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FDA (Again) Rejects Petition To Further Restrict Marijuana

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The Food and Drug Administration (FDA) once again rejected an attempt by a prohibitionist group to add marijuana and THC to a list of restricted over-the-counter drugs.

Drug Watch International (DWI), an anti-drug group led by a former Drug Enforcement Administration special agent, initially submitted a petition asking FDA to classify cannabis and THC as “negative monographs” in November 2017, arguing that doing so would send a message to the marijuana industry and mitigate public health risks.

A negative monograph is a classification for substances that FDA does not consider “generally recognized as safe and effective,” meaning they are illegal to market.

FDA denied that petition in July 2018 and laid out various reasons the request was unfounded. While stating that FDA appreciated the petitioners concerns about the unlawful marketing of products containing cannabis, the agency said defining marijuana and THC as negative monographs “is not necessary for the protection of public health” and that existing laws are in place to prevent such illegal marketing.

Two months later, DWI submitted a “petition for reconsideration,” stating that FDA is “not enforcing laws to halt unlawful marketing of unapproved cannabinoid medicines.” The group argued that adding the substances as negative monographs would “clarify the [legal] status of cannabinoid drugs” and emphasized that FDA has added other drugs to the restricted list “that are less dangerous than marijuana.”

In a letter dated July 18, 2019, FDA shot down the appeal and systematically rejected each of DWI’s arguments.

“We have carefully considered the Reconsideration Petition and comments submitted to the public docket for the Reconsideration Petition,” FDA wrote. “For the reasons set forth below, FDA denies your Reconsideration Petition.”

To start with, FDA explained that it is not required to consider petition appeal requests that include “new information and views,” which is exactly what DWI included in its request. The agency decided to review the appeal anyway, and it still found that the request was baseless.

“We conclude that the Reconsideration Petition does not warrant modifying or overruling the Original Petition Response,” Lowell Schiller, FDA’s principal associate commissioner for policy, wrote. “We have not found that granting the Reconsideration Petition would be in the public interest or in the interest of justice. Additionally, the relevant information and views in the administrative record were adequately considered when we denied the Original Petition.”

Here are the other reasons that FDA said it wouldn’t be accepting the petition for reconsideration: 

—Citizen petitions aren’t supposed to be used to force enforcement action by FDA.

—Laws prohibiting the marketing of unapproved over-the-counter drugs are “unambiguous” and so classifying cannabis and THC as negative monographs would not, as DWI argued, clarify their legal status.

—FDA has an arsenal of communications tools to convey its concerns about the public health risks of marijuana; therefore, it disagreed that “undertaking the monograph rulemaking process is a necessary, effective, or efficient way to communicate to the public” about such risks.

—Although DWI said the inclusion of other substances that it claims are less harmful than marijuana as negative monographs demonstrated a need to add marijuana, FDA replied that inclusion on the list “does not necessarily mean that therapeutic categories and active ingredients that are not included in negative monographs pose comparatively more or less serious potential risks to the public health.”

“While we appreciate the safety and public health concerns that motivate your requests, the Reconsideration Petition does not persuade us to modify or overrule the Original Petition Response,” FDA concluded. “We have not found that granting the Reconsideration Petition would be in the public interest or in the interest of justice. Additionally, the relevant information and views in the administrative record were adequately considered when we denied the Original Petition.”

Though FDA’s response to the petition is far from an endorsement of cannabis or its derivatives, it signals that the current administration is not interested in entertaining bad faith attempts to disrupt the legal industry.

That said, the agency has made clear that it will continue to take enforcement action against marijuana and hemp companies that make unsanctioned claims about the therapeutic potential of their products. Most recently, it sent a warning letter to CBD company Curaleaf for selling “unapproved products with unsubstantiated therapeutic claims,” causing the company’s stocks to plummet.

At the same time that FDA is working to hold cannabis businesses accountable, it is also working to develop regulations for hemp-derived CBD, which was federally legalized under the 2018 Farm Bill. Earlier this month, the agency said it was speeding up its rulemaking process amid growing pressure from industry stakeholders and policymakers.

Read FDA’s full letter rejecting the further restricting of marijuana below:

FDA marijuana negative monograph rejection by Marijuana Moment on Scribd

Hundreds Of Pet Owners Tell FDA That CBD Is Helping Their Furry Companions

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.

