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FDA Rejects Petition To Further Restrict Marijuana

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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 15-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

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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New Industry-Backed Marijuana Legalization Measure Filed In Florida

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Another measure to legalize marijuana has been filed in Florida—and this one is being spearheaded by a major industry stakeholder, the multi-state dispensary chain MedMen.

Make It Legal Florida—a political committee that was registered earlier this month and is chaired by Nick Hansen, MedMen’s director of government affairs in the Southeastern U.S —filed the 2020 ballot initiative on August 6.

The campaign shared language of the measure, which isn’t yet available on the Florida Department of State elections division site, with Marijuana Moment.

“Make it Legal Florida is proud to present a ballot initiative that will legalize the safe, adult use of marijuana,” Hansen said via email. “Public opinion is on our side, and the time to act is now. Florida voters on every side of the aisle overwhelmingly support this initiative and at Make it Legal Florida, we are committed to ensuring Floridians have a chance to have their voices heard.”

The proposed constitutional amendment would legalize the possession, use, transportation and retail sale of up to 2.5 ounces of cannabis for adults 21 and older. Medical marijuana dispensaries in the state would be permitted to sell marijuana to adults. The initiative doesn’t mention a licensing system to establish separate recreational shops, though the legislature will likely enact more detailed regulations consistent with the constitutional amendment’s text should it pass.

It also requires cannabis products to be “clearly labeled and in childproof packaging” and prohibits advertisements that are targeted at those under 21.

There’s also no mention of a home cultivation option, which is something that many advocates regard as a necessary civil liberties component but that some industry players have resisted or actively opposed.

A medical cannabis industry association based in New York faced backlash from advocates earlier this year after it was reported that it sent a document to Gov. Andrew Cuomo (D) recommending that the state prevent consumers from growing their own marijuana at home. MedMen was among the companies listed as members of the association at the time, though a representative later told Marijuana Moment that the business supports giving adults the right to grow their own cannabis.

The new Florida language is “currently being reviewed by the Florida Division of Elections to ensure the petition is in the proper form and we are awaiting their approval, per the usual process,” a spokesperson told Marijuana Moment.

It’s not clear to what extent MedMen will be funding or running the campaign, but the cannabis company appears to be taking a more active role in legalization efforts this election cycle.

In Arizona, an adult-use legalization measure filed at the beginning of the month is also reportedly being backed by MedMen, as well as other existing medical cannabis companies in the state.

Make it Legal Florida will be competing against at least one other campaign that’s working to legalize cannabis in Florida. Sensible Florida, another advocacy group, announced last month that it had collected enough signatures to prompt a state Supreme Court review of the ballot language. It’s collected about 80,000 signatures so far.

To qualify for the ballot, the campaigns will have to gather a total of 766,200 valid signatures. If an effort clears that hurdle, passing a constitutional amendment requires 60 percent support from voters.

“Floridians are ready to legalize marijuana,” Ben Pollara, a political consultant who worked on 2014 and 2016 medical cannabis measures in the state, the latter of which was enacted, told Marijuana Moment. “If this measure makes it on the ballot in 2020, it is almost certain to pass.”

Personal injury attorney John Morgan, who bankrolled the state’s previous medical cannabis initiatives but only recently expressed interest in contributing to this recreational push, told The Miami Herald that Sensible Florida’s challenge will be raising millions of dollars to push their measure forward, whereas Hansen’s operation is well supported by the industry.

“Last time I did, I was the lone trombone player marching down the street,” he said of his role in medical marijuana legalization. “This will be the University of Miami marching band with trumpets and tubas and snare drums. I’ll just be one trombone player, marching with them.”

Read the full text of Make It Legal Florida’s marijuana proposal below: 

Florida marijuana legalizat… by Marijuana Moment on Scribd

Arizona Marijuana Legalization Initiative Takes First Step Toward 2020 Ballot

Photo courtesy of WeedPornDaily.

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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Defense Department Official Stresses CBD Ban For Military Members

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A Department of Defense (DOD) official is reiterating that military service members are barred from using CBD products despite the legalization of hemp and its derivatives under the 2018 Farm Bill.

Patricia Deuster, director of the Human Performance Laboratory at the federal government-run Uniformed Services University of the Health Sciences, said in a call with reporters this week that the non-intoxicating compound is “completely forbidden for use by any service member in any of the services at this point of time.”

While CBD products are widely available—in grocery stores, gas stations and online—the lack of regulations for these items from the Food and Drug Administration (FDA) creates uncertainty about levels of THC in the preparations. And military members who test positive for THC can be punished with an other-than-honorable discharge and the potential loss of other benefits.

“It’s a real conundrum, and it’s going to be a major issue for the military because it is available [nearly everywhere],” Deuster said, according to Military.com, which first reported her remarks. “You go into any store, and you can find gummy bears with a supplement fact panel on it.”

Though the Tuesday press call simply provided clarity on existing military CBD policy, it represents the latest example of DOD interest in preventing the use of cannabis among service members.

The Navy released a notice earlier this month stipulating that “all hemp and CBD products are strictly prohibited for use by Sailors” no matter the legal status. And the Coast Guard said its members aren’t even allowed to visit marijuana shops or use online or delivery cannabis services, according to an order released last month.

That order didn’t specify policy around hemp-derived CBD, but a Coast Guard official told Mililtary.com that if members “have a desire to use a product that may or may not fall into the definition of what’s prohibited, they should seek guidance or use caution.”

Last year, the Air Force wrote in a post that “consumption [of marijuana] is not permitted in any fashion, period.” It emphasized the need to take caution as more states legalize, with one risk factor being your “friend’s grandma’s miracle sticky buns” that “might look mighty tasty and get rave reviews at the big shindig,” but could contain THC.

In a memo released in April, the Air Force said that “Airmen are advised against using CBD products” and could face disciplinary action if they use CBD that isn’t the FDA-approved drug Epidiolex.

The Army issued a similar notice in November 2016 that stated service members may not use marijuana, hemp or hemp oil.

Though not a military branch, NASA also sent a warning to its workforce this month that the unregulated nature of CBD products means employees could inadvertently consume THC that could get them fired.

“The problem is there is no regulatory framework to ensure that the CBD products being sold meet the Farm Act,” Deuster said on the call this week. “[CBD] is everywhere. We are waiting for the FDA to do something,”

She added that service members shouldn’t “believe what [the companies] are telling you” about the benefits of CBD.

Navy Bans Sailors From Using CBD Despite Federal Hemp Legalization, New Memo Says

Photo by Sam Doucette on Unsplash.

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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