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U.S. Food and Drug Administration

FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD)

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There is a significant interest in the development of therapies and other consumer products derived from cannabis and its components, including cannabidiol (CBD). FDA recognizes the potential opportunities that cannabis or cannabis-derived compounds may offer and acknowledges the significant interest in these possibilities. However, FDA is aware that some companies are marketing products containing cannabis and cannabis-derived compounds in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act) and that may put the health and safety of consumers at risk. The agency is committed to protecting the public health while also taking steps to improve the efficiency of regulatory pathways for the lawful marketing of appropriate cannabis and cannabis-derived products. FDA has a number of resources available that address cannabis and cannabis-derived products, such as CBD, and the agency wants to ensure that consumers and other stakeholders have access to these resources in a centralized location.

Consumer Information

  • What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD
  • What You Should Know About Using Cannabis, Including CBD, When Pregnant or Breastfeeding
  • Some Medicines and Driving Don’t Mix

FDA Communications

  • Better Data for a Better Understanding of the Use and Safety Profile of Cannabidiol (CBD) Products
  • FDA Warns Companies Illegally Selling CBD Products
  • FDA Approves New Indication for Drug Containing an Active Ingredient Derived from Cannabis to Treat Seizures in Rare Genetic Disease
  • FDA Issues Draft Guidance to Encourage Cannabis-Related Clinical Research
  • FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity
  • Congressional Testimony: Cannabis Policies for the New Decade
    • Archived Video
  • FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns
  • Remarks at the Council for Responsible Nutrition Conference
  • Remarks at the National Industrial Hemp Council 2019 Hemp Business Summit
  • FDA, FTC warn company marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD, Parkinson’s and Alzheimer’s disease
  • Congressional Testimony: Hemp Production and the 2018 Farm Bill
    • Archived Video
  • FDA is Committed to Sound, Science-based Policy on CBD
  • Remarks at the FDA Public Hearing on Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds
  • Statement on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products
  • Statement on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds
  • Statement on the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components
  • FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy

Regulatory Resources

  • Scientific Conference on November 19, 2020: CBD and Other Cannabinoids: Sex and Gender Differences in Use and Responses
  • Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Draft Guidance for Industry
  • Information on CBD Data Collection and Submission
  • FDA and Cannabis: Research and Drug Approval Process
  • FDA Regulation of Dietary Supplement & Conventional Food Products Containing Cannabis and Cannabis-Derived Compounds
  • Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds; Public Hearing
    • Federal Register Notice
    • Public Hearing Page
    • Public Docket
  • Warning Letters and Test Results for Cannabidiol-Related Products
  • State, Local, Tribal, Territorial (SLTT) Regulatory Officials: FDA is committed to working with our SLTT public health regulatory partners as developments occur in the regulatory landscape. Please contact the Intergovernmental Affairs team with any questions at [email protected]

Questions and Answers

Below are a number of frequently asked questions and answers on this topic.

1. What are cannabis and marijuana?

A. Cannabis is a plant of the Cannabaceae family and contains more than eighty biologically active chemical compounds. The most commonly known compounds are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Parts of the Cannabis sativa plant have been controlled under the Controlled Substances Act (CSA) since 1970 under the drug class “Marihuana” (commonly referred to as “marijuana”) [21 U.S.C. 802(16)]. “Marihuana” is listed in Schedule I of the CSA due to its high potential for abuse, which is 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.

2. How does the 2018 Farm Bill define hemp? What does it mean for FDA-regulated products?

A. At the federal level, the Agriculture Improvement Act of 2018, Pub. L. 115-334, (the 2018 Farm Bill) was signed into law on Dec. 20, 2018. Among other things, this new law changes certain federal authorities relating to the production and marketing of hemp, defined as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” These changes include removing hemp from the CSA, which means that cannabis plants and derivatives that contain no more than 0.3 percent THC on a dry weight basis are no longer controlled substances under federal law.

The 2018 Farm Bill, however, explicitly preserved FDA’s authority to regulate products containing cannabis or cannabis-derived compounds under the FD&C Act and section 351 of the Public Health Service Act (PHS Act). FDA treats products containing cannabis or cannabis-derived compounds as it does any other FDA-regulated products — meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance. This is true regardless of whether the cannabis or cannabis-derived compounds are classified as hemp under the 2018 Farm Bill.

3. Has FDA approved any medical products containing cannabis or cannabis-derived compounds such as CBD?

A. To date, the agency has not approved a marketing application for cannabis for the treatment of any disease or condition. FDA has, however, approved one cannabis-derived and three cannabis-related drug products. These approved products are only available with a prescription from a licensed healthcare provider.

FDA has approved Epidiolex, which contains a purified form of the drug substance CBD for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 1 years of age and older. It has also approved Epidiolex for the treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age or older. That means FDA has concluded that this particular drug product is safe and effective for its intended use.

The agency also has approved Marinol and Syndros for therapeutic uses in the United States, including for the treatment of anorexia associated with weight loss in AIDS patients. Marinol and Syndros include the active ingredient dronabinol, a synthetic delta-9- tetrahydrocannabinol (THC) which is considered the psychoactive component of cannabis. Another FDA-approved drug, Cesamet, contains the active ingredient nabilone, which has a chemical structure similar to THC and is synthetically derived.

4. Aside from Epidiolex, are there other CBD drug products that are FDA-approved? What about the products I’ve seen in stores or online?

A. No. There are no other FDA-approved drug products that contain CBD. We are aware that some firms are marketing CBD products to treat diseases or for other therapeutic uses , and we have issued several warning letters to such firms. Under the FD&C Act, any product intended to have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug. Drugs must generally either receive premarket approval by FDA through the New Drug Application (NDA) process or conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review. CBD was not an ingredient considered under the OTC drug review. An unapproved new drug cannot be distributed or sold in interstate commerce.

FDA continues to be concerned at the proliferation of products asserting to contain CBD that are marketed for therapeutic or medical uses although they have not been approved by FDA. Often such products are sold online and are therefore available throughout the country. Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective. This deceptive marketing of unproven treatments also raises significant public health concerns, because patients and other consumers may be influenced not to use approved therapies to treat serious and even fatal diseases.

Unlike drugs approved by FDA, products that have not been subject to FDA review as part of the drug approval process 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.

The agency has and will continue to monitor the marketplace and take action as needed to protect the public health against companies illegally selling cannabis and cannabis-derived products that can put consumers at risk and that are being marketed for therapeutic uses for which they are not approved. At the same time, FDA recognizes the potential therapeutic opportunities that cannabis or cannabis-derived compounds could offer and acknowledges the significant interest in these possibilities. FDA continues to believe that the drug approval process represents the best way to help ensure that safe and effective new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy. The Center for Drug Evaluation and Research (CDER) is committed to supporting the development of new drugs, including cannabis and cannabis-derived drugs, through the investigational new drug (IND) and drug approval process (see Question #16).

5. Why hasn’t FDA approved more products containing cannabis or cannabis-derived compounds for medical uses?

A. FDA is aware that unapproved cannabis or cannabis-derived products are being used for the treatment of a number of medical conditions including, for example, AIDS wasting, epilepsy, neuropathic pain, spasticity associated with multiple sclerosis, and cancer and chemotherapy-induced nausea.

To date, FDA has not approved a marketing application for cannabis for the treatment of any disease or condition and thus has not determined that cannabis is safe and effective for any particular disease or condition. The agency has, however, approved one cannabis-derived and three cannabis-related drug products (see Question #2).

FDA relies on applicants and scientific investigators to conduct research. The agency’s role, as laid out in the FD&C Act, is to review data submitted to the FDA in an application for approval to ensure that the drug product meets the statutory standards for approval.

The study of cannabis and cannabis-derived compounds in clinical trial settings is needed to assess the safety and effectiveness of these substances for the treatment of any disease or condition. FDA’s December 2016 Guidance for Industry: Botanical Drug Development provides specific recommendations on submitting INDs for botanical drug products, such as those derived from cannabis, in support of future marketing applications for these products. The agency’s July 2020 draft guidance, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry, highlights quality considerations for anyone wishing to conduct clinical research in this area, particularly those who are less familiar with the FDA.

The FDA will continue to facilitate the work of companies interested in appropriately bringing safe, effective, and quality products to market, including scientifically-based research concerning the medicinal uses of cannabis. Additional information concerning research on the medical use of cannabis is available from the National Institutes of Health, particularly the National Cancer Institute (NCI) and National Institute on Drug Abuse (NIDA).

6. What is FDA’s reaction to states that are allowing cannabis to be sold for medical uses without the FDA’s approval?

A. The FDA is aware that several states have either passed laws that remove state restrictions on the medical use of cannabis and its derivatives or are considering doing so. It is important to conduct medical research into the safety and effectiveness of cannabis products through adequate and well-controlled clinical trials. We welcome the opportunity to talk with states who are considering support for medical research of cannabis and its derivatives, so that we can provide information on Federal and scientific standards.

7. Has the agency received any adverse event reports associated with cannabis use for medical conditions?

A. The agency has received reports of adverse events in patients using cannabis or cannabis-derived products to treat medical conditions. The FDA reviews such reports and will continue to monitor adverse event reports for any safety signals, with a focus on serious adverse effects. Consumers and healthcare providers can report adverse events associated with cannabis or cannabis-derived products via the FDA’s MedWatch reporting system, either online or by phone at 1-800-FDA-1088. For more information, please see the FDA’s webpage on MedWatch.

Information from adverse event reports regarding cannabis use is extremely limited; the FDA primarily receives adverse event reports for approved products. General information on the potential adverse effects of using cannabis and its constituents can come from clinical trials that have been published, as well as from spontaneously reported adverse events sent to the FDA. Additional information about the safety and effectiveness of cannabis and its constituents is needed. Clinical trials of cannabis conducted under an IND application could collect this important information as a part of the drug development process.

8. Is it legal for me to sell CBD products?

A. It depends, among other things, on the intended use of the product and how it is labeled and marketed. Even if a CBD product meets the definition of “hemp” under the 2018 Farm Bill (see Question #2), it still must comply with all other applicable laws, including the FD&C Act. The below questions and answers explain some of the ways that specific parts of the FD&C Act can affect the legality of CBD products.

We are aware that state and local authorities are fielding numerous questions about the legality of CBD. There is ongoing communication with state and local officials to answer questions about requirements under the FD&C Act, to better understand the landscape at the state level, and to otherwise engage with state/local regulatory partners.

9. Can THC or CBD products be sold as dietary supplements?

A. No. Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)]. Under that provision, if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are excluded from the definition of a dietary supplement. FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDA’s regulations (21 CFR 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.

There is an exception to section 201(ff)(3)(B) if the substance was “marketed as” a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized, as applicable. However, based on available evidence, FDA has concluded that this is not the case for THC or CBD.

FDA is not aware of any evidence that would call into question its current conclusions that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act. Interested parties may present the agency with any evidence that they think has bearing on this issue. Our continuing review of information that has been submitted thus far has not caused us to change our conclusions.

When a substance is excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act, the exclusion applies unless FDA, in the agency’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under the FD&C Act. To date, no such regulation has been issued for any substance.

