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:
14. Will FDA take action against cannabis or cannabis-related products that are in violation of the FD&C Act?
15. Can I import or export cannabis-containing or cannabis-derived products?
Research and Expanded Access
20. Does the FDA have concerns about administering a cannabis product to children?
A. 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 1 years of age and older. It has also approved Epidiolex for the treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age or older. That means the FDA has concluded that this particular drug product is safe and effective for its intended use. Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring cannabis-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, and the assurance of manufacturing quality standards, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes.
A. The agency has received reports of adverse events in patients using cannabis or cannabis-derived products to treat medical conditions. The FDA reviews such reports and will continue to monitor adverse event reports for any safety signals, with a focus on serious adverse effects. Consumers and healthcare providers can report adverse events associated with cannabis or cannabis-derived products via the FDA’s MedWatch reporting system, either online or by phone at 1-800-FDA-1088. For more information, please see the FDA’s webpage on MedWatch.
2. How does the 2018 Farm Bill define hemp? What does it mean for FDA-regulated products?
A. The FDA has sent warning letters in the past to companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.
Ethanol extraction, meanwhile, can be conducted at warmer temperatures in a process similar to making liquor, said Kimberly Provera, the operations manager at CT Pharma.
They’re among many in the U.S. who are peering through the fog of the clinical claims, legal quagmires and social stigma around weed.
Raise your hand if you’ve heard someone state a version of the following:
The math that’s fueling the CBD green rush
“Marijuana” is any cannabis plant with abundant amounts — technically, more than 0.3 percent — of the mind-altering drug THC. Though 11 states and Washington, D.C., have legalized recreational marijuna, this version of cannabis remains federally illegal and classified as a schedule 1 drug by the Drug Enforcement Administration.
“So how do we make a distinction when … basically looking at the plant structure, you really can’t tell the difference?” DeBacco, one of the cannabis course professors, asked us on the campus quad after class (located in the university’s largest lecture hall, due to its popularity).
A cheat guide to CBD
“With other highly valuable crops — like saffron or vanilla — you get a small percentage of the plant that’s actually usable yield,” Apicella explained. But with hemp, “it’s a huge amount.” Some strains have are upwards of 12 to 15 percent CBD by weight.
Cannabis makes most of its cannabinoids in its flowers, which are more commonly called “buds.”