These approved drugs are only available with a prescription from an authorized health care provider. It is important to note that the FDA has not approved any other cannabis product, derived from cannabis or from cannabidiol (CBD) currently available on the market. gov means it's official, federal government websites often end in. government or.
Thousand. Before sharing sensitive information, make sure you're on a federal government site. FDA News Releases and Statements The FDA Cannabis Products Committee (CPC) develops and implements inter-agency strategies and policies for the regulation of cannabis products. Below you will find a series of frequently asked questions and answers on this topic.
To date, the agency has not approved a marketing application for cannabis for the treatment of any disease or condition. However, the FDA has approved one drug derived from cannabis and three related to cannabis. These approved products are only available with a prescription from an authorized 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 or older.
It has also approved Epidiolex for the treatment of seizures associated with the tuberous sclerosis complex in patients aged 1 year or 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 AIDS patients. 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 that are marketed for therapeutic or medical uses, even though they have not been approved by the FDA. Often, these 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 it can also put patients at risk, since these products have not been proven to be safe or effective.
This misleading marketing of unproven treatments also raises significant public health problems, as patients and other consumers can be influenced not to use approved therapies to treat serious and even fatal diseases. Unlike FDA-approved drugs, products that haven't undergone FDA review as part of the drug approval process haven't been evaluated to determine if they work, what the appropriate dose is, if they work, how they might interact with other drugs, or if they have dangerous side effects or other safety issues. The FDA knows that unapproved cannabis or cannabis products are used to treat a number of medical conditions, such as wasting due to AIDS, epilepsy, neuropathic pain, spasticity associated with multiple sclerosis, and nausea induced by cancer and chemotherapy. The FDA depends on applicants and scientific researchers to carry out research.
The agency's function, as set forth in Act FD&C, 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 bringing safe, effective, and quality products to the market, including scientifically based research on the medical uses of cannabis. There is additional information on research on the medical use of cannabis at the National Institutes of Health, in particular the National Cancer Institute (NCI) and the National Institute on Drug Abuse (NIDA). 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, so that we can provide information on federal and scientific regulations. Information on adverse event reports related to cannabis use is extremely limited; the FDA primarily receives adverse event reports from approved products. General information on the possible adverse effects of using cannabis and its components may come from clinical trials that have been published, as well as from adverse events reported spontaneously and submitted 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 collect this important information as part of the drug development process. An exception to section 201 (ff) (B) exists 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 for THC or CBD.
The FDA is not aware of any evidence to call into question its current findings that THC and CBD products are excluded from the definition of dietary supplement under section 201 (ff) (B) of Act FD&C. Interested parties can submit to the agency any evidence they consider related to this topic. 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&C, 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&C.
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 can be found in all product areas 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 warnings contain only trace amounts of THC and CBD, which the seeds can pick up during harvest and processing when in contact with other parts of the plant.
The consumption of these ingredients derived from hemp seeds is not capable of causing consumers to get high. The GRAS findings can be applied to human food ingredients marketed by other companies, if they are manufactured in a manner consistent with the warnings 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, sauces, dressings, plant-based alternatives to meat products, desserts, baked goods, cereals, snacks, and nutrition 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 the addition of 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 any part of it to clean, beautify, promote attractiveness, or alter appearance) and (articles intended to be used as a component of any such article), except that such term shall 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 notification 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 webpage on how to report a complaint related to a cosmetic. 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&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to foods. When a product violates Act FD&C, the FDA considers many factors when deciding whether or not to initiate enforcement 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 when making decisions about whether or not to initiate federal enforcement action. To carry out 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 request to the Center for Drug Evaluation and Research (CDER). The IND application process provides researchers with a path to follow that includes regular interactions with the FDA to support effective drug development and, at the same time, protect patients participating in trials.
