Current FDA food and dietary supplement authorities provide only limited tools to manage many of the risks associated with CBD products. Under the law, any substance, including CBD, must meet specific safety regulations to be legally marketed as a dietary supplement or food additive. 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 an authorized healthcare 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 and older. That means that the FDA has concluded that this particular medication is safe and effective for its intended use.
The agency has also approved Marinol and Syndros for therapeutic uses in the United States, including 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) considered to be 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 across the country. Selling unapproved products with unfounded 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 deceptive marketing of unproven treatments also poses 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 have not been reviewed by the FDA as part of the drug approval process have not been evaluated to determine if they work, what is the appropriate dosage if they work, how they might interact with other medications, or if they have dangerous side effects or other safety issues.
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 new pharmacological research 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 that could challenge its current findings that THC and CBD products are excluded from the definition of a dietary supplement under section 201 (ff) (B) of the FD&C Act. Interested parties can submit to the agency any evidence they consider related to this topic.
Our continuous review of the information that has been submitted 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 the FD&C Act, 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 the FD&C Act. To date, no such regulation has been issued for any substance. 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 trace amounts of THC and CBD, which the seeds can collect during harvest and processing when they are in contact with other parts of the plant.
The consumption of these ingredients derived from hemp seeds is not capable of drugging consumers. The findings of the GRAS 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, vegetable alternatives to dairy products), soups, sauces, dressings, vegetable 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 adding CBD and THC to food. 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 cleanse, beautify, promote attractiveness or alter appearance) and (articles) intended to be used as a component of such articles; except that such term shall not include soap. 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 diseases, such as cancer. Some of these products were even more in 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 violates the FD&C Act, 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 take federal action to enforce the law. Expanded access is a possible avenue for a patient with a serious or potentially fatal illness or condition to try an investigational medical product (drug, biological product, or medical device) for treatment outside of clinical trials when comparable or satisfactory therapies are not available.
Manufacturers may be able to make investigational drugs available to individual patients under certain circumstances through greater access, as described in the FD&C Act and in the implementing 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 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 sound, 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 plant-based or synthetic) has been approved as safe and effective for use in any patient population, whether pediatric or adult. 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 the assurance of manufacturing quality standards, prescribers can rely on the consistent concentration and consistent administration of the drug, supporting the appropriate dosage 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 stress that the FDA has not approved the use of cannabis in animals and cannot guarantee the safety or effectiveness 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. While the agency is aware of reports of pets consuming 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 how to report drugs and devices 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. In addition, under 21 CFR 530.20, the 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 a manner not indicated on the label for use.
In addition, according to 21 CFR 530,20 (b) (), if scientific information is not available on the human food safety aspect related to 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 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. In general terms, hemp tends to contain significantly lower levels of THC and, depending on the variety, substantially higher levels of CBD than marijuana. In view of the regulatory landscape discussed above, an important part of any legal analysis of the proper status of a hemp-derived CBD product, in particular consumer products sold at retail, is necessarily based on the scope and breadth of the claims made in advertising and product labeling.
The FDA will continue to take action against CBD and other cannabis products to protect the public, according to Thursday's release. It would be useful for companies to evaluate and understand the specific regulatory requirements applicable to the cultivation, processing, distribution and consumption of hemp-derived CBD and products containing CBD in each state in which the company intends to do business or distribute products. The Food and Drug Administration said Thursday that it cannot regulate CBD products in their current structure because the ingredient derived from hemp or marijuana has not been proven to be safe enough for food or supplements. With respect to products labeled that contain hemp and that may also contain THC or CBD, as mentioned above, it is prohibited under section 301 (ll) of the FD&C Act to introduce or deliver for introduction into interstate commerce any animal feed to which THC or CBD has been added.
Questions remain about the effects of CBD on the liver, the male reproductive system and on pregnant women and children, according to the FDA statement. Ingredients that are derived from parts of the cannabis plant that do not contain THC or CBD could fall outside the scope of this exclusion and could therefore be marketed as dietary supplements. Therefore, the FDA has concluded that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any food or animal feed) to which THC or CBD has been added. The FDA's action comes after repeated calls from legislators, advocates, and consumer groups to allow CBD in foods and supplements.
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