Senators urge FDA to speed up CBD regulation

Senator Richard Blumenthal (D-CT) and five other senators are calling on the Food and Drug Administration (FDA) to issue guidance on CBD within 90 days.

“Consumers need and deserve guidance. So do manufacturers and hemp growers. That is why I am calling on the FDA to establish a regulatory framework as it has promised to do for these products,” said Blumenthal.

Hemp-derived CBD was legalized under the 2018 Farm Bill, but since then, the FDA hasn’t issued any rules for cannabis companies selling CBD products.

“Consumers rely on the FDA to conduct timely and appropriate oversight of new and emerging ingredients, and guidance from the FDA would also help manufacturers to develop safer, more effective, and more credible products for consumer use,” the lawmakers wrote in a letter to the FDA. “The market for CBD products is rapidly outpacing the FDA’s current regulatory efforts, and your agency clearly must expedite its efforts to promote accuracy and transparency within the CBD industry.

Along with Sen. Blumenthal, Sens. Patrick Leahy (D-VT), Jon Tester (D-MT), Tammy Duckworth (D-IL), Chuck Schumer (D-NY) and Kirsten Gillibrand (D-NY) signed the letter addressed to the FDA.

Teen cannabis use in Washington declined after legalization

One of the arguments against legalizing marijuana was that it would increase teen drug use, but in Washington and other states that have ended cannabis prohibition, the opposite is true.

According to a new study by the Centers for Disease Control, marijuana use “decreased or remained stable through 2016 among King County students in grades 6, 8, 10, and 12. Among grade 10 students, the decline in use occurred among males while the rate among females remained steady. Use of alcohol or other substances was four times as frequent among marijuana users as among nonusers.”

Washington saw its first decline in teen marijuana use in 2012, the year it legalized cannabis. The researchers noted that the decline in youth marijuana use after legalization was consistent with trends reported in both Colorado and Oregon.

“Although the relationship between legal adult recreational use and youth use is not well understood, two possible reasons for the observed decline in youth use include reduction of illicit market supply through competition and loss of novelty appeal among youths,” according to the study. “Furthermore, it would be important to monitor the long-term role legalization might play to foster a permissive use environment given observed strong associations with use and individual and family factors that influence youth use.”

Study finds marijuana legalization doesn’t lead to increased crime

A federally funded study published in Justice Quarterly found that violent and property crime rates in Colorado and Washington did not increase after recreational marijuana was legalized. The crime rates stayed close to the average of other states where adult-use cannabis isn’t legal. Plus, since Washington legalized marijuana, burglary rates have actually declined more sharply than in states that haven’t legalized.

“Our results suggest that marijuana legalization and sales have had minimal to no effect on major crimes in Colorado or Washington,” according to researchers. “We observed no statistically significant long-term effects of recreational cannabis laws or the initiation of retail sales on violent or property crime rates in these states.”

Researchers looked at crime rates in Colorado and Washington from 1999 to 2016 and compared the data to 21 non-legal states. The study used crime statistics from the FBI.

“As the nationwide debate about legalization, the federal classification of cannabis under the Controlled Substances Act, and the consequences of legalization for crime continues, it is essential to center that discussion on studies that use contextualized and robust research designs with as few limitations as possible,” said Dale Willits, one of the study’s co-authors. “This is but one study and legalization of marijuana is still relatively new, but by replicating our findings, policymakers can answer the question of how legalization affects crime.”

Senate Majority Leader Mitch McConnell and other members of Congress are urging the Food and Drug Administration (FDA) to speed up its guidance on hemp-derived CBD products. Specifically, Congress wants the FDA to issue formal “enforcement discretion” regarding CBD.

Hemp was legalized last year thanks to the 2018 Farm Bill, which made CBD legal as well. However, without guidance from the FDA, hemp and CBD are in a regulatory gray area. Lawmakers say that the FDA’s current approach to CBD has “created significant regulatory and legal uncertainty for participants in this quickly evolving industry.”

Currently, the FDA prohibits adding CBD to food or drinks marketed beyond a single state or to be added to food as a dietary supplement. Because of the regulatory confusion, some local governments have insisted that CBD is illegal in their state.

“Given the widespread availability of CBD products, growing consumer demand, and the expected surge in the hemp farming in the near future, it’s critical that FDA act quickly to provide legal and regulatory clarity to support this new economic opportunity,” lawmakers wrote.

The FDA has said it could take years to finalize CBD regulations. Congress isn’t waiting, and the US Senate Appropriations Subcommittee on Agriculture is working on guidelines to submit to the FDA. According to U.S. Hemp Rountable, Congress is working on rules that would require the FDA to:

Lawmakers wrote that they appreciate that the FDA has pursued “enforcement actions against the worst offenders,” but that “it can do so while eliminating regulatory uncertainty for farmers, retailers, and consumers.”

“Without a formal enforcement discretion policy, anyone participating in the growing marketplace for legal hemp-derived products will continue to face significant legal and regulatory uncertainty.”

McConnell, who has been supportive of the hemp industry, does not support ending marijuana prohibition. Asked to comment of legalizing hemp but not cannabis, McConnell said that hemp is “a different plant. It has an illicit cousin which I choose not to embrace.”

On Monday, the US Food and Drug Administration approved a cannabis-derived medication used to treat certain forms of epilepsy. The drug, Epidiolex, is made from cannabidiol (CBD) and contains no THC. This is the first time the FDA has approved a cannabis-based medication.

