Do you have feelings about how the federal government is handling the regulation of CBD products? Now you can share those thoughts—along with studies, data and other important information—with the Food and Drug Administration (FDA).
On Wednesday, the agency published an official notice announcing a public hearing for next month on its approach to regulating products, including dietary supplements and foods, that contain cannabidiol.
But you don’t have to participate in the meeting itself to make your voice heard. In conjunction with the May 31 event, regulators have also opened up an official docket to take feedback on the issue. The public comment period is open through July 2.
Specifically, FDA is requesting information related to health and safety risks, manufacturing and product quality and the way in which products containing cannabis or cannabis-derived compounds are marketed and sold.
As the agency writes in its notice: “While the use of cannabis and cannabis-derived products, including hemp and hemp-derived products, has increased dramatically in recent years, questions remain regarding the safety considerations raised by the widespread use of these products. These questions could impact the approaches we consider taking in regulating the development and marketing of products.”
Broadly, the FDA wants to see information concerning the notion that hemp-derived CBD is safe to consume in food, what kind of standards need to be put into place to ensure product quality and consistency and what information needs to be included on labels to ensure consumers know exactly what risks they’re taking, if any.
Other questions include:
- What levels of cannabis and cannabis-derived compounds cause safety concerns?
- How do cannabis and cannabis-derived compounds interact with other substances (e.g., drug ingredients)?
- What validated analytical testing is needed to support the manufacturing of safe and consistent products?
David Mangone is the director of government affairs at Americans for Safe Access (ASA). He told Marijuana Moment that submitting comments to the FDA is an opportunity for the general public to help shape policy—and that every comment is read.
“The federal government is anywhere from 10 to 15 years behind the American public and the state-level politics on this issue,” he said in a phone interview. “It’s important for people to be able to use their voice,” and this is one way to do that.
If you’re planning to submit a public comment on the issue, here are a few things to keep in mind:
Be thoughtful about your comment.
“When you see comments particularly on this issue from the general public, you see a lot of brief comments that are very opinionated,” Mangone said.
Last month, another cannabis-related docket was opened to gauge public interest in how the United States should vote on World Health Organization recommendations to reschedule cannabis and its compounds. Nearly 2,000 comments were filed, and an overwhelming number of them support marijuana reclassification.
But, Mangone pointed out, many of those comments were brief, boiling down to “Legalize it” or offering stories about how medical cannabis helps people who are struggling with debilitating conditions.
“That’s not really what the FDA is ever looking for,” he said. “I wish we could sway federal policy with patient stories—and, to a degree, we can on Capitol Hill—but with a regulatory body like the FDA, they’re looking for very specific answers to very specific questions.”
As such, Mangone suggested picking one question from the public notice document on CBD and focusing on it.
Include scientifically sound research.
“This is not a popularity contest. It’s not like an up/down vote on how many comments in favor and how many comments against [CBD products],” he explained. “It’s based off the quality and content of the comments.”
That’s why including studies and data in your submissions is so important. Start by looking for scientific studies that include a large number of people in the sample. Pay attention to who it was conducted by (a university or international body is ideal) and whether or not the authors have a financial interest in the outcome of the study, Mangone said.
Remember who your audience is.
“You’re writing to a government regulatory body that for the past 40 to 50 years has worked actively against allowing CBD—and cannabis largely—as a medicine,” Mangone said. “You have to be respectful in your comments, but you also can’t leave anything on the table.”
Photo courtesy of Rick Proctor.
Idaho Senator Files Bill To Decriminalize Drug Possession
A new bill filed by an Idaho senator would decriminalize possession of currently illegal drugs in the state, though it also contains a provision that advocates consider troubling, allowing the government to involuntarily commit people convicted of certain offenses to treatment.
Sen. Grant Burgoyne (D) introduced the legislation, which would remove criminal penalties for drug use and possession by “requiring intention to deliver for criminal trafficking.”
Burgoyne told Marijuana Moment the bill has been referred to the Judiciary and Rules Committee, where Chairman Todd Lakey (R) has agreed to hold a hearing on it.
“We have too much of a focus on prosecution and punishment and not enough on treatment,” Burgoyne said in a separate interview with KTVB. “We don’t have a functioning mental health treatment and substance abuse treatment capability for the needs of our people. We need new strategies, how we draw the lines between what is criminal conduct and what is not criminal conduct when it comes to drug possession and usage.”
The bill sets different possession thresholds for different drugs. Having just two grams of heroin could be considered trafficking, while for cocaine and methamphetamine, the amount is set at 28 grams. One pound of marijuana, or 25 plants, could be treated as a trafficking offense.
Any amount of LSD could be considered a trafficking offense, as could any amount of a “simulated controlled substance,” possibly referring to synthetic opioids like fentanyl. Using drugs with friends would also be harshly penalized, as “sharing or providing a controlled substance for use by another person shall constitute intent to deliver.”
“This will reduce arrests, but how much is very hard to predict,” Burgoyne told Marijuana Moment. “Unfortunately, illegal drug use, even in private, is too often accompanied by the commission of other crimes, which my bill does not excuse and which could lead to arrest.”