Ingredients that are derived from parts of the cannabis plant that do not contain THC or CBD might fall outside the scope of this exclusion, and therefore might be able to be marketed as dietary supplements. However, all products marketed as dietary supplements must comply with all applicable laws and regulations governing dietary supplement products. For example, manufacturers and distributors who wish to market dietary supplements that contain “new dietary ingredients” (i.e., dietary ingredients that were not marketed in the United States in a dietary supplement before October 15, 1994) generally must notify FDA about these ingredients (see section 413(d) of the FD&C Act [21 U.S.C. § 350b(d)]). Generally, the notification must include information demonstrating that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling. A dietary supplement is adulterated if it contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that the ingredient does not present a significant or unreasonable risk of illness or injury (see section 402(f)(1)(B) of the FD&C Act [21 U.S.C. 342(f)(1)(B)]).

Numerous other legal requirements apply to dietary supplement products, including requirements relating to Current Good Manufacturing Practices (CGMPs) and labeling. Information about these requirements, and about FDA requirements across all product areas, can be found on FDA’s website.

10. Is it legal, in interstate commerce, to sell a food (including any animal food or feed) to which THC or CBD has been added?

A. No. Under section 301(ll) of the FD&C Act [21 U.S.C. § 331(ll)], it is prohibited to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which has been added a substance which is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or a drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. There are exceptions, including when the drug was marketed in food before the drug was approved or before the substantial clinical investigations involving the drug had been instituted or, in the case of animal feed, that the drug is a new animal drug approved for use in feed and used according to the approved labeling. However, based on available evidence, FDA has concluded that none of these is the case for THC or CBD. FDA has therefore concluded that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which THC or CBD has been added. FDA is not aware of any evidence that would call into question these conclusions. Interested parties may present the agency with any evidence that they think has bearing on this issue. Our continuing review of information that has been submitted thus far has not caused us to change our conclusions.

When this statutory prohibition applies to a substance, it prohibits the introduction into interstate commerce of any food to which the substance has been added unless FDA, in the agency’s discretion, has issued a regulation approving the use of the substance in the food (section 301(ll)(2) of the FD&C Act [21 U.S.C. § 331(ll)(2)]). To date, no such regulation has been issued for any substance.

Ingredients that are derived from parts of the cannabis plant that do not contain THC or CBD might fall outside the scope of 301(ll), and therefore might be able to be added to food. For example, as discussed in Question #12, certain hemp seed ingredients can be legally marketed in human food. However, all food ingredients must comply with all applicable laws and regulations. For example, by statute, any substance intentionally added to food is a food additive, and therefore subject to premarket review and approval by FDA, unless the substance is generally recognized as safe (GRAS) by qualified experts under the conditions of its intended use, or the use of the substance is otherwise excepted from the definition of a food additive (sections 201(s) and 409 of the FD&C Act [21 U.S.C. §§ 321(s) and 348]). Aside from the three hemp seed ingredients mentioned in Question #12, no other cannabis or cannabis-derived ingredients have been the subject of a food additive petition, an evaluated GRAS notification, or have otherwise been approved for use in food by FDA. Food companies that wish to use cannabis or cannabis-derived ingredients in their foods are subject to the relevant laws and regulations that govern all food products, including those that relate to the food additive and GRAS processes.

11. In making the two previous determinations about THC, why did FDA conclude that THC is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act? In making the two previous determinations about CBD, why did FDA determine that substantial clinical investigations have been authorized for and/or instituted, and that the existence of such investigations has been made public?

A. THC (dronabinol) is the active ingredient in the approved drug products, Marinol capsules (and generics) and Syndros oral solution. CBD is the active ingredient in the approved drug product, Epidiolex.

The existence of substantial clinical investigations regarding THC and CBD have been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex. (See Sativex Commences US Phase II/III Clinical Trial in Cancer Pain )

12. Can hulled hemp seed, hemp seed protein powder, and hemp seed oil be used in human food?

A. In December 2018, FDA completed its evaluation of three generally recognized as safe (GRAS) notices for the following hemp seed-derived food ingredients: hulled hemp seed, hemp seed protein powder, and hemp seed oil. FDA had no questions regarding the company’s conclusion that the use of such products as described in the notices is safe. Therefore, these products can be legally marketed in human foods for the uses described in the notices, provided they comply with all other requirements. These GRAS notices related only to the use of these ingredients in human food. To date, FDA has not received any GRAS notices for the use of hemp-derived ingredients in animal food (see Question #25).

Hemp seeds are the seeds of the Cannabis sativa plant. The seeds of the plant do not naturally contain THC or CBD. The hemp seed-derived ingredients that are the subject of these GRAS notices contain only trace amounts of THC and CBD, which the seeds may pick up during harvesting and processing when they are in contact with other parts of the plant. Consumption of these hemp seed-derived ingredients is not capable of making consumers “high.”

The GRAS conclusions can apply to ingredients for human food marketed by other companies, if they are manufactured in a way that is consistent with the notices and they meet the listed specifications. Some of the intended uses for these ingredients include adding them as source of protein, carbohydrates, oil, and other nutrients to beverages (juices, smoothies, protein drinks, plant-based alternatives to dairy products), soups, dips, spreads, sauces, dressings, plant-based alternatives to meat products, desserts, baked goods, cereals, snacks and nutrition bars. Products that contain any of these hemp seed-derived ingredients must declare them by name on the ingredient list.

These GRAS conclusions do not affect the FDA’s position on the addition of CBD and THC to food.

13. What is FDA’s position on cannabis and cannabis-derived ingredients in cosmetics?

A. A cosmetic is defined in 201(i) as “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.”

Under the FD&C Act, cosmetic products and ingredients are not subject to premarket approval by FDA, except for most color additives. Certain cosmetic ingredients are prohibited or restricted by regulation, but currently that is not the case for any cannabis or cannabis-derived ingredients. Ingredients not specifically addressed by regulation must nonetheless comply with all applicable requirements, and no ingredient – including a cannabis or cannabis-derived ingredient – can be used in a cosmetic if it causes the product to be adulterated or misbranded in any way. A cosmetic generally is adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling, or under such conditions of use as are customary or usual (section 601(a) of the FD&C Act [21 U.S.C. § 361(a)]).

If a product is intended to affect the structure or function of the body, or to diagnose, cure, mitigate, treat or prevent disease, it is a drug, or possibly both a cosmetic and a drug, even if it affects the appearance. (See Question #3 for more information about drugs.)

FDA can take action if it has information that an ingredient or cosmetic product is unsafe to consumers. Consumers can report adverse events associated with cosmetic products via the FDA’s MedWatch reporting system, either online or by phone at 1-800-FDA-1088, or by contacting your nearest FDA district office consumer complaint coordinator. For more information, please see the FDA’s webpage on how to report a cosmetic-related complaint.

14. Will FDA take action against cannabis or cannabis-related products that are in violation of the FD&C Act?

A. The FDA has sent warning letters in the past to companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.

When a product is in violation of the FD&C Act, FDA considers many factors in deciding whether or not to initiate an enforcement action. Those factors include, among other things, agency resources and the threat to the public health. FDA also may consult with its federal and state partners in making decisions about whether to initiate a federal enforcement action.

15. Can I import or export cannabis-containing or cannabis-derived products?

A. General information about the import/export of drug products regulated by FDA can be found online here. The Drug Enforcement Administration (DEA) is the federal agency responsible for enforcing the controlled substance laws and regulations in the U.S. and, as such, should be consulted with respect to any regulations/requirements they may have regarding the import or export of products containing cannabis. Please see here for information about importing or exporting food ingredients.

Regarding imports, if it appears that an article is adulterated, misbranded, in violation of section 505 of the FD&C Act, or prohibited from introduction or delivery for introduction into interstate commerce under section 301(ll) of the FD&C Act, such article will be refused admission (see section 801(a)(3) of the FD&C Act [21 U.S.C. § 381(a)(3)]).

Research and Expanded Access

16. What is FDA’s role when it comes to the investigation of cannabis and cannabis-derived products for medical use?

A. To conduct clinical research that can lead to an approved new drug, including research using materials from plants such as cannabis, researchers need to work with the FDA and submit an IND application to the Center for Drug Evaluation and Research (CDER). The IND application process gives researchers a path to follow that includes regular interactions with the FDA to support efficient drug development while protecting the patients who are enrolled in the trials. For research for use as an animal drug product, researchers would establish an investigational new animal drug (INAD) file with the Center for Veterinary Medicine to conduct their research, rather than an IND with CDER.

As discussed above (see Question #2), the 2018 Farm Bill removed hemp from the CSA. This change may streamline the process for researchers to study cannabis and its derivatives, including CBD, that fall under the definition of hemp, which could speed the development of new drugs.

As also discussed above (see Question #5) the agency also issued a draft guidance in July 2020, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry, for individuals considering clinical research in this area.

Conducting clinical research using cannabis-related substances that are scheduled by the DEA often involves interactions with several federal agencies. This includes: a registration administered by the DEA; obtaining the cannabis for research from NIDA, within the National Institutes of Health, or another DEA-registered source; and review by the FDA of the IND or INAD application and research protocol. Additionally:

  • For a Schedule I controlled substance under the CSA, DEA provides researchers with investigator and protocol registrations and has Schedule I-level security requirements at the site cannabis will be studied.
  • NIDA provides research-grade cannabis for scientific study. The agency is responsible for overseeing the cultivation of cannabis for medical research and has contracted with the University of Mississippi to grow cannabis for research at a secure facility. Cannabis of varying potencies and compositions is available. DEA also may allow additional growers to register with the DEA to produce and distribute cannabis for research purposes.
  • Researchers work with the FDA and submit an IND application to the appropriate division in the Office of New Drugs in CDER depending on the therapeutic indication. Based on the results obtained in studies conducted at the IND stage, sponsors may submit a marketing application for formal approval of the drug.

17. Does the FDA object to the clinical investigation of cannabis for medical use?

A. No. The FDA believes that 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. The FDA supports the conduct of that research by:

  1. Providing information on the process needed to conduct clinical research using cannabis.
  2. Providing information on the specific requirements needed to develop a drug that is derived from a plant such as cannabis. In December 2016, the FDA updated its Guidance for Industry: Botanical Drug Development, which provides sponsors with guidance on submitting IND applications for botanical drug products.
  3. Providing specific support for investigators interested in conducting clinical research using cannabis and its constituents as a part of the IND process through meetings and regular interactions throughout the drug development process.
  4. Providing general support to investigators to help them understand and follow the procedures to conduct clinical research through the FDA Center for Drug Evaluation and Research’s Small Business and Industry Assistance group.

18. How can patients gain access to cannabis or cannabis-derived products for medical use through expanded access?

A. Expanded access is a potential pathway for a patient with a serious or life-threatening disease or condition to try an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when there are no comparable or satisfactory therapies available. Manufacturers may be able to make investigational drugs available to individual patients in certain circumstances through expanded access, as described in the FD&C Act and implementing regulations.

