The Food and Drug Administration (FDA) announced earlier this month that it was accepting public comments on CBD regulations, and more than 400 people have already made their voices heard.
Comments published on Regulations.gov range widely in subject matter, but the main theme running through them is that regulations should be light and companies should be able to lawfully market products containing cannabidiol. Many added that marijuana in general should be legalized, even though the agency did not request that people weigh in on that broader issue.
The comment period was designed to help inform an upcoming public hearing on CBD regulations that the FDA is holding on May 31. Amy Abernethy, principal deputy commission of the FDA, tweeted a link for stakeholders to register for the hearing on Wednesday.
Are there particular safety concerns re: products with cannabis/cannabis-derived compounds? How does the mode of delivery (e.g., ingestion, absorption, inhalation) affect the safety & exposure? Comments/data on important issues like these can help inform FDA reg. oversight.
— Dr. Amy Abernethy (@DrAbernethyFDA) April 17, 2019
We’re seeking input re: FDA’s reg. strategy for existing products, lawful pathways by which appropriate products containing cannabis/cannabis-derived compounds can be marketed & how to make them more predictable/efficient. Register or submit to the docket: https://t.co/xISRzDgN1S pic.twitter.com/maBllYjr3O
— Dr. Amy Abernethy (@DrAbernethyFDA) April 17, 2019
The FDA listed out several questions mostly concerning the safety of cannabis-derived products, how to enact quality control measures and what “validated analytical testing is needed” to ensure that CBD is manufactured in a consistent manner.
David Mangone, director of government affairs at Americans for Safe Access, offered some tips on how to submit effective comments in an earlier interview with Marijuana Moment, and one of the takeaways was that the FDA is primarily interested in receiving scientific evidence that addresses the agency’s specific questions—as opposed to personal anecdotes about CBD use.
Some, like Matthew Lubeck, followed that advice. He commented that CBD should be allowed into the food supply because “the bioavailability and reactiveness within the human body and the cannabinoid system” isn’t ideal when the compound is isolated.
Brent King offered an assessment examining the potential use of CBD as an exit drug from addictive substances such as opioids. He cited a study that showed reduced opioid overdoses in states that have loosened marijuana laws as an example.
“The gateway theory falls victim to the mistaken assumption that correlation alone implies causation,” King said. “Using the same logic, one could argue that drinking milk is a gateway to illicit drug use since most people who use illicit drugs also drank milk as young people.”
Others raised questions about the CBD market as it exists today—unregulated by the FDA as the agency continues to weigh possible options to allow hemp-derived CBD into the food supply or as dietary supplements. An anonymous comment expressed concerns about product consistency across companies that are already selling CBD, arguing that “variance from product to product is confusing” and makes it difficult to “make an informed decisions” about what products to use.
“The public needs protection from unscrupulous companies goals to get rich,” the person wrote.
All that said, most comments did not adhere to Mangone’s or the FDA’s guidelines. The vast majority of comments were anecdotal and individualized. People suffering from conditions such as anxiety, pain, post-traumatic stress disorder and insomnia urged the FDA to loosen restrictions on CBD, describing their own life-changing experience with the product. Several others talked about the health benefits of CBD that they observed in pets.
While that might not be what the agency asked for, that doesn’t change the fact that there is a broad consensus among those who took the time to comment: CBD is safe and has proven medical value, and people should be allowed to freely access it.
It’s not that simple from the FDA’s perspective, however. Former Commissioner Scott Gottlieb has repeatedly stressed that because CBD exists as an FDA-approved drug (Epidiolex) and hasn’t previously been introduced to the food supply, there’s no clear regulatory framework to put it through, even if that was the intention of the 2018 Farm Bill that legalized hemp and its derivatives.
Gottlieb has told members of Congress that additional legislation may be required to provide for the marketing of CBD, or else it may take years before the FDA can identify an alternative regulatory pathway. In the meantime, the FDA is taking a “risk-based” approach to enforcing laws governing CBD marketing that involves cracking down on companies making unsanctioned claims about the health benefits of their CBD products.
Federal requests for public input on cannabis-related policies are nothing new. Thousands offered their perspective on marijuana scheduling under international treaties when the FDA requested feedback on that issue last year. More recently, another federal agency solicited studies from the public on how cannabis can treat symptoms of Alzheimer’s disease.
Photo courtesy of Rick Proctor.
Biden Says Marijuana Might Be A Gateway Drug
Former Vice President Joe Biden (D) said on Saturday that he’s not sure if marijuana is a gateway drug that leads to the use of other, more dangerous substances.
“The truth of the matter is, there’s not nearly been enough evidence that has been acquired as to whether or not it is a gateway drug,” the 2020 presidential candidate claimed at a town hall meeting in Las Vegas. “It’s a debate, and I want a lot more before I legalize it nationally. I want to make sure we know a lot more about the science behind it.”