Kyle Jaeger is Marijuana Moment's Los Angeles-based associate editor. His work has also appeared in High Times, VICE and attn.

Politics

Andrew Yang Peddles Marijuana-Themed Presidential Campaign Merchandise

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2020 candidate Andrew Yang announced on Saturday that his campaign for the Democratic Party’s presidential nomination is rolling out a line of marijuana-themed merch.

The limited edition products blend Yang’s love of mathematics with his support for cannabis reform. A t-shirt being offered for $30 simply says, “Math. Money. Marijuana.” And a now-sold-out baseball cap says “Math” on the front and displays a cannabis leaf on back. There’s also a bumper sticker that says, “Legalize Marijuana.”

Please visit Forbes to read the rest of this piece.

(Marijuana Moment’s editor provides some content to Forbes via a temporary exclusive publishing license arrangement.)

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Buttigieg Pledges To Decriminalize Possession Of All Drugs In First Term As President

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South Bend, Indiana Mayor Pete Buttigieg released a comprehensive plan on Friday that calls for “decriminalizing all drug possession” in his first presidential term as a means to combat the opioid epidemic and treat addiction as a public health, rather than criminal justice, issue.

Decriminalization is just one action the 2020 Democratic presidential candidate said he’d pursue in order to reform the country’s mental health care system and bolster substance abuse treatment. His plan also includes proposals to reduce sentences for drug offenses other than possession, increase access to the opioid overdose reversal drug naloxone and make it easier to implement syringe exchange programs.

Buttigieg’s “Healing and Belonging in America” plan emphasizes the need to divert people suffering from addiction away from prisons and into treatment. He said he’d accomplish that by expanding diversionary programs and evidence-based training “for drug courts, mental health courts, and other alternatives to incarceration for justice-involved persons.”

The goal of decriminalization and diversion is to reduce “the number of people incarcerated due to mental illness or substance use by 75 percent in the first term.”

Under his plan, sentencing reform for drug offenses other than possession would be applied retroactively and coupled with expungements for past convictions. Buttigieg pointed to research demonstrating that “incarceration for drug offenses has no effect on drug misuse, drug arrests, or overdose deaths” and instead “actually increases the rate of overdose deaths.”

“We cannot incarcerate ourselves out of this public health problem.”

“To ensure that people with a mental illness or substance use disorder can heal, we will decriminalize these conditions,” the proposal states. “When someone is undergoing a crisis or is caught using a drug, they should be treated by a health professional rather than punished in a jail cell.”

“All presidential candidates should join Pete Buttigieg in recognizing that the criminalization of people for their drug use is wrong and simply bad policy,” Maria McFarland Sánchez-Moreno, executive director of the Drug Policy Action, said in a press release. “Possession of drugs for personal use is the single most arrested offense in the United States, eclipsing arrest rates for any other offense. With overdose numbers skyrocketing and entire communities, disproportionately black or brown, suffering from criminalization, it’s time for policymakers to shift gears. Taking an evidence-based, health-centered approach to address this crisis is not only true leadership – it’s common sense.”

The mayor also made harm reduction policies a key component of his strategy. He said take-home naloxone programs would be expanded to all 50 states by 2024 and that harm reduction services would be expanded “to reduce overdose deaths and the spread of infectious diseases related to needle sharing.”

The plan would make naloxone “broadly available in order to reverse overdoses” and remove “legislative and regulatory restrictions on the use of federal funds for syringe service programs.”

Buttigieg said the federal government should provide funding for state and local health departments to purchase the medication, make sure that it’s “available in public spaces and workplaces” similar to first aid kids and encourage “co-prescribing of naloxone with opioids, either by individual physicians or direct dispensing by pharmacists.”

Existing federal law makes it difficult to establish syringe exchange programs, in part because federal funds can’t be used to buy needles. The restrictions “hamper state and local responses, both because they limit resources and because they convey a negative message about the value of these programs, despite overwhelming scientific evidence that they can prevent transmission of HIV and hepatitis.”

In addition to lifting those barriers, the candidate said the Centers for Disease Control and Prevention “would also work with states to remove any criminal liability for those participating in” syringe exchange programs.

“Harm reduction programs are a critical part of any effective response to the opioid and injection drug use crisis. They minimize the negative impact of drug use without encouraging it, while reducing other side effects of drug use. In particular, this means access to syringe service programs for people who inject drugs, that link them to treatment, and provides access to sterile syringes. These programs help prevent transmission of HIV, viral hepatitis, and other infectious diseases associated with needle sharing, and reduce overdoses by deploying medication such as naloxone that help reverse the effects of opioids.”

