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medicine made from hemp

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.

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:

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.

Children and Pregnant/Lactating Women

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 The agency’s July 2020 draft guidance, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry, highlights quality considerations for anyone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.

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.

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.)

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:

The passage of the 2018 Farm Bill made it legal to sell hemp and hemp products in the U.S. But that doesn’t mean that all hemp-derived cannabidiol products are legal. Since cannabidiol has been studied as a new drug, it can’t be legally included in foods or dietary supplements. Also, cannabidiol can’t be included in products marketed with therapeutic claims. Cannabidiol can only be included in “cosmetic” products and only if it contains less than 0.3% THC. But there are still products labeled as dietary supplements on the market that contain cannabidiol. The amount of cannabidiol contained in these products is not always reported accurately on the product label.

Some medications changed by the liver include proton pump inhibitors including omeprazole (Prilosec), lansoprazole (Prevacid), and pantoprazole (Protonix); diazepam (Valium); carisoprodol (Soma); nelfinavir (Viracept); and others. Medications changed by the liver (Cytochrome P450 2C8 (CYP2C8) substrates) Some medications are changed and broken down by the liver. Cannabidiol might decrease how quickly the liver breaks down some medications. In theory, using cannabidiol along with some medications that are broken down by the liver might increase the effects and side effects of some medications. Before using cannabidiol, talk to your healthcare provider if you take any medications that are changed by the liver.
Some medications changed by the liver include amiodarone (Cordarone), carbamazepine (Tegretol), chloroquine (Aralen), diclofenac (Voltaren), paclitaxel (Taxol), repaglinide (Prandin) and others. Medications changed by the liver (Cytochrome P450 2C9 (CYP2C9) substrates) Some medications are changed and broken down by the liver. Cannabidiol might decrease how quickly the liver breaks down some medications. In theory, using cannabidiol along with some medications that are broken down by the liver might increase the effects and side effects of some medications. Before using cannabidiol, talk to your healthcare provider if you take any medications that are changed by the liver.

How effective is it?

Moderate Be cautious with this combination. Brivaracetam (Briviact) Brivaracetam is changed and broken down by the body. Cannabidiol might decrease how quickly the body breaks down brivaracetam. This might increase levels of brivaracetam in the body. Carbamazepine (Tegretol) Carbamazepine is changed and broken down by the body. Cannabidiol might decrease how quickly the body breaks down carbamazepine. This might increase levels of carbamazepine in the body and increase its side effects. Clobazam (Onfi) Clobazam is changed and broken down by the liver. Cannabidiol might decrease how quickly the liver breaks down clobazam. This might increase the effects and side effects of clobazam. Eslicarbazepine (Aptiom) Eslicarbazepine is changed and broken down by the body. Cannabidiol might decrease how quickly the body breaks down eslicarbazepine. This might increase levels of eslicarbazepine in the body by a small amount. Everolimus (Zostress) Everolimus is changed and broken down by the body. Cannabidiol might decrease how quickly the body breaks down everolimus. This might increase levels of everolimus in the body. Lithium Taking higher doses of cannabidiol might increase levels of lithium. This can increase the risk of lithium toxicity. Medications changed by the liver (Cytochrome P450 1A1 (CYP1A1) substrates) Some medications are changed and broken down by the liver. Cannabidiol might decrease how quickly the liver breaks down some medications. In theory, using cannabidiol along with some medications that are broken down by the liver might increase the effects and side effects of some medications. Before using cannabidiol, talk to your healthcare provider if you take any medications that are changed by the liver.

Some medications changed by the liver include nonsteroidal anti-inflammatory drugs (NSAIDs) such as diclofenac (Cataflam, Voltaren), ibuprofen (Motrin), meloxicam (Mobic), piroxicam (Feldene), and celecoxib (Celebrex); amitriptyline (Elavil); warfarin (Coumadin); glipizide (Glucotrol); losartan (Cozaar); and others. Medications changed by the liver (Cytochrome P450 2D6 (CYP2D6) substrates) Some medications are changed and broken down by the liver. Cannabidiol might decrease how quickly the liver breaks down some medications. In theory, using cannabidiol along with some medications that are broken down by the liver might increase the effects and side effects of some medications. Before using cannabidiol, talk to your healthcare provider if you take any medications that are changed by the liver.

Cannabidiol has effects on the brain. The exact cause for these effects is not clear. However, cannabidiol seems to prevent the breakdown of a chemical in the brain that affects pain, mood, and mental function. Preventing the breakdown of this chemical and increasing its levels in the blood seems to reduce psychotic symptoms associated with conditions such as schizophrenia. Cannabidiol might also block some of the psychoactive effects of delta-9-tetrahydrocannabinol (THC). Also, cannabidiol seems to reduce pain and anxiety.

Del Bo’ C, Deon V, Abello F, et al. Eight-week hempseed oil intervention improves the fatty acid composition of erythrocyte phospholipids and the omega-3 index, but does not affect the lipid profile in children and adolescents with primary hyperlipidemia. Food Res Int. 2019;119:469-476. View abstract.

Hazekamp A. The trouble with CBD oil. Med Cannabis Cannabinoids. 2018 Jun;1:65-72.

Insufficient Evidence for

Prociuk M, Edel A, Gavel N, et al. The effects of dietary hempseed on cardiac ischemia/reperfusion injury in hypercholesterolemic rabbits. Exp Clin Cardiol. 2006;11(3):198-205. View abstract.

Alkhammash S, Tsui H, Thomson DMP. Cannabis and hemp seed allergy. J Allergy Clin Immunol Pract. 2019;7(7):2429-2430.e1. View abstract.

Gavel NT, Edel AL, Bassett CM, et al. The effect of dietary hempseed on atherogenesis and contractile function in aortae from hypercholesterolemic rabbits. Acta Physiol Hung. 2011;98(3):273-83. View abstract.