U.S. Food and Drug Administration (FDA) Says Cannabidiol Does Not Fit Food or Supplement Rules and Asks Congress for a New Pathway (2023)

Table of Contents

1. What the U.S. Food and Drug Administration Did
2. What Cannabidiol Is and Where It Sits in Federal Law
3. Why Cannabidiol Is Excluded From Supplements and Foods
4. The Three Petitions and the U.S. Food and Drug Administration’s Answer
5. The Safety Concerns the U.S. Food and Drug Administration Named
6. What the Working Group Reviewed
7. What a New Pathway Could Include
8. Animal Food and Products for Animals
9. What the Decision Does Not Do
10. The Clinical Research Guidance Two Days Earlier
11. Dates and Legal Status as of 18 October 2026
12. How the Decision Fits Earlier and Later U.S. Food and Drug Administration Actions
13. Primary Documents
14. Key Research Papers
15. Connections
16. Featured Videos

1. What the U.S. Food and Drug Administration Did

Two U.S. Food and Drug Administration documents dated 26 January 2023 make up the action:

• A U.S. Food and Drug Administration statement from Janet Woodcock, M.D., then the agency’s Principal Deputy Commissioner, titled “U.S. Food and Drug Administration Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward.” It says that, “given the growing cannabidiol products market,” the U.S. Food and Drug Administration “convened a high-level internal working group to explore potential regulatory pathways for cannabidiol products,” and that “after careful review, the U.S. Food and Drug Administration has concluded that a new regulatory pathway for cannabidiol is needed that balances individuals’ desire for access to cannabidiol products with the regulatory oversight needed to manage risks.”
• A constituent update (a short U.S. Food and Drug Administration notice to industry and the public) titled “U.S. Food and Drug Administration Issues Response to Three Citizen Petitions Related to cannabidiol and Dietary Supplements.” It reports that the U.S. Food and Drug Administration “denied the requests in three citizen petitions” that asked it to “issue a regulation that would allow cannabidiol products to be marketed as dietary supplements.” The update describes the group behind the review as the cross-agency Cannabis Product Committee.

The statement’s conclusion about rulemaking is direct: “we do not intend to pursue rulemaking allowing the use of cannabidiol in dietary supplements or conventional foods.” It reached the same conclusion for animal food. Instead, the U.S. Food and Drug Administration said it “looks forward to working with Congress to develop a cross-agency strategy for the regulation of these products to protect the public’s health and safety.”

The action was not a Federal Register rule. It consisted of the statement, the update and three letters answering the petitions. The letters themselves are linked from the constituent update but were not read for this page; what is reported here about them comes from the update’s summary.

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2. What Cannabidiol Is and Where It Sits in Federal Law

The U.S. Food and Drug Administration’s question-and-answer page on cannabis products describes cannabis as “a plant of the Cannabaceae family” that “contains more than eighty biologically active chemical compounds,” of which the best known are delta-9-tetrahydrocannabinol and cannabidiol. Tetrahydrocannabinol (THC) is described there as the main source of cannabis’s psychoactive effects.

Two separate bodies of federal law apply:

• Controlled-substance law. According to the U.S. Food and Drug Administration page, parts of the Cannabis sativa plant have been controlled under the Controlled Substances Act since 1970 as “marihuana,” which is listed in Schedule I. The U.S. Food and Drug Administration page gives the reason as its “high potential for abuse,” attributable in large part to the psychoactive effects of tetrahydrocannabinol, and “the absence of a currently accepted medical use of the plant in the United States.” The Agriculture Improvement Act of 2018 (the 2018 Farm Bill), signed on 20 December 2018, removed “hemp” from that Act. It defines hemp as the plant and its derivatives, extracts and cannabinoids “with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.”
• Food and drug law. The U.S. Food and Drug Administration page states that the 2018 Farm Bill “explicitly preserved U.S. Food and Drug Administration’s authority” over products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The agency treats them like any other product it regulates, “regardless of whether the cannabis or cannabis-derived compounds are classified as hemp.”

So a cannabidiol product can be legal hemp under the Farm Bill and still fail to meet the FD&C Act’s requirements for a food, a supplement or a drug. The U.S. Food and Drug Administration page puts it this way: even a product that meets the hemp definition “still must comply with all other applicable laws, including the FD&C Act.”

