Is CBD FDA Approved? Epidiolex, Supplements, Food and the FDA

If you have seen CBD oils, gummies or creams for sale, it is natural to assume someone has checked them. Here is what the FDA has approved, how it treats other CBD and what changed in 2026. We do not recommend products or brands.

At a glance

The one approved CBD medicine: Epidiolex

The FDA approved Epidiolex, a CBD oral solution, on June 25, 2018 (Drugs@FDA). According to the FDA, no other approved drug contains CBD (FDA 2024).

Its current prescribing information (revised May 2026) lists one use: seizures associated with Lennox-Gastaut syndrome, Dravet syndrome or tuberous sclerosis complex in patients 1 year of age and older. DailyMed lists its DEA schedule as "None," meaning it is not a controlled substance (DailyMed 2026). It is available only with a prescription (FDA 2024). Research by condition: Dravet syndrome, Lennox-Gastaut syndrome and tuberous sclerosis complex.

What "approved" means

For a new drug, the company must show that it is safe and effective for its intended use and that it can be manufactured to federal quality standards; approval means the FDA has decided the benefits outweigh the risks for that use (FDA 2026).

Epidiolex's label describes four randomized, double-blind, placebo-controlled trials: two in Lennox-Gastaut syndrome, one in Dravet syndrome and one in tuberous sclerosis complex, with treatment lasting up to 14 weeks (Lennox-Gastaut and Dravet) or 16 weeks (tuberous sclerosis complex) (DailyMed 2026). The FDA says these studies and assured manufacturing quality let prescribers rely on consistent strength and delivery (FDA 2024). The label also warns that it can raise liver enzymes and cause sleepiness, and calls for liver blood tests before treatment starts (DailyMed 2026).

Strength of evidence: high for these three conditions, based on these FDA-reviewed controlled trials of up to 16 weeks. Approval says nothing about other conditions or other CBD products.

Other approved cannabinoid drugs: synthetic THC, not CBD

The FDA has approved two other cannabis-related active ingredients, and neither is CBD. Dronabinol is a synthetic form of delta-9 THC, approved for uses that include loss of appetite with weight loss in people with AIDS. Nabilone is a lab-made substance with a chemical structure similar to THC (FDA 2024). Its label lists one use: nausea and vomiting from cancer chemotherapy when standard anti-nausea treatment has not worked well enough (FDA 2022). Drugs@FDA lists the only approved nabilone product, Cesamet 1 mg capsules (NDA 018677), as discontinued (checked November 3, 2026) (Drugs@FDA). The FDA has not approved cannabis itself for any condition (FDA 2024). See also THC vs. CBD.

Source type: FDA drug labels and database records.

Why CBD can't be a supplement or a food ingredient

The reason is a drug exclusion rule in the Federal Food, Drug, and Cosmetic Act:

• Supplements: A dietary supplement may not contain a substance that is an approved drug, or one authorized for investigation as a new drug with substantial, publicly known clinical studies, unless it was sold as a supplement or food first (21 U.S.C. 321(ff)). The FDA has concluded that CBD is excluded: it is the active ingredient in Epidiolex, substantial clinical studies of it were made public, and it was not marketed as a supplement or food before that (FDA 2024).
• Food and drinks: A similar rule bans adding such a drug to any food sold across state lines (21 U.S.C. 331(ll)). The FDA has concluded that this covers CBD, including in animal food (FDA 2024).

The law lets the FDA make an exception by regulation, but in January 2023 the agency said it would not. It concluded that existing food and supplement rules are not appropriate for CBD, that it had not found adequate evidence on how much CBD can be consumed, and for how long, before causing harm, and that a new regulatory pathway is needed, to be worked out with Congress. It listed possible harm to the liver, interactions with certain medicines and possible harm to the male reproductive system among its concerns (FDA 2023).

Strength of evidence: the legal points are federal statute plus the FDA's stated interpretation, in force as of November 2026. The safety concerns are the FDA's summary of studies; the agency says evidence on long-term use is lacking.

What the FDA does instead: warning letters

The 2018 Farm Bill took hemp out of the Controlled Substances Act but kept the FDA's authority over hemp products (FDA 2024). So a product can be legal hemp and still break FDA rules. In deciding whether to act, the FDA weighs factors such as its resources and the threat to public health (FDA 2024). It keeps a public list of warning letters to companies selling CBD and delta-8 THC products, going back to 2015; when we checked in November 2026, the newest letters listed were from 2025 (FDA 2025).