19. Can patients gain access to cannabis or cannabis-derived products for medical use through Right to Try?

A. Information for patients on Right to Try (RTT) is available on our website. RTT is designed to facilitate access to certain investigational drugs through direct interactions between patients, their physicians and drug sponsors – FDA is not involved in these decisions. Sponsors developing drugs for life-threatening conditions are responsible for determining whether to make their products available to patients who qualify for access under RTT. If you are interested in RTT, you should discuss this pathway with your licensed physician. Companies who develop drugs and biologics, also known as sponsors, can provide information about whether their drug/biologic is considered an eligible investigational drug under RTT and if they are able to provide the drug/biologic under the RTT Act.

Children and Pregnant/Lactating Women

20. Does the FDA have concerns about administering a cannabis product to children?

A. We understand that parents are trying to find treatments for their children’s medical conditions. However, the use of untested drugs can have unpredictable and unintended consequences. Caregivers and patients can be confident that FDA-approved drugs have been carefully evaluated for safety, efficacy, and quality, and are monitored by the FDA once they are on the market. The FDA continues to support sound, scientifically-based research into the medicinal uses of drug products containing cannabis or cannabis-derived compounds, and will continue to work with companies interested in bringing safe, effective, and quality products to market. With the exception of Epidiolex, Marinol, and Syndros, no product containing cannabis or cannabis-derived compounds (either plant-based or synthetic) has been approved as safe and effective for use in any patient population, whether pediatric or adult.

21. Does the FDA have concerns about administering a cannabis product to pregnant and lactating women?

A. The FDA is aware that there are potential adverse health effects with use of cannabis products containing THC in pregnant or lactating women. Published scientific literature reports potential adverse effects of cannabis use in pregnant women, including fetal growth restriction, low birth weight, preterm birth, small-for-gestational age, neonatal intensive care unit (NICU) admission, and stillbirth. [1, 2, 3] Based on published animal research, there are also concerns that use of cannabis during pregnancy may negatively impact fetal brain development. [4, 5, 6 ] The American College of Obstetricians and Gynecologists (ACOG) recommends that women who are pregnant or contemplating pregnancy should be encouraged to discontinue cannabis use. In addition, ACOG notes that there are insufficient data to evaluate the effects of cannabis use on breastfed infants; therefore, cannabis use is discouraged when breastfeeding. [7] Pregnant and lactating women should talk with a health care provider about the potential adverse health effects of cannabis use.

22. What does the FDA think about making CBD available to children with epilepsy?

A. The FDA has approved Epidiolex, which contains a purified form of the drug substance CBD, for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 1 years of age and older. It has also approved Epidiolex for the treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age or older. That means the FDA has concluded that this particular drug product is safe and effective for its intended use. Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring cannabis-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, and the assurance of manufacturing quality standards, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes.

23. What should I do if my child eats something containing cannabis?

A. With the exception of products such as the hemp seed ingredients discussed in Question #12, which have been evaluated for safety, it is important to protect children from accidental ingestion of cannabis and cannabis-containing products. FDA recommends that these products are kept out of reach of children to reduce the risk of accidental ingestion. If the parent or caregiver has a reasonable suspicion that the child accidentally ingested products containing cannabis, the child should be taken to a physician or emergency department, especially if the child acts in an unusual way or is/feels sick.

Pets and other Animals

24. I’ve seen cannabis products being marketed for pets. Are they safe?

A. FDA is aware of some cannabis products being marketed as animal health products. We want to stress that FDA has not approved cannabis for any use in animals, and the agency cannot ensure the safety or effectiveness of these products. For these reasons, FDA cautions pet-owners against the use of such products and recommends that you talk with your veterinarian about appropriate treatment options for your pet.

Signs that your pet may be suffering adverse effects from ingesting cannabis may include lethargy, depression, heavy drooling, vomiting, agitation, tremors, and convulsions.

If you have concerns that your pet is suffering adverse effects from ingesting cannabis or any substance containing cannabis, consult your veterinarian, local animal emergency hospital or an animal poison control center immediately.

While the agency is aware of reports of pets consuming various forms of cannabis, to date, FDA has not directly received any reports of adverse events associated with animals given cannabis products. However, adverse events from accidental ingestion are well-documented in scientific literature. If you feel your animal has suffered from ingesting cannabis, we encourage you to report the adverse event to the FDA. Please visit Reporting Information about Animal Drugs and Devices to learn more about how to report an adverse event related to an animal drug or for how to report an adverse event or problem with a pet food.

25. Can hemp be added to animal food?

A. All ingredients in animal food must be the subject of an approved food additive petition or generally recognized as safe (GRAS) for their intended use in the intended species. If an animal food contains an ingredient that is not the subject of an approved food additive petition or GRAS for its intended use in the intended species, that animal food would be adulterated under section 402(a)(2)(C)(i) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(i)]. In coordination with state feed control officials, CVM also recognizes ingredients listed in the Official Publication (OP) of the Association of American Feed Control Officials (AAFCO) as being acceptable for use in animal food. At this time, there are no approved food additive petitions or ingredient definitions listed in the AAFCO OP for any substances derived from hemp, and we are unaware of any GRAS conclusions regarding the use of any substances derived from hemp in animal food. Learn more about animal food ingredient submissions here.

With respect to products labeled to contain “hemp” that may also contain THC or CBD, as mentioned above it is a prohibited act under section 301(ll) of the FD&C Act to introduce or deliver for introduction into interstate commerce any animal food to which THC or CBD has been added.

26. Can approved human drugs containing CBD or synthetic THC be used extralabel in animals?

A. The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA), permits veterinarians to prescribe extralabel uses of approved human and animal drugs for animals under certain conditions. Extralabel use must comply with all the provisions of AMDUCA and its implementing regulation at 21 CFR § 530. Among other limitations, these provisions allow extralabel use of a drug only on the lawful order of a licensed veterinarian in the context of a valid veterinarian-client-patient relationship and only in circumstances when the health of an animal is threatened or suffering, or death may result from failure to treat.

In addition, under 21 CFR 530.20, extralabel use of an approved human drug in a food-producing animal is not permitted if an animal drug approved for use in food-producing animals can be used in an extralabel manner for the use. In addition, under 21 CFR 530.20(b)(2), if scientific information on the human food safety aspect of the use of the approved human drug in food-producing animals is not available, the veterinarian must take appropriate measures to ensure that the animal and its food products will not enter the human food supply.
For more information on extralabel use of FDA approved drugs in animals, see Extralabel Use of FDA Approved Drugs In Animals.

[1] Gray, et al. Identifying Prenatal Cannabis Exposure and Effects of Concurrent Tobacco Exposure on Neonatal Growth. Clinical Chemistry. 2010; 56(9): 1442-1450.

[2] Gunn, et al. Prenatal Exposure to cannabis and maternal and child health outcomes: a systematic review and meta-analysis. BMJ Open. 2016; 6:e009986.

[3] Hayatbakhsh, et al. Birth Outcomes associated with cannabis use before and during pregnancy. Pediatric Research. 2012; 71 (2): 215-219.

[4] Silva, et al. Prenatal tetrahydrocannabinol (THC) alters cognitive function and amphetamine response from weaning to adulthood in the rat. Neurotoxicol and Teratol 2012; 34(1): 63-71.

[5] Trezza, et al. Effects of perinatal exposure to delta-9-tetrahydrocannabinol on the emotional reactivity of the offspring: a longitudinal behavioral study in Wistar rats. Psychopharmacology (Berl) 2008; 198(4): 529-537.

[6] Campolongo, et al. Perinatal exposure to delta-9-tetrahydrocannabinol causes enduring cognitive deficits associated with alteration of cortical gene expression and neurotransmission in rats. Addict Biol 2007; 12(3-4): 485–495.

Questions and answers about FDA regulation of cannabis and cannabis-derived products

FDA Regulation of Cannabidiol (CBD) Consumer Products: Overview and Considerations for Congress

January 21, 2020 R46189

Cannabidiol (CBD), a compound in the Cannabis sativa plant, has been promoted as a treatment for a range of conditions, including epileptic seizures, post-traumatic stress disorder, anxiety, inflammation, and sleeplessness. However, limited scientific evidence is available to substantiate or disprove the efficacy of CBD in treating these conditions. In the United States, CBD is marketed in food and beverages, dietary supplements, cosmetics, and tobacco products such as electronic nicotine delivery systems (ENDS)—products that are primarily regulated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. §§301 et seq.). CBD is also the active ingredient in Epidiolex, an FDA-approved pharmaceutical drug.

The Regulation of Marijuana and Hemp

CBD is derived from the Cannabis sativa plant (commonly referred to as cannabis), which includes both hemp and marijuana. Marijuana is a Schedule I controlled substance under the Controlled Substances Act (CSA, 21 U.S.C. §§802 et seq.) and is regulated by the Drug Enforcement Administration (DEA). Schedule I substances are subject to the most severe CSA restrictions and penalties. Except for purposes of federally approved research, it is a federal crime to grow, sell, or possess marijuana.

Until December 2018, hemp was included in the CSA definition of marijuana and was thus subject to the same restrictions. Legislative changes enacted as part of the 2018 farm bill (Agriculture Improvement Act of 2018, P.L. 115-334) removed longstanding federal restrictions on the cultivation of hemp. No longer subject to regulation and oversight as a controlled substance by DEA, hemp production is now subject to regulation and oversight as an agricultural commodity by the U.S. Department of Agriculture (USDA). The 2018 farm bill expanded the statutory definition of what constitutes hemp to include “all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers,” as long as it contains no more than a 0.3% concentration of delta-9 tetrahydrocannabinol (THC; 7 U.S.C. §1639o). All non-hemp cannabis and cannabis derivatives—including marijuana-derived CBD—are considered to be marijuana under the CSA and remain regulated by DEA.

Production and Marketing of Hemp Products

Legislative changes related to hemp enacted as part of the 2018 farm bill were widely expected to generate additional market opportunities for the U.S. hemp market. However, the farm bill explicitly preserved FDA’s authority under the FFDCA and Section 351 of the Public Health Service Act (PHSA, 42 U.S.C. §262), including for hemp-derived products. Following enactment of the farm bill, in a December 2018 statement, FDA stated that it is “unlawful under the [FFDCA] to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived.” The agency has maintained this view in subsequent communications.

Despite FDA’s determination, CBD continues to be widely marketed and sold in both food and dietary supplements in the United States. To date, FDA has generally prioritized enforcement against companies and products that pose the greatest risk to consumers—for example, CBD products claiming to treat Alzheimer’s or stop cancer cell growth.

In 2014, total U.S. CBD sales were a reported $108 million. In 2018, more than 1,000 companies produced and marketed CBD for the U.S. market, and U.S. CBD sales were estimated at $534 million, according to the Hemp Business Journal. That dollar amount is projected to exceed $1 billion in 2020 and to reach nearly $2 billion in 2022. This amount includes sales from hemp-derived CBD, marijuana-derived CBD (currently a Schedule I controlled substance), and pharmaceutical CBD (currently only Epidiolex).