(Marijuana Moment’s editor provides some content to Forbes via a temporary exclusive publishing license arrangement.)
Vote To Federally Legalize Marijuana Planned In Congress
A key congressional committee plans to hold a historic vote on a bill to end the federal prohibition of marijuana next week, two sources with knowledge of the soon-to-be-announced action said.
The legislation, sponsored by House Judiciary Committee Chairman Jerrold Nadler (D-NY), would remove cannabis from the Controlled Substances Act and set aside funding to begin repairing the damage of the war on drugs, which has been disproportionately waged against communities of color.
Image element courtesy of Tim Evanson.
Where Presidential Candidate Deval Patrick Stands On Marijuana
Former Massachusetts Gov. Deval Patrick (D) announced on November 14, 2019, that he is seeking the 2020 Democratic presidential nomination.
The latecomer to the race does not have an especially reform-friendly record on drug policy issues compared to many of his rival contenders, and questions remain about where he stands on legalization for adult-use—or even medical use for that matter.
During his time as governor, he voiced opposition to a marijuana decriminalization proposal and raised concerns about a medical cannabis legalization measure. After voters approved that latter initiative, he said he wished the state didn’t have the program, and his administration faced criticism over its implementation.
That said, Patrick, who also served as the U.S. assistant attorney general for the civil rights division, does not appear to have expressed hostility to marijuana reform in recent years and during his time in office did take action in support of modest proposals such as resentencing for people with non-violent drug convictions. Here’s where the former governor stands on cannabis:
Legislation And Policy Actions
Patrick’s administration said that despite a marijuana decriminalization policy going into effect following the passage of a 2008 ballot initiative, law enforcement should be able to continue to search people suspected of possession. However, his office declined to approve a request from prosecutors to delay the implementation of the voter-approved policy change.
After the decriminalization proposal passed, Patrick directed the Executive Office of Public Safety and Security (EOPSS) to develop an implementation plan.
“Our office will continue to work collaboratively with EOPSS and the district attorneys and law enforcement agencies on implementation,” a spokesperson said. “It’s an ongoing process.”
The then-governor said he would work to toughen up enforcement of fines levied against people possessing marijuana.
“The bottom line is the governor believes that if people are fined they should pay the fines,” a spokesperson for his administration said.
Following the passage of a 2012 medical cannabis initiative in Massachusetts, Patrick said simply that the “voters have voted,” and pledged that he wouldn’t seek to repeal the law.
But there were some complications that arose during his administration’s medical marijuana licensing approval process.
In February 2014, Patrick contradicted the state health department, which had recently announced that 20 business licenses had been accepted.
“No licenses have been given. No provisional licenses have been given. What we have is a multi-step process of screening out applicants,” he said. “Don’t get ahead of where we are. There was a balance struck here about trying to let the public in through transparency to the process even though the process was unfinished.”
When reports emerged that certain medical cannabis applicants had apparently provided false or misleading information in their application forms, Patrick said “[n]o good dead goes unpunished.”
“Rather than wait till the end when all that vetting and screening had been done, we’re going to do that first cut from 100 [applicants] down to 20, and we’re going to tell everybody,”
The next month, he dismissed requests for a review of the licensing process by applicants who the health department had rejected.
“I don’t think we gain anything by starting over,” he said. “We are in the middle of a process. Nobody has a license, no one is going to get a license until we meet the standards of the application process.”
Patrick was also criticized for failing to follow up with patient advocates who urged him to effectively implement the program.
“It appears the governor wants to skip out of office without addressing medical marijuana because he doesn’t want to talk about it and he doesn’t want to deal with it,” Massachusetts Patient Advocacy Alliance Executive Director Matthew Allen said in 2014.
Patrick’s successor, Gov. Charlie Baker (R), overhauled the his predecessor’s medical cannabis licensing process to create “a more streamlined, efficient, and transparent process that allows the Commonwealth to maintain the highest standards of both public safety and accessibility.”
Despite opposing marijuana decriminalization and expressing concerns about medical cannabis legalization, the governor did sign several drug policy reform bills during his time in office.
Patrick signed legislation in 2012 that reduced mandatory minimum sentences for people with non-violent drug convictions. He’d introduced a package of bills that included a call for the repeal of such mandatory minimums the previous year, earning praise from reform advocates.
“We need an effective and accountable re-entry program for those leaving the criminal justice system,” Patrick said in a statement. “Combining probation and parole, and requiring supervision after release, takes the best practices from other states to assure both public safety and cost savings.”
Another piece of legislation the then-governor proposed was to reduce the scope of “drug-free school zones,” where people charged with drug crimes would face mandatory minimum sentences. He recommended reducing the size of these zones from within 1,000 feet of a school to 100 feet.
Patrick signed off on a bill in 2014 to expand access to drug treatment.