The U.S. Food and Drug Administration has approved one prescription drug containing a purified form of cannabidiol, for seizures associated with Lennox-Gastaut syndrome, Dravet syndrome and tuberous sclerosis complex in patients 1 year of age and older. The page states that there are no other U.S. Food and Drug Administration-approved drug products that contain cannabidiol. It also lists approved prescription drugs containing dronabinol, a synthetic form of tetrahydrocannabinol, and nabilone, a synthetic compound similar to tetrahydrocannabinol.

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3. Why Cannabidiol Is Excluded From Supplements and Foods

The constituent update explains why the petitioners needed a regulation at all: “a provision in the law prohibits the marketing of certain drug ingredients as dietary supplements.” The U.S. Food and Drug Administration’s question-and-answer page names the provision and its effect.

• The drug-exclusion clause for supplements. Under section 201(ff)(3)(B) of the FD&C Act, a substance is excluded from the definition of a dietary supplement if it is an active ingredient in an approved drug, or if it has been authorized for investigation as a new drug and substantial clinical investigations of it have been started and made public. The U.S. Food and Drug Administration has concluded that tetrahydrocannabinol and cannabidiol products are excluded on this basis: tetrahydrocannabinol is the active ingredient in approved drugs, and cannabidiol is both the active ingredient in an approved drug and the subject of public clinical investigations.
• The “marketed first” exception. The clause does not apply if the substance was marketed as a dietary supplement or a conventional food before the drug was approved or the investigations were authorized. The U.S. Food and Drug Administration states that, based on available evidence, it has concluded this is not the case for tetrahydrocannabinol or cannabidiol, and that its continuing review of information submitted so far “has not caused us to change our conclusions.”
• The regulation route. The exclusion applies unless the U.S. Food and Drug Administration, “in the agency’s discretion,” issues a regulation, after notice and comment, finding that the product would be lawful. That is the regulation the three petitions asked for. The U.S. Food and Drug Administration page states that, to date, no such regulation has been issued for any substance.
• The parallel rule for foods. Section 301(ll) of the FD&C Act prohibits selling across state lines (in “interstate commerce”) any food, including animal food, to which an approved drug ingredient, or a drug under substantial public clinical investigation, has been added, with similar exceptions. The U.S. Food and Drug Administration has concluded that none of the exceptions applies to tetrahydrocannabinol or cannabidiol, so adding either to food sold across state lines is a prohibited act. Here too the law allows the U.S. Food and Drug Administration to approve such a use by regulation, and here too no such regulation has been issued for any substance.

The U.S. Food and Drug Administration page adds that ingredients from parts of the cannabis plant that do not contain tetrahydrocannabinol or cannabidiol might fall outside these exclusions, and that in December 2018 the U.S. Food and Drug Administration completed its evaluation of three “generally recognized as safe” (generally recognized as safe, GRAS) notices for hulled hemp seed, hemp seed protein powder and hemp seed oil in human food. Generally recognized as safe is the legal status of a food substance that qualified experts generally recognize as safe for its intended use. The page states that these conclusions “do not affect the U.S. Food and Drug Administration’s position on the addition of cannabidiol and tetrahydrocannabinol to food.”

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4. The Three Petitions and the U.S. Food and Drug Administration’s Answer

A citizen petition is a formal written request from outside the agency asking the U.S. Food and Drug Administration to act. The three petitions answered on 26 January 2023 came from three trade associations representing makers of dietary supplements and consumer-health products. Each asked the U.S. Food and Drug Administration to issue the regulation described in section 3, which would have opened a potential route for cannabidiol products to be marketed lawfully as dietary supplements.

The constituent update summarizes the answer: the U.S. Food and Drug Administration’s responses “explain that we do not intend to initiate such a rulemaking, because in light of the available scientific evidence, it is not apparent how cannabidiol products could meet the applicable safety standard for dietary supplements.” The update adds that the petitions “included other requests related to cannabidiol and dietary supplements that were all thoroughly reviewed and addressed in the respective U.S. Food and Drug Administration responses.” Those other requests are not described in the update.

The statement gives the underlying reason in plainer terms: “Under the law, any substance, including cannabidiol, must meet specific safety standards to be lawfully marketed as a dietary supplement or food additive,” and “we have not found adequate evidence to determine how much cannabidiol can be consumed, and for how long, before causing harm.”

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5. The Safety Concerns the U.S. Food and Drug Administration Named

The statement says that “the use of cannabidiol raises various safety concerns, especially with long-term use,” and lists them:

• The liver. “Studies have shown the potential for harm to the liver.”
• Other medicines. Studies have shown the potential for “interactions with certain medications.”
• Male reproduction. Studies have shown “possible harm to the male reproductive system.”
• Vulnerable groups. “cannabidiol exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant.”