Congress has expressed concern about the proliferation of CBD products marketed in violation of federal law and has called on FDA to provide guidance on lawful pathways for marketing hemp-derived CBD in food and dietary supplements. In absence of a regulatory framework for hemp-derived CBD, in the explanatory statement accompanying the FY2020 enacted appropriation, Congress directed FDA to issue a policy of enforcement discretion with respect to CBD products that meet the statutory definition of hemp. In addition to the activities directed in the explanatory statement, Congress could also take further legislative action in the future, such as requiring FDA to issue a regulation, under its FFDCA authorities, expressly permitting CBD that meets the definition of hemp to be used as a food additive or dietary supplement. Congress also could amend the FFDCA provisions that FDA has identified as restricting marketing of CBD in food and dietary supplements. In determining whether a legislative approach is appropriate, Congress may consider the potential for adverse health effects and other unintended consequences.

FDA Regulation of Cannabidiol (CBD) Consumer Products: Overview and Considerations for Congress

Contents

  • Background
  • FDA Regulation of CBD Products
  • Pharmaceutical Drugs
  • Foods and Food Additives
  • Animal Food and Feed Considerations
  • Dietary Supplements
  • Cosmetics and Personal Care Products
  • Tobacco Products
  • Alcohol Beverage Products
  • Therapeutic Uses of CBD and ResearchВ Considerations
  • Considerations for Congress: Marketing of CBD
  • What Are the Circumstances Under Which FDA-Regulated Products Containing CBD Can Be MarketedВ Currently?
  • What Is the Current State of the CBD Market?
  • What Could Congress Do to Allow CBD to Be Marketed as a Food Additive or Dietary Supplement?

Figures

  • Figure 1. Cannabis sativa
  • Figure 2. Products Derived from Cannabis
  • Figure 3. Total U.S. CBD Sales, by Channel

Tables

  • Table 1. Summary of Selected FDA Requirements, by CBD Product Type
  • Table B-1. Abbreviations Used in this Report

Appendixes

  • Appendix A. Food Additive Petition Process and GRAS Notification Submission
  • Appendix B. Abbreviations Used in this Report

Summary

Cannabidiol (CBD), a compound in the Cannabis sativa plant, has been promoted as a treatment for a range of conditions, including epileptic seizures, post-traumatic stress disorder, anxiety, inflammation, and sleeplessness. However, limited scientific evidence is available to substantiate or disprove the efficacy of CBD in treating these conditions. In the United States, CBD is marketed in food and beverages, dietary supplements, cosmetics, and tobacco products such as electronic nicotine delivery systems (ENDS)—products that are primarily regulated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. §§301 et seq.). CBD is also the active ingredient in Epidiolex, an FDA-approved pharmaceutical drug.

The Regulation of Marijuana and Hemp

CBD is derived from the Cannabis sativa plant (commonly referred to as cannabis), which includes both hemp and marijuana. Marijuana is a Schedule I controlled substance under the Controlled Substances Act (CSA, 21 U.S.C. §§802 et seq.) and is regulated by the Drug Enforcement Administration (DEA). Schedule I substances are subject to the most severe CSA restrictions and penalties. Except for purposes of federally approved research, it is a federal crime to grow, sell, or possess marijuana.

Until December 2018, hemp was included in the CSA definition of marijuana and was thus subject to the same restrictions. Legislative changes enacted as part of the 2018 farm bill (Agriculture Improvement Act of 2018, P.L. 115-334 ) removed longstanding federal restrictions on the cultivation of hemp. No longer subject to regulation and oversight as a controlled substance by DEA, hemp production is now subject to regulation and oversight as an agricultural commodity by the U.S. Department of Agriculture (USDA). The 2018 farm bill expanded the statutory definition of what constitutes hemp to include “all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers,” as long as it contains no more than a 0.3% concentration of delta-9 tetrahydrocannabinol (THC; 7 U.S.C. В§1639o). All non-hemp cannabis and cannabis derivatives—including marijuana-derived CBD—are considered to be marijuana under the CSA and remain regulated by DEA.

Production and Marketing of Hemp Products

Legislative changes related to hemp enacted as part of the 2018 farm bill were widely expected to generate additional market opportunities for the U.S. hemp market. However, the farm bill explicitly preserved FDA’s authority under the FFDCA and Section 351 of the Public Health Service Act (PHSA, 42 U.S.C. В§262), including for hemp-derived products. Following enactment of the farm bill, in a December 2018 statement, FDA stated that it is “unlawful under the [FFDCA] to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived.” The agency has maintained this view in subsequent communications.

Despite FDA’s determination, CBD continues to be widely marketed and sold in both food and dietary supplements in the United States. To date, FDA has generally prioritized enforcement against companies and products that pose the greatest risk to consumers—for example, CBD products claiming to treat Alzheimer’s or stop cancer cell growth.

In 2014, total U.S. CBD sales were a reported $108 million. In 2018, more than 1,000 companies produced and marketed CBD for the U.S. market, and U.S. CBD sales were estimated at $534 million, according to the Hemp Business Journal. That dollar amount is projected to exceed $1 billion in 2020 and to reach nearly $2 billion in 2022. This amount includes sales from hemp-derived CBD, marijuana-derived CBD (currently a Schedule I controlled substance), and pharmaceutical CBD (currently only Epidiolex).

Congress has expressed concern about the proliferation of CBD products marketed in violation of federal law and has called on FDA to provide guidance on lawful pathways for marketing hemp-derived CBD in food and dietary supplements. In absence of a regulatory framework for hemp-derived CBD, in the explanatory statement accompanying the FY2020 enacted appropriation, Congress directed FDA to issue a policy of enforcement discretion with respect to CBD products that meet the statutory definition of hemp. In addition to the activities directed in the explanatory statement, Congress could also take further legislative action in the future, such as requiring FDA to issue a regulation, under its FFDCA authorities, expressly permitting CBD that meets the definition of hemp to be used as a food additive or dietary supplement. Congress also could amend the FFDCA provisions that FDA has identified as restricting marketing of CBD in food and dietary supplements. In determining whether a legislative approach is appropriate, Congress may consider the potential for adverse health effects and other unintended consequences.

Background

Cannabidiol (CBD) , a compound in the Cannabis sativa plant , has been promoted as a treatment for a range of conditions, including epileptic seizures, post-traumatic stress disorder, anxiety, inflammation, and sleeplessness . However, limited scientific evidence exists to substantiate or disprove the efficacy of CBD in treating these conditions . In the United States, CBD is being marketed in food and beverages, dietary supplements, cosmetics , and tobacco products such as electronic nicotine delivery systems (ENDS , the overarching term encompassing electronic cigarettes) —products that are primarily regulated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FFDCA). CBD is also the active ingredient in Epidiolex , an FDA-approved pharmaceutical drug used to treat seizures associated with two rare and severe forms of epilepsy .

CBD is derived from the Cannabis sativa plant (commonly referred to as cannabis), which includes both hemp and marijuana (defined further below). CBD and tetrahydrocannabinol (THC) are thought to be the most abundant cannabinoids in the cannabis plant and are among the most researched cannabinoids for their potential medical value. 1 THC—a psychoactive 2 compound—is found at high levels in m arijuana and low levels in hemp (see Figure 1). 3

Figure 1. Cannabis sativa

Source: Created by CRS.

Notes: This figure is intended to provide a high-level illustration of the relationship between cannabis, marijuana, and hemp, per the statutory distinction in the Controlled Substances Act (CSA).

CBD, on the other hand, is generally considered to be nonpsychoactive and may be derived from either hemp or marijuana. As described below, this distinction is relevant for purposes of oversight by the Drug Enforcement Administration (DEA), but generally not for FDA oversight. FDA has stated that it “treats products containing cannabis or cannabis-derived compounds as it does any other FDA-regulated products—meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other [non-cannabis] substance. 4 This is true regardless of whether the cannabis or cannabis-derived compounds are classified as hemp under [7 U.S.C. Section 1639o] as amended by the 2018 [f]arm [b]ill.” 5 In contrast, the DEA does not regulate cannabis or cannabis-derived compounds that meet the statutory definition of hemp.

Botanically, marijuana and hemp are from the same species of plant, Cannabis sativa, but from different varieties or cultivars. 6 Marijuana and hemp have separate definitions in U.S. law and are subject to different statutory and regulatory requirements.

Marijuana (as defined in statute) generally refers to the cultivated plant used as a psychotropic drug, either for medicinal or recreational purposes. 7 Marijuana is a Schedule I controlled substance under the Controlled Substances Act (CSA) 8 and is regulated by DEA. Schedule I substances are subject to the most severe CSA restrictions and penalties; with exceptions for federally approved research, it is a federal crime to grow, sell, or possess the drug. Thus, under the CSA, the unauthorized manufacture, distribution, dispensation, and possession of marijuana and its derivatives (including marijuana-derived CBD) are prohibited. 9

Hemp (as defined in statute separately from marijuana), on the other hand, may be legally cultivated under federal law, subject to oversight by the U.S. Department of Agriculture (USDA). 10 Hemp is generally grown for use in the production of a wide range of products, including foods and beverages, personal care products, dietary supplements, fabrics and textiles, paper, construction materials, and other manufactured and industrial goods (see Figure 2).

Figure 2. Products Derived from Cannabis

Source: Created by CRS.

Notes: While marijuana is cultivated to promote the development of flowering tops and leaves of psychoactive cannabis plant varieties with elevated concentrations of THC, hemp is cultivated depending on its intended use across three different crops: fiber, seeds, and flower. While not defined in statute, there are additional industry-developed terms that are used to describe hemp extracts (e.g., full spectrum and broad spectrum). Because these terms lack standardized definitions, they are not used in this report.

Until December 2018, hemp was included in the CSA definition of marijuana and was thus subject to the same restrictions as marijuana. The Agriculture Improvement Act of 2018 (2018 farm bill; P.L. 115-334 ) removed hemp and its derivatives (including hemp-derived CBD) from the CSA definition of marijuana. As a result, hemp is no longer subject to regulation and oversight as a controlled substance by DEA. Instead, hemp production is now subject to regulation and oversight as an agricultural commodity by USDA. CBD and CBD-related products that do not meet the statutory definition of hemp (in 7 U.S.C. В§1639o) continue to be prohibited (aside from lawful use for research purposes) under the CSA and remain regulated by DEA.

Related CRS Products

Congressional Distribution memo on cannabis extraction methods is available to Congressional clients upon request

Changes enacted in the 2018 farm bill related to hemp were expected by many to generate additional market opportunities for hemp-derived consumer products such as hemp-derived CBD. However, the farm bill also explicitly preserved FDA’s authorities under the FFDCA and Section 351 of the Public Health Service Act, including for hemp-derived products. 11 As mentioned above, cannabis and cannabis-derived FDA-regulated products are subject to the same authorities and requirements as FDA-regulated products—including pharmaceutical drugs, food, dietary supplements, and cosmetics—containing any other substance (whether cannabis-derived or otherwise). As described below, FDA has determined that it is unlawful to introduce food containing added CBD into interstate commerce, or to market CBD as or in dietary supplements. 12 FDA has not made similar determinations for other FDA-regulated product categories (pharmaceutical drugs, cosmetics, and tobacco products).