The FDA approved Epidiolex to treat two rare forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. Lennox-Gastaut syndrome causes multiple types of seizures that begin in early childhood, usually between the ages of 3 and 5. Dravet syndrome causes seizures due to a rare genetic dysfunction of the brain. The medication is approved to be administered to patients 2 and older twice daily as an oral solution.

“Today’s announcement gives individuals with Lennox-Gastaut Syndrome and their families much-needed hope,” said LGS Foundation Executive Director Christina SanInocencio.

Dravet Syndrome Foundation Executive Director Mary Anne Meskis agreed with SanInocencio.

“We are very pleased to see the approval of Epidiolex for Dravet and Lennox-Gastaut syndromes. While each of our disorders are different in terms of etiology, both of our communities suffer from intractable seizures, an increased risk of mortality and many devastating co-morbid conditions that significantly affect quality of life.”

CBD can be found in both hemp and marijuana, and unlike other cannabinoids, like THC, CBD has no psychoactive effects. Cannabis, including CBD, is still considered a Schedule I drug under US law.

In a statement Monday, FDA Commissioner Dr. Scott Gottlieb said, “This is an important medical advance. Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery.”

“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,”

Epidiolex was developed by UK-based GW Pharmaceuticals, who also manufacture Sativex, another cannabis-based medication used to treat muscle stiffness and spasms associated with multiple sclerosis.

There’s loads of anecdotal evidence that cannabis is effective in treating PTSD in veterans, but the Department of Veterans Affairs is not having any of it. Physicians in the VA are still prohibited from recommending cannabis to their patients, leaving veterans struggling with symptoms and addictive medications.

However, there is hope for veterans struggling to access medical marijuana. The first FDA-approved study on the effects of cannabis in treating veterans’ PTSD is nearly complete, and we could be one step closer to federally legalizing cannabis as a treatment.

The study, now in its third year, is being conducted by Dr. Sue Sisley and is funded by a $2.15 million grant from the University of Colorado. Sisley fought for seven years to get approval from federal officials to study the effects of marijuana, and while she may be well known as a marijuana advocate these days, she wasn’t always a fan.

“I was dismissive and judgmental, then I started losing a lot of vets in my practice to suicide, and it became a big wake-up call. The veteran community has a higher rate of prescription drug overdose, and many vets discovered they can substitute cannabis for the more addictive medications they’ve been prescribed, which is how we started to examine this,” Sisley told Healio.

The phase 2 study aims to provide more than anecdotal evidence through a controlled clinical trial. The study is triple-blind, randomized, and placebo-controlled. After a familiarization stage, veterans are given cannabis to take home and self administer. Subjects are randomly assigned to receive either high THC, high CBD, an equal THC/CBD mix, or placebo and asked to administer the medication at their own discretion for three weeks, followed by two weeks with no cannabis. Researchers monitor PTSD symptoms throughout the process.

In addition to PTSD, Sisley and her colleagues are also assessing biomarkers for inflammation and anti-inflammatory effect of cannabis.

Sisley said that only 19 additional veterans are needed to complete the dataset, and she hopes that the FDA will approve a phase-3 trial.

While that’s all good news, there is a potential hiccup in the research, and it has to do with the notoriously low-quality weed supplied by the government. The flower used in the study is grown at the University of Mississippi, and in addition to being full of stems and seeds, some samples also contain mold and lead.

“If half is extraneous nonmedical plant material, it could be sabotaging efficacy studies, meaning that if you’re trying to measure effectiveness of cannabis and you’re forced to use a very sub-optimal plant material, this could harm the outcome of tests looking at how effective cannabis is at treating a certain illness,” Sisley said to Healio.

 

The U.S. Food and Drug Administration (FDA) is seeking public comment (yep, that means you) regarding the classification of marijuana as a Schedule I substance under both U.S. law and international drug agreements. The FDA is putting together a recommendation for the United Nations’ World Health Organization (WHO). WHO is currently reviewing the international classification of cannabis, including THC, CBD and other cannabinoids.

Cannabis was listed in the UN’s Single Convention on Narcotic Drugs as a Schedule I drug in 1961, and the WHO says that cannabis is “the most commonly used psychoactive substance under international control.” Schedule I drugs include LSD and heroin–drugs that are considered high risk for abuse and addiction and that have no currently accepted medical use.

The FDA is specifically looking for input regarding the “abuse potential, actual abuse, medical usefulness, trafficking and impact of scheduling changes on availability for medical use of” marijuana. The FDA will forward public comments to the United Nations World Health Organization (WHO). Recommendations from the WHO are used to inform public health policy and drug laws.

In December, the WHO released a preliminary review of CBD, a non-psychoactive compound found in marijuana, that said CBD should not be scheduled as a controlled substance. They concluded that CBD has a low potential for abuse and that it “has been demonstrated as an effective treatment of epilepsy in several clinical trials” and “is generally well tolerated with a good safety profile.”

The preliminary review also found that “there is no evidence of…any public health related problems associated with the use of pure CBD.”

The deadline to submit public comments to the FDA is April 23.

Want to support the declassification of cannabis, but you don’t know where to start? NORML has posted a pre-drafted comment on their website, and they will be hand delivering all comments to the FDA.