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.
Mexican Lawmakers Circulate Amended Marijuana Legalization Bill That’s Set For A Vote On Monday
Lawmakers in Mexico’s Chamber of Deputies are finally set to take up a bill to legalize marijuana nationally in the coming days, but the proposal has recently been subject to several significant revisions since being approved by the Senate last year.
First, a joint hearing of the chamber’s Health and Justice committees will take place on Monday, and a vote in the full chamber is expected the following day or on Wednesday. Advocates have been eagerly awaiting the introduction of new language, hopeful that it would address certain concerns with the Senate proposal, and now they’re getting details about what is being changed by the joint panels.
Generally speaking, most of the main provisions of the legislation remain intact. Adults 18 and older would still be allowed to purchase and possess up to 28 grams of marijuana and cultivate up to six plants for personal use, for example. But lawmakers revised the regulatory structure, rules for the commercial market and licensing policies, among other aspects.
Among the most significant amendments is that the revised bill would not establish a new independent regulatory body to oversee the licensing and implementation of the program as was approved by the Senate. Instead, it would give that authority to an existing agency, the National Commission Against Addictions.
Another change would be the creation of a license category for vertically integrated marijuana businesses that could control all areas of production and sales. However, there is language included in the measure to “prevent undue concentration that affects the market.”
While the bill would give priority for those licenses to marginalized communities, advocates are worried that there might not be strict criteria to actually ensure that ends up being the case. They had wanted to specific percentage of licenses to be set aside for those communities, but that’s not in the new bill.
For the purposes of public consumption, cannabis would be treated the same as tobacco under the amended legislation, but it could not be sold online or through the mail.
According to Heraldo de Mexico, the amended legislation includes “substantive modifications” to 15 provisions, deletes seven components and adds five new ones.
The text of the revised measure also seeks to reframe the reform as being about protecting public health rather than economic growth.
“Given that the proposed legislation would open the legal market for cannabis, a substance considered to be a narcotic in the international treaties signed by our country, it is essential that the law issued for this purpose has a clear and defined public health approach,” it says. “For this reason, it is essential to modify the approach that predominates in the bill, which considers the cultivation of cannabis as a means for economic growth and community development; which, if maintained like this, would encourage production and commercialism, neglecting public health, contrary to the guiding model that these committees intend to build.”
Already, there’s been criticism of the revised bill.
The advocacy group Mexico Unido said that the revised proposal still “criminalizes users, puts criminal and administrative sanctions on them and invades their privacy.”
El actual dictamen criminaliza a las personas usuarias, les pone sanciones penales y administrativas e invade su privacidad. Esto quiere decir que, aunque la #cannabis Aunque esté regulada, la policía podrá realizar detenciones a personas usuarias 👉🏽 https://t.co/BROQgkWd73
— México Unido (@MUCD) March 5, 2021
“The current ruling removed the locks on vertical market integration and the entry of the junk food and beverage industry,” it said. “And it did not eliminate excessive requirements such as seed control, traceability and testing, which exclude small participants.”
El dictamen actual eliminó los candados a la integración vertical del mercado y la entrada de la industria de comida y bebidas chatarra. Y no eliminó requisitos excesivos como el control de las semillas, la trazabilidad y el testeo, que excluyen a los pequeños participantes. pic.twitter.com/Ert8f4XvSM
— México Unido (@MUCD) March 5, 2021
Activists are happy, however, that a proposed permitting requirement for people to grow their own cannabis that was included in an earlier draft in circulation is no longer in the new version. They also appreciate that proposed fines for possessing too much marijuana have been reduced.
“The Federal Law for the Regulation of Cannabis is intended, through a public health approach, to link the right to consume cannabis with the right to production for self-consumption, either personally in homes, or as participants in legally constituted civil associations,” the bill states. “Through the proposed system, the production of cannabis and its derivatives would be aimed at self-consumption, either at home or in cannabis associations.”
There would be six licensing categories under the proposal: production, distribution, sales, marketing and research—in addition to one that would provide for vertical integration.
Another change in the latest version concerns edibles, which would not be allowed to be marketed on a temporary basis until additional research is conducted into the products, 24 Horas reported.
Martha Tagle Martínez, a member of the chamber’s Health Committee, said earlier this week that the original Senate reform legislation did not fulfill the requirements of the Supreme Court, which deemed the prohibition on personal possession and cultivation of marijuana unconstitutional in a 2018 ruling. Lawmakers have since been tasked with ending criminalization, but they’ve repeatedly pushed back deadlines to enact the policy change.
Now the legislature has until the end of April to legalize cannabis nationwide, and it seems next week’s action will set the stage for Congress to make good on its obligation.
In the meantime, the Health Committee already held a preliminary discussion on the issue last month.
