CBD Is Hemp-Derived, but FDA Rules Still Govern How It Can Be Sold
The 2018 Farm Bill changed CBD’s status under federal drug law—but it did not create a blanket approval for CBD products. Hemp and hemp-derived compounds containing no more than 0.3% delta-9 THC by dry weight were removed from the federal definition of marijuana under the Controlled Substances Act. At the same time, Congress expressly preserved the FDA’s authority to regulate cannabis-derived products under the Federal Food, Drug, and Cosmetic Act.
That distinction is central to the FDA’s position. A product may fall outside the Controlled Substances Act and still violate federal food, drug, or supplement laws. The FDA evaluates CBD products according to their intended use and how they are marketed, rather than treating all hemp-derived products as automatically lawful.
Epidiolex is the key exception
In June 2018, the FDA approved Epidiolex, a prescription oral solution containing purified cannabidiol. It was initially approved for seizures associated with Lennox-Gastaut syndrome and Dravet syndrome. The FDA later expanded its approval to include seizures associated with tuberous sclerosis complex. The current prescribing information covers patients 1 year of age and older.
Epidiolex is not equivalent to the CBD oils, gummies, beverages, and other products sold directly to consumers. Its approval was based on controlled clinical studies, standardized manufacturing, defined dosing, and medical monitoring. The FDA has also identified risks associated with CBD, including liver injury, drug interactions, sedation, and other adverse effects. Because of those risks, the product is used under the supervision of a health care professional.
Following the drug’s approval, the Drug Enforcement Administration placed Epidiolex in Schedule V, the least restrictive category under the Controlled Substances Act. That action applied to the approved prescription medication, not to every CBD product on the market. The DEA’s announcement specifically distinguished Epidiolex from marijuana- and CBD-derived products that had not received FDA approval.
CBD in foods and dietary supplements
The FDA’s published position is that CBD may not lawfully be added to conventional foods sold in interstate commerce or marketed as a dietary supplement under the existing federal framework. The agency bases that conclusion partly on provisions of the Federal Food, Drug, and Cosmetic Act that restrict the use of substances that are active ingredients in approved drugs or are the subject of publicly disclosed substantial clinical investigations.
The FDA also says that CBD is not generally recognized as safe for use in human or animal food and is not authorized as a food additive. As a result, removing hemp from the Controlled Substances Act did not authorize CBD-infused foods, drinks, pet treats, or supplements.
This restriction does not apply in the same way to certain hemp-seed ingredients. The FDA has concluded that hulled hemp seed, hemp-seed protein powder, and hemp-seed oil may be used in human food for specified purposes, provided the products meet other applicable legal requirements. Hemp seeds themselves do not naturally contain CBD or THC in the way other parts of the cannabis plant do.
Health claims can trigger enforcement
Companies face additional restrictions when they claim that a CBD product can diagnose, treat, cure, or prevent a disease. Marketing a product for conditions such as opioid addiction, cancer, COVID-19, pain, or seizures can cause the product to be treated as an unapproved drug if the claims are not supported by an FDA-approved application.
The FDA has repeatedly issued warning letters to companies making unproven medical claims, selling CBD products as dietary supplements, or adding CBD to foods and animal products. The agency’s database of warning letters for cannabis-derived products includes enforcement actions from 2025 as well as earlier years.
For consumers, the FDA cautions that the presence of CBD on store shelves does not mean the product has been evaluated for safety, effectiveness, dosage, or drug interactions. The agency has also found products whose CBD content did not match the label or that contained undeclared substances.
The regulatory debate continues
In January 2023, the FDA said that the existing regulatory pathways for foods and dietary supplements were not appropriate for CBD and called for Congress to create a new framework. The agency cited unresolved questions about long-term exposure, vulnerable populations, product quality, manufacturing standards, and the effect that broad nonprescription access could have on pharmaceutical research.
Until federal law changes or the FDA establishes a lawful pathway, the agency’s position remains narrow: hemp-derived CBD may be outside the Controlled Substances Act if it meets the statutory THC limit, but that status does not authorize CBD in foods or dietary supplements. Epidiolex remains the FDA-approved CBD drug, and companies marketing other CBD products must comply with the Federal Food, Drug, and Cosmetic Act—including its restrictions on medical claims, food additives, labeling, and product safety.
