FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD)
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.
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:
- Providing information on the process needed to conduct clinical research using cannabis.
- 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.
- 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.
- 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.  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.
 Gray, et al. Identifying Prenatal Cannabis Exposure and Effects of Concurrent Tobacco Exposure on Neonatal Growth. Clinical Chemistry. 2010; 56(9): 1442-1450.
 Gunn, et al. Prenatal Exposure to cannabis and maternal and child health outcomes: a systematic review and meta-analysis. BMJ Open. 2016; 6:e009986.
 Hayatbakhsh, et al. Birth Outcomes associated with cannabis use before and during pregnancy. Pediatric Research. 2012; 71 (2): 215-219.
 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.
 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.
 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.
Weed seeds may be legal to ship across the US, DEA says
Cannabis commercial and home growers alike may be able to get their seeds from all over the country now, and not have to worry about breaking federal law. Before, because of federal illegality, cannabis seeds have been restricted to the state in which they were produced, so a strain bred and grown in one state, legally, could not go beyond that state’s boundaries.
A recent legal clarification by the federal Drug Enforcement Administration (DEA) could mean that the seeds of cannabis strains popular in one part of the country could legally be shipped to another part of the country, because the DEA considers all forms of cannabis seeds to be federally legal hemp.
That means strains popular in mature markets like Washington, Oregon, and California could make their way to legal markets on the East Coast in Massachusetts and Maine, and soon-to-open markets like New Jersey and New York.
Marijuana Moment reporter Kyle Jaeger recently unearthed a letter from DEA officials that clarifies the definition of cannabis seeds, clones, and tissue cultures, which could open up a whole range of possibilities for cannabis growers, and could spread a diversity of strains across legal markets all over the country, opening up the gene pool and leading to new trends and tastes in weed.
Are weed seeds illegal?
Right now, cannabis strains are somewhat isolated in the regions they are bred and created, as they can’t be transported beyond state lines. For example, even though recreational weed is legal at the state level in both California and Oregon, moving a plant from one of those states to the other is illegal at the federal level. This forces cannabis growers and breeders to operate within the confines of a specific state.
That’s not to say that a strain bred in California won’t end up in Oregon—it happens all the time, but it is technically illegal, according to federal law.
Many cannabis breeders and seed banks sell seeds throughout the US, but they operate in a legal gray area. Typically, seed producers say their seeds are sold for “novelty” or “souvenir” purposes, giving them a loophole to skirt the law.
If cannabis seeds are found in the mail, they could be seized and the sender or receiver arrested, however, the fact of the matter is that seeds are very difficult to detect. Cannabis seeds are usually less than a ¼” in diameter and don’t smell like weed. A packet of 10 seeds is about the size of four quarters stacked.
But all that might have changed in 2018 without anyone knowing.
Defining ‘source’ vs. ‘material’
In 2018, Congress passed a farm bill that legalized hemp in the US. It defined “hemp” as any cannabis plant with less than 0.3% THC. This allows hemp to be grown and used for industrial purposes—for creating textiles and materials. The 2018 bill also opened up hemp production for the creation of cannabinoids other than delta-9 THC, such as CBD, delta-8, and others.
Because CBD and delta-8 products are usually extracted from hemp plants, that is, cannabis plants containing less than 0.3% THC, they can be found in states that don’t have legal, recreational cannabis.
In November, Shane Pennington, counsel at Vicente Sederberg LLP in New York, wrote to DEA officials asking for clarification of the definition of a cannabis seed, clone, and tissue culture.
Cannabis seeds have always been deemed illegal because they come from plants that are high in THC. The source of the seeds is above 0.3% THC, and therefore anything that comes from those plants, such as seeds, has also been considered illegal cannabis.
Pennington argued that the source of the material doesn’t determine legality, but the material itself—meaning that because a cannabis seed itself contains less than 0.3% THC, it should be classified as hemp. If seeds are hemp, they are not a controlled substance—and are therefore federally legal.
“When it comes to determining whether a particular cannabis-related substance is federally legal ‘hemp’ or schedule I “marihuana,” it is the substance itself that matters—not its source,” Pennington wrote in a blog post.
Exotic Genetix Mike, founder of cannabis producer Exotic Genetix, said the DEA’s ruling “Is what we’ve always kind of practiced. [Seeds contain] less than 0.3% THC—they’re not a controlled substance.”
Mike welcomed the news: “It’s been clarified. Not just what we do is legal, but the money we make for doing it is also legal and not an illegal enterprise.”
What implications does this have for the weed industry?