Members of the panel said they wanted to hold four sessions to debate the legislation, but its president, Carmen Medel Palma, has yet to convene them and wants to speed up the process, La Jornada reported.
The Justice Committee also met to discuss the matter on Sunday, according to the group Cáñamo México. The two panels were initially expected to send a revised legalization proposal to the floor last month, but that didn’t happen. However, they met jointly on Thursday to discuss the latest version in advance of the expected formal approval on Monday.
¡La regulación de la cannabis! 🪴
El día de hoy tuve video conferencia de comisiones unidas para su regulación.
Un enorme reto a nivel salud y justicia. pic.twitter.com/lBzd1CzGbl
— Ana Paty Peralta (@anapatyp) March 4, 2021
Martínez of the Health Committee has signaled that she doesn’t feel lawmakers have been provided sufficient time to analyze the revised bill ahead of the planned floor vote in the coming days.
President Andres Manuel Lopez Obrador, for his part, said in December that an earlier anticipated vote on legalization legislation was delayed due to minor “mistakes” in the proposal.
He said “there was no time to conduct a review” in the legislature before the prior December 15 Supreme Court deadline, but he noted that issues that need to be resolved are “matters of form” and “not of substance.”
The Senate passed the legalization bill in November and transmitted it to the Chamber of Deputies. Several committees took up the bill, with the Human Rights and Budget and Public Account Committees representing one panel that considered and advanced it just before the the court granted lawmakers’ latest deadline extension request.
While advocates are pushing for lawmakers to formally end prohibition, they hoped the delay would give them more time to try to convince the legislature to address their concerns about certain provisions of the current bill, namely the limited nature of its social equity components and strict penalties for violating rules.
The legalization bill cleared a joint group of Senate committees prior to the full floor vote in that chamber, with some amendments being made after members informally considered and debated the proposal during a virtual hearing.
Members of the Senate’s Justice, Health, and Legislative Studies Committees had approved a prior version of legal cannabis legislation last March, but the coronavirus pandemic delayed consideration of the issue.
The legislation as ultimately approved by the Senate made some attempts to mitigate the influence of large marijuana corporations. For example, it stated that for the first five years after implementation, at least 40 percent of cannabis business licenses must be granted to those from indigenous, low-income or historically marginalized communities.
Households where more than one adult lives would be limited to cultivating a maximum of eight plants. The legislation also says people “should not” consume cannabis in homes where there are underaged individuals. Possession of more than 28 grams but fewer than 200 grams would be considered an infraction punishable by a fine but no jail time.
Sen. Julio Ramón Menchaca Salazar of the MORENA party said in April that legalizing cannabis could fill treasury coffers at a time when the economy is recovering from the pandemic.
As lawmakers work to advance the reform legislation, there’s been a more lighthearted push to focus attention on the issue by certain members and activists. That push has mostly involved planting and gifting marijuana.
In September, a top administration official was gifted a cannabis plant by senator on the Senate floor, and she said she’d be making it a part of her personal garden.
A different lawmaker gave the same official, Interior Ministry Secretary Olga Sánchez Cordero, a marijuana joint on the floor of the Chamber of Deputies in 2019.
Cannabis made another appearance in the legislature in August, when Sen. Jesusa Rodríguez of the MORENA party decorated her desk with a marijuana plant.
Drug policy reform advocates have also been cultivating hundreds of marijuana plants in front of the Senate, putting pressure on legislators to make good on their pledge to advance legalization.
Read the text of the revised Mexico legalization bill below:
West Virginia Governor Would Support Taxing The ‘Absolute Crap’ Out Of Marijuana To Replace Income Tax
The governor of West Virginia isn’t personally a fan of marijuana legalization, but for the second time in a week, he said that he’d support the reform if the legislature sent a bill to his desk.
In response to a question about the prospect of taxing “the absolute crap” out of cannabis, Gov. Jim Justice (R) said during a virtual town hall event on Friday that he’s “not a proponent of recreational marijuana.” However, he noted, “it seems like the entire nation is going to end up moving that way.”
“If in fact the entire nation is going to move that way, if our legislature from the standpoint of the Republicans in the House were to bring me that, and it would be tied to using those extra dollars [to] get rid of additional personal income tax, I would support it,” he said.
Watch Justice talk about marijuana reform policy in the video below:
“I’m not in favor, but I would support it if people got on board and brought that to me,” the governor said.
The voter who posed the question was primarily concerned that no new taxes be placed on nicotine vaping products, and wanted to suggest legalizing cannabis as an alternative means to raise revenue.
“Please don’t do a 70 dollar tax on my vapes, man,” he told the governor.
Friday’s event was focused on the state’s move to eliminate the personal income tax, but this isn’t the first time that Justice discussed how regulating cannabis sales could factor into that effort.
