Has the FDA Approved Medical Marijuana?

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Marijuana (scientific name cannabis) refers to several species of plants with psychoactive properties. Those three species Indica, Sativa, and Ruderalis have chemicals like  delta-9-tetrahydrocannabinol(THC) and cannabidiol(CBD), which cause their psychoactive properties. Under the Controlled Substance Act of 1970, marijuana is a Schedule 1 substance, but according to DigiDrs, Medical marijuana cards have become a conduit by which to bypass specific FDA mandates.

The Schedule 1 listing of marijuana is because of its high potential for abuse by its users. This risk is mainly due to THC, the active substance most responsible for marijuana’s mind-altering effects.

The Food and Drug Administration(FDA) appreciates and acknowledges the growing interest surrounding cannabis and its related products in treating specific ailments and medical conditions. The FDA is aware of companies that try to circumvent its jurisdiction by selling these products in ways that contravene the Federal Food, Drug, and Cosmetic Act (FD&C Act). Efficient regulatory pathways are crucial mechanisms through which the FDA enables lawful introduction and marketing of all controlled substances, including cannabis products.

Consumers and all other stakeholders should have access to all FDA resources that efficiently address issues related to cannabis products. 

What Does the 2018 Farm Bill Mean for Certain Controlled Substances?

There is a common misconception that hemp and cannabis are identical. Hemp, much like cannabis, is a plant of the Cannabaceae family. It’s mainly grown for its use in ropes, fibers, paper, and other industrial products like wood preservatives. The Farm Bill( also known as the Agriculture Improvement Act) of 2018 sheds more light on the above issue. This law removed hemp from the list of controlled substances and made it legal to market its extracts, salts, isomers, and other hemp products.

Hemp contains a THC concentration of less than 0.3%, which the scientific community does not consider significant enough to induce strong psychoactive effects. Therefore, the concentration of THC seems the crucial factor in differentiating hemp from regular marijuana.

This Bill, however, does not diminish the FDA’s authority with regards to controlled substances. Marijuana and all other cannabis products are still subject to stringent FDA standards. However, the agency has allowed legal consumption of marijuana for those people who need it medically. It also has permitted marijuana dispensaries for quick and efficient treatment. Getting a medical marijuana card starts with a quick online consultation with the dispensaries’ doctors. Patients can discuss their concerns regarding cannabis and receive appropriate responses. Several online marijuana dispensaries have also become an option for patients. In these digital dispensaries, patients receive advice and medication in real-time from medical marijuana doctors.

Has the FDA Approved Any Cannabis Products?

 In recognition of more findings and ongoing research, the FDA has approved some cannabis-related products. The agency has approved Syndros and Marinol. Both drugs treat nausea and vomiting in cancer patients undergoing chemotherapy. AIDS patients that suffer anorexia due to weight loss and a lack of appetite also take Marinol. A doctor recommends Syndros when other antiemetic therapies have failed. Dronabinol, the active substance in both Syndros and Marinol, is a synthetic version of delta-9-tetrahydrocannabinol(THC).

Perhaps Epidiolex is the best known cannabis-related drug that the FDA has approved.  A purified extract of cannabidiol (CBD) is the active ingredient in Epidiolex. The drug is essential in treating epileptic seizures related to Dravet Syndrome and Lennox-Gastaut Syndrome. Epidiolex is also effective against seizures associated with tuberous sclerosis complex. In all cases, the patients must be one year or older.

Can Cannabis Products be Sold as Dietary Supplements? 

The FDA does not consider cannabis products as dietary supplements. All cannabinoids, including CBD, are considered drug substances by the FDA. This initial classification ensures that drug companies do not include such substances in food materials meant for human consumption.

 What about Jurisdictions Allowing the Sale of Cannabis Without FDA Approval? 

Medical research into the efficacy and safe use of cannabis and its products are at the heart of FDA drug approval processes (or lack thereof). The agency is aware that some states choose to pass legislation that removes restrictions on the medical use of marijuana. Lack of well-documented clinical trials of such cannabis derivatives can pose immense health risks.

FDA resources are available to these states to enable their legislators to make accurate decisions regarding the use of marijuana for medical use.

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