The FDA's Federal Prohibition on CBD in Food
Following the passage of the 2018 Farm Bill, which legalized hemp and its derivatives with less than 0.3% delta-9 THC, many assumed that hemp-derived CBD products, including edibles, were now universally legal. However, the Farm Bill explicitly preserved the FDA's authority to regulate products containing cannabis and cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FDCA).
The FDA's position is clear and has been consistently stated: it is illegal to introduce food to which CBD has been added into interstate commerce. This prohibition is based on two key regulatory principles:
- The Drug Exclusion Rule: The FDCA prohibits an ingredient from being marketed in food or dietary supplements if it was first studied as a new drug or approved as a drug. Since CBD is the active ingredient in the FDA-approved drug Epidiolex, it is subject to this rule and cannot be sold as a food additive.
- Lack of Safety Information: The FDA has not concluded that CBD is "Generally Recognized As Safe" (GRAS) for use in food. The agency has cited insufficient scientific information regarding its safety, especially with long-term use.
FDA's Current Stance and Enforcement
Despite the federal prohibition, the market for CBD-infused food has expanded significantly. The FDA has acknowledged the widespread interest but has not initiated rulemaking to allow CBD in foods or dietary supplements. Instead, the agency announced in January 2023 that a new regulatory pathway is needed and committed to working with Congress to develop it.
In the meantime, the FDA has focused its enforcement actions on products that pose the greatest risk to consumers, such as those making unsubstantiated health claims or containing dangerously high levels of THC. However, the agency reserves the right to take action against any company violating the FDCA.
The State-Level Patchwork of CBD Food Laws
The lack of a comprehensive federal framework has led to a patchwork of state-level regulations. Some states have passed legislation or issued guidance that explicitly permits or regulates the sale of CBD-infused foods, often with specific requirements. This creates a confusing and inconsistent legal landscape where a product legal in one state may be illegal in another.
Examples of State Regulations
- States with Explicit Rules: Jurisdictions like Texas and Maine have established robust consumable hemp programs, regulating the manufacturing, distribution, and retail of CBD food products. These regulations often include licensing, testing, and labeling requirements.
- States with Restrictive Rules: Some states and local health departments prohibit the addition of CBD to food and beverages, considering it an adulterant. State laws can be more restrictive than federal guidelines.
Key Considerations for Businesses and Consumers
Navigating this legal complexity requires due diligence. Here are some key aspects to consider:
- Third-Party Lab Testing: Consumers and businesses should always prioritize products with third-party lab testing results. These tests verify the THC content (under 0.3% is federally legal for hemp-derived products) and check for contaminants like pesticides and heavy metals.
- Source of CBD: The legality often hinges on whether the CBD is derived from hemp (federally legal, under 0.3% THC) or marijuana (federally illegal, higher THC content).
- Interstate Commerce: Federal law prohibits shipping CBD-infused food products across state lines. This is a significant risk for online retailers and manufacturers operating nationwide.
Comparative Table: US Federal vs. Typical State Regulation
| Feature | US Federal Stance (FDA) | Typical State Regulation |
|---|---|---|
| Legality | Illegal to add CBD to food for interstate commerce due to drug exclusion rule and lack of GRAS status. | Varies widely. Some states explicitly permit and regulate CBD in food; others ban it. |
| Safety Evaluation | Not considered safe for food use due to insufficient data, with concerns about liver toxicity and drug interactions. | Varies. States with regulation often require product testing for contaminants and potency. |
| Enforcement Focus | Targets significant public health risks and unsubstantiated health claims. Enforcement against general CBD edibles is less common but possible. | State or local health authorities enforce specific state-level rules, often requiring licenses and adherence to safety standards. |
| Future Outlook | Actively seeking new regulatory pathways with Congress, signaling a shift but no immediate change. | Evolving rapidly as states react to consumer demand and federal inaction. |
Conclusion: Uncertainty and the Need for Caution
The question of whether it is legal to put CBD in food is not a simple yes or no. Federally, the answer is no, due to the FDA's enforcement of the FDCA. However, many states have created their own regulations, allowing for a burgeoning and sometimes ambiguous market for CBD-infused food products. This contradiction puts businesses and consumers at risk. The ultimate path forward depends on federal action, with the FDA looking to Congress to create a new regulatory framework. For now, anyone involved with CBD edibles must navigate a complex, fragmented legal system, prioritizing transparent, well-tested products and staying informed about changing state and federal laws.
For more information on the FDA's current position, visit their page on FDA Regulation of Cannabis and Cannabis-Derived Products.
