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.
Where Presidential Candidate Joe Sestak Stands On Marijuana
Joe Sestak, a former congressman from Pennsylvania and three-star vice admiral in the Navy, announced on Sunday that he is launching a relatively late run for the 2020 Democratic presidential nomination.
Though his record in Congress doesn’t offer many insights into where Sestak stands on marijuana policy, he took one vote in support of shielding state medical cannabis laws from federal interference, and his current campaign site proposes reforming federal laws to facilitate research into the therapeutic potential of psychedelics.
Legislation And Policy Actions
Sestak served in Congress from 2007 to 2011. In that time, he did not proactively sponsor or cosponsor any cannabis-related legislation.
The congressman was present for a vote on just one marijuana amendment attached to a spending bill—one to protect states that have legalized medical cannabis from Justice Department intervention—and he voted in favor of the proposal, even though his state had not yet enacted its own medical marijuana law.
Quotes And Social Media Posts
It’s difficult to assess exactly where the candidate stands on marijuana in part because a scan for relevant terms on his social media posts turns up nil.
Adding to the confusion is the apparent lack of public comments about cannabis policy from Sestak—at least any comments that have been reported by media.
The Philadelphia Inquirer did publish an article in 2016 that described Sestak, a former U.S. Navy admiral, as a “longtime supporter of medical access [to marijuana]—especially for vets” but it did not quote the congressman directly. That piece also noted that his position on cannabis decriminalization is unclear.
Statements on his campaign site do provide a small window into his views on the drug war more broadly.
Sestak argued that President Donald Trump’s proposed wall along the U.S.-Mexico border would be ineffective because “most illicit trafficking of drugs, humans, and weapons, actually happens right under the noses of our border security agents” at legal ports of entry.
He also partially blamed “misguided US policies and the high demand for illegal drugs in the United States” for creating crises that leave many to flee their home countries to seek asylum in the U.S.
“Our country, which sends hundreds of millions in foreign aid to these countries, must do a better job of holding Central American officials accountable for seeing that our funds are spent effectively—and that they do not become fuel for the fires of corruption and instability,” he said.
One of the most revealing positions on drug policy that Sestak has offered also comes from his campaign site: he said that he supports efforts to combat mental health conditions and addiction, and one part of that plan involves changing “federal law to allow doctors and scientists to expand research into the potential of certain psychedelic drugs to complement traditional substance abuse and other mental health treatment.”
“Anti-drug laws should never be an impediment to sound scientific research, but especially not during a public health crisis such as this one,” he said.
Discussing veterans issues, Sestak said that the country “must learn from innovative approaches taken to reduce chronic veteran homelessness like Phoenix’s ‘housing first’ strategy in which homeless veterans are given housing before being required to prove sobriety or pass a drug test,” which also seems to indicate an openness to alternative approaches to drug policy.
Personal Experience With Marijuana
It does not appear that Sestak has publicly commented on any personal experience he’s had with marijuana.
Marijuana Under A Sestak Presidency
Though some reports indicate that Sestak supports medical cannabis reform, and he took one step to protect states that have implemented such programs during his time in Congress, there are more questions than answers when it comes to the candidate’s position on marijuana.
At the very least, his willingness to vote in favor of medical cannabis protections ahead of his state enacting a medical marijuana law should give patients in legal states some sense of comfort, although his limited record on the issue raises questions about whether he’d be willing to extend those protections to adult-use states—and whether cannabis reform would be a priority of his administration at all.
That said, the fact that he included a position on psychedelics reform on his campaign website signals that he’s cognizant of the issue and that his views on broader drug policy reform may have simply flown under the radar.
Hawaii Marijuana Decriminalization Will Take Effect, Governor Says
Hawaii Gov. David Ige (D), who has at times expressed serious concerns about marijuana policy reform, announced that he will allow a legislature-passed bill to decriminalize small amounts of cannabis to go into effect.
Ige didn’t include the decrim proposal in a list of legislation he intends to veto by Monday’s deadline.
Lawmakers sent the bill, which punishes possession of three grams of marijuana with a $130 fine instead of jail time, to the governor’s desk in April. As originally introduced, it covered greater amounts of marijuana in line with decriminalization policies in other states, but was watered down as it advanced through the legislative process.
Under current law, possessing cannabis is a petty misdemeanor that carries up to a $1,000 fine.
