EPIDIOLEX is the only prescription CBD drug approved by the FDA, which, among many things, means that it has a safety and efficacy profile that has been thoroughly evaluated in clinical trials. The. gov means it's official, federal government websites often end in. Gov or.
Thousand. Before sharing sensitive information, make sure you're on a federal government site. There is significant interest in the development of therapies and other consumer products derived from cannabis and its components, including cannabidiol (CBD). The FDA recognizes the potential opportunities that cannabis or cannabis-derived compounds may offer and recognizes the strong interest in these possibilities.
However, the FDA knows that some companies market products containing cannabis and cannabis-derived compounds in ways that violate the Federal Food, Drug and Cosmetic Act (Act FD%26C) and that may jeopardize the health and safety of consumers. The agency is committed to protecting public health and, at the same time, to taking steps to improve the efficiency of regulatory channels for the legal marketing of appropriate cannabis and cannabis-derived products. The FDA has several resources available that address cannabis and cannabis-derived products, such as CBD, and the agency wants to ensure that consumers and other interested parties have access to these resources in a centralized place. Below are a series of frequently asked questions and answers on this topic.
To date, the agency has not approved an application for the marketing of cannabis for the treatment of any disease or condition. However, the FDA has approved one cannabis-derived drug and three cannabis-related drugs. These approved products are only available with a prescription from a licensed health care provider. 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 aged 1 year and older.
Epidiolex has also been approved for the treatment of seizures associated with the tuberous sclerosis complex in patients aged 1 year and older. That means that the FDA has concluded that this particular drug is safe and effective for its intended use. The agency has also approved Marinol and Syndros for therapeutic uses in the United States, including for the treatment of anorexia associated with weight loss in patients with AIDS. Marinol and Syndros include the active ingredient dronabinol, a synthetic delta-9-tetrahydrocannabinol (THC) that 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. The FDA remains concerned about the proliferation of products that claim to contain CBD and are marketed for therapeutic or medical purposes, even though they have not been approved by the FDA. Often, these products are sold online and are therefore available everywhere. Selling unapproved products with baseless therapeutic claims is not only a violation of the law, but it can also put patients at risk, as these products have not been proven to be safe or effective.
This misleading marketing of unproven treatments also poses significant public health problems, since patients and other users can be influenced not to use approved therapies to treat serious and even fatal illnesses. Unlike FDA-approved drugs, products that have not been reviewed by the FDA as part of the drug approval process have not been evaluated to determine if they work, what the appropriate dose may be, if they work, how they might interact with other drugs, or if they have side effects. hazardous or other safety factors concerns. The FDA knows that unapproved cannabis or cannabis-derived products are used to treat a number of medical conditions, such as the wasting of AIDS, epilepsy, neuropathic pain, spasticity associated with multiple sclerosis, and cancer-induced nausea and chemotherapy.
FDA relies on applicants and scientific researchers to conduct research. The agency's role, as set out in Act FD%26C, is to review data submitted to the FDA in an approval request to ensure that the drug meets legal approval standards. The FDA will continue to facilitate the work of companies interested in properly marketing safe, effective and quality products, including science-based research on the medicinal uses of cannabis. The National Institutes of Health, in particular the National Cancer Institute (NCI) and the National Institute on Drug Abuse (NIDA), provide additional information on research on the medical use of cannabis.
The FDA knows that several states have 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 on the safety and efficacy of cannabis products through adequate and well-controlled clinical trials. We welcome the opportunity to speak with states that are considering supporting medical research on cannabis and its derivatives, in order to provide information on federal and scientific regulations. Information on reports of adverse events related to cannabis use is extremely limited; the FDA mainly receives reports of adverse events from approved products.
General information on the possible adverse effects of the use of cannabis and its components may come from clinical trials that have been published, as well as from spontaneously reported adverse events sent to the FDA. Additional information is needed on the safety and efficacy of cannabis and its components. Cannabis clinical trials conducted under an IND request could gather this important information as part of the drug development process. There is an exception to section 201 (ff) (B) if the substance was marketed as a dietary supplement or as a conventional food before the drug was approved or before research on new drugs was authorized, as appropriate.
However, based on the available evidence, the FDA has concluded that this is not the case with THC or CBD. The FDA is not aware of any evidence that could question its current findings that products containing THC and CBD are excluded from the definition of a dietary supplement under section 201 (ff) (B) of Act FD%26C. Interested parties can submit to the agency any evidence they consider related to this issue. Our continuous review of the information that has been presented so far has not led us to change our conclusions.
