The U.S. Food and Drug Administration (FDA) has denied a request from an anti-legalization group to place marijuana and its derivatives on a list of restricted substances that are not “generally recognized as safe and effective.”
The move is “not necessary for the protection of public health,” Janet Woodcock, the director of FDA’s Center for Drug Evaluation and research wrote on Monday in a letter to the group, Drug Watch International.
The organization had filed its petition requesting the cannabis crackdown in December, writing that the move would “send an industry-wide warning to the estimated 33,000 marijuana businesses in the U.S., many of which are making unsupported medical claims for marijuana and THC drug products sold as ‘medical marijuana.'”
The prohibitionist organization pleaded with FDA to take action that would “reduce or end the ability of [over-the-counter] sellers of these drugs to assert and advertise unsupported medical claims for their products.”
“It would immediately make such claims unlawful and subject the sponsors to regulatory action, including injunctive seizure of mislabeled and misbranded drugs, as well as other potential sanctions permitted under the [Food, Drug and Cosmetic Act].”
But FDA balked, saying that while it “appreciates the safety and public health concerns that motivate” the request, the agency “already has adequate authority to remove unapproved new OTC drugs containing marijuana or THC from the market.”
“In order for FDA to take enforcement action against illegal marketing of unapproved new OTC drugs containing marijuana or THC, it is not necessary for FDA to establish a negative monograph for marijuana or THC.”
While the decision by FDA not to assign so-called “negative monograph” status to marijuana and THC won’t do anything to make marijuana more available, or change its legal status—which remains prohibited under Schedule I of the Controlled Substances Act—the rejection suggests that the Trump administration is not looking for excuses to go out of its way to deal public relations blows to the cannabis industry.
In fact, despite a move by U.S Attorney General Jeff Sessions this January to rescind Obama-era protections for state marijuana laws, President Trump himself indicated last month that he supports pending congressional legislation to end federal cannabis prohibition.
Last week, the powerful U.S. Senate Appropriations Committee issued a report criticizing roadblocks to research on marijuana that are caused by its ongoing Schedule I status.
The FDA’s negative monograph list currently contains unapproved drug products such as certain daytime sedatives, aphrodisiacs and deterrents to nailbiting or thumbsucking.
The list is “not intended to be comprehensive lists of all classes of OTC products, active ingredients, or conditions of use that cannot be marketed without FDA approval,” the agency wrote in its rejection of the Drug Watch International petition.
“While you suggest that a negative monograph would reduce or end the unlawful marketing of unapproved new OTC drugs containing marijuana or THC, existing law makes very clear that such unapproved products cannot be marketed under the FD&C Act,” the feds said. “FDA has not determined that any OTC drug products containing marijuana or THC are [generally recognized as safe and effective] for their intended indications. Therefore, these products are ‘new drugs’ per section 201 of the FD&C Act that must be approved by FDA to be legally marketed.”
“That the Agency has not promulgated a negative monograph specific to marijuana or THC does not absolve a drug manufacturer or marketer from its responsibility to obtain an approved NDA or ANDA if one is required by law.”
“It is the responsibility of companies marketing drug products in the United States to ensure that their products are safe and effective and marketed in compliance with the law,” FDA’s Woodcock wrote. “[A]s discussed above, FDA has existing authority to pursue regulatory or enforcement actions regarding unapproved new OTC drugs, including those containing THC or marijuana.”
Indeed, FDA sent a series of warning letters in November to manufacturers of products containing cannabidiol (CBD), a marijuana component that is increasingly used to treat epilepsy and other medical conditions, and which is sometimes marketed as having tumor-shrinking properties.
“Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors. We don’t let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer and we’re not going to look the other way on enforcing these principles when it comes to marijuana-containing products,” FDA Commissioner Scott Gottlieb said in a press release at the time. “There are a growing number of effective therapies for many cancers. When people are allowed to illegally market agents that deliver no established benefit they may steer patients away from products that have proven, anti-tumor effects that could extend lives.”
More recently, however, FDA approved a CBD pharmaceutical drug, Epidiolex, to treat severe epilepsy.
“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. And, the FDA is committed to this kind of careful scientific research and drug development,” Gottlieb said in the press release announcing the move last month. “But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”
For now, that Gottlieb’s FDA passed up the opportunity to add marijuana to the restrictive negative monograph list allows the cannabis industry to avoid another round of headlines about finger-wagging federal regulators calling them out.
Andrew Yang Wants To Legalize Psychedelic Mushrooms For Military Veterans
Andrew Yang says he wants to legalize psilocybin mushrooms for military veterans to help them combat mental health conditions such as post-traumatic stress disorder (PTSD).
