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.
Border Patrol Reflects On Feds’ Friendlier Historical Approach To Marijuana
Canada’s decision to legalize marijuana nationwide has stoked concerns that its citizens traveling across the U.S. border will risk temporary detention or even permanent visitation bans if they fess up having ever consumed cannabis, or even working in the industry.
Enforcement officials have told reporters that there’s no travel policy change in light of Canada’s end of prohibition, emphasizing that it remains illegal to bring cannabis across the border under federal law. Violating the policy “could potentially result in seizure, fines, and apprehension,” U.S. Customs and Border Protection (CBP) said in a recent statement.
But let’s take you back to a simpler time, courtesy of CBP.
“Did You Know… Marijuana Was Once a Legal Cross-Border Import?”
That’s the title of a 2015 blog post published by the federal agency—which seems to have gone mostly unnoticed until now—recalls how cannabis was historically recognized as a legal import by the government.
“One hundred years ago, the federal government was not overly concerned with marijuana, the common name for the Cannabis sativa L. plant,” the feds’ post reads.
Through the mid-1930s, the plant flew under the government’s radar, despite the fact that “several state governments and other countries had banned the drug.”
“The U.S. government hesitated, in part because therapeutic uses of Cannabis were still being explored and American industry profited from commercial applications of hemp fiber, seeds and oil.”
That all changed in the decades to come—first with the 1937 Marihuana Tax Act, which imposed taxes and regulations on cannabis imports, cultivation, distribution and possession, and then with full prohibition under the Nixon administration.
Up until that point, the Customs Agency Service (later rebranded as CBP) didn’t put too much stock in pot. Just before the Marihuana Tax Act passed, the agency described its cannabis policy here:
“Marihuana may be cultivated or grown wild in almost any locality. Inasmuch as this drug is so readily obtained in the United States, it is not believed to be the subject of much organized smuggling from other countries.”
It seems like pretty basic supply and demand, but federal prohibition changed the equation. Suddenly, marijuana wasn’t “so readily obtained” in the country—and even simple possession carried serious criminal penalties—so the legal supply dried up. In the absence of legal access, criminal organizations swooped in to meet the demand for marijuana in the United States.
“Today, however, marijuana trafficking is a major concern of CBP, Immigration and Customs Enforcement and the Drug Enforcement Administration,” CBP wrote. “Well over 3 million pounds of ‘pot’ were confiscated at our borders in 2011, making an impact on this multibillion-dollar illegal enterprise.”
The more you know!
Photo courtesy of Gerald Nino, U.S. Department of Homeland Security.
Why Congressional Democrats Deleted Their Anti-Marijuana Tweet
A Democratic organization tasked with regaining the party’s control of the U.S. House of Representatives tweeted a bizarre anti-marijuana attack on a politically vulnerable Republican congressman this week, but the group meekly walked back the comments after being called out about it…by me and some of the lawmakers it represents.
It started with a tweet, posted on Monday by the Democratic Congressional Campaign Committee (DCCC).
“GOP Rep. Dana Rohrabacher…has a ‘cult-like fixation on marijuana,'” the supposedly progressive group tweeted, quoting an article from conservative magazine National Review bashing the California congressman.
“It’s why [Democratic opponent] @HarleyRouda needs your help flipping this seat Clinton won from #RedToBlue,” the party organ added.
I was immediately struck by the tweet when I saw it minutes after it was posted. The vast majority of Democratic voters support marijuana legalization, as do all of the party’s U.S. senators who are thought to be weighing 2020 presidential campaigns.
Whenever Rohrbacher’s amendment to protect state medical cannabis laws from federal interference has reached the House floor, the overwhelming majority of Democratic lawmakers have consistently voted for it.
“There are a lot of reasons why Democrats and progressives would wish for Rohrabacher to lose his reelection fight, aside from the fact that ‘flipping this seat from red to blue’ could make the difference in determining which party controls the House come January. But marijuana is not one of them,” I wrote in a Los Angeles Times op-ed on Thursday.
“The Democratic committee could have highlighted Rohrabacher’s position that homeowners should have the right to refuse to sell property to gay people — something mentioned by National Review in the same sentence as that cannabis quip. Or his position on climate change. Or healthcare.
“Rep. Earl Blumenauer (D-Ore.), who has cosponsored many marijuana measures with Rohrabacher, told me in an emailed statement that the campaign committee’s tweet was ‘stupid,’ adding that he expressed those sentiments directly to the organization itself.”
Hours after the publication of my piece, DCCC has deleted the offending tweet, without comment.
In addition to Blumenauer’s public blasting of the organization’s tweet in my op