When a substance is excluded from the definition of a dietary supplement under section 201 (ff) (B) of Act FD%26C, the exclusion applies unless the FDA, at the agency's discretion, has issued a regulation, after prior notice and comment, determining that the item would be legal under Act FD%26C. To date, no such regulation has been issued for any substance. Many other legal requirements apply to dietary supplement products, including requirements related to current good manufacturing practices (cGMP) and labeling. Information on these requirements and on FDA requirements in all product areas can be found on the FDA website.
THC (dronabinol) is the active ingredient in approved medications, Marinol capsules (and generics) and Syndros oral solution. CBD is the active ingredient in the approved drug, Epidiolex. Hemp seeds are the seeds of the Cannabis sativa plant. The seeds of the plant do not naturally contain THC or CBD.
The ingredients derived from hemp seeds that are the subject of these GRAS notices contain only traces of THC and CBD, which the seeds can collect during harvesting and processing when in contact with other parts of the plant. The consumption of these ingredients derived from hemp seeds is not capable of making consumers high. The GRAS findings can be applied to ingredients for human foods marketed by other companies, if they are manufactured in a manner consistent with the notices and meet the specifications listed. Some of the intended uses of these ingredients include adding them as a source of protein, carbohydrates, oil and other nutrients to beverages (juices, shakes, protein drinks, plant-based alternatives to dairy products), soups, sauces, dressings, plant-based alternatives to meat products, desserts, products baked goods, cereals, snacks and nutritional bars.
Products that contain any of these ingredients derived from hemp seeds must declare them by name in the list of ingredients. These GRAS findings do not affect the FDA's position on adding CBD and THC to foods. A cosmetic is defined in 201 (i) as (articles intended to be rubbed, poured, sprayed or sprayed, introduced or otherwise applied to the human body or to any part of it to clean, beautify, promote attractiveness or alter appearance) and (articles intended to be used as components of any such article ; except that the term does not include soap. The FDA can take action if it has information that a cosmetic ingredient or product is not safe for consumers.
Consumers can report adverse effects related to cosmetic products through the FDA's MedWatch reporting system, either online or by phone at 1-800-FDA-1088, or by contacting the consumer complaint coordinator at the nearest FDA district office. For more information, see the FDA website on how to report a cosmetics complaint. The FDA has sent warning letters in the past to companies that illegally sell CBD products that claim to prevent, diagnose, treat or cure serious illnesses, such as cancer. Some of these products further violated the FD%26C Act because they were marketed as dietary supplements or because they involved the addition of CBD to foods.
When a product violates Act FD%26C, the FDA takes many factors into account when deciding whether or not to initiate compliance action. These factors include, among other things, the agency's resources and the threat to public health. The FDA can also consult with its federal and state partners to make decisions about whether to initiate federal compliance action. To conduct clinical research that could lead to the approval of a new drug, including research with plant materials such as cannabis, researchers must work with the FDA and submit an IND application to the Center for Drug Evaluation and Research (CDER).
The IND application process provides researchers with a path forward that includes regular interactions with the FDA to support efficient drug development and, at the same time, protect patients participating in trials. For research for use as a drug for animals, researchers would establish a research file on new drugs for animals (INAD) at the Center for Veterinary Medicine to carry out their research, rather than an IND with CDER. Expanded access is a possible avenue for a patient with a serious or life-threatening illness or condition to try an investigational medical product (drug, biological product, or medical device) for treatment outside of clinical trials when there are no comparable or satisfactory treatments available. Manufacturers can make investigational drugs available to individual patients under certain circumstances through expanded access, as described in Act FD%26C and the applicable regulations.
We understand that parents are trying to find treatments for their children's medical conditions. However, the use of untested drugs can lead to unpredictable and unforeseen consequences. Caregivers and patients can rest assured 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 strong, science-based research on the medicinal uses of drugs containing cannabis or cannabis-derived compounds, and will continue to work with companies interested in marketing safe, effective and quality products.
With the exception of Epidiolex, Marinol and Syndros, no product containing cannabis or cannabis-derived compounds (whether of plant or synthetic origin) has been approved as safe and effective for use in any patient population, whether pediatric or adult. 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 aged 1 year and older. This means that the FDA has concluded that this particular drug is safe and effective for its intended use. Controlled clinical trials that test the safety and efficacy of a drug, together with careful review through the FDA drug approval process, are the most appropriate way to bring cannabis-derived treatments to patients.
