FDA Says CBD Does Not Fit Food or Supplement Rules and Asks Congress for a New Pathway (2023)

Table of Contents

1. What the FDA Did
2. What CBD Is and Where It Sits in Federal Law
3. Why CBD Is Excluded From Supplements and Foods
4. The Three Petitions and the FDA’s Answer
5. The Safety Concerns the FDA 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 FDA Actions
13. Primary Documents
14. Key Research Papers
15. Connections
16. Featured Videos

1. What the FDA Did

Two FDA documents dated 26 January 2023 make up the action:

• An FDA statement from Janet Woodcock, M.D., then the agency’s Principal Deputy Commissioner, titled “FDA 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 (CBD) products market,” the FDA “convened a high-level internal working group to explore potential regulatory pathways for CBD products,” and that “after careful review, the FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.”
• A constituent update (a short FDA notice to industry and the public) titled “FDA Issues Response to Three Citizen Petitions Related to CBD and Dietary Supplements.” It reports that the FDA “denied the requests in three citizen petitions” that asked it to “issue a regulation that would allow cannabidiol (CBD) 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 CBD in dietary supplements or conventional foods.” It reached the same conclusion for animal food. Instead, the FDA 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 CBD Is and Where It Sits in Federal Law

The FDA’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 (THC) and cannabidiol (CBD). 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 FDA 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 FDA page gives the reason as its “high potential for abuse,” attributable in large part to the psychoactive effects of THC, 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 FDA page states that the 2018 Farm Bill “explicitly preserved FDA’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 CBD 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 FDA 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 FDA has approved one prescription drug containing a purified form of CBD, 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 FDA-approved drug products that contain CBD. It also lists approved prescription drugs containing dronabinol, a synthetic form of THC, and nabilone, a synthetic compound similar to THC.

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3. Why CBD 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 FDA’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 FDA has concluded that THC and CBD products are excluded on this basis: THC is the active ingredient in approved drugs, and CBD 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 FDA states that, based on available evidence, it has concluded this is not the case for THC or CBD, 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 FDA, “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 FDA 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 FDA has concluded that none of the exceptions applies to THC or CBD, so adding either to food sold across state lines is a prohibited act. Here too the law allows the FDA to approve such a use by regulation, and here too no such regulation has been issued for any substance.

The FDA page adds that ingredients from parts of the cannabis plant that do not contain THC or CBD might fall outside these exclusions, and that in December 2018 the FDA completed its evaluation of three “generally recognized as safe” (GRAS) notices for hulled hemp seed, hemp seed protein powder and hemp seed oil in human food. GRAS 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 FDA’s position on the addition of CBD and THC to food.”

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4. The Three Petitions and the FDA’s Answer

A citizen petition is a formal written request from outside the agency asking the FDA 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 FDA to issue the regulation described in section 3, which would have opened a potential route for CBD products to be marketed lawfully as dietary supplements.

The constituent update summarizes the answer: the FDA’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 CBD products could meet the applicable safety standard for dietary supplements.” The update adds that the petitions “included other requests related to CBD and dietary supplements that were all thoroughly reviewed and addressed in the respective FDA 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 CBD, 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 CBD can be consumed, and for how long, before causing harm.”

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5. The Safety Concerns the FDA Named

The statement says that “the use of CBD 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. “CBD 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 CBD can be taken, and for how long, before harm occurs. The FDA’s question-and-answer page adds that unapproved CBD 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 CBD 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 CBD-based prescription drug;
• published scientific literature;
• information submitted to a public docket (a docket is the public file in which the FDA 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 CBD products could meet safety standards for dietary supplements or food additives.” The FDA’s cannabis page also lists, among its science resources, a literature review titled “Safety of CBD 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 CBD and other cannabinoids.

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7. What a New Pathway Could Include

The statement says that the FDA’s existing food and supplement authorities “provide only limited tools for managing many of the risks associated with CBD 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;
• CBD 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 CBD-containing products for animals.” The statement does not propose bill text; creating such a pathway was left to Congress, working with the FDA 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: “CBD also poses risks to animals, and people could be unknowingly exposed to CBD through meat, milk and eggs from animals fed CBD. Because it is not apparent how CBD products could meet the safety standard for substances in animal food, we also do not intend to pursue rulemaking allowing the use of CBD in animal food.”

The FDA’s cannabis page states that the FDA “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 GRAS conclusions for hemp-derived substances in animal food. Adding THC or CBD 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 CBD 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 CBD drug. That drug’s approval and status are untouched.
• It does not create a new pathway. The FDA 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 FDA action.
• It does not end enforcement. The statement says the FDA “will continue to take action against CBD 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 FDA 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 “FDA’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 THC 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 FDA 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 FDA 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 FDA 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: FDA statement on CBD and a new pathway; the three citizen petitions denied.
• 16 January 2025: FDA 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 FDA regulatory pathway for CBD in food or dietary supplements exists. A check of the Federal Register for FDA 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 FDA document there on CBD itself is the January 2025 request for information described in section 12. The FDA’s cannabis page, current as of 16 July 2024, still answers “No” to the question of whether THC or CBD products can be sold as dietary supplements.

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12. How the Decision Fits Earlier and Later FDA Actions

Before 2023. The FDA’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 CBD products; and repeated rounds of warning letters from 2017 through 2022 to sellers of CBD 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 THC snacks. In July 2023 and July 2024 the FDA and the Federal Trade Commission warned sellers of copycat food products containing delta-8 THC. Those actions are reported on FDA and FTC Warn Sellers of Copycat Delta-8 THC Snacks (2024).

Animals, 2025. On 16 January 2025 the FDA asked for comments, particularly from veterinarians, on the use of cannabis-derived products, with an emphasis on CBD, 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 CBD decision, was also at the centre of the FDA’s 2025 reversal on NMN, reported on FDA Reverses Course: NMN Allowed in Dietary Supplements (2025). The broader question of what counts as a dietary ingredient is the subject of FDA Public Meeting on What Counts as a Dietary Ingredient (2026). Other 2023 supplement actions include the FDA’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). FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward. FDA Statement, Janet Woodcock, M.D., Principal Deputy Commissioner, 26 January 2023 — fda.gov statement
2. U.S. Food and Drug Administration (2023). FDA Issues Response to Three Citizen Petitions Related to CBD and Dietary Supplements. Constituent Update, 26 January 2023 — fda.gov constituent update
3. U.S. Food and Drug Administration. FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD). Public Health Focus page with questions and answers, content current as of 16 July 2024 — fda.gov cannabis and CBD page
4. Food and Drug Administration, 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, HHS (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 FDA scientists in 201 healthy adults given CBD 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 CBD 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 CBD-containing products; the fourth reviews studies of CBD and the male reproductive system, mostly in animals; the fifth is a general review of CBD’s adverse effects and toxicity; the sixth compares the labels of CBD 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

• FDA Actions of 2023
• FDA and Regulation
• Cannabis, CBD and Medical Marijuana for Fibromyalgia
• Natural Anxiety Relief
• Copycat Delta-8 THC Snacks (2024)
• NMN 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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