If the DEA and federal government allow seeds to cross state lines, adults could grow and consume seeds and strains from all over the country in their own state. Certain strains would no longer be confined to a specific region, but could be enjoyed all across the nation.
“It’ll spark innovation, if people can bring it above ground, it can be regulated,” said Pennington in an interview with Leafly.
Regulation can bring more investment, a bigger industry, and more acceptance of the plant.
Breaking down transportation barriers across states would also open up the cannabis gene pool, giving breeders a bigger diversity of strains to work with. The number and diversity of new strains would likely increase, tapping into new consumer trends and flavors.
More strains also means that certain strains could be pinpointed and bred specifically for certain effects, whether for medical or recreational purposes.
But according to Pennington, perhaps the biggest implication is that “This sends a signal, clearly, to state legislators, state regulators, and to groups that lobby those folks… the federal law is more flexible than you assumed.”
States take their cue from the DEA when creating their own drug laws, so seeing the agency relax its stance on shipping cannabis genetics could cause states to follow suit, breaking down protectionist state laws.
This could also open up more accurate research on the plant, according to Pennington. For decades, cannabis research was limited to The University of Mississippi, which grew weed with a low potency, around 8% THC. However, most dispensaries sell cannabis with a THC percentage around 20%. Being able to ship genetics across the country would allow for more robust research into the plant, using strains that mirror what adults are actually buying in stores and consuming.
How binding is the DEA letter?
The DEA calls the letter an “official determination,” but whether or not they are legally bound to this position is a bit hazy.
“That to me sure seems like something the agency would either be bound to going forward or at least be very hesitant to deviate from in any kind of enforcement context,” said Pennington.
For now, the DEA’s acknowledgment that cannabis seeds, clones, and tissue cultures are not controlled substances isn’t law, but it is a big step forward in relaxing restrictions on cannabis.
USDA Releases Long-Awaited Industrial Hemp Regulations
On Tuesday, Oct. 29, USDA released the text of its interim final rule for regulations establishing a domestic hemp production program. Since this is an interim final rule, it will be in effect immediately upon being published in the Federal Register. The 2018 farm bill legalized the production of hemp as an agricultural commodity while removing it from the list of controlled substances (2018 Farm Bill Provides A Path Forward for Industrial Hemp). Industrial hemp is defined as Cannabis sativa L. and required to be below a THC threshold of 0.3%. Hemp production is legal in 46 states and the farm bill allows Idaho, Mississippi, New Hampshire and South Dakota to continue to ban production of the crop within their borders.
Ever since the 2018 farm bill was signed, farmers, regulators, stakeholders and law enforcement have been operating in a state of uncertainty as they waited for USDA to release this guidance. As is always the case in such circumstances, the rule doesn’t make everyone totally happy and there are still a few lingering questions. However, the department deserves significant credit for putting together a comprehensive set of regulations for a complicated issue in a relatively short period of time.
General Overview on Regulations for Hemp Production
In order to produce hemp, a farmer must first be licensed or authorized under a state or tribal hemp program or through the USDA hemp program. If a state or Indian tribe desires to have primary regulatory authority over hemp production in their borders, they may submit a plan for monitoring and regulating hemp production to USDA. States that have already submitted a plan will be given the chance to reaffirm the plan they want USDA to evaluate, or to submit a new plan if desired. The rule also establishes a USDA plan to regulate hemp production in states or areas where hemp production has been legalized, but no approved state plan is in place. Farmers may not grow hemp in states that have not legalized its production within their borders. Once a license application has been approved, USDA will issue a license. License applications will not be approved until Nov. 30, and a farmer cannot receive a hemp production license from a state, tribe or USDA if he/she has been convicted of a felony related to a controlled substance in the last 10 years.
In addition to the land information that must be submitted to the appropriate state or tribe, licensed farmers are also required to report their hemp crop acreage to the Farm Service Agency. This will give USDA and stakeholders a better idea of how much hemp is planted and grown in the U.S., as it is currently difficult to obtain this information. FSA reports crop acreage, including hemp, but the hemp acreage is underreported because it was not mandatory for farmers to provide the information. However, the numbers that were reported provide a general idea of where in the country hemp is grown, and at least provide a lower limit baseline to start with (Figure 1).
Remaining Under the THC Limit and Testing Procedures
A key cause of heartburn for farmers was the potential of a hemp crop coming in at a THC concentration above the 0.3% threshold. Unfortunately, seeds grown in two different geographical regions can express certain traits differently, i.e., the same type of seed grown in two different parts of the country can produce one crop with THC concentrations less than 0.3% and another with plants above that THC threshold.
