Connect with us

Politics

FDA Rejects Petition To Further Restrict Marijuana

Published

on

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.

This piece was first published by Forbes.

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.

Tom Angell is the editor of Marijuana Moment. A 20-year veteran in the cannabis law reform movement, he covers the policy and politics of marijuana. Separately, he founded the nonprofit Marijuana Majority. Previously he reported for Marijuana.com and MassRoots, and handled media relations and campaigns for Law Enforcement Against Prohibition and Students for Sensible Drug Policy. (Organization citations are for identification only and do not constitute an endorsement or partnership.)

Politics

Connecticut Governor Says He’s Open To Smoking Marijuana After He Signs Legalization Bill

Published

on

The governor of Connecticut said on Friday that he isn’t ruling out smoking marijuana after he formally signs a legalization bill into law next week.

While most top politicians might still demure when asked if they’d partake in cannabis given ongoing stigma and federal prohibition, Gov. Ned Lamont (D) said matter-of-factly that “time will tell” when asked by a reporter if people can “expect to see the governor smoking a joint” after legalization goes into effect in the state.

News 12’s John Craven replied incredulously, “Really? You’re open to it?”

The governor first shrugged, then nodded his head yes.

“Not right now, but we’ll see” Lamont said.

Other governors in legal states have been playful about cannabis culture and their own relationship to the plant. But while a growing number of lawmakers are comfortable discussing their past marijuana use, this is a fairly remarkable exchange for the sitting top executive officer of a state.

It’s also a sign of the times, as congressional lawmakers step up the push to end federal prohibition and legalization bills move through numerous state legislatures.

Connecticut lawmakers sent Lamont an adult-use legalization bill on Thursday, and he’s confirmed his intent to sign it into law. It would make the state the 19th to have enacted the policy change and the fourth this year alone.

And while the governor has consistently emphasized the important of social equity in legalization legislation—at one point threatening to veto the bill because of a provision he felt could undermine its intent to effectively stand up disparately impacted communities—he also seems to see the personal benefits of the reform.

Similar to Lamont’s new comments, Washington Gov. Jay Inslee (D) raised some eyebrows in 2018 when he said in an interview that he grows cannabis himself. But then a spokesperson for his office denied that he actually personally cultivates marijuana.

Minnesota Marijuana Reform Could ‘Move Forward’ In Special Session That Just Launched, Top Lawmaker Says

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.
Continue Reading

Politics

Minnesota Marijuana Reform Could ‘Move Forward’ In Special Session That Just Launched, Top Lawmaker Says

Published

on

Even though a Minnesota House-passed marijuana legalization bill died in the Senate without action by the end of this year’s regular session, a top lawmaker says there’s still a “possibility to move forward” on cannabis reform as part of a special session that began this week.

“Nobody really expected the medical program to be so successfully changed this year,” House Majority Leader Ryan Winkler (D) said at a rally with cannabis reform advocates on Wednesday, referencing a separate measure Gov. Tim Walz (D) signed last month that will allow patients to access smokable cannabis products.

According to The Star Tribune, Winkler added that “surprising things can happen” during a special session. “When you see Republican support and Democratic support in the House and Senate, there is a possibility to move forward.”

Advocates with Minnesota NORML are pushing for several specific policies to be incorporated into legislation that is set to be taken up by the legislature during the special session. The first is to expand the state’s decriminalization policy, and the second is to have the state petition for a federal exemption for Minnesota’s medical cannabis program.

Part of the motivation behind that latter proposal is to ensure that registered patients are able to lawfully purchase and possess firearms in spite of federal restrictions.

At the rally, which was organized by NORML, Republicans Against Marijuana Prohibition (RAMP) and other groups, Winkler and several other lawmakers spoke in favor of modest policy changes such as decriminalizing cannabis.

“Decriminalizing small amounts is important,” Rep. Jeremy Munson (R), one of only a handful of Republicans who voted for Winkler’s broad adult-use legalization bill, said at the rally. “If someone in Minnesota gets caught with two gummy bears, it’s a felony and they’ll lose their gun rights forever.”

The coalition proposed several key reforms that they say should be integrated into public safety and health legislation that’s currently moving through committee during the special session:

-Further reduce penalties for simple possession of marijuana.

-Allow people convicted of possession up to eight grams of cannabis to petition the courts for expungement.

-Require the Minnesota health commissioner to petition the Drug Enforcement Administration (DEA) for an exemption for its medical marijuana program.

”Reducing or eliminating the criminal penalties we’re seeing around marijuana is where we have consensus,” Thomas Gallagher of RAMP said in a press release. “Let’s focus on the people who have small quantities. There is injustice in a trivial amount of marijuana resulting in life-changing punishments like imprisonment, criminal records, and lost jobs and kids.”

Similar to the Minnesota activists’ call, Iowa officials have requested that federal agencies guarantee some level of protection for people participating in the state’s medical marijuana program.

The Hawaii legislature adopted a resolution in April seeking an exemption from DEA stipulating that the state is permitted to run its medical cannabis program without federal interference.

Back in Minnesota, the House approved a bill last month to legalize marijuana for recreational use following 12 committee assignments. That legislation stalled in the GOP-controlled Senate, however.

Advocates are hopeful about the possibility that further cannabis reforms could be accomplished in the special session, but they see an obstacle in Senate Majority Leader Paul Gazelka (R), who has been relatively silent on the issue since the end of the regular session.

He did previously say, however, that “we’re always said we were open to lowering the criminal penalties [for marijuana].”

The decriminalization legislation that advocates are rallying behind would make possession of up to eight grams of cannabis a petty misdemeanor. It would also make people with prior convictions for that level of possession eligible for expungements.