The statement does not give doses or rates for these findings. Its central point is about what is missing: the agency had not found adequate evidence to set how much cannabidiol can be taken, and for how long, before harm occurs. The U.S. Food and Drug Administration’s question-and-answer page adds that unapproved cannabidiol products sold with therapeutic claims “have not been evaluated as to whether they work, what the proper dosage may be if they do work, how they could interact with other drugs, or whether they have dangerous side effects or other safety concerns.” Questions about cannabidiol and other medicines are ones for a clinician.

Several of the papers under Key Research Papers below examine these same questions, including liver-enzyme rises in healthy adults, drug interactions and animal studies of the male reproductive system.

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6. What the Working Group Reviewed

According to the statement, the working group, which Dr. Woodcock chaired, “closely examined” four kinds of evidence:

• studies related to the approved cannabidiol-based prescription drug;
• published scientific literature;
• information submitted to a public docket (a docket is the public file in which the U.S. Food and Drug Administration collects comments and documents on a topic);
• studies both conducted and commissioned by the agency.

“Given the available evidence,” the statement concludes, “it is not apparent how cannabidiol products could meet safety standards for dietary supplements or food additives.” The U.S. Food and Drug Administration’s cannabis page also lists, among its science resources, a literature review titled “Safety of cannabidiol in Humans,” a May 2019 public hearing on scientific data about cannabis products, and a November 2020 scientific conference on sex and gender differences in responses to cannabidiol and other cannabinoids.

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7. What a New Pathway Could Include

The statement says that the U.S. Food and Drug Administration’s existing food and supplement authorities “provide only limited tools for managing many of the risks associated with cannabidiol products,” and that a new pathway “would benefit consumers by providing safeguards and oversight to manage and minimize risks.” It names possible tools:

• clear labels;
• prevention of contaminants;
• Cannabidiol content limits;
• measures, such as a minimum purchase age, “to mitigate the risk of ingestion by children.”

It adds that a new pathway “could provide access and oversight for certain cannabidiol-containing products for animals.” The statement does not propose bill text; creating such a pathway was left to Congress, working with the U.S. Food and Drug Administration on what the statement calls “a cross-agency strategy.”

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8. Animal Food and Products for Animals

The statement extends the decision to animal food: “cannabidiol also poses risks to animals, and people could be unknowingly exposed to cannabidiol through meat, milk and eggs from animals fed cannabidiol. Because it is not apparent how cannabidiol products could meet the safety standard for substances in animal food, we also do not intend to pursue rulemaking allowing the use of cannabidiol in animal food.”

The U.S. Food and Drug Administration’s cannabis page states that the U.S. Food and Drug Administration “has not approved cannabis for any use in animals,” that there are no approved food additive petitions or recognized feed-ingredient definitions for any substance derived from hemp, and that the agency is unaware of any generally recognized as safe conclusions for hemp-derived substances in animal food. Adding tetrahydrocannabinol or cannabidiol to animal food sold across state lines falls under the same section 301(ll) prohibition described in section 3.

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9. What the Decision Does Not Do

• It does not ban cannabidiol products or order recalls. No product was removed from the market by this decision. It confirmed the agency’s existing legal position rather than changing it.
• It does not change the approved prescription cannabidiol drug. That drug’s approval and status are untouched.
• It does not create a new pathway. The U.S. Food and Drug Administration said a new pathway is needed and left its creation to Congress.
• It does not change hemp’s status under the Controlled Substances Act. That status comes from the 2018 Farm Bill, not from U.S. Food and Drug Administration action.
• It does not end enforcement. The statement says the U.S. Food and Drug Administration “will continue to take action against cannabidiol and other cannabis-derived products to protect the public, in coordination with state regulatory partners, when appropriate,” while “monitoring the marketplace, identifying products that pose risks and acting within our authorities.”

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10. The Clinical Research Guidance Two Days Earlier

On 24 January 2023 the U.S. Food and Drug Administration published a notice in the Federal Register (88 FR 4186–4188, Docket No. FDA-2020-D-1079) announcing a final guidance for industry, “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.” The notice describes the guidance as outlining “U.S. Food and Drug Administration’s current thinking” on the topics it covers.