One harm reduction policy that didn’t make the cut in Buttigieg’s plan is safe injection sites, where people could use illicit drugs under the supervision of medical professionals who could reverse overdoses and recommend treatment options. Sens. Bernie Sanders (I-VT) and Elizabeth Warren (D-MA), who are also running for the Democratic nomination, both proposed legalizing such facilities as part of criminal justice reform plans they released this month.

“Decades of failed mental health and addiction policy, coupled with mass incarceration that criminalized mental illness and drug use, have left us with a mental health and addiction care system so broken that today there are more people with serious mental illness in prisons than in treatment facilities,” Buttigieg said.

The candidate also made ending incarceration for drug possession—as well as legalizing marijuana—central principles of his previously released criminal justice reform plan, which he released last month.

But while the prior plan did not explicitly describe the move as “decriminalizing” drugs, even though advocates commonly use that word to refer to policies that remove the threat of being imprisoned for possession, the new document does use that terminology—signaling a shift in clarity as Buttigieg continues to develop his campaign messaging.

In other instances, he borrowed language from his criminal justice reform plan, specifically as it concerns how criminalizing drug use can increase rates of overdose, for his mental health proposal.

“Despite equal rates of use, Black Americans are nearly four times as likely to be arrested for using marijuana,” the criminal justice plan states. “Research shows that incarceration for drug offenses has no effect on drug misuse, drug arrests, or overdose deaths. In fact, some studies show that incarceration actually increases the rate of overdose deaths.”

Buttigieg mentioned that, as with drug offenses, black people are also more likely to die from overdoses. And that’s due to “the current broken system that criminalizes mental illness and addiction” that was “built during the crack epidemic of the 1980s.”

Elizabeth Warren’s Criminal Justice Plan Involves Legalizing Marijuana And Safe Injection Sites

This story was updated to include comment from the Drug Policy Action.

Photo courtesy of Flickr/Gage Skidmore.

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.
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White House Drug Officials Say Legal Marijuana Is Up To States

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Two top federal drug officials, including the White House drug czar, recently said that marijuana legalization should be left up to states.

The comments stand out coming from the Office of National Drug Control Policy (ONDCP), which has historically played a central role in defending blanket federal prohibition.

Jim Carroll, the Trump-appointed drug czar who directs the administration’s drug policies, told Fox 59 reporter Kayla Sullivan that he considers legalization a states’ right issue. He added that he’d like to see targeted education campaigns concerning cannabis use during pregnancy and underage usage as well as research into impaired driving.

It’s a particularly notable position given that federal law stipulates that the drug czar is required to “take such actions as necessary to oppose any attempt to legalize the use of a substance” listed as Schedule I under the Controlled Substances Act, including marijuana.

Even if Carroll’s remarks arguably don’t directly violate that statute, they are significant in that he doesn’t seem to have taken the opportunity to proactively oppose state legalization efforts when asked by a reporter.

Anne Hazlett, senior advisor at ONDCP, also weighed in on cannabis legalization on Wednesday, telling CentralIllinoisProud.com that marijuana legalization is “a state decision.”

“Marijuana is an ongoing challenge that is being addressed in many of our states,” she said. “This is a state decision, and we would like to see additional research done so that these decisions being made at a state level are being made in a manor that is fully informed.”

Though the comments from Carroll and Hazlett seem to reflect an evolving understanding of the federal government’s role in imposing prohibition on the states, the ONDCP director has previously made clear he’s not enthusiastic about the burgeoning legal market.

During a House Committee on Oversight and Reform hearing in May, Carroll raised concerns about THC potency in marijuana products, saying “the marijuana we have today is nothing like what it was when I was a kid, when I was in high school.”

“Back then the THC, the ingredient in marijuana that makes you high, was in the teens in terms of the percentage,” he said. “Now what we’re seeing is twice that, three times that, in the plant.”

He also said that more research is needed and that the Drug Enforcement Administration as well as the Department of Health and Human Services are “working hard to make sure that we understand the impact of legalization of marijuana on the body.”

Federally Funded Journal Exposes How Marijuana Prohibition Puts Consumers At Risk

Photo courtesy of Philip Steffan.

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.
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