During a town hall event at an Iowa college on Thursday, the 2020 Democratic presidential candidate was asked whether he would take initiative and allow veterans to access medical marijuana if elected. Yang replied he “will be so excited to be that commander-in-chief” that he would not only end federal cannabis prohibition but would go one step further by legalizing the psychedelic fungus for veterans as well.
“We need to get marijuana off of the Controlled Substances Act and legalize it at the federal level, make it freely available,” he said. “I say this because I’ve talked to hundreds of veterans and other Americans who benefit from marijuana as a pain relief treatment, and it’s much less deadly than the opiates that many, many people are using for the same conditions.”
“I’ve talked to veterans who’ve also benefited from psilocybin mushrooms,” he added. “They said it was the only thing that actually has helped combat their PTSD. I’m for legalizing psilocybin mushrooms for veterans as well. Pretty much if it’s going to help a veteran, we should make it easier, not harder, for them to get access to it.”
Yang’s drug policy reform platform is unique in that respect. While the majority of Democratic candidates support marijuana legalization, he’s pushed unique proposals such as decriminalizing possession of opioids and making psilocybin mushrooms “more freely available” for therapeutic purposes. The candidate also wants to invest federal funds in safe injection facilities where individuals can use prohibited drugs in a medically supervised environment and receive help getting into treatment.
He hasn’t gone so far as embracing the decriminalization of all drugs, as former South Bend, Indiana Mayor Pete Buttigieg has, however.
That said, Yang did signal that he’s open to legalizing and regulating “certain drugs” beyond cannabis, which he argued would disrupt international drug cartels. Rep. Tulsi Gabbard (D-HI) recently said she backs “legalizing and regulating” currently illegal controlled substances to protect public safety and combat the illicit market.
At the Iowa town hall, Yang went on to say that he’s particularly interested in legalizing marijuana, and he again pledged to “pardon everyone who’s in jail for a non-violent marijuana-related offense because they shouldn’t be in jail for something that’s frankly legal in other parts of the country.”
“And I would pardon them all on April 20, 2021, high-five them on the way out of jail and be like, ‘things got a lot better in the last year,'” he said, referencing the unofficial cannabis holiday 4/20.
Photo element courtesy of Gage Skidmore.
Tom Steyer Calls For Marijuana Legalization And Opioid Decriminalization
Billionaire philanthropist Tom Steyer is calling for the legalization of marijuana and decriminalization of opioid possession.
In a criminal justice reform plan released on Thursday, the 2020 Democratic presidential candidate laid out a vision for ending the drug war, which he said has contributed to mass incarceration and is enforced in a racially disproportionate manner.
“Tom believes we must end the failed War on Drugs. Based on the flawed idea that incarceration is the answer to addiction, federal and state elected officials passed severe sentencing laws that encouraged incarceration for low-level drug offenses,” the plan states. “Unfortunately, communities of color were and continue to be disproportionately affected and targeted by these laws, even when other ethnicities were committing the same drug crimes at the same rates.”
Today @TomSteyer announced a new criminal justice plan to:
– Reform the juvenile system
– Improve prison conditions
– Redirect funds to education
– Eliminate cash bail
– Release more rehabilitated people
– End the war on drugs
And much more! 👉 https://t.co/3VYRw7ioXB
— TeamTom 🌎 (@TomHQ) January 24, 2020
There are six proposals in the drug war section, including legalizing cannabis and expunging prior marijuana convictions, ending mandatory minimum sentences and empowering judges to use more discretion in non-violent drug cases, diverting people convicted of drug offenses to treatment or drug court, ending the sentencing disparity between crack and powder cocaine, sealing the records of certain drug convictions and decriminalizing opioids while investing $75 billion in treatment programs and holding pharmaceutical companies accountable.
Steyer specifically endorsed House Judiciary Committee Chairman Jerrold Nadler’s (D-NY) Marijuana Opportunity Reinvestment and Expungement (MORE) Act, which would deschedule cannabis, expunge prior convictions and set aside tax revenue to support communities most impacted by the drug war.
“Policing marijuana use has led to too many unfair incarcerations and predominantly impacted communities of color,” the plan says. It also criticizes then-Attorney General Jeff Sessions’s 2018 move on “repealing leniency given to states for marijuana laws.”
Today, I'm meeting with formerly incarcerated individuals to talk about transforming the criminal justice system through police accountability, ending cash bail, providing adequate funding to re-entry programs, and so much more. pic.twitter.com/m9lDEKWwwU
— Tom Steyer (@TomSteyer) January 23, 2020
“A Steyer Administration will also open equitable pathways to banking for marijuana businesses,” it continues. “The federal government—including the Federal Deposit Insurance Corporation—should not be a barrier to marijuana businesses receiving support from their local banks.”
“Incarceration is not the answer to addiction, and low-level drug offenses should not carry a severe sentence. Tom will legalize marijuana, let states pass their own policies, expunge past records, and direct the federal government to open banking services to the marijuana industry. Tom’s administration will end the disparity between crack and cocaine sentences, decriminalize opioid possession, and invest $75 billion to address the opioid crisis.”