In a press conference to discuss his veto list, Ige called the marijuana legislation “a very tough call” and said went “go back and forth” on the issue before deciding to let the bill take effect.
The governor said he would have preferred if the decriminalization proposal included provisions aimed at “young people who we would want to get into substance abuse or other kinds of programs to help them deal with drug use.”
In the end, he said, he decided “it would be best not to veto that.”
Watch Ige discuss his decision not to veto marijuana decriminalization, about 23:35 into the video below:
Some legislative leaders have expressed interest in considering legislation to legalize and regulate marijuana.
Asked by a reporter about the possibility of broader cannabis reforms in Hawaii, Ige said that the state “can benefit from not being at the head of the table.”
“We continue to learn from other states about the problems that they see with recreational marijuana,” he said, echoing concerns he has about legalization and noting that he’s been discussing the possible reform with governors from some western states that have already enacted it. “We would be smart to engage and recognize what’s happening in other states, acknowledge the challenges and problems it has raised.”
Nikos Leverenz, board president for the Drug Policy Forum of Hawaii, told Marijuana Moment that Ige should be “commended” for not vetoing the bill.
“It’s also encouraging that he’s having ongoing conversations with other governors from states that have legalized adult-use cannabis,” he said. “Hawai’i can indeed learn a great deal from other states, including the enactment of social equity measures to ensure broad local participation by women, underrepresented minorities, and those harmed by the drug war.”
Also on Monday, Ige announced that he intends to veto a bill allowing medical cannabis patients to transport their medicine between islands.
“Marijuana, including medical cannabis, remains illegal under federal law. Both the airspace and certain areas of water fall within the exclusive jurisdiction of the federal government,” he wrote. “This bill may lead travelers, acting in reliance on this provision, to erroneously believe they are immune from federal prosecution.”
Another proposal on the governor’s veto list would establish a hemp licensing program.
“There are concerns that this bill creates a licensing structure that cannot be enforced, will not meet USDA requirements for an approved industrial hemp program, and creates practical problems in the enforcement of existing medical cannabis,” he reasoned.
Finally, Ige plans to veto a bill to scale back the use of asset forfeiture, which is often used against people accused of drug crimes, with the governor calling the practice “an effective and critical law enforcement tool that prevents the economic benefits of committing a crime from outweighing consequential criminal penalties and punishment.”
USDA Sets Target Deadline To Release Hemp Regulations
The U.S. Department of Agriculture (USDA) offered new insights into its rulemaking process for hemp regulations in a notice published in the Federal Register on Monday.
Of particular note is the deadline by which USDA is aiming to release its interim final rule for the newly legal crop: August. Previously, the department simply said it would have the rules in place in time for the 2020 planting season.
“This action will initiate a new part 990 establishing rules and regulations for the domestic production of hemp,” the new notice states. “This action is required to implement provisions of the Agriculture Improvement Act of 2018 (Farm Bill).”
The hemp update update is part of a larger regulatory agenda for various agencies that’s being released by the Trump administration.
“It is great to see that USDA is on track to complete federal hemp farming regulations this year,” Eric Steenstra, president of Vote Hemp, told Marijuana Moment.
A USDA spokesperson told Marijuana Moment in an email that the August projection is the department’s “best estimate” for when the regulations will be released. It remains USDA’s intention “to have the regulations in place by this fall to allow for a 2020 planting season.”
“However, the clearance process will dictate the actual timing of the publication,” the spokesperson said.
While USDA officials have said the department didn’t plan to expedite the regulatory process despite strong interest among stakeholders, it seems to be making steady progress so far. The department said in March that it has “begun the process to gather information for rulemaking.”
USDA has also outlined the basic elements that will be required when states or tribes are eventually able to submit regulatory plans for federal approval. Those proposals will have to include information about the land that will be used to cultivate hemp, testing standards, disposal procedures, law enforcement compliance, annual inspections and certification for products and personnel.
The new update comes about six months after hemp and its derivatives were federally legalized under the 2018 Farm Bill. But until USDA releases its guidelines, hemp farmers must adhere to the earlier rules established under a narrower research-focused provision of the 2014 version of the agriculture legislation.
While the rules are yet to be published and there are therefore some restrictions on what hemp farmers can lawfully do, USDA has clarified several policies that have already gone into effect in recent months.
The department is accepting intellectual property applications for hemp products, for example. It also explained that hemp seeds can be lawfully imported from other countries and that the crop can be transported across state lines since it’s been federally descheduled.