The goal of the hearing is to identify and collate all data to help us answer these questions in order to make sure that the public is protected. , "Michael Felberbaum, FDA spokesman, said in an email to CNN.
CBD, also known as cannabidiol, is the ingredient in marijuana and hemp alled to have many medicinal benefits. It's different from tetrahydrocannabinol or THC, the hand psychoactive component of cannabis.
Last June, the FDA for the first time approved plant-derived cannabis, CBD-based drug, Epidiolex, which is approved to treat severe and severe forms of epilepsy: Dravet Syndrome and Lennox-Gastaut syndrome.
Dr. Amy Abernathy, senior deputy commissioner of the FDA and head of the CBD working group, said in a
tweet Last week, "The FDA has not approved any other CBD-containing products.
Testimonials from the Supplementary Industry, Researchers, Doctors, and Patients are all expected to test their experiences with cannabis at Friday's hearing. The agency will also make a comment for public comments that will close on July 2.
In April, then-FDA commissioner Dr. Scott Gottlieb warned in a statement that "open questions remain about the safety" of widespread use of CBD products. He also noted there is concern about a lack of standards around CBD concentrations in products and the possible impacts of long-term CBD use.
"It's critical that we address these questions about CBD and other cannabis and cannabis-derived products to help inform the FDA's regulatory oversight of these products," he said. "Especially as regards the use of CBD in dietary supplements and other foods."
It is illegal to introduce CBD or THC into the food supply or market it as a dietary supplement. Marijuana remains illegal under federal law. However, at least 10 states have moved ahead of the use of marijuana.
Growing to a $ 15-20 billion market
As states have been liberalized by marijuana, CBD-related products such as oils, lotions, chocolates and even dog food have been marketed.
In December, President Donald Trump signed the Bill Farming Law, legalizing hemp, which also contains high levels of CBD. Market analysts expect the hemp-derived CBD market alone to hit between $ 15-20 billion in the next five to six years.
"The industry is exploding, it's growing in popularity every day," said Jonathan Miller, general counsel for the US Hemp Roundtable, an industry-backed advocacy group. "There are products that make false claims." It's important that FDA develop standards. "
Earlier this year, FDA Sent to PotNetwork Holdings in Florida, Nutra Pure in Washington State and New Zealand Spice and Bread in New Jersey for "Making Unsubstantiated Claims". media websites. " These companies made claims that CBD could help with cancer and dementia.
Since 2015, the FDA has issued 48 similar types of letters about the marketing of CBD products.
Miller said the industry wants regulation. "Our biggest enemy is not the FDA or the DEA, but CBD companies making false claims," he said.
'The genie' is 'out of the bottle'
CBD, "Dr. Yasmin Hurd, director of the Addiction Institute at Mount Sinai in New York and a cannabis researcher, wrote in an e-mail to CNN.
But Hurd worries that the FDA is coming to the table too late.
"The market and the public are already in the marketplace and will be in a position to do so," he said.
While a FDA, Miller is hopeful that the FDA will prioritize creating regulations for cannabis-based products. He anticipates that CBD can be regulated both as a drug and as a supplement, based on dosing and concentration.
Maintaining a distinction between Hurd said.
"It is critical that the FDA consider a separate pathway to expedite CBD research to make it possible to quickly inform policy makers, patients and physicians about the potential health impact, dosing regimens, adverse effects as necessary for the development of any medication. It needs to be made clear that such a pathway would be different from recreational or nutraceutical / supplement market. "
