FDA Sends Warning Letters to CBD Product Brands with GW Pharmaceuticals Links

Warning letters have been sent to four cannabidiol (CBD) product brands as the FDA makes good on their promises from a month ago.

The brands that received these warning letters are:

The letters take issue with a number of different violations and give each company 15 days to respond. Happy Halloween.

In each letter, the FDA spells out how they take issue with stating treatment for any type of illness or condition. Whether it is bipolar disorder, cancer, autism, or anything in between.

“Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.”

Additionally, the FDA took issue in many complains regarding the fact that there were no “adequate directions for use.”

“A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.”

Three of the four letters contain reference to GW Pharmaceuticals and their clinical trials for Sativex and Epidolex with the letter to the Stanley Brothers going into the most detail:

“The existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex[1] Under FDA’s regulations [21 CFR § 312.2], unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the Act. FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the Act, but you may present FDA with any evidence that has bearing on this issue. . FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect.”

The links to the GW Pharmaceuticals references are:

The letters came from three different parties with two from Steven E. Porter, Jr. Director, Division of Pharmaceutical Quality Operations IV, one from Maridalia Torres-Irizarry Director San Juan District Program Division Director OHAFO IV East, and one from Darla R. Bracy, District Director Office of Human and Animal Food Division 5 West.

These are some of the clearest indications of desire for control of labeling from the federal government as CBD products begin to hit shelves and get quickly pulled from them as well.

These letters also come just one day after GW Pharmaceuticals made a significant announcement. From GW Pharmaceuticals and Its U.S. Subsidiary Greenwich Biosciences Completes Rolling New Drug Application Submission to U.S. Food and Drug Administration for Epidiolex® (cannabidiol) in the treatment of Lennox-Gastaut syndrome and Dravet syndrome:

“The submission of the Epidiolex NDA is an important milestone for patients with LGS and Dravet syndrome in that a potential new treatment option is within sight for these very difficult to treat and devastating conditions,” stated Justin Gover, CEO of GW Pharmaceuticals. “On behalf of all those patients, clinicians and GW employees who have supported the Epidiolex program, we are pleased to submit this promising therapy for FDA review and we look forward to working with the FDA throughout the review process. This regulatory submission is a demonstration of GW’s commitment to developing innovative cannabinoid-based treatments that have the potential to address significant unmet medical needs.”

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Jeff Sessions: “Healthy to Have Some More Competition” in Medical Cannabis Research Supply

Attorney General Jeff Sessions responded to “reports that DOJ and DEA are at odds on marijuana research, particularly when it comes to granting applications to grow marijuana for further research.” This concern came from Senator Hatch [R-UT] during an Oversight of the U.S. Department of Justice hearing.

Earlier in the year, the Drug Enforcement Administration opened up Applications To Become Registered Under the Controlled Substances Act To Manufacture Marijuana To Supply Researchers in the United States. The application itself consists of four pages and asks:

“Make checks payable to “Drug Enforcement Administration”.

Depending on the type of “Business Activity”, the fees range from $244 per year, to $3,047.

Fees for Business Types on Application

Screenshot from Application

You’ll be able to tick the box next to substances like Heroin, Mescaline, Peyote, or MDMA.

Screenshot of Substances from Application

Screenshot of Substances from Application

According to Sessions:

“I believe there are now 26 applications for approval of suppliers who would provide marijuana for medicinal research. Each one of those has to be supervised by the DEA and I have raised questions about how many and let’s be sure we’re doing this in the right way ’cause it costs a lot of money to supervise these events.”

Senator Hatch wasn’t just bringing this up out of nowhere. Alongside Senator Schatz [D-HI] he:

“introduced…the bipartisan Marijuana Effective Drug Studies Act of 2017 or the MEDS Act because I believe that scientists need to study the potential benefits and dangers of marijuana.”

The MEDS Act pushes for more research and production when it comes to medical cannabis and pushes for standards to be written for “good manufacturing practices.”

And while Sessions thinks “it’d be health to have some competition in this supply,” he’s quick to state:

“I’m sure we don’t need 26 new suppliers.”

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Government-Funded Cannabis PTSD Study Running into Hurdles in Colorado

Denied access to veterans and provided with subpar cannabis, Dr. Sue Sisley continues to pursue the first study of its kind on cannabis and PTSD.

Rocky Mountain PBS recently released a detailed report into what’s going on with Colorado’s desire to find out what cannabis can do for treatment-resistant post-traumatic stress disorder or PTSD. There was enough evidence that the state of Colorado allotted $2,156,000 to the Multidisciplinary Association for Psychedelic Studies, or MAPS, for research into cannabis for treating PTSD that was resistant to other types of treatment like pharmaceuticals or therapy.

While we currently list 22 studies on cannabis and PTSD, this study aimed to be a tightly controlled study on a specific population entitled: “Placebo-controlled, Triple-Blind, Randomized Crossover Pilot Study of the Safety and Efficacy of Four Potencies of Smoked Marijuana in 76 Veterans with Chronic, Treatment- Resistant Post Traumatic Stress Disorder (PTSD).”

Unfortunately, the population that would benefit most from this has been made off limits to Dr. Sue Sisley and her team. The Phoenix VA hospital treats upwards of 91,000 patients. She says, they need to screen another five to six thousand veterans and most of them are right there.

“I worry that we won’t be able to complete this study because the absolute highest density of treatment-resistant PTSD patients is in that hospital.”

The other big issue, which has been brought to the government’s attention before, is that the quality of government-provided cannabis is dreadful and not comparable to what patients are actually using.

Cannabis from the United States Government

Cannabis from the United States Government

“It doesn’t necessarily represent the cannabis in the real world. Real world cannabis can be 20 to 30 percent THC. Ours is about 10 to 11 percent.”

Dr. Sisley also opened up about her initial reluctance to even consider cannabis medicine:

“I was highly judgmental because I didn’t believe that cannabis was a medicine. I’d never been trained to believe that cannabis was anything except a deeply dangerous, highly addictive drug.”

She stresses the importance of doing good science and studies like the one MAPS has received funding for:

“I certainly believe all these veterans when they tell me that their subjective experience is that cannabis helped them. But until we put it through the rigors of a controlled trial, I will never be able to fully embrace the idea that cannabis is a legitimate medication.”

When one of her patients became a victim of the opioid crisis, she realized something had to be done.

“He was in great shape when he was using the cannabis. And then, I had actively discouraged him. He was already getting a massive amount of opioids from the VA, and he graduated to heroin. And then, his mom called me when she found him the next morning with a needle in his arm and he was dead. And I couldn’t help but feel completely responsible for that.”

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