Letters have targeted:

• Disease claims: products said to prevent, diagnose, treat or cure serious diseases such as cancer (FDA 2024); the list has a separate group of COVID-19 letters (FDA 2025).
• Food look-alikes and children: in 2022 the FDA warned companies selling CBD in forms people may confuse with ordinary foods, calling gummies, hard candies and cookies especially concerning (FDA 2022a).
• Animals: letters cited CBD added to pet treats (FDA 2022a) and claims that CBD helps farm animals with stress, anxiety, pain or inflammation (FDA 2022b).
• Delta-8 THC: with its first delta-8 warning letters in 2022, the FDA said such products often claim to treat cancer, multiple sclerosis, chronic pain, nausea and anxiety, and that some are packaged in ways that may appeal to children (FDA 2022c). In 2023 and 2024, the FDA and the Federal Trade Commission warned companies selling delta-8 edibles in packaging that copied popular snacks (FDA 2023b; FDA 2024b). More: what is delta-8 THC?

Companies are asked to respond within 15 working days; failing to fix the problems may lead to legal action such as product seizure or an injunction (FDA 2022a).

Source type: FDA pages and press releases; warning letters are advisory, not final court actions.

CBD cosmetics and pet products

Cosmetics do not need FDA approval before sale, and as of July 2024, the FDA said no regulation banned or restricted any cannabis-derived ingredients in them. They must still be safe and properly labeled, and a cream claiming to treat a disease is regulated as a drug (FDA 2024). Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the company responsible for a cosmetic generally must list its products with the FDA (certain small businesses are exempt) and must report serious adverse events within 15 business days (FDA 2026b). Listing is not approval, and cosmetic labeling needs no FDA approval either (FDA 2026).

Pets: the FDA has not approved cannabis for any use in animals, says it cannot ensure these products are safe or effective and recommends talking with your veterinarian. No hemp-derived substance is approved or recognized as safe for animal food (FDA 2024), and in 2023 the FDA said it does not intend to make rules allowing CBD in animal food (FDA 2023).

Source type: FDA pages explaining federal law, including MoCRA, and the FDA's 2023 statement.

What "FDA approved" on a CBD label means

Apart from Epidiolex, no CBD product is approved, so "FDA approved" on a store-bought CBD product is not accurate (FDA 2024). Similar wording can mislead too: registering a facility, or listing a drug or device, does not mean approval, and the FDA logo is for official government use only (FDA 2026).

As for "FDA CBD labeling requirements," we could not find an FDA rule written specifically for CBD labels. The FDA has said a new pathway could include clear labels, contaminant controls and CBD content limits (FDA 2023). What you can check yourself: how to read a CBD label.

Source type: FDA consumer pages and the FDA's 2023 statement.

How to report a side effect

The FDA says consumers and health care providers can report problems with cannabis or CBD products through MedWatch (FDA 2024). You can fill in the online form yourself or take the form to your doctor, who is not required to report. There is also a consumer paper form, Form FDA 3500B, and a separate route for problems with animal products (FDA 2025b).

Source type: FDA program pages.

What changed in 2026

• A narrow Medicare exception. In an April 1, 2026, letter, the FDA Commissioner said the agency does not intend to enforce certain drug rules against a hemp-derived CBD product taken by mouth if it is made, marketed and labeled in a way consistent with the dietary supplement framework (including a Supplement Facts panel), is not contaminated, is not packaged to appeal to children, and is provided through a Medicare program under the direction of the patient's doctor. The letter also restates that FDA-regulated CBD products are subject to the same legal and regulatory requirements as other FDA-regulated products (FDA 2026c). This is an enforcement policy, not an approval. A related CMS program lets participants in certain Medicare innovation models give eligible patients hemp products worth up to $500 a year (CMS 2026); see CBD and Medicare.
• Marijuana rescheduling. In a final rule effective April 28, 2026, the Justice Department moved FDA-approved drug products containing marijuana, and state-licensed medical marijuana, to Schedule III (Federal Register 2026). According to the Congressional Research Service, as of October 28, 2026, the department was still considering rescheduling marijuana entirely, and other marijuana remained in Schedule I (CRS 2026).
• The new hemp definition. A 2025 law rewrote the federal definition of hemp, and a September 2026 law split its start into two steps: from November 12, 2026, only the part excluding cannabinoids the plant cannot produce naturally applies; starting December 11, 2026, unless Congress delays it again, the rest takes effect: cannabinoids synthesized or made outside the plant are excluded, THC is counted as total THC (including THCA), and final products are limited to 0.4 mg of total THC and similar cannabinoids per container. FDA-approved drugs are excluded from the law's definition of a hemp-derived cannabinoid product (Pub. L. 119-37; Pub. L. 119-103). Details: what changes and when.

Source type: a signed FDA enforcement letter (not a rule), a CMS program page, a final rule and two enacted laws.

When to talk to a doctor or pharmacist

Tell your doctor or pharmacist about any CBD product you use, especially if you take other medicines. Epidiolex's label describes a higher risk of liver enzyme increases with some seizure medicines, and more sleepiness with alcohol or other sedating drugs (DailyMed 2026); store-bought CBD products have not been evaluated by the FDA for interactions (FDA 2024). See our drug interaction tool. If a child eats a cannabis product, the FDA advises taking the child to a doctor or emergency department, especially if the child seems unwell (FDA 2024).

Frequently asked questions

References