According to the notice, the guidance covers the source of cannabis for clinical studies, general quality considerations for developing human drugs that contain cannabis and cannabis-derived compounds, and how to calculate the percent of delta-9 tetrahydrocannabinol in raw plant material, intermediates and finished drugs “to determine their control status” (that is, whether the material counts as hemp or as a controlled substance). It finalizes a draft of the same title issued on 22 July 2020.

The two steps of that week point in the same direction: the U.S. Food and Drug Administration kept the drug-development route open and gave it more detailed guidance, while declining to open the supplement and food routes. The cannabis page states that the U.S. Food and Drug Administration believes “scientifically valid research conducted under an IND application is the best way to determine what patients could benefit from the use of drugs derived from cannabis.” An IND (Investigational New Drug application) is the application the U.S. Food and Drug Administration page says researchers submit before clinical studies that can lead to an approved new drug.

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11. Dates and Legal Status as of 18 October 2026

• 22 July 2020: draft guidance on quality considerations for clinical research with cannabis issued.
• 24 January 2023: final version of that guidance announced in the Federal Register (88 FR 4186).
• 26 January 2023: U.S. Food and Drug Administration statement on cannabidiol and a new pathway; the three citizen petitions denied.
• 16 January 2025: U.S. Food and Drug Administration request for information on cannabis-derived products in veterinary practice (90 FR 4746, Docket No. FDA-2024-N-5976); comments were due 16 April 2025.

Status as of 18 October 2026: the petition denials are final, and no U.S. Food and Drug Administration regulatory pathway for cannabidiol in food or dietary supplements exists. A check of the Federal Register for U.S. Food and Drug Administration documents mentioning cannabidiol or cannabis published from 27 January 2023 through 18 October 2026 found no rule, proposed rule or notice creating such a pathway and none withdrawing the 2023 position. The only U.S. Food and Drug Administration document there on cannabidiol itself is the January 2025 request for information described in section 12. The U.S. Food and Drug Administration’s cannabis page, current as of 16 July 2024, still answers “No” to the question of whether tetrahydrocannabinol or cannabidiol products can be sold as dietary supplements.

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12. How the Decision Fits Earlier and Later U.S. Food and Drug Administration Actions

Before 2023. The U.S. Food and Drug Administration’s cannabis page lists a long run of earlier steps: the June 2018 approval of the “first drug comprised of an active ingredient derived from marijuana,” for rare, severe forms of epilepsy; a December 2018 statement on the signing of the Farm Bill; an April 2019 statement on evaluating possible pathways; a May 2019 public hearing; a March 2020 statement on cannabidiol products; and repeated rounds of warning letters from 2017 through 2022 to sellers of cannabidiol products marketed to treat diseases, sold as pain relievers, added to foods and beverages, or intended for food-producing animals. The April 2019 statement concerned the agency’s “continued evaluation of potential regulatory pathways”; the January 2023 statement reported where that evaluation ended.

Copycat tetrahydrocannabinol snacks. In July 2023 and July 2024 the U.S. Food and Drug Administration and the Federal Trade Commission warned sellers of copycat food products containing delta-8 tetrahydrocannabinol. Those actions are reported on U.S. Food and Drug Administration and FTC Warn Sellers of Copycat Delta-8 tetrahydrocannabinol Snacks (2024).

Animals, 2025. On 16 January 2025 the U.S. Food and Drug Administration asked for comments, particularly from veterinarians, on the use of cannabis-derived products, with an emphasis on cannabidiol, in animals: usage trends, quality standards, benefits, possible drug interactions, adverse events and toxicological concerns. The notice says the information will add to the Center for Veterinary Medicine’s knowledge of possible safety signals. It is a request for information, not a rule.

The same legal clause, other ingredients. Section 201(ff)(3)(B), the drug-exclusion clause behind the cannabidiol decision, was also at the centre of the U.S. Food and Drug Administration’s 2025 reversal on nicotinamide mononucleotide (NMN), reported on U.S. Food and Drug Administration Reverses Course: nicotinamide mononucleotide Allowed in Dietary Supplements (2025). The broader question of what counts as a dietary ingredient is the subject of U.S. Food and Drug Administration Public Meeting on What Counts as a Dietary Ingredient (2026). Other 2023 supplement actions include the U.S. Food and Drug Administration’s dietary supplement ingredient directory and its warning on probiotics given to preterm infants.