Stakeholders were hoping these regulations would provide some clarity on the testing process as there was little uniformity across states in how the crop would be tested; some states would just test the top 8 inches of a plant, while others would test 6 inches, and there was little consistency in how to build up a statistically significant sample of a farmer’s crop.
These regulations require the crop be tested within 15 days prior to the anticipated harvest. There is still some confusion surrounding this. For example, if a sample is pulled 15 days before anticipated harvest, would harvest be allowed if there is a backlog at the testing laboratory and the results are not back in time? The THC concentration typically increases as the plants mature, so a crop could potentially rise above the threshold if the testing process isn’t completed early enough in those 15 days. Additionally, does the 15-day window mark the beginning of harvest or the end of harvest? Some fields may take multiple days to harvest and could conceivably be started before but finished after the 15-day window closes. USDA is requesting public comment and information regarding this sampling and harvest timeline.
Testing procedures must ensure the testing is completed by a Drug Enforcement Administration-registered laboratory using a reliable methodology for testing the THC level. USDA has issued sampling and testing procedure guidelines in separate documents attached to this interim rule. Part of the reasoning for this is to allow the department flexibility as new technologies and procedures are developed over time. Setting the testing and sampling procedures outside of the interim rule allows the guidance documents to be improved without going through an all-out rulemaking.
These new rules acknowledge the statistical uncertainty that comes with sampling and testing a hemp crop for THC. The regulations allow for the inclusion of the measurement of uncertainty as laboratories report THC test results. Essentially, the measurement of uncertainty could be understood to be similar to a margin of error (or for the economists in the room: confidence interval). When the measurement of uncertainty (e.g. +/- 0.05) is combined with the reported measurement, it produces a range resulting in the actual measurement having a known probability of falling within that range. If the 0.3% THC limit is within the range, then the sample will be considered to be hemp under these regulations, and not rise to a controlled substance. For example, say a laboratory reports a result of 0.33% THC with a measurement uncertainty of +/- 0.04. The distribution ranges from 0.29% to 0.37%, and because 0.3% is within that range, the sample will be considered industrial hemp. Again, for the economists and statistics nerds tuning in, think of a hypothesis test that fails to reject the null hypothesis that the result is statistically different than 0.3%. The measurement of uncertainty depends on multiple variables, such as the equipment being used, the methodology of the test, the sample size, the sample quality and other variables, and as such it will vary with each sample that is tested.
These new rules also acknowledge the fact that a farmer may unintentionally produce a crop that tests over the limit despite their efforts to produce a crop that complies with federal law. The rule determines that a producer does not commit a negligent violation if they produce plants that exceed the acceptable hemp THC level as long as they use reasonable efforts to grow the plant and it does not test at more than 0.5% THC on a dry weight basis. Although a farmer testing above 0.3% but below 0.5% may not be negligent, the crop is still considered a controlled substance and must be disposed of accordingly. While states and tribes will differ in how they handle farmers who become negligent, at a minimum, if a farmer negligently violates a state or tribal plan three times in a five-year period, they will be ineligible to produce hemp for the next five years. Additionally, negligent violations are not subject to criminal enforcement action.
Disposal of ‘Hot Crops’
Before the release of the interim rule, some in the industry were hoping for flexibility in the disposal of “hot crops,” or hemp crops that test over the 0.3% THC limit. Many were hoping for rules that would let farmers dispose of the plants in a more productive manner, such as composting or for soil amendments. Farmers will put considerable time, cost and effort into the crop, and it would be a shame to have to completely destroy the product with nothing to show for it. Ultimately, this rule does not address this problem the way farmers hoped. However, this aspect of the rule was essentially out of USDA’s hands. If a crop is above the THC limit, it is considered to be marijuana under the Controlled Substances Act and must be disposed of accordingly. Laws and regulations for the procedures of destroying a controlled substance are not set by USDA, and so the department was constrained in how it could address this issue. It will have to be collected for destruction by someone authorized to handle a Schedule I controlled substance, such as a DEA-registered reverse distributor or a federal, state or local law enforcement officer. Farmers must document the disposal of the crop, which is now considered marijuana. This can be accomplished by providing USDA with a copy of the documentation of disposal provided by the authorized agent or by using reporting requirements established by USDA.