Burgoyne’s bill would also allow people using drugs to be “placed in protective custody” or “admitted for community-assisted behavioral health treatment.” This would apply to people under the influence and in various circumstances, such as being pregnant, posing a risk to themselves or others or in withdrawal.
But existing research on mandatory drug treatment suggests it is not helpful for people with substance use disorder. A 2016 study published in the British Medical Journal, for example, found that when people are ordered to undergo drug treatment without their informed consent, the practice does more harm than good and does not reduce their drug use. The researchers explained that harm reduction efforts like syringe exchanges and drug education were more effective.
“Although there is some theoretical danger of adverse consequences to mandated drug treatment, we already mandate it for prisoners with drug issues,” Burgoyne said. “I’d like to shift treatment out of our jails and prisons to a more appropriate place. Furthermore, a civil commitment is not an easy thing to obtain, and I think our courts will be conservative in how they handle them.”
If the senator’s legislation passes, it remains to be seen what effect it would have on drug arrest rates in Idaho. According to the FBI, in 2017 Idaho had 8,432 arrests for “drug abuse violations,” which is a little over 16 percent of all arrests that year.
Burgoyne’s reform proposal comes amid a growing national debate about the value of decriminalizing drug use over more arrests. Last year in May, Denver became the first city in the U.S. to decriminalize personal use and possession of psilocybin mushrooms. Oakland’s City Council followed the next month by decriminalizing a wide range of psychedelics.
Advocates are also raising the issue on the national stage. Rep. Alexandria Ocasio-Cortez (D-NY) proposed decriminalizing drug consumption in November. Former South Bend, Indiana Mayor Pete Buttigieg, a 2020 Democratic presidential candidate, has proposed decriminalizing drug possession and reducing sentences. His primary opponent, Rep. Tulsi Gabbard (D-HI), recently called for legalizing and regulating drugs in order to treat substance misuse as a public health issue.
Photo coutersy of Markus Spiske.
U.S. Virgin Islands Governor Pushes For Marijuana Legalization In Annual Speech
The governor of the U.S. Virgin Islands (USVI) repeated his call for marijuana legalization in his annual State of the Territory address.
Gov. Albert Bryan Jr. (D), who called the legislature into a special session last month to begin taking up cannabis reform legislation, stressed that establishing a commercial marijuana market would bring in needed tax revenue to support a variety of government programs.
The proposed amendment to the territory’s existing medical cannabis law, which Bryan signed last year, would allow adults 21 and older to obtain a license from the government in order to purchase and cultivate marijuana. It would also promote participation in the industry by small farmers and local businesses, as well as providing for automatic expungements of prior cannabis convictions.
“Most importantly, it creates a taxing regime for the local industry that will generate higher revenues than the current law allows,” he said in the speech last Monday, noting that tax revenue will be distributed between the Government Employees Retirement System (GERS) fund (75 percent), implementation of regulations (20 percent) and services for senior citizens (5 percent).
“The revenues generated from this industry can benefit the system as a direct contribution,” the governor said. “However, the goal is to create a funding stream that is reliable enough to ultimately support a revenue bond that can provide a needed cash infusion to the system.”
Watch Bryan’s marijuana comments, first reported by Vibe High, about 36:24 into the video below:
“This is by no means the panacea or final solution for the GERS crisis, but a small part of a larger solution,” he continued. “It begins the process of generating the new revenues required to stave off the insolvency of the System. It takes existing policy, approved by this body, and leverages it to support this critical area of need.”
“We must acknowledge the opportunities that regulated expansion of this industry can bring to the territory and the potential benefits to the GERS,” he said. “I urge this body to take the necessary action to approve the amending legislation we have proposed.”
Bryan’s proposal calls for a 30 percent tax on marijuana sales, with revenue expected to be upwards of $20 million annually. His administration is also expecting the policy change to stimulate tourism, and visitors interested in participating in the market would be charged a $10 per day fee to access legal cannabis.
This year has seen several governors voice support for marijuana reform during their high-profile annual addresses and in legislative agendas. New York Gov. Andrew Cuomo (D) reaffirmed his commitment to legalization in his State of the State speech and Virginia Gov. Ralph Northam (D) pledged to pursue decriminalization, for example.
In New Mexico, the governor included legalization in her 2020 agenda, and lawmakers followed suit by filing a cannabis reform bill on Thursday. Rhode Island Gov. Gina Raimondo (D) proposed legalizing marijuana through a state-run model in a budget proposal released on Thursday.
Photo courtesy of Nicholas C. Morton.
Tulsi Gabbard Endorses Legalizing Drugs
Rep. Tulsi Gabbard (D-HI) is calling for the U.S. to legalize currently illicit drugs.
“If we take that step to legalize and regulate, then we’re no longer treating people who are struggling with substance addiction and abuse as criminals and instead getting them the help that they need,” the 2020 presidential candidate said at a campaign stop in Merrimack, New Hampshire on Friday.
(Marijuana Moment’s editor provides some content to Forbes via a temporary exclusive publishing license arrangement.)
Photo element courtesy of Lorie Shaull.