FDA Regulation of CBD Products

In the United States, CBD is the active ingredient in the prescription drug Epidiolex. CBD is also being marketed in food and beverages, dietary supplements, cosmetics, and tobacco products such as ENDS. Each of these product types is governed by different statutory and regulatory requirements, primarily administered by FDA. The agency also shares regulatory authority with other entities; for example, the Alcohol and Tobacco Tax and Trade Bureau (TTB), 13 with regard to alcoholic beverages, and the Federal Trade Commission (FTC), with regard to the advertising and promotion of certain CBD products. This section provides an overview of how FDA regulates drugs, food, dietary supplements, cosmetics, and tobacco products, and the applicability of those requirements to products that contain CBD. Table 1 summarizes selected regulatory requirements by CBD product type.

Pharmaceutical Drugs

FDA, under the FFDCA, regulates the safety and effectiveness of prescription and nonprescription (over-the-counter, or OTC) drugs sold in the United States. Prescription drugs require health practitioner supervision to be considered safe for use—due to drug toxicity, potential harmful effect, or method of use—and may be dispensed only pursuant to a prescription. 14 In contrast, OTC drugs may be used without a prescriber’s authorization, provided they have an acceptable safety margin, low potential for misuse or abuse, and are adequately labeled so that consumers can self-diagnose the condition, self-select the medication, and self-manage the condition. 15 The statutory definition of the term drug includes “articles (other than food) intended to affect the structure or any function of the body of man or other animals” and “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.” 16 In general, a new drug may not be introduced into interstate commerce without FDA approval. 17

For purposes of new drug approval, except under very limited circumstances, FDA requires data from clinical trials to provide evidence of a drug’s safety and effectiveness. Before testing in humans—called clinical testing—the drug’s sponsor (usually its manufacturer) must file an investigational new drug (IND) application with FDA. Once a manufacturer completes clinical trials, it submits the results of those investigations, along with other information, to FDA in a new drug application (NDA). 18 In reviewing an NDA, FDA considers whether the drug is safe and effective for its intended use; whether the proposed labeling is appropriate; and whether the methods used to manufacture the drug and the controls used to maintain the drug’s quality are adequate to preserve the drug’s identity, strength, quality, and purity. 19 The NDA process can be used to obtain approval of both prescription and OTC drugs. If a sponsor wants to transfer an approved drug from prescription to OTC status (called an Rx-to-OTC switch), the sponsor must submit to FDA an NDA (or a supplement 20 to an NDA) providing data to support the switch. 21 As part of an NDA for an OTC drug, FDA may require the sponsor to conduct label comprehension studies assessing the extent to which consumers understand the information in the proposed labeling. 22 FDA also may recommend that the sponsor conduct self-selection studies to assess whether consumers can appropriately self-select a drug based on the information on the labeling. 23

In June 2018, FDA approved an NDA for the prescription drug Epidiolex, submitted by GW Pharmaceuticals, for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients two years old and older. 24 The active ingredient in Epidiolex is CBD, although its mechanism of action—that is, the mechanism by which it exerts its anticonvulsant effects—is not known. 25 FDA approved Epidiolex in June 2018; at that time, the drug contained a chemical constituent of marijuana (CBD) that was considered a Schedule I controlled substance. 26 Therefore, it could not be marketed unless rescheduled by the DEA. Upon FDA approval, Epidiolex no longer met the criteria for placement in Schedule I, as it now had an accepted medical use in the United States. 27 On September 28, 2018, based on a recommendation from FDA, DEA issued an order placing FDA-approved drugs that contain cannabis-derived CBD and no more than 0.1% THC in Schedule V. 28 Epidiolex is available by prescription and only at specialty pharmacies. 29 It is the first (and only) pharmaceutical formulation of highly purified, plant-derived CBD available in the United States. 30 Because Epidiolex is designated as an orphan drug (i.e., a drug that treats a rare disease or condition), it was awarded seven years of marketing exclusivity upon approval. 31 This means that FDA cannot approve an NDA for the same drug—in this case, one that has CBD as its active ingredient—for the same disease or condition (i.e., for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years old and older) for seven years, with limited exceptions. 32

Foods and Food Additives

The FFDCA defines food to mean “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.” 33 FDA’s Center for Food Safety and Applied Nutrition (CFSAN) is responsible for oversight of human food, while FDA’s Center for Veterinary Medicine (CVM) is responsible for oversight of animal food (feed). The FFDCA requires that all human and animal foods are safe to eat, produced in compliance with current good manufacturing practices (CGMPS), contain no harmful substances, and are truthfully labeled, among other things. 34 Generally, food intended for human or animal consumption is not approved by FDA prior to marketing. However, any substance added to food is a food additive, subject to premarket review and approval by FDA. 35 An exception to this is if a substance is generally recognized as safe (i.e., GRAS) under the conditions of its intended use, among qualified experts, or unless the use of the substance is otherwise excepted from the definition of a food additive. 36 To obtain approval of a substance as a food additive, a person may submit to FDA a food additive petition, which proposes the issuance of a regulation prescribing the conditions under which the additive may be safely used. 37 Food additives are approved for specific uses (e.g., to improve taste, texture, or appearance; to improve or maintain nutritional value; or to maintain or improve safety and freshness). 38 If FDA determines, after reviewing the data submitted in a petition, that a proposed use of a food additive is safe, the agency issues a regulation authorizing that specific use of the substance.

The use of a food substance may be determined to be GRAS either through scientific procedures or, for a substance used in food before 1958, through scientific procedures or experience based on common use in food. 39 FDA established a voluntary GRAS notification process that permits any person to notify the agency of a conclusion that a substance is GRAS under the conditions of its intended use in human food. 40 A substance is considered GRAS on the basis of common knowledge about its safety for its intended use, and the data and information relied upon for the GRAS substance must be generally available. 41 This is in contrast to the data and information used to support a food additive petition, which are generally privately held and submitted to FDA for evaluation. Additional information about the food additive petition process and submission of GRAS notifications is available in Appendix A.

Under the FFDCA, it is unlawful to introduce into interstate commerce a food (human or animal) to which a drug has been added—either an approved drug or a drug for which substantial clinical investigations have been instituted and made public. 42 There are several exceptions to this: (1) if the drug was marketed in food before it was approved as a drug or before clinical drug investigations were instituted; (2) if the Secretary has issued a regulation, after notice and comment, approving the use of such drug in the food; (3) if the use of the drug in the food is to enhance the safety of the food and not to have independent biological or therapeutic effects on humans, and the use is in conformity with specified requirements; or (4) if the drug is a new animal drug whose use is not unsafe under FFDCA Section 512. 43 FDA has concluded, based on available evidence, that none of these are the case for CBD, and because CBD is an active ingredient in an approved drug, FDA has taken the position that it is unlawful to introduce into interstate commerce food containing added CBD (i.e., to use CBD as a food additive). 44

However, according to FDA, cannabis-derived ingredients that do not contain CBD (or THC) may fall outside the scope of this prohibition. 45 Foods containing parts of the hemp plant that include only trace amounts of CBD (e.g., hemp seed and ingredients derived from hemp seed) may be lawfully marketed under certain circumstances—pursuant to FDA approval as a food additive or a GRAS determination. In December 2018, FDA announced that it had completed its evaluation of three GRAS notices related to hemp seed-derived ingredients (i.e., hulled hemp seeds, hemp seed protein, and hemp seed oil). 46 FDA had no questions regarding the company’s conclusion that the use of such products as described in the notices is safe. Thus, FDA allowed them to be marketed in human foods—without food additive approval—for the uses specified in the GRAS notices, provided they comply with all other applicable requirements. Intended uses of the hemp seed-derived ingredients include adding them as a source of protein, carbohydrates, oil, and other nutrients to beverages (e.g., smoothies, protein drinks, and plant-based alternatives to dairy products), as well as to soups, dressings, baked goods, snacks, and nutrition bars.

While FDA has determined that it is unlawful to introduce into interstate commerce food to which CBD has been added, independent of CBD’s status as a drug ingredient, CBD has not been approved as a food additive. FDA also has determined that “[b]ased on a lack of scientific information supporting the safety of CBD in food … it cannot conclude that CBD is [GRAS] among qualified experts for its use in human or animal food.” 47

Animal Food and Feed Considerations

As previously noted, the FFDCA definition of food includes animal food. Similar to food intended for human consumption, animal food is not subject to premarket approval by FDA unless it meets the definition of a food additive. In that case, it would be subject to the premarket requirements for food additives (or GRAS exemption). Depending on the claims made, certain animal feed/food may meet the FFDCA definition of a drug. 48 Like human drugs, animal drugs require FDA approval prior to marketing. 49 In some cases, animal food may be considered both a food and a drug simultaneously. 50 Although premarket approval by FDA is not required for most animal food (excluding animal drugs), other federal and state rules govern their manufacture and sale. These include, for example, labeling requirements and ingredient definitions. 51

As previously noted, it is a prohibited act, with certain exceptions, under the FFDCA to introduce into interstate commerce animal food to which a drug has been added—either an approved drug or a drug for which substantial clinical investigations have been instituted and made public. 52 Some cannabis-derived ingredients that do not contain CBD or contain only trace amounts of CBD (e.g., hemp seed and ingredients derived from hemp seed) may fall outside the scope of this prohibition and may be lawfully marketed pursuant to FDA approval as a food additive or a GRAS determination. 53 However, to date, FDA has not approved any food additive petitions or evaluated any GRAS notices related to use of hemp seed and hemp-seed derived ingredients in animal food. 54 In addition, as previously mentioned, FDA has stated that “[b]ased on a lack of scientific information supporting the safety of CBD in food … it cannot conclude that CBD is [GRAS] among qualified experts for its use in human or animal food.” 55

While FDA is the primary federal agency responsible for regulating the safety of food, the agency works with states and the Association of American Feed Control Officials (AAFCO) in the implementation of uniform policies for regulating the use of animal food products. For example, FDA provides scientific and technical assistance to the AAFCO ingredient Definition Request Process, the purpose of which is to “identify the safety, utility, and identity of ingredients used in animal feed.” 56 CVM recognizes ingredients listed in the Official Publication of the AAFCO as being acceptable for use in animal food. According to FDA, “there are no approved food additive petitions or ingredient definitions listed in the AAFCO OP for any substances derived from hemp, and we are unaware of any GRAS conclusions regarding the use of any substances derived from hemp in animal food.” 57 AAFCO has issued guidelines on hemp in animal food, which are generally consistent with FDA’s policy. 58 The guidelines also note that, based on discussions with FDA and the hemp industry,

materials and products that are CBD-infused need to be treated as drugs because the intended uses are largely associated with drug claims. This means that parts of the hemp plant will not be appropriate for approval as an animal feed ingredient. As such, products that contain CBD as a feed ingredient could be labeled adulterated or misbranded and be subject to regulatory actions by state agencies. 59

