the FDA scrutinizes.
THC-free context: testing, COAs, and LOQ
“THC-free” typically means a product contains non-detectable THC at the testing laboratory’s limit of quantitation (LOQ). Because trace THC can appear in some extracts, buyers should review a recent third-party Certificate of Analysis (COA) that shows ND-THC and clearly states the LOQ. This is especially important for individuals concerned about workplace drug testing. While verified ND-THC lowers risk, no testing regime can guarantee zero risk.
The FDA expects products to be safe and accurately labeled. Independent COAs that verify identity, potency, and contaminants (residual solvents, heavy metals, pesticides, microbials) support quality claims and reduce the chance of enforcement for adulteration or misbranding.
Pathways and policy outlook
The FDA has indicated that existing frameworks for foods and dietary supplements may not be well-suited to CBD and that a new regulatory pathway may require action by Congress. Until a formal pathway exists, the FDA will continue to exercise enforcement discretion, focusing on safety, claims, and consumer protection.
For broader jurisdictional questions (state-by-state or international), refer to our legal overviews: Legality, USA State Laws (Overview), US State-by-State THC-Free CBD Laws, EU Laws (Overview), and EU Laws by Country.
FAQ: CBD FDA regulation
Is CBD approved by the FDA?
Only one prescription drug containing CBD is FDA-approved for specific seizure disorders. Nonprescription CBD products are not FDA-approved for medical use.
Can CBD be sold as a dietary supplement?
Currently, the FDA does not recognize CBD as a lawful dietary ingredient in supplements. The agency has objected to NDI notifications for CBD and issues warning letters, particularly where disease claims are made.
Can CBD be added to foods or drinks?
Under current FDA policy, CBD is not permitted in conventional foods or beverages sold in interstate commerce. State rules may differ but do not override federal interstate restrictions.
What claims trigger FDA scrutiny?
Claims that CBD diagnoses, treats, cures, or prevents disease are drug claims and require FDA approval. The FDA also scrutinizes unsubstantiated or misleading wellness claims. See Labeling & Claims Compliance.
Does FDA have a definition for “THC-free”?
No. In practice, “THC-free” generally refers to non-detectable THC at a lab’s LOQ, documented by a third-party COA. Verify LOQ and ND-THC results on each batch.
Does the FDA test CBD products?
The FDA conducts sampling and issues periodic updates. It also sends warning letters when it identifies safety, labeling, or claim issues.
Ready to explore rigorously tested THC-free CBD options? Shop carefully vetted products at Cannagea THC-Free.
Summary
Today’s FDA policy allows only one prescription CBD drug; otherwise, CBD is not broadly permitted in dietary supplements or conventional foods, and marketing with disease claims can trigger enforcement. Cosmetics and certain topicals may be sold without medical claims if safe and properly labeled. For THC-free buyers and brands, prioritize current COAs showing ND-THC at the lab’s LOQ and follow conservative labeling practices while policy continues to evolve.