The issue of interstate commerce arises when something, like industrial hemp, is legal in some states and at the federal level, but illegal in other states. There are still four states in which growing hemp is not legal, and since the 2018 farm bill was passed, the issue of transportation has been somewhat of a grey area. As an example, earlier this year, Idaho state police seized a truck carrying $1.3 million worth of hemp cultivated lawfully in Oregon that was on its way to Colorado for processing. In the 2018 farm bill and in a legal memo USDA affirmed a state’s right to enact and enforce laws regulating the production of hemp within its borders, but explicitly stated that a state or Indian tribe may not restrict the transportation of hemp within its borders. These new regulations reaffirm that no restrictions on the transportation of hemp may occur, providing farmers access to nationwide markets.
Clarity for Financial Institutions
Prior to the rule, many in the banking sector were looking for additional clarity on the legal and regulatory landscape surrounding financing in the hemp sector. Even though hemp production was legalized under the 2018 farm bill, many banks concluded the regulatory uncertainty (especially when factoring in marijuana, which is legal in many states, but illegal at the federal level) presented too great of a legal risk and opted to not participate in financing hemp production. There has been some movement over the past year to provide additional certainty, including the passage of the SAFE Banking Act in the House. However, financial institutions still remain wary of participating in this market. The banking industry has been awaiting these regulations in order to develop their own procedures regarding deposits from hemp operations. Hopefully with the release of this rule, the banking industry will develop appropriate guidance, allowing farmers to obtain financing and utilize other financial services if they produce hemp.
Felony Background Check on Workers
The 2018 farm bill limited the participation of certain convicted felons in hemp production. A person with a state or federal felony conviction relating to a controlled substance is subject to a 10-year ineligibility restriction on producing hemp, with an exclusion for those who were lawfully growing hemp under the 2014 farm bill. A question that had been subsequently raised was whether or not this restriction would only apply to the owner of the operation applying for the license, or if this would apply to every employee on the operation. Basically, in an industry already suffering from increasing labor shortages, is it really necessary to limit the pool of labor by requiring every field hand, tractor driver or janitor be subjected to this background check before an operation can grow hemp? This is an issue where the rule provides much-needed relief and clarity for producers. When filing an application to grow hemp, farmers must provide a completed criminal history report, and if the application is for a business entity, the criminal history report must be provided for each “key participant.” The rule goes on to clarify that a key participant is any individual who has a direct or indirect financial interest in the business entity, such as an owner or partner. The definition does not include shift managers or field workers. Thankfully, these rules do not make it more difficult to secure reliable farm labor.
Crop Insurance and Other Programs
After the farm bill authorized industrial hemp as a covered crop under crop insurance, some of the insurance-related uncertainty was moderated when USDA issued a bulletin in early 2019 establishing that a farmer who derived part of his or her revenue from hemp would not be found ineligible to participate in the Whole Farm Revenue Protection Plan. The bulletin also stated that hemp as a commodity was not insurable for the 2019 crop year. Later in 2019, Congress included a provision in the Disaster Relief Act requiring the Federal Crop Insurance Corporation to offer coverage under WFRP for hemp in the 2020 reinsurance year.
This interim final rule does not necessarily provide more information or clarity about crop insurance but having the rule in place is critical for hemp farmers looking to manage their risk through crop insurance. For FCIC to offer the WFRP policy in 2020, this interim final rule must take effect this fall to provide USDA’s Risk Management Agency sufficient time to take the necessary steps for authorization and for producers to start their own steps to qualify for coverage. For the 2020 crop year WFRP is available for hemp grown for fiber, flower or seeds. In order to participate in crop insurance, a farmer will need to certify acreage with FSA and identify each field, subfield or lot in which hemp is grown. Additionally, a farmer will be required to have a contract for the purchase of the hemp before being able to purchase insurance. One key point that has been made by RMA is that a crop breaching the 0.3% THC limit is not considered a covered loss under WFRP, even if that may be driven by weather conditions.
These new regulations offer much-needed guidance for farmers and others involved in the production of industrial hemp. Importantly, we now have a better idea of how the crop will be sampled and tested for its THC content and what happens when a crop breaches the 0.3% THC limit. USDA has acknowledged some of the uncertainty surrounding testing and understands that a farmer could do everything right but still have a “hot crop” and should not be unduly punished for results outside of their control. Also, the rules, thankfully, do not make it more difficult to secure reliable farm labor and they reaffirm that states that have not legalized hemp may not interfere in the interstate transportation of the crop.
Having these rules in place make it possible for other agencies and industries, such as financial institutions and crop insurance providers, to begin establishing their own guidelines and procedures for dealing with industrial hemp. While it is impressive that the department was able to put together a comprehensive set of regulations for a complicated issue in a short period of time, questions remain about some aspects of hemp production. USDA is requesting public comment on these questions and it is important for farmers and stakeholders to participate in the process.