The Food and Drug Administration (FDA) regulates cannabis and cannabis-derived compounds under the Federal Food, Drug and Cosmetic Act (FD&C) (21 U, S, C). 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&C) 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&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 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&C. 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&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 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&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 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&C 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&C 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. The NBA will not test players for marijuana for the third consecutive season, a report says that marijuana is a more valuable crop than potatoes or rice, a new leafy report on the adult market reveals that Congress is “very close” to approving the bill on banking and the elimination of records marijuana penalties after working with a representative of “A Lot of Republicans”.
Mark Pocan (D-WI) put even more pressure on the FDA Commissioner. James Comer (R-KY), a high-ranking member of the House Oversight and Reform Committee, called on congressional leaders to hold an independent hearing to hold the FDA accountable for its inaction with respect to delta-8 CBD and THC products. The therapeutic benefits, or the underlying mechanism of action for obtaining therapeutic benefits, of CBD remain uncertain, even in CBD-containing drugs that have been approved by regulatory agencies. If a food additive is already subject to FDA regulation for its intended intended use, it does not require pre-market approval through a petition.
Legislation was introduced in the 116th Congress that would expand the authority of the FDA to regulate cosmetic products and would require a review of the safety of certain ingredients, among other things. As such, the FDA has determined that CBD cannot be sold as a dietary supplement unless the FDA enacts regulations that conclude otherwise, regardless of whether the CBD comes from hemp or marijuana. Pocan, who has regularly spoken out favorably on the use of kratom as an alternative to opioids, called the FDA's position on the drug “extremely outdated.”. The FDA does not evaluate the safety and efficacy of dietary supplements before they are marketed; however, supplements are subject to several legal and regulatory requirements.
However, FDA's authority over cosmetic products is generally more limited than that of other products regulated by the agency. Many major state markets, including New York (in the proposed regulations), impose product labeling requirements that go beyond those of the FDA, and several states prohibit marketing that is attractive to minors. To date, the FDA has not issued any such regulation for any substance (whether derived from cannabis or not) that is an active ingredient in an approved drug or that is authorized for research as a new drug. Federal regulation of CBD products is welcome and should have been done a long time ago, and hemp companies are eager for regulatory stability and treatment.
While the FDA could issue regulations that allow CBD to be added to foods or allow its use in dietary supplements, the agency has never issued such a regulation for any substance (whether derived from cannabis or not) that is a drug approved or authorized for research as a new drug. While there is speculation that the final FDA regulation on CBD products will include a serving size limit for foods and dietary supplements, the FDA is still evaluating safety data to inform any such regulations. Alaska, Kentucky, Colorado, New York and many other countries are leading the way in product safety testing and standards. While the Republican congressman seemed to support regulations that would correct problems related to the mislabeling and contamination of CBD products, he also mentioned the fact that companies are increasingly marketing items containing delta-8 THC, an intoxicating cannabinoid commonly synthesized with CBD and that it is in a particularly gray legal area because, unlike delta-9 THC, it is not expressly prohibited by federal law.
Under FDA regulations (21 CFR 312), unless a clinical investigation meets the limited criteria of that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act. . .