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13. Primary Documents

1. U.S. Food and Drug Administration (2023). U.S. Food and Drug Administration Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward. U.S. Food and Drug Administration Statement, Janet Woodcock, M.D., Principal Deputy Commissioner, 26 January 2023 — fda.gov statement
2. U.S. Food and Drug Administration (2023). U.S. Food and Drug Administration Issues Response to Three Citizen Petitions Related to cannabidiol and Dietary Supplements. Constituent Update, 26 January 2023 — fda.gov constituent update
3. U.S. Food and Drug Administration. U.S. Food and Drug Administration Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol. Public Health Focus page with questions and answers, content current as of 16 July 2024 — fda.gov cannabis and cannabidiol page
4. Food and Drug Administration, U.S. Department of Health and Human Services (HHS) (2023). Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research; Guidance for Industry; Availability. Notice of availability. Federal Register 88:4186–4188, 24 January 2023. Docket No. FDA-2020-D-1079 — FR Doc. 2023-01286
5. Food and Drug Administration, U.S. Department of Health and Human Services (2025). Use of Cannabis-Derived Products, Including Cannabidiol, in Veterinary Practice; Request for Information. Federal Register 90:4746–4748, 16 January 2025. Docket No. FDA-2024-N-5976 — FR Doc. 2025-00945

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Key Research Papers

1. Florian J, Salcedo P, Burkhart K, Shah A, Chekka LMS, Keshishi D, Patel V, Yang S, Fein M, DePalma R, Matta M, Strauss DG, Rouse R (2025). Cannabidiol and liver enzyme level elevations in healthy adults: a randomized clinical trial. JAMA Internal Medicine 185(9):1070-1078 — PubMed PMID: 40622698
2. Watkins PB, Church RJ, Li J, Knappertz V (2021). Cannabidiol and abnormal liver chemistries in healthy adults: results of a phase I clinical trial. Clinical Pharmacology and Therapeutics 109(5):1224-1231 — PubMed PMID: 33022751
3. Brown JD, Winterstein AG (2019). Potential adverse drug events and drug-drug interactions with medical and consumer cannabidiol (CBD) use. Journal of Clinical Medicine 8(7):989 — PubMed PMID: 31288397
4. Carvalho RK, Andersen ML, Mazaro-Costa R (2020). The effects of cannabidiol on male reproductive system: a literature review. Journal of Applied Toxicology 40(1):132-150 — PubMed PMID: 31313338
5. Huestis MA, Solimini R, Pichini S, Pacifici R, Carlier J, Busardò FP (2019). Cannabidiol adverse effects and toxicity. Current Neuropharmacology 17(10):974-989 — PubMed PMID: 31161980
6. Bonn-Miller MO, Loflin MJE, Thomas BF, Marcu JP, Hyke T, Vandrey R (2017). Labeling accuracy of cannabidiol extracts sold online. JAMA 318(17):1708-1709 — PubMed PMID: 29114823

The first paper is a placebo-controlled trial run by U.S. Food and Drug Administration scientists in 201 healthy adults given cannabidiol at 5 mg/kg per day for 28 days, published in 2025, after the 2023 decision; it reports liver-enzyme rises above three times the upper limit of normal in 8 participants (5.6%) on cannabidiol and none on placebo, and no differences in the reproductive and thyroid hormones measured. The second is a small 2021 phase I study in 16 healthy adults taking 1,500 mg a day, in which 5 met international criteria for drug-induced liver injury. The third reviews adverse effects and drug interactions listed in prescribing information for approved cannabidiol-containing products; the fourth reviews studies of cannabidiol and the male reproductive system, mostly in animals; the fifth is a general review of cannabidiol’s adverse effects and toxicity; the sixth compares the labels of cannabidiol extracts sold online with laboratory measurements of what they contained.

PubMed Topic Searches

1. PubMed: cannabidiol safety
2. PubMed: cannabidiol and liver injury
3. PubMed: cannabidiol drug interactions
4. PubMed: cannabidiol product labeling accuracy

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Connections

• U.S. Food and Drug Administration Actions of 2023
• U.S. Food and Drug Administration and Regulation
• Cannabis, Cannabidiol and Medical Marijuana for Fibromyalgia
• Natural Anxiety Relief
• Copycat Delta-8 Tetrahydrocannabinol Snacks (2024)
• Nicotinamide Mononucleotide Supplement Status Reversal (2025)
• What Counts as a Dietary Ingredient (2026)
• Dietary Supplement Ingredient Directory (2023)
• Probiotics in Preterm Infants Warning (2023)
• Xylazine Import Restriction (2023)

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