On Tuesday, he similarly said that he’d be inclined to sign legalization legislation if lawmakers sent it to him, in part because he’s heard from he’s from members of the medical community who feel that regulating cannabis sales could actually reduce “drug-type problems” like the opioid overdose epidemic, which has hit his state especially hard.
“I’ll just tell it like it is, I’m not educated enough to make a really good assessment as of yet,” he said. “But I can tell you just this: I do believe that that is coming, and the wave is coming across all of our states, and as that wave comes, if our House Republicans and Democrats and Senate Republicans and Democrats would get behind that effort from a standpoint of legalization of recreational marijuana and they would be supportive of that, I would too.”
These comments come after House Majority Whip Paul Espinosa (R) circulated an internal poll among Republican lawmakers, inquiring about what kind of policies—including marijuana legalization—they’d be willing to support to make up revenue for the state as part of the plan to gut the income tax.
When asked about legalization as a means to raise tax revenue that could theoretically be used to get ride of the income tax, the governor said this week that he’s principally opposed to broad reform but “I’m weakening on that position” because while his instinct is to reject regulating marijuana amid the state’s drug crisis, the medical community has shifted his perspective.
Experts “tell me that really and truly the legalizing of marijuana in certain areas or certain states that have that, from a recreational standpoint, have lowered their drug-type problems,” he said.
“If we could bucket the proceeds [from cannabis tax revenue] and use them in a way, just like this personal income tax reduction…in a really beneficial way for all our people,” he would be supportive of that.
West Virginia approved medical cannabis legalization in 2017, which Justice signed into law, and patients were just recently approved to start registering for the program. That said, the state must still partner with a testing laboratory before marijuana products are made available.
Two Democratic candidates who lost their bids for West Virginia House seats last year had pledged to introduce legislation to legalize marijuana in the state if they were elected.
Photo courtesy of WeedPornDaily.
Local Activists In Washington State Push For Psilocybin Decriminalization
Voters in Spokane, Washington could make the city one of the latest to decriminalize psilocybin mushrooms under a proposed ordinance that was recently filed by local activists.
The initiative, which was introduced by the group Decriminalize Spokane, would make enforcement of laws prohibiting the personal possession, cultivation and limited distribution of psilocybin for adults 21 and over among the city’s lowest priorities and would further ban officials from using “any city funds or resources to assist in the enforcement of laws imposing criminal penalties for the use, possession, transportation, cultivation, or distribution of psilocybin mushrooms.”
The measure, which activists intend to qualify for the city’s ballot, includes stipulations prohibiting the use or display of the psychedelic fungi in public spaces.
The “whereas” section of the measure points to scientific research on the therapeutic potential of psilocybin and the relatively low health risks it poses.
“Psilocybin can alleviate end-of-life anxiety for hospice and terminal cancer patients, can reduce prison recidivism, and can effectively treat depression, cluster headaches, addiction and trauma,” it says.
The proposed ordinance was submitted to the City Council last month, and lawmakers had the option of endorsing and enacting it into law themselves, rejecting it and proposing an alternative or approving the petition and placing it before voters. But while the proposal was on the agenda for Monday, local legislators chose not to act, which means it will be vetted by city officials to ensure its language is lawful and then cleared for signature gathering by activists.
If they are successful in collecting enough valid petitions from registered voters, the ordinance could go before voters as early as November of this year. As currently drafted, here’s the language of the ballot question that voters would see:
“Shall the Spokane Municipal Code be amended to make adult possession and transfer of limited quantities of psilocybin mushrooms the lowest possible law enforcement priority?”
According to The Spokane Spokesman-Review, activists will need 3,477 signatures to put the reform on the ballot.
Mason Lord, the chief petitioner, told the local newspaper that the proposal “is mostly about safety, and this is acknowledging certain legal substances that are accessible—like alcohol, for one—are far more dangerous.” He added that it’s about “the criminalization of a substance that has so much research showing that it’s so much safer than legal substance adults (can access).”
This is the latest iteration of a the decriminalization movement that’s evolved since Denver became the first city in the U.S. to decriminalize psilocybin mushrooms in 2019 via a citizen initiative.
Six other cities—Oakland, Santa Cruz, Ann Arbor, Washington, D.C., Somerville and Cambridge—have decriminalized possession of a broader collection plant-and fungi-based psychedelics since Denver’s move.
A Republican lawmaker in Iowa introduced a bill to remove psilocybin from the list of controlled substances, which received a subcommittee hearing this week but did not advance. He also filed another piece of legislation to let seriously ill patients use psychedelic mushrooms, LSD, DMT and other drugs.
Read the text of the Spokane psilocybin decriminalization ordinance below:
Photo courtesy of Dick Culbert.