Thanks to the adequate and well-controlled clinical studies that supported this approval, and to the guarantee of manufacturing quality standards, prescribers can rely on the uniform concentration and consistent administration of the drug, which support the appropriate dosage needed to treat patients with these complexes. and severe epileptic syndromes. The FDA is aware that some cannabis products are marketed as animal health products. We want to emphasize that the FDA has not approved the use of cannabis in animals, and the agency cannot guarantee the safety or efficacy of these products.
For these reasons, the FDA warns pet owners against using such products and recommends that you talk to your veterinarian about appropriate treatment options for your pet. Signs that your pet may be suffering from adverse effects from ingesting cannabis may include lethargy, depression, severe drooling, vomiting, agitation, tremors and seizures. If you are concerned that your pet is suffering adverse effects from ingesting cannabis or any substance containing cannabis, immediately consult your veterinarian, local emergency hospital for animals, or a poison control center for animals. While the agency is aware of reports of pets using various forms of cannabis, to date, the FDA has not directly received any reports of adverse events associated with animals being administered cannabis products.
However, the adverse effects of accidental ingestion are well documented in the scientific literature. If you think your animal has suffered from the ingestion of cannabis, we recommend that you report the adverse event to the FDA. See Information on how to report medications and devices for animals for more information on how to report an adverse event related to an animal drug or how to report an adverse event or problem with a pet food. With respect to products labeled to contain hemp that may also contain THC or CBD, as mentioned above, it is prohibited under Article 301 (ll) of Act FD%26C to introduce or deliver for introduction into interstate commerce any food of animal origin to which THC or CBD has been added.
In addition, according to 21 CFR 530.20, the use of an additional label of an approved human drug on a food-producing animal is not allowed if an animal drug approved for use in food-producing animals can be used extralably for that use. In addition, according to 21 CFR 530.20 (b) (), if scientific information is not available on the human food safety aspect of the use of the approved human drug in food-producing animals, the veterinarian must take appropriate measures to ensure that the animal and its food products do not enter the food supply for humans. For more information on the use of FDA-approved drugs in animals, see Extra-label use of FDA-approved drugs in animals. Over a short period of time, our society has seen a rapid increase in the interest and availability of cannabidiol (CBD) products and other cannabis-derived products.
However, we still have limited knowledge of the safety profile of CBD and many other cannabis-derived compounds, including potential safety risks for people and animals. In the US, we see these knowledge gaps as an opportunity to develop new ways of constructing science to inform public health decisions. The FDA evaluates CBD like any other substance we regulate, under a regulatory framework defined by law and with rigorous scientific evidence as the basis for both our regulatory approach and the information we communicate. We have consistently reported concerns and questions about the science, safety and quality of many of these products based on currently available evidence.
We still don't have clear answers to important questions, such as what adverse reactions may be associated with CBD products and what risks are associated with long-term use of CBD products. Better data is needed in these areas so that FDA and other public health agencies can make informed, science-based decisions that impact public health. We see an important public health opportunity in the use of novel data sources and rigorous analytical methods to build a stronger scientific evidence base on the safety profile and use of CBD products. The FDA is in a unique position to contribute its experience in evaluating data from different sources to inform regulatory decision-making.
We believe that real-world data (RWD) on the use and safety of CBD play a crucial role, together with data from other types of studies, in filling current gaps in our understanding. The following is a brief description of our work on the CBD and a framework for building a stronger evidence base that serves as an evidence base for informing public health decisions. The FDA has approved a drug, Epidiolex, containing a highly purified form of CBD for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS) or the tuberous sclerosis complex (TSC) in people aged one year and older. During the review of the Epidiolex marketing application, the FDA identified certain safety risks, including the possibility of liver injury and adverse reactions caused by the interaction between Epidiolex and other drugs.
These risks are listed on the approved Epidiolex label. While the FDA appreciates the information and commitment of many interested parties on issues related to CBD, there are still many gaps in the evidence. Bridging these gaps will not be a trivial exercise, but will require high-quality data analyzed with robust methods. We believe that there is an opportunity to develop better sources of RWD to provide gradual improvements in our scientific understanding of the safety profile of CBD in the general population and, potentially, in specific populations.
