Cannabinoids Win FDA Approval
While 2017 was the year that cannabis went mainstream for its therapeutic benefits, 2018 is proving to be the year that cannabinoid (CBD) gains legal recognition for medicinal purposes.
On Monday the Federal Drug Administration approved Epidiolex, a pharmaceutical-grade version of CBD oil used to treat rare and severe forms of epilepsy. As the FDA states itself, “this is the first FDA-approved drug that contains a purified drug substance derived from marijuana.” Epidiolex happens to also be the first drug approved for treatment of Dravet syndrome.
The drug, manufactured by London based GW Pharmaceuticals, is specifically targeted to treat rare, early onset seizure disorders including Dravet and Lennox-Gastaut syndromes, Tuberous Sclerosis Complex and Infantile Spasms. These neurological disorders can have debilitating seizures associated with them causing a decreased quality of life and reduced cognitive abilities.
GW Pharmaceuticals is currently testing other CBD treatments for glioblastoma and schizophrenia, which could lead to additional cannabinoids receiving FDA approval.
CBD has gotten a lot of buzz recently. And now with the legalization of Epidiolex, CBD has captured the attention of the FDA and the mainstream medical community. FDA Commissioner Scott Gottlieb is quoted in The Washington Post stating, “a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies.”
However, CBD companies now have a heightened responsibility (and the watchful eye of the FDA) to truthfully advertise their CBD products in a transparent and honest way. The FDA has stated it will still “take action” against illegal CBD products making “serious, unproven medical claims.”
That is why here at CBD Thera our products are grown, distilled, mixed and bottled in the United States. Every batch is triple tested by leading US certified laboratories to verify each bottle conforms to its labeling content. The hemp oil used to make CBD Thera is high in the cannabinoids that countless patients have found to provide relief, yet does NOT have THC in quantities greater than .3 percent. While CBD Thera is not a pharmaceutical product and cannot be “indicated” for any particular condition, we encourage you to investigate the many benefits of cannabinoids through reputable sources. There are considerable editorials, videos and news articles of individuals who have benefited from CBD oil.
There are further justifications for celebrating this decision; FDA approval of CBD indicates the DEA will need to adjust its scheduling for CBD in order to allow sale of the product, which is currently a Schedule I substance. Prior to Monday’s announcement, a press officer for the DEA confirmed to Leafly that the FDA decision will elicit action from the DEA. “If they announce that they’re approving Epidiolex, absolutely we’ll go into a different schedule. There’s no ifs, ands, or buts about it.” Given the stamp of approval on Epidiolex by the FDA, expect the DEA to reclassify cannabinoids within 90 days.
As heighted consumer interest and growing medical research on the benefits of CBD drive the Federal Drug Administration towards expanding approval of cannabinoids for medical treatment, the DEA approval will be the next milestone in the cannabis industry. And here at CBD Thera we look forward to a community where CBD oils are widely accepted and federally approved for the multitude of benefits they provide.
For more information about CBD Thera and how you can incorporate CBD oils into your wellness regimen visit https://cbdthera.com/.