Dietary Supplements

A dietary supplement is defined as a product (other than tobacco) that

  • is intended to supplement the diet;
  • is intended to be taken by mouth as a pill, capsule, powder, tablet, or liquid; and
  • contains one or more of the following dietary ingredients: vitamins, minerals, herbs or other botanicals, amino acids, and other substances or their constituents. 60

Dietary supplements are generally regulated as food under the FFDCA 61 and, as such, are not subject to premarket approval. Dietary supplements must comply with FDA’s regulations prescribing CGMPs related to manufacturing, packaging, labeling, or holding dietary supplements to ensure their quality. 62 A dietary supplement may not claim to diagnose, cure, mitigate, treat, or prevent a specific disease or class of diseases. 63

FDA does not evaluate the safety and effectiveness of dietary supplements prior to marketing; however, supplements are subject to various statutory and regulatory requirements. Among other things, a firm that seeks to market a dietary supplement containing a new dietary ingredient (NDI) must notify FDA at least 75 days prior to marketing. The manufacturer or distributor of the dietary supplement that contains an NDI subject to the notification requirements may not market the supplement until 75 days after the filing date. 64 An NDI is defined as a dietary ingredient that was not marketed as a dietary supplement in the United States before October 15, 1994. 65 An exception to the NDI notification requirement is if the dietary ingredient was “present in the food supply as an article used for food in a form in which the food has not been chemically altered.” 66 In this case, the dietary ingredient would still be considered an NDI because it was not marketed prior to October 15, 1994, but it would be exempt from the notification requirement. 67 An NDI notification must include a “history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe,” along with other information. 68 FDA acknowledges receipt of the NDI notification and notifies the submitter of the date of receipt, which is also the NDI notification filing date. FDA must keep the information in the NDI notification confidential for the first 90 days after receiving it. 69 If the manufacturer or distributor submits additional information in support of the NDI notification, FDA may reset the 75-day period and assign a new filing date. 70 FDA does not approve NDI notifications. Instead, the agency generally issues one of four response letters: (1) a letter of acknowledgment without objection; (2) a letter listing deficiencies that make the notification incomplete; (3) an objection letter raising safety concerns based on information in the notification or identifying gaps in the history of use or other evidence of safety; or (4) a letter raising other regulatory issues with the NDI or dietary supplement (e.g., the NDI or supplement is excluded from the definition of a dietary supplement). 71

Under the FFDCA, an article that is an active ingredient in an approved drug, or that has been authorized for investigation as a new drug and for which the existence of such clinical investigations has been made public, is excluded from the definition of a dietary supplement and may not be marketed as such. 72 An exception to this is if FDA issues a regulation finding that the use of such substance in a dietary supplement is lawful. An article that is approved as a drug or being investigated as a drug may be marketed in or as a dietary supplement if it was marketed as a dietary supplement or as a food prior to approval or clinical investigation (before the IND became effective). 73 According to FDA, CBD is an active ingredient in an FDA-approved drug (i.e., Epidiolex), and it was authorized for investigation as a new drug for which substantial clinical investigations had been instituted and made public before its marketing as a dietary supplement. As such, FDA has determined that CBD may not be sold as a dietary supplement unless FDA promulgates regulations concluding otherwise, regardless of whether the CBD is hemp-derived or marijuana-derived. 74 FDA has issued several public statements maintaining that it is unlawful to market CBD as, or in, dietary supplements. 75

FDA may issue a regulation, after notice and comment, creating an exception that allows CBD to be marketed as a dietary supplement. 76 Such a regulation may be requested by an interested person through the filing of a citizen petition. 77 If an interested party has evidence challenging FDA’s conclusion excluding CBD from the dietary supplement definition, the party may submit to FDA a citizen petition asking the agency to issue a regulation, subject to notice and comment, finding that the ingredient, when used as or in a dietary supplement, would be lawful. To date, FDA has not issued such a regulation for any substance (whether cannabis-derived or not) that is an active ingredient in an approved drug or is authorized for investigation as a new drug. 78 If FDA were to issue a regulation allowing CBD to be marketed as a dietary supplement, that product likely would be expected to comply with the various requirements governing lawful marketing of supplements, including compliance with CGMPs and NDI notification. Despite FDA’s determination that marketing CBD as a dietary supplement is unlawful, these products remain on the market.

On November 14, 2019, the Consumer Healthcare Products Association (CHPA) submitted a citizen petition to FDA, asking the agency to “exercise its statutory authority and discretion to engage in rulemaking that establishes a regulatory pathway to legally market dietary supplements containing [CBD] derived from hemp (as defined in 7 U.S.C. В§1639o(1))” and to require that manufacturers of CBD-containing dietary supplements submit NDI notifications. 79 It is unclear whether other citizen petitions have been submitted to FDA requesting that it issue a regulation allowing CBD to be marketed as a dietary supplement.

Cosmetics and Personal Care Products

The FFDCA defines cosmetics as “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.” 80 FDA has the authority to take certain enforcement action against adulterated or misbranded cosmetics. A cosmetic is deemed adulterated if, among other things, it contains a poisonous or deleterious substance, or if it has been made or held in unsanitary conditions. 81 A cosmetic is deemed misbranded if, among other things, “its labeling is false or misleading in any particular,” or if the label lacks required information. 82 In addition, if a product makes therapeutic claims (i.e., that its intended use is the cure, mitigation, treatment, or prevention of a disease), FDA generally considers that product to be a drug (or a drug-cosmetic) and subject to the FFDCA drug requirements. If a company has not obtained approval of a new drug prior to marketing, it is in violation of the FFDCA. For example, in October 2019, FDA sent a warning letter to a manufacturer marketing a CBD body butter with therapeutic claims. 83

However, FDA’s authority over cosmetic products is generally more limited than for the other products that the agency regulates. FDA does not have the authority to conduct premarket review of cosmetic ingredients, nor can FDA require cosmetics manufacturers to submit data substantiating the safety of their cosmetics. While FDA regulations prohibit or restrict the use of certain ingredients in cosmetics, the regulations do not apply to any cannabis or cannabis-derived ingredients (e.g., CBD). 84

Legislation has been introduced in the 116 th Congress that would expand FDA’s authority to regulate cosmetic products and would require a safety review of certain ingredients, among other things. 85 If CBD were included in such a review and found to be unsafe for use in cosmetics, that finding would likely affect whether CBD could be marketed in cosmetics.

Tobacco Products

FDA regulates the manufacture, marketing, and distribution of tobacco products, per its authorities in the FFDCA, as amended by the Family Smoking Prevention and Tobacco Control Act of 2009 (TCA; P.L. 111-31 ). A tobacco product is defined as “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)” that is not a drug, device, or drug-device combination product. 86 Nicotine is an addictive chemical compound present in the tobacco plant. Tobacco products—including cigarettes, cigars, smokeless tobacco, hookah tobacco, and most ENDS—contain nicotine. 87 Tobacco-derived nicotine (as well as any other tobacco-derived compound) meets the statutory definition of a tobacco product. 88

In 2016, FDA promulgated regulations (known as the deeming rule) 89 that extend authority over all products meeting the definition of a tobacco product that were not already subject to the FFDCA, including ENDS. In the deeming rule, FDA clarified its authority to regulate all components and parts associated with ENDS, including e-liquids. E-liquids, which can include nicotine, flavorings, and other ingredients, are heated in ENDS to create a vapor that a user inhales. If an e-liquid contains CBD and makes therapeutic claims, it may be considered an unapproved drug and may be in violation of the FFDCA. In addition, if an e-liquid contains any tobacco-derived compound (e.g., nicotine) and CBD, but does not make therapeutic claims for CBD, the product may still meet the statutory definition of a tobacco product because it includes tobacco-derived compounds. In such case, the product may be subject to FDA’s tobacco regulatory authorities, although the product might not receive marketing authorization if it is determined that allowing the product to be marketed would not be appropriate for the protection of public health. 90 However, if the e-liquid contains CBD only, with no tobacco-derived compounds, and does not make therapeutic claims, FDA’s enforcement options might be limited. In this case, it would be unclear whether the product meets the statutory definition of a tobacco product and is therefore subject to FDA’s tobacco regulatory authorities. FDA has stated that it intends to make a determination about regulating such products as tobacco products on a case-by-case basis. 91

Table 1. Summary of Selected FDA Requirements, by CBD Product Type

Foods and Food Additives

[21 U.S.C. В§360; 21 C.F.R. Part 207]

[21 U.S.C. В§350d; 21 C.F.R. Part 1 Subpart H]

[21 U.S.C. В§350d; 21 C.F.R. Part 1 Subpart H]

[21 U.S.C. В§360(j); 21 C.F.R. Part 207]

Yes [21 U.S.C. В§387j] b

Compliance with CGMPs

[21 U.S.C. В§351(a)(2)(B); 21 C.F.R. Part 210 and 211]

[21 U.S.C. В§342(a); 21 C.F.R. Part 110]

[21 U.S.C. В§342(g); 21 C.F.R. Part 111]

[21 U.S.C. В§387f(e); regulations not promulgated yet]

Adverse event reporting

[21 U.S.C. В§355(k); 21 C.F.R. В§314.80]

Mandatory recall authority

No (with the exception of controlled substances c )

21 U.S.C. В§342; 21 U.S.C. В§350b

Source: Table created by CRS based on 21 U.S.C. §§301 et. seq.

a. Food is generally not approved by FDA prior to marketing. However, food additives are subject to premarket review and approval by FDA unless generally recognized as safe (i.e., GRAS).

b. FDA has delayed enforcement of premarket review requirements for certain tobacco products—including ENDS—providing manufacturers more time to prepare for the review process. Accordingly, manufacturers may soon need to obtain FDA authorization for such products to remain on the market, or risk enforcement action.

c. In general, FDA does not have mandatory recall authority over drugs. Instead, FDA can ask a manufacturer to voluntarily recall a drug. However, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act ( P.L. 115-271 ; the SUPPORT Act) authorized FDA to order a mandatory recall for a controlled substance that presents a public health risk [21 U.S.C. §360bbb–8d].

Alcohol Beverage Products

While TTB is the primary federal regulator of alcoholic beverages, FDA plays a role in determining what ingredients may be used in the production of alcoholic beverages. In general, before a hemp ingredient may be used in the production of an alcohol beverage product—whether it be a distilled spirit, wine, or beer—the producer may be required to request formula approval from TTB. Requirements are outlined in the Federal Alcohol Administration Act (27 U.S.C. В§201 et seq.) and in regulation. 92 For distilled spirits, for example, an approved formula is required to “blend, mix, purify, refine, compound, or treat spirits in a manner which results in a change of character, composition, class or type of the spirits;” any change in an approved formula requires a new filing. 93 For wine, formula approval is required for “special natural wine, agricultural wine, and other than standard wine (except distilling material or vinegar stock).” 94 For beer, formula approval is required for any fermented product that “is not generally recognized as a traditional process in the production of a fermented beverage designated as ‘beer,’ ‘ale,’ ‘porter,’ ‘stout,’ ‘lager,’ or ‘malt liquor'” or to which certain ingredients are added. 95 Specific labeling requirements also apply, and generally require prior approval. 96 In addition, regarding interstate and foreign commerce in spirits, wine, and beer, it is unlawful for businesses to operate without a permit. 97 Certain states and local jurisdictions might also have their own alcohol product prohibitions and production requirements, as well as restrictions on interstate commerce.

