The FDA Secretly Fast Tracked A Synthetic CBD From Big Pharma
Meanwhile, They Take Their Sweet Time With Regulating CBD…
While no one was looking, the US Food and Drug Administration quietly granted Fast Track status for a Main Line company, for their synthetic CBD designed to treat Fragile X Syndrome.
On Monday morning, Zynerba Pharmaceuticals announced that they won the status for a transdermal CBD topical. The benefits of Fast Track status means that it shortens the time needed to review medications designed to treat conditions that aren’t responsive to conventional medications. There are no known drugs for treating Fragile X syndrome, and patients are often left vulnerable to cognitive impairment, learning, and developmental issues.
According to Zynerba spokesperson Will Roberts, the drug Zygel is already in the final stages of the clinical trial. It is expected to be available by late 2020.
What About The Real CBD?
We’re already seeing CBD being placed in everything from gel capsules to luxury beauty products.
Despite that, Washington is seeing a major obstacle because the FDA is being ambiguous about its rules for dietary supplements and medicines. As of the moment, they still haven’t come up with clear guidelines for CBD, even if thousands of consumers all over the country are now using it for treating anxiety, insomnia, skin problems, and everything else in between.
Last year, the Farm Bill legalized hemp; hemp is the very plant from which CBD is derived from yet the FDA has no idea on how to regulate it. But the FDA is known for its lengthy, tedious approval processes that keep patients waiting for medications. Yet, companies like Zynerba Pharmaceuticals have been given the fast track status to speed up reviews while leaving genuine CBD behind in the dust.
CBD manufacturers have gone full steam ahead, no longer waiting for the FDA to create guidelines for the medicines they’re selling. Large pharmacy chains like Walgreens and CVS are already selling CBD on their shelves, and patients want in, too.
“I fear that the FDA is behind the eight ball on this one,” says Peter Pitts, co-founder and president of the Center for Medicine in the Public Interest and ex-FDA officer. “The FDA needs to take a leadership position as quickly as possible to make sure that the wild west of CBD doesn’t harm the public health.”
People also want more studies on CBD, despite the current strong evidence that it’s effective for treating seizures as well as a host of other life-threatening conditions.
Despite that, the FDA has approved synthetic forms of CBD and Zynerba is by no means the first. Last year, they approved Epidiolex, a drug made by GW Pharmaceuticals for treating seizures caused by rare forms of epilepsy in patients aged 2 and up. Sure, GW Pharmaceuticals also had to go through a rigorous process to approve the drug, but they made it; this process hasn’t been done by any other authentic form of CBD so far.
The thing is, we who are in the know, know 100% that CBD is safe.
But people who are new to it are unable to trust CBD’s safety without a seal of approval from the FDA. In fact, some people are starting to call it “the modern day snake oil”.
So What Is The FDA Doing About It?
Outgoing FDA commissioner Scott Gottlieb already sent out a press release regarding the possible regulation of CBD products. On May 31, there will be a public hearing designed for stakeholders, including opponents and proponents of CBD, to share their experiences as well as safety concerns. The hearing will cover health and safety, manufacturing and product quality, marketing, sales, and labeling of CBD products.
They will also be creating an internal group designed to “explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed.”
Additionally, we can soon expect a new FAQ on the FDA website where they will be answering questions with regard to CBD as well as THC products.
Even if the press release indicates the steps that the FDA needs to take to develop a regulatory framework for CBD products, it also states that infusing CBD or THC is still illegal.
Well, that hasn’t stopped anyone so far.
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