The opioid decriminalization proposal is similar to that of entrepreneur Andrew Yang, another 2020 candidate who said removing criminal penalties for possessing the substance is necessary in order to help get people into treatment and curb the opioid crisis. Former South Bend, Indiana Mayor Pete Buttigieg and Rep. Tulsi Gabbard (D-HI) have gone further, calling for the decriminalization of all drug possession and, in Gabbard’s case, also the legalization and regulation of illicit drugs.
“Tom supports decriminalizing small amounts of opioid possession for personal use at the federal level,” the plan states. “He will address the opioid crisis through $75 billion in new funding over ten years to resource state and local treatment programs, hold big pharmaceutical corporations and their executives accountable, and strongly enforce laws that end the illicit distribution and sale of opioids.”
This is a notable development for Steyer, who hasn’t discussed drug policy reform as much as many other candidates in the race and whose views on decriminalization of substances beyond marijuana were previously unknown.
Last year, Steyer said he supported creating a national referendum process so that Americans can made decisions about a wide range of policy issues, including cannabis legalization.
He also previously discussed his support for ending marijuana prohibition and providing the industry with access to banking, saying that he and his wife wanted to provide financial services to minority- and women-owned cannabis firms through their community bank, but federal prohibition means the business would be put at risk if they did that.
Steyer’s new plan also calls for juvenile justice reform, ending cash bail, banning facial recognition technology in policing, demilitarizing law enforcement, improving prison conditions and eliminating the death penalty, among other reforms.
Photo courtesy of Flickr/Gage Skidmore.
Austin City Council Approves Measure To End Most Marijuana Arrests
The decision to back away from pursuing criminal charges against people with small amounts of pot comes after state lawmakers last year legalized hemp in a way that threw marijuana prosecution into chaos.
The Austin City Council approved a resolution Thursday that will largely end arrests and fines for low-level marijuana possession. This comes after Texas’ legalization of hemp last June threw marijuana prosecution into chaos since the plants look and smell identical.
The resolution directing Austin police not to spend city resources on newly necessary lab tests to distinguish marijuana from now-legal hemp passed unanimously with nine votes. Council member Jimmy Flannigan and Mayor Steve Adler were absent. Debate on the measure lasted just under an hour and a half. Of about 20 people who spoke on the resolution, only Austin Police Association President Ken Casaday was against it.
The council’s resolution states that it stems directly from Texas’ new law legalizing hemp. Last summer, following a federal hemp bill, state lawmakers approved a measure to create an agricultural industry for the crop in Texas. But the law also complicated marijuana prosecutions by narrowing the legal definition of the drug from cannabis to cannabis that contains more than 0.3% THC, the psychoactive ingredient in the plant.
Joint Effort: #ATXCouncil takes steps to eliminate the use of arrest or other enforcement action for low-level cannabis-related possession offenses + ensure City resources are focused on citizens’ public safety priorities. View the draft resolution: https://t.co/qNJ6L2ZPjJ. pic.twitter.com/rdwiLjx0w8
— City of Austin (@austintexasgov) January 23, 2020
All of a sudden, some district attorneys were dropping hundreds of low-level pot possession cases and not accepting new ones, arguing they couldn’t tell without lab testing if something was marijuana anymore. New misdemeanor marijuana cases filed by Texas prosecutors have dropped by more than half. And numerous Texas prosecutors, including those in Austin’s Travis County, require police to submit lab reports on a substance’s THC concentration before they will pursue misdemeanor marijuana charges. They argue circumstantial evidence like smell can no longer be used to authoritatively say something is marijuana.
Part of what prompted the Austin resolution — which prohibits spending city funds on such testing except in felony cases — is that public state labs are still working on establishing a way to test for that THC concentration. Right now they can only tell if something is cannabis. For some counties and cities, that has meant putting more money into shipping seized cannabis to private labs that can tell if it’s hemp or marijuana.
Even in places where police don’t have or aren’t spending funds on such testing and new cases aren’t being accepted by prosecutors, people are still being cited or arrested. They are sometimes taken to jail but then released with no charges being pursued. Austin police said this month that they still arrest or cite people who are suspected of possessing marijuana.
This resolution changes that, directing the city to get as close as possible to eliminating enforcement action for low-level cannabis possession.
The measure prohibits spending city funds on testing in low-level possession cases, and it directs police not to arrest or cite people in such cases — unless there is a safety concern — if they know the district attorney will automatically reject the charges or testing won’t be approved. It clarifies that lab testing can be used for suspected felonies or when the cannabis is not for personal use, like trafficking cases. A revised version also specifies that the measure will not affect toxicology testing.
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