Below, we describe a framework for FDA's work in developing research projects that lay the methodological foundation for high-quality RWD science on the safety and use of CBD products. These research projects would be aimed at taking advantage of the independent quality and safety monitoring efforts currently existing at the state and national levels, data models from observational studies, and novel data sources to develop stronger capacities and methods for collection and analysis of CBD data. We know from experience that collaborative projects with researchers from government, academia and the private sector can stimulate rapid progress in developing rigorous methods for collecting and analyzing RWD. More recently, in the context of COVID-19, collaborative research projects between the FDA and external data experts have focused on the use of RWD to improve analytical methods and inform the public health response to the pandemic.
It is important to note that there are research questions for which RWD research projects are unlikely to replace certain types of traditional studies. We don't expect observational data analysis to replace other types of studies in certain contexts. For example, properly designed animal studies can address toxicological problems that are difficult to study in humans, such as chronic, developmental and reproductive toxicity. However, we strongly believe that RWD, when compiled and analyzed using rigorous methods, can be important in advancing science, including by helping to generate hypotheses and refining the design of follow-up studies.
For example, the RWD can identify new potential adverse events or subpopulations of CBD users that should be the focus of follow-up studies. For CBD data collection and analysis efforts to have maximum scientific impact, they must be designed to address the most important practical and scientific challenges in this area. Below, we highlight the challenges in current capacities to collect and evaluate CBD-related data and point to a framework for the development of research projects by the FDA that take advantage of novel data sources and can lay the foundation for further research on the safety profile of CBD products. First, we describe the principles that we believe should guide this work.
The use of novel data sources to complement other scientific data (p. ex. We see promise in small, specific projects that improve short-term data methods and point to future opportunities to collect and analyze data on CBD products and, potentially, other types of products in the future. Sign up for FDA Voices email notifications.
Cannabidiol (CBD) is a compound found in marijuana. CBD is not harmful, meaning it doesn't cause a “high”. Hemp is defined as any part of the cannabis sativa plant with no more than 0.3% tetrahydrocannabinol (THC), the mind-altering substance in marijuana. Scientists are still learning how CBD affects the body.
The Food and Drug Administration (FDA) approved Epidiolex, a drug containing CBD purified from hemp, to help treat rare seizure disorders. The FDA has concluded that this medication is safe and effective for this intended use. However, other marketed products and uses of CBD may not be approved by the FDA. CBD is not recommended for use during pregnancy.
The potential health effects of using CBD products during pregnancy are currently unknown. In animals, high doses of CBD have caused negative effects on developing fetuses. 4 We don't know if CBD is transmitted to a baby through breast milk. Since the negative effects have been associated with the consumption of CBD, people who are breastfeeding are advised to avoid CBD.
We don't know the effects of CBD on children's developing brains. If you use products that contain CBD or THC, store them in child-proof containers and out of reach of children. If you have more questions, contact your health care provider, health department, or local or regional poison control center at 1-800-222-1222 or 911 if it's an emergency. There are a lot of things we don't know about CBD.
Currently, we don't know how CBD consumption affects a person over time. Nor do we know how the different modes of CBD are used (smoking, vaping, eating, applying it to the skin, etc.). Many companies that sell hemp and CBD products also sell products that contain THC. People should be careful not to confuse THC products with hemp or CBD products.
Products containing THC can cause psychoactive effects and adverse events. In addition, most CBD products are not regulated by the FDA. Therefore, consumers should know that products labeled as hemp or CBD may contain other ingredients, such as THC, pesticides, heavy metals, bacteria or fungi. 5 If consumers experience adverse effects from products containing THC or CBD that pose an immediate danger to their health, they should call their local or regional poison control center at 1-800-222-1222 or 911, or seek medical attention at the local emergency room and report the ingredients of the products What has consumed health care providers.
Epidiolex treats two rare forms of epilepsy in children over two years of age, Lennox-Gastaut syndrome and Dravet syndrome. Specifically, the warning letters address the illegal marketing of unapproved drugs labeled as containing CBD. This alert warns consumers about the potential for adverse effects due to insufficient labeling of products containing THC and CBD. CBD and delta-8 THC are food additives not approved for use in any human or animal food product, since the FDA knows no basis for concluding that the substances are generally recognized as safe (GRAS) or are exempt from food additive requirements.