TTB’s current policy is that the agency “will not approve any formulas for alcohol beverages that contain ingredients that are controlled substances under the CSA” (e.g., marijuana or marijuana-derived CBD). 98 With regard to CBD derived from hemp, TTB is in the process of updating its guidance on the use of hemp ingredients to reflect changes in the 2018 farm bill. TTB also states that it consults with FDA on ingredient safety issues and, in some cases, may “require formula applicants to obtain documentation from FDA indicating that the proposed use of an ingredient in an alcohol beverage would not violate [FFDCA].” 99 Thus, in general, TTB treats hemp-derived ingredients for alcohol beverage products as any other product ingredient. As such, any ingredients added to alcohol beverage products must be either an FDA-approved food additive or determined to be GRAS. As aforementioned, to date, FDA has evaluated GRAS determinations for three different hemp seed-derived ingredients that do not contain CBD, although allowed uses do not include addition to alcoholic beverages. 100 With regard to CBD, FDA has determined that it is unlawful to introduce into interstate commerce food to which certain drug ingredients (e.g., CBD) have been added. Additionally, independent of CBD’s status as a drug ingredient, CBD has not been approved as a food additive, and FDA has determined that “[b]ased on a lack of scientific information supporting the safety of CBD in food … it cannot conclude that CBD is [GRAS] among qualified experts for its use in human or animal food.” 101

Formulations seeking approval to use other types of hemp extracts as an ingredient—including but not limited to CBD—would likely not be approved by TTB, since these extracts have not been authorized for use in food by FDA. 102

Therapeutic Uses of CBD and ResearchВ Considerations

Cannabinoids such THC and CBD interact with specific cell receptors in the brain and throughout the body to produce their intended effects. Although THC activates certain receptors that then produce euphoric or intoxicating effects, 103 CBD has low affinity for those same receptors and therefore does not produce intoxicating effects. 104 This property may make CBD an attractive compound for drug developers. In addition, preclinical (e.g., animal model) research suggests that CBD may interact with other brain-signaling systems that can produce therapeutic effects, such as the reduction of seizures, pain, and anxiety. 105

The therapeutic benefits, or underlying mechanism of action for therapeutic benefits, of CBD remain uncertain, even in CBD-containing drugs that have been approved by regulatory agencies. For example, in the United States, GW Pharmaceuticals’ Epidiolex (CBD) is approved for the treatment of seizures associated with two rare and severe forms of epilepsy. However, according to the drug’s labeling, the mechanism by which the drug exerts its anticonvulsant effects is not known. 106 In addition, while not yet approved in the United States, GW Pharmaceuticals’ drug Sativex (nabiximols)—a cannabis extract spray containing a 1:1 ratio of CBD and delta-9 THC—has regulatory approval in more than 25 countries for the treatment of spasticity (muscle stiffness/spasm) due to multiple sclerosis (MS). 107 In Canada, Sativex has conditional marketing authorization as an adjunctive treatment for neuropathic pain in adult patients with MS and “as adjunctive analgesic [pain relieving] treatment in adult patients with advanced cancer who experience moderate to severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain.” 108 However, Phase III clinical trials previously conducted by GW Pharmaceuticals found that Sativex failed to show superiority over placebo in treating the pain of patients with advanced cancer who experience inadequate analgesia during optimized chronic opioid therapy. 109 Furthermore, while CBD is predicted to have anti-inflammatory properties, which may play a role in its analgesic effects, preliminary evidence suggests that the analgesia is mediated by THC, and the extent to which CBD contributes to those therapeutic effects is unclear. 110

CBD is the subject of numerous ongoing randomized controlled trials (RCTs). 111 As of December 2019, a database maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH) lists numerous domestic and international ongoing RCTs involving cannabinoids—including CBD—as a treatment for a variety of conditions, including chronic pain, tremors associated with Parkinson’s disease, and anxiety. 112 GW Pharmaceuticals is also studying CBD and CBD variants in clinical trials for autism and schizophrenia. 113 Other pharmaceutical manufacturers are conducting clinical trials with CBD and its variants for other indications, including severe acne and graft-versus-host disease (GVHD). 114 However, until such studies are completed, conclusive evidence supporting the use of CBD to treat various health conditions is limited.

In February 2017, the National Academies of Sciences, Engineering, and Medicine (NASEM) published a comprehensive review of fair- and good-quality systematic reviews of literature and high-quality primary research on cannabis and cannabinoids. 115 NASEM did not make specific comparisons between cannabinoids derived from hemp versus marijuana, or between cannabinoids from low versus high THC strains of marijuana. However, for CBD or CBD-enriched cannabis specifically, the report noted research gaps among existing literature in treating numerous conditions, including cancer in general, chemotherapy-induced nausea, epilepsy, and post-traumatic stress disorder (PTSD), among other conditions. 116 Nonetheless, CBD is promoted as treatment for a range of conditions, including PTSD, anxiety, inflammation, and sleeplessness—despite limited scientific evidence substantiating or disproving these claims. 117

These research gaps can be attributed, in part, to the status of marijuana as a Schedule I controlled substance under the CSA. Individuals who seek to conduct research on any controlled substance must do so in accordance with the CSA and other federal laws. 118 DEA research requirements are more stringent for Schedule I and Schedule II substances than for substances in Schedules III-V. For example, for Schedule I substances such as marijuana, even if practitioners have a DEA registration for a substance in Schedules II-V, they must obtain a separate DEA registration for researching a Schedule I substance. In addition, due to its Schedule I status, the DEA strictly limits the quantity of marijuana manufactured each year. These requirements can prolong the process of acquiring marijuana (including marijuana-derived CBD) for research. As mentioned previously, the 2018 farm bill removed hemp and hemp derivatives (including hemp-derived CBD) from the CSA definition of marijuana, making them no longer subject to regulation and oversight as a controlled substance by DEA. DEA has confirmed that a DEA registration is no longer required to grow or research hemp plants and CBD preparations that meet the statutory definition of hemp. 119 However, CBD preparations containing above the 0.3% delta-9 THC level (i.e., meeting the statutory definition of marijuana) continue to be subject to Schedule I CSA requirements. As a result, conducting research on these substances may continue to be a challenge. 120

Considerations for Congress: Marketing of CBD

What Are the Circumstances Under Which FDA-Regulated Products Containing CBD Can Be MarketedВ Currently?

As mentioned previously, FDA has determined that at this time, CBD cannot be added to any food that is sold in interstate commerce and that CBD cannot be marketed as a dietary supplement. Although FDA could issue a regulation allowing CBD to be added to food or allowing its use in dietary supplements, the agency has never issued such a regulation for any substance (whether cannabis-derived or not) that is an approved drug or authorized for investigation as a new drug. 121 Although FDA has determined that CBD (and THC) may not be added to food or marketed as a dietary supplement, the agency has not made this same determination for other compounds derived from cannabis, although those compounds may be subject to DEA restrictions; FDA’s determination is specific to CBD and THC because both are active ingredients in FDA-approved drugs. 122 FDA also has not determined that CBD may not be added to cosmetics; 123 however, if a CBD-containing cosmetic product makes therapeutic claims (e.g., that it is intended to diagnose, treat, cure, mitigate, or prevent a disease), FDA would likely consider the product to be a drug subject to the new drug approval requirements.

CBD may be lawfully marketed as a drug, pursuant to FDA approval, and in compliance with applicable statutory and regulatory requirements. If a firm seeks to market CBD as a treatment or an otherwise therapeutic product, the firm generally would need to obtain premarket approval from FDA via the new drug approval pathway. To date, FDA has approved one CBD-containing drug, Epidiolex, which is available by prescription for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years old and older. Epidiolex is marketed by GW Pharmaceuticals.

On May 31, 2019, FDA held a public hearing “to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.” 124 Prior to the hearing, FDA had opened a docket to which interested stakeholders could submit a request for FDA to review scientific data and information about products containing cannabis or cannabis-derived compounds. 125 Although FDA has maintained that it is unlawful to add CBD to food or to market CBD as a dietary supplement, CBD continues to be marketed in violation of this determination. The agency has generally prioritized enforcement against companies and products that pose the greatest risk to consumers—for example, products making claims that CBD can treat Alzheimer’s or stop cancer cell growth. 126 FDA has said that it “does not have a policy of enforcement discretion with respect to any CBD products,” 127 although this is expected to change in light of language included in the explanatory statement accompanying the FY2020 enacted appropriation (see “What Could Congress Do to Allow CBD to Be Marketed as a Food Additive or Dietary Supplement?”).

Some industry stakeholders are recommending that, absent an FDA regulatory framework for CBD products, manufacturers and marketers of dietary supplements or foods that contain hemp or CBD comply with federal regulations for supplements and food in the interim to help ensure the quality of these CBD products. Such compliance would include facility registration, adherence to CGMPs, and meeting labeling requirements. 128 In an effort to establish industry-wide standards, one organization has established its own third-party certification program designed for hemp food, dietary supplements, and cosmetic companies. 129 This certification program is independent of federal requirements, and FDA has not validated or verified any third-party certification program for hemp.

What Is the Current State of the CBD Market?

At the retail level, consumer products labeled as containing CBD are being marketed and sold in food and beverages, cosmetics and personal care products, certain tobacco products, and dietary supplements—despite FDA’s position that CBD may not be sold in food and beverages or dietary supplements. CBD-containing products that claim to meet the definition of hemp are sold through specialty retailers, such as natural/organic grocery stores, tobacco (or smoke) shops, yoga studios, and farmers’ markets; through direct-to-consumer and online sales; from herbal practitioners; and by large retailers such as CVS and Walgreens.

Although some industry analysts foresee a strong market for marijuana-derived CBD, it remains prohibited (aside for lawful research purposes) under the CSA if the product does not meet the statutory definition of hemp in 7 U.S.C. §1639o. The DEA has confirmed that a DEA registration is not required to grow or research hemp plants and CBD preparations that meet the statutory definition of hemp. 130 Despite the federal prohibition on growing, selling, or possessing marijuana, marijuana-derived CBD products that have not been approved by FDA have been made available in states where medical and/or recreational cannabis is legal under state law, in violation of federal law. Depending on where a CBD product is manufactured and sold, it may primarily be produced using only drug-grade cannabis and marketed as a medicinal or therapeutic product, in violation of FDA requirements. To date, most of the CBD products sold in states where medical and/or recreational cannabis is legal do not meet the statutory definition of hemp. Typically, these products contain 0.45% to 1.5% THC, with some products containing up to 9% THC—levels that could result in psychoactive effects by the user. 131

In 2018, CBD sales in the United States were estimated at $534 million, according to the Hemp Business Journal. 132 This amount includes sales from hemp-derived CBD products, marijuana-derived CBD products (currently a Schedule I controlled substance), and the FDA-approved drug Epidiolex. In 2018, more than 1,000 companies were producing and marketing CBD products for the U.S. market. 133 Since 2014, when total CBD sales were a reported $108 million, U.S. sales of CBD have risen fivefold ( Figure 3). In 2018, hemp- and marijuana-derived CBD sales were $240 million and $264 million, respectively, while sales of Epidiolex were estimated at $30 million ( Figure 3).