For research for use as an animal drug, researchers would establish a new animal drug under investigation (INAD) archive at the Center for Veterinary Medicine to carry out their research, instead of an IND with the CDER. Expanded access is a potential avenue for a patient with a serious or potentially fatal disease 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 therapies available. Manufacturers may be able to make investigational drugs available to individual patients under certain circumstances through expanded access, as described in Act FD&C and enforcement regulations. 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 unforeseen 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 solid, scientifically based research on the medicinal uses of drugs containing cannabis or compounds derived from cannabis, and will continue to work with companies interested in bringing safe, effective, and quality products to the market. With the exception of Epidiolex, Marinol and Syndros, no product containing cannabis or compounds derived from cannabis (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 or older. Controlled clinical trials that test the safety and efficacy of a drug, along 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 the assurance of manufacturing quality standards, prescribers can rely on the uniform concentration and uniform administration of the drug, which support the appropriate dosing needed to treat patients with these complex and serious 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 that 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 treatment options that are right for your pet. Signs that your pet may be experiencing adverse effects from ingesting cannabis may include lethargy, depression, profuse drooling, vomiting, agitation, tremors, and seizures. If you are concerned that your pet will suffer adverse effects from ingesting cannabis or any substance containing cannabis, immediately consult your veterinarian, local emergency animal hospital, or an animal poison control center.
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 receiving cannabis products. However, the adverse effects of accidental ingestion are well documented in the scientific literature. If you think your animal has suffered from ingesting cannabis, we recommend that you report the adverse effect to the FDA. Visit Information on Drug and Device Notification for animals for more information on how to report an adverse event related to an animal drug or on 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 section 301 (ll) of Act FD&C to introduce or deliver for introduction into interstate commerce any animal food to which THC or CBD has been added. In addition, under 21 CFR 530.20, off-label use of an approved human drug in a food-producing animal is not allowed if an animal drug approved for use in food-producing animals can be used in an unlabeled manner for use in food-producing animals can be used in an unlabeled manner for use. In addition, according to 21 CFR 530.20 (b) (), 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 steps to ensure that the animal and its food products do not enter the human food supply. For more information on off-label use of FDA-approved drugs in animals, see Off-label Use of FDA-Approved Drugs in Animals.
Risks are managed differently in the context of approved drugs. The FDA has approved a drug containing CBD to treat certain serious seizure disorders. As part of the drug review and approval process for Epidiolex, it was determined that the benefits outweigh the risks for the intended population, when used under close medical supervision. Cannabidiol (CBD) is a compound found in marijuana.
CBD is not harmful, which means 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. The use of CBD during pregnancy is not recommended. 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 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, keep 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 the different ways of using CBD (smoking, vaping, eating, applying 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 fungs.5 If consumers experience adverse effects from products containing THC or CBD that pose an immediate danger to their health, they should call the local or regional poison control center at 1-800-222-1222 or 911 or seek medical attention at the local emergency room and inform health care about the ingredients of the products they have Consumed suppliers. The data on CBD point to real risks, and the FDA is especially concerned about the risks to children, people who are pregnant or breastfeeding, and people taking other medications. Because CBD is an unapproved drug, the FDA has not had an opportunity to evaluate CBD residues in food or to establish an adequate abstinence period. As such, consumers should know that products labeled as hemp or CBD may contain other ingredients, such as THC, pesticides, heavy metals, bacteria, or fungi.
In addition, the FDA has not reviewed the manufacturing processes for unapproved CBD drugs as part of the approval processes for drugs for humans or animals. This alert warns consumers of the possibility of adverse events due to underlabeling of products containing THC and CBD. If consumers experience adverse effects from products containing THC or CBD that pose an immediate danger to their health, they should call the local or regional poison control center at 1-800-222-1222 or 911 or seek medical attention at the local emergency room and inform health care providers about the ingredients in the products they have consumed. In addition, using food to administer CBD makes it difficult for people to control the amount of CBD they take.
The FDA is concerned about these CBD products for food-producing animals, not only because CBD could pose a risk to the safety of the animals themselves, but also because of the lack of data on the safety of human food products (meat, milk, and eggs) from animals that have consumed these CBD products. Consumers eat food for reasons other than to take CBD, and they may end up consuming more CBD than they thought. .