“This bill creates some new rules and new tools for us to use together to turn to our brothers and sisters who are dealing with these illnesses and addiction and help them help themselves,” he said.
But in 2012, Patrick signed a bill prohibiting certain synthetic drugs called “bath salts.”
On The Campaign Trail
So far, Patrick has not made drug policy a center-stage issue in his campaign. However, his website says his agenda involves “making meaningful fixes to the big systems that consistently fail to meet modern needs.”
“This means a justice system that focuses less on warehousing people than on preparing them to re-enter responsible life,” the site says.
Previous Quotes And Social Media Posts
In 2007, a spokesperson for Patrick’s office said the governor would veto a proposed marijuana possession decriminalization bill. Patrick told the Associated Press that he had other priorities when asked whether he would sign the legislation.
He was listed as a supporter for a campaign that opposed the 2008 decriminalization ballot measure that voters later approved.
Oddly, two years earlier, Patrick was asked about a decriminalization proposal during a debate and said that while he’s “very comfortable with the idea of legalizing marijuana,” he doesn’t “think it ought to be our priority.” He went on to say that he would veto a proposed decriminalization measure in the legislature.
Massachusetts voters also approved a 2012 medical cannabis initiative while Patrick was in office—in spite of the fact that he declined to endorse the measure.
Asked about the proposal during a radio interview with WBZ, the then-governor first cited an argument in support of legalization made by conservative author William F. Buckley Jr., who said regulating drug sales would remove a profit motive for illicit dealers. Yet he went on to say that “I’m not endorsing” the initiative.
“I’m not expressing a point of view and I’m not dodging, it’s just I’ve got so much else I’m working on,” he said.
The host asked if Patrick would implement the law if voters approved it and he said “that’s, I think, what we’re supposed to do.”
In September 2012, he said that he doesn’t “have a lot of enthusiasm for the medical marijuana” measure, which was set to go before voters two months later.
“I mean I have heard the views on both sides and I’m respectful of the views of both sides, and I don’t have a lot of energy around that,” he said. “I think California’s experience has been mixed, and I’m sympathetic to the folks who are in chronic pain and looking for some form of relief.”
“I really have to defer to the medical views about this and individuals will get a chance to vote on this,” Patrick said in April 2012. “I haven’t been paying much attention to it.”
While his administration struggled to implement the program after voters had approved it, Patrick said in August 2014 that “I wish frankly we didn’t have medical marijuana.”
Responding to q abt medical marijuana dispensaries in westrn Mass @massgovernor says "Look, I wish frankly we didn't have medical marijuana"
— Sharman Sacchetti (@SharmanTV) August 20, 2014
Patrick doesn’t appear to have publicly weighed in during the Massachusetts campaign about legalizing marijuana for adult-use, which voters approved in 2016 after he had left office.
In 2012, Patrick said during a State of the State Address that Massachusetts should reevaluate how it treats people convicted of non-violent drug offenses.
“In these cases, we have to deal with the fact that simply warehousing non-violent offenders is a costly policy failure,” he said. “Our spending on prisons has grown 30 percent in the past decade, much of that because of longer sentences for first-time and nonviolent drug offenders. We have moved, at massive public expense, from treatment for drug offenders to indiscriminate prison sentences, and gained nothing in public safety.”
“We need more education and job training, and certainly more drug treatment, in prisons and we need mandatory supervision after release,” he said. “And we must make non-violent drug offenders eligible for parole sooner.”
He also said that the “biggest problem is that our approach to public safety has been to warehouse people,” and that the “answer is new policies, not bigger warehouses.”
“We’ve been warehousing people for whom what they really need is treatment and not just time,” he said during a town hall event in 2009.
Patrick voiced support in 2006 for a bill that would legalize the over-the-counter sale of needles in order to prevent the spread of disease.
“Deval Patrick supports this legislation because he believes it will reduce dangerous diseases in our state,” a campaign spokesperson said. “Studies in other states have shown that programs such as these decrease the rates of disease infection without increasing drug use.”
Patrick later criticized then-Gov. Mitt Romney (R) for vetoing the legislation, stating that the official “put misguided ideology before leadership in public health.”
Personal Experience With Marijuana
Patrick said in 2012 that he has never “experienced marijuana myself” but that during his school years there “was probably enough around me that there was a second-hand, a contact-high.”
Marijuana Under A Patrick Presidency
It is difficult to assess how Patrick would approach federal marijuana policy if elected president, but his vocal opposition to decriminalization in Massachusetts and his administration’s troubled implementation of medical cannabis legalization is likely to give advocates pause. While his current position on legalizing marijuana for adult-use is unclear, given that drug policy reform has become a mainstream issue that candidates are routinely pressed on, it is likely the former governor will be asked to weigh in on the campaign trail.
But for the time being, it appears that Patrick would not make marijuana reform a priority and, in fact, might prove more resistant to policy changes such as descheduling that the majority of candidates now embrace.