Current projections of U.S. sales of CBD indicate expected growth over the next few years. Such sales are expected to exceed $1 billion in 2020 and reach nearly $2 billion in 2022, roughly split between the three markets (hemp-derived, marijuana-derived, and pharmaceutical CBD; see Figure 3). Others forecast sales well beyond these levels, with some predicting that sales of hemp-derived CBD will eventually dominate the cannabis market, since hemp-derived CBD does not tend to carry the stigma associated with marijuana. 134 An ATKearney survey shows that U.S. consumers, regardless of age, strongly believe that cannabis can “offer wellness and therapeutic benefits,” ranging from 74% to 83% of those surveyed across all age demographics. 135 Some global markets where cannabis is legal are already reporting product shortages of CBD medicinal cannabis products. 136 In the United States, growth in CBD sales is expected despite continued regulatory and legal uncertainty, given continued FDA, DEA, and state and local restrictions.

Figure 3. Total U.S. CBD Sales, by Channel

Source: Hemp Business Journal, The CBD Report: 2018 Industry Outlook, 2019 (New Frontier Data).

Notes: All pharmaceutical channel sales are represented by the drug Epidiolex.

What Could Congress Do to Allow CBD to Be Marketed as a Food Additive or Dietary Supplement?

Despite FDA’s current determination that CBD cannot be marketed as a food additive or a dietary supplement, these products continue to be sold. In response, some members of Congress have expressed support for a regulatory framework for hemp-derived CBD in certain FDA-regulated consumer products. In absence of a regulatory framework for hemp-derived CBD products, Congress has directed FDA to issue a policy of enforcement discretion with respect to CBD products that meet the statutory definition of hemp that also come under FDA jurisdiction. More specifically, the explanatory statement accompanying the enacted FY2020 appropriation states that

[t]he agreement includes $2,000,000 for research, policy evaluation, market surveillance, issuance of an enforcement discretion policy, and appropriate regulatory activities with respect to products under the jurisdiction of the FDA which contain CBD and meet the definition of hemp, as set forth in section 297A of the Agricultural Marketing Act of 1946 (7 U.S.C. 16390). Within 60 days of enactment of this Act, the FDA shall provide the Committees with a report regarding the agency’s progress toward obtaining and analyzing data to help determine a policy of enforcement discretion and the process in which CBD meeting the definition of hemp will be evaluated for use in products. The FDA is further directed to perform a sampling study of the current CBD marketplace to determine the extent to which products are mislabeled or adulterated and report to the Committees within 180 days of enactment of this Act. 137

The statement does not explicitly require FDA to set a safe level or threshold for CBD in consumer products. However, the activities conducted pursuant to this directive may inform the establishment of such a level in the future. In addition to the activities directed in the explanatory statement, Congress also could take further legislative action, such as requiring FDA to issue a regulation, under its FFDCA authorities, expressly permitting CBD that meets the definition of hemp to be used as a food additive or dietary supplement. For example, such a regulation could prescribe the conditions under which CBD may be safely used as a food additive (e.g., to add flavor or nutritional value to food, in specified quantities, subject to specified labeling requirements). However, because FDA has never before issued such a regulation allowing an approved drug or a substance authorized for investigation as a new drug to be a food additive or added to a dietary supplement, it is not clear what such a regulation would look like.

Congress also could consider amending the FFDCA provisions that FDA has identified as restricting marketing of CBD in food and dietary supplements. 138 For example, Congress could exclude from these provisions CBD that meets the statutory definition of hemp. 139 However, even if the marketing of CBD-containing products were no longer restricted by these provisions, CBD-containing products may still be subject to other FFDCA requirements. For example, to lawfully market a CBD product as a dietary supplement, a firm may need to submit an NDI notification to FDA, in addition to meeting other statutory and regulatory requirements for supplements. To lawfully market CBD as a food additive, a firm would be expected to either obtain approval via a food additive petition or pursuant to a GRAS determination. As FDA has said that the agency “is not aware of any basis to conclude that CBD is GRAS among qualified experts for its use in human or animal food,” 140 a food additive petition may be necessary.

As mentioned above, food and dietary supplements are not evaluated by FDA for safety and effectiveness prior to marketing. Given this fact, in determining whether a legislative approach is appropriate, Congress may consider the potential for adverse health effects and other unintended consequences. For example, clinical trials to support the approval of Epidiolex demonstrated the potential for liver injury at certain doses, and CBD may interact with other drugs or dietary supplements. 141 Other concerns include the potential dosing and cumulative effects of exposure to CBD from multiple sources (e.g., food, supplements, and cosmetics); whether there are populations for whom CBD is not appropriate (e.g., pregnant or lactating women); and whether allowing CBD to be marketed as a supplement or food additive could undermine incentives for conducting clinical trials and obtaining evidence of safety and effectiveness to support drug approval. 142

FDA’s position with respect to the status of CBD impacts other agencies’ and regulatory bodies’ policies and guidance. For example, TTB consults with FDA on alcohol ingredient safety issues and generally requires that any ingredient added to alcohol beverages must be either an FDA-approved food additive or determined to be GRAS. CBD is not an approved food additive nor has it been found to be GRAS for use in alcohol or otherwise. It remains to be seen whether TTB would allow CBD that meets the definition of hemp to be added to alcoholic beverages if FDA issues a policy of enforcement discretion as directed by the explanatory statement accompanying the FY2020 enacted appropriation. Similarly, the AAFCO has issued guidelines on hemp in animal food, which are generally consistent with FDA’s policy. A new policy of enforcement discretion issued pursuant to the language in the explanatory statement may affect AAFCO’s guidelines. Additionally, in May 2019, the U.S. Patent and Trademark Office (USPTO) issued guidance that limits trademark registrations for CBD products. USPTO’s guidance describes how it would review marks for cannabis and cannabis-related goods and services, and clarifies that compliance with federal law is a condition of federal trademark registration, regardless of the legality of the activities under state law. It further states that a “determination of whether commerce involving cannabis and cannabis-related goods and services is lawful requires consultation of several different federal laws,” including the CSA, FFDCA, and the 2018 farm bill ( P.L. 115-334 ). 143 Therefore, “registration of marks for foods, beverages, dietary supplements, or pet treats containing CBD will still be refused as unlawful under the FDCA, even if derived from hemp, as such goods may not be introduced lawfully into interstate commerce.” 144 Some claim that because the guidance does not specifically address cosmetic products, this could suggest that federal USPTO registration could be possible for such products; however, they also assert that USPTO is looking to FDA to further clarify conditions under which CBD foods, beverages, dietary supplements or pet treats may be lawfully marketed. 145

Appendix A. Food Additive Petition Process and GRAS Notification Submission

Food Additive Petition Process

FDA has determined that CBD cannot be added to any food that is sold in interstate commerce. FDA is authorized to issue a regulation, after notice and comment, approving the use of a drug (e.g., CBD) as a food additive, 146 although the agency has never done so for any substance. 147 The FFDCA does not specify a process for FDA to issue such a regulation, other than that it must be after notice and comment.

In regard to the process for food additive approval, FDA is authorized to “by order establish a regulation” that prescribes the conditions under which a food additive may be safely used. 148 The issuance of such regulation may be proposed by FDA on its own initiative or by an interested person via submission of a food additive petition. 149 A food additive petition must include, in addition to any explanatory or supporting data, the following information:

  • the name and all pertinent information relating to the food additive, including its chemical identity and composition (if possible);
  • a statement of the conditions of its proposed use, including directions, recommendations, and suggestions, and the proposed labeling;
  • “all relevant data bearing on the physical or other technical effect such additive is intended to produce, and the quantity of such additive required to produce such effect”;
  • a description of methods for determining the quantity of such additive in or on food, and any substance formed in or on food, because of its use; and
  • full reports of safety investigations, including the methods and controls used in conducting such investigations. 150

FDA may request that the petitioner also provide information about the manufacturing methods, facilities, and controls, as well as samples of the food additive (or articles used as its components) and samples “of the food in or on which the additive is proposed to be used.” 151 Additional requirements are specified in FDA regulations. 152 Within 30 days of the petition filing date, FDA must publish notice in the Federal Register of the regulation proposed by the petitioner. 153 Within 90 days of petition filing, FDA must issue either an order denying the petition or an order establishing a regulation prescribing the conditions under which the food additive may be used safely (e.g., particular foods in which it may be used, maximum quantity, labeling and directions). 154 This 90-day period may be extended by FDA, as specified. FDA may not issue such a regulation if a fair evaluation of the data “fails to establish that the proposed use of the food additive, under the conditions of use to be specified in the regulation, will be safe,” subject to specified limitations, or if a fair evaluation of the data “shows that the proposed use of the additive would promote deception of the consumer in violation of [the FFDCA] or would otherwise result in adulteration or in misbranding of food.” 155 FDA is authorized to fix a “tolerance limitation” if necessary to ensure safe use of the additive. 156 In considering whether the use of a food additive is safe, FDA must consider, among other relevant factors, the probable consumption of the additive and cumulative effect in the diet. 157 Any person adversely affected by such order may file objections with FDA and request a public hearing and may file for judicial review, as specified. 158 Food additive regulations may be amended or repealed. 159 An interested person may, for example, submit a food additive petition requesting issuance of a regulation allowing a new use of a previously approved additive.

If a food additive is already subject to an FDA regulation for the proposed intended use, it does not require premarket approval via a petition. 160 Instead, that food additive may be marketed by complying with the applicable food additive regulation.

GRAS Notice Submission 161

Any person may submit a notice to FDA expressing the view that a substance is GRAS and not subject to the premarket review requirements for food additives under FFDCA Section 409. A GRAS notice has seven parts, each of which must be included in a submission to FDA. If one of the seven parts of a GRAS notice is omitted, the submission must explain why that part does not apply. The seven parts of a GRAS notice are as follows:

  • 1. signed statements and certification;
  • 2. identity, method of manufacture, specifications, and physical or technical effect;
  • 3. dietary exposure;
  • 4. self-limiting levels of use;
  • 5. experience based on common use in food before 1958;
  • 6. narrative; and
  • 7. a list of supporting data and information in the GRAS notice.

FDA evaluates the submission to determine whether to file it and then informs the submitter of the agency’s decision. If FDA decides to file the GRAS notice, the agency sends a letter to the submitter with the filing date. The regulations do not specify a filing deadline for FDA. The regulations do state that FDA is required to respond to a GRAS notice within 180 days of filing. FDA may extend that timeframe by 90 days as needed. Filed GRAS notices are made public by FDA. 162

Appendix B. Abbreviations Used in this Report

Table B-1. Abbreviations Used in this Report

FDA Regulation of Cannabidiol (CBD) Consumer Products: Overview and Considerations for Congress January 21, 2020 R46189 Cannabidiol (CBD), a compound in the Cannabis sativa plant, has been