Under the separate medical cannabis expansion bill that the governor has signed, adults 21 and older will be able to access smokable marijuana products. That policy must take effect by March 1, 2022, or earlier if rules are developed and the state’s cannabis commissioner authorizes it.

Dispensaries could also provide a curbside pickup option for patients under the new law. It further removes restrictions for designated caregivers and allows them to tend to six registered patients at once, rather than just one.

Walz, who hadn’t been especially vocal about legalization as the broader legislation advanced during the regulator session, said, “I’ve thought for a long time about that,” adding that “we know that adults can make their own decisions on things, we know that criminalization and prohibition has not worked.”

“I’ve always thought that it makes sense to control how you’re doing this and to make sure that adults know what they’re getting into, and use it wisely,” he said. “I also think there’s a lot of inequity about how folks have spent time in jail or been arrested around this, especially in communities of color.”

The majority leader’s legalization legislation as introduced was identical to a proposal he filed last year, with some minor technical changes. Winkler, who led a statewide listening to gather public input ahead of the measure’s introduction, called it the “best legalization bill in the country” at the time. It did not advance in that session, however.

Under the measure, social equity would be prioritized, in part by ensuring diverse licensing and preventing the market from being monopolized by corporate players. Prior marijuana records would also be automatically expunged.

Walz in January he called on lawmakers to pursue the reform as a means to boost the economy and promote racial justice. He did not include a request to legalize through his budget proposal, however.

The governor did say in 2019 that he was directing state agencies to prepare to implement reform in anticipation of legalization passing.

Winkler, meanwhile, said in December that if Senate Republicans don’t go along with the policy change legislatively, he said he hopes they will at least let voters decide on cannabis as a 2022 ballot measure.

Heading into the 2020 election, Democrats believed they had a shot of taking control of the Senate, but that didn’t happen. The result appears to be partly due to the fact that candidates from marijuana-focused parties in the state earned a sizable share of votes that may have otherwise gone to Democrats, perhaps inadvertently hurting the chances of reform passing.

In December, the Minnesota House Select Committee On Racial Justice adopted a report that broadly details race-based disparities in criminal enforcement and recommends a series of policy changes, including marijuana decriminalization and expungements.

California Senator Previews Next Steps For Psychedelics Bill And Says It’s A Step Toward Decriminalizing All Drugs

Photo courtesy of Mike Latimer.

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.
Continue Reading

Politics

Maine Lawmakers Approve Bill To Decriminalize All Drugs On 50th Anniversary Of Nixon’s ‘War On Drugs’

Published

on

The Maine House of Representatives on Thursday approved a bill to decriminalize possession of all currently illicit drugs, delivering a victory to reform advocates on the 50th anniversary of President Richard Nixon’s declaration of the war on drugs.

The Senate also began consideration of the legislation on Thursday, but has not yet taken a vote.

The proposal, LD 967, was approved in 77-62 vote in the House. It would make possession of controlled substances for personal use punishable by a $100 fine, without the threat of incarceration. That fine could also be waived if a person completes a substance misuse assessment within 45 days of being cited.

“We are continually trying to criminalize a symptom of a disease. It hasn’t worked. It won’t work,” Rep. Charlotte Warren (D), who serves as the House chair of the legislature’s Criminal Justice and Public Safety Committee, said before the vote. “We have tried criminalizing this disease for decades, and 11 Mainers a week are dying.”

Rep. Anne Perry (D), sponsor of the bill, said that incarcerating people who are suffering from addiction “only proves to them that they are as bad as they think they are” and perpetuates the cycle of substance misuse. “Law enforcement is not the gateway to treatment and recovery. It’s a gateway to isolation and suicide.”

The measure’s passage flies in the face of Gov. Janet Mills (D), whose administration opposes the reform, as does the state attorney general. Coupled with opposition from Republican legislators, the bill faces an uphill battle to final passage.


Marijuana Moment is already tracking more than 1,100 cannabis, psychedelics and drug policy bills in state legislatures and Congress this year. Patreon supporters pledging at least $25/month get access to our interactive maps, charts and hearing calendar so they don’t miss any developments.

Learn more about our marijuana bill tracker and become a supporter on Patreon to get access.

The Senate also began consideration of the legislation on Thursday night, adopting a different committee report than the House approved, but setting it aside as unfinished business before taking a final vote on the bill. The version moving forward in that chamber would similarly impose a $100 fine for possession, but only for the first two offenses. Subsequent offenses would be considered Class E crimes that could carry jail time.

These actions come one month after a joint House and Senate committee advanced the decriminalization bill with several conflicting recommendations, as well as another measure to reform the state’s drug trafficking laws.

Supporters of the legislation include the American Academy of Pediatrics’s Maine Chapter, Maine Medical Association, Alliance for Addiction and Mental Health Services in Maine and Maine Council of Churches.

Thursday’s decriminalization vote represents a continuation of a national conversation about the need to reform laws criminalizing people over drugs and treat substance misuse as a public health issue, rather than a criminal justice matter.

For the first time ever, a congressional bill to federally decriminalize possession of controlled substances—and incentivize states to do the same—was formally introduced on Thursday.

Last year, Oregon voters elected to end criminalization of low-level drug possession at the ballot.

Vermont lawmakers also introduced a bill in March that would end criminal penalties for possessing small amounts of drugs in the state.

Also that month, a Rhode Island Senate committee held a hearing on decriminalization legislation to replace criminal penalties for possessing small amounts of drugs with a $100 fine.

Back in Maine, a bill was recently introduced that would legalize psilocybin mushrooms for therapeutic purposes.

Senators Publicly Pressure Key Chairman For Vote On Marijuana Banking Bill

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.
Continue Reading
Advertisement

Marijuana News In Your Inbox

Support Marijuana Moment

Marijuana News In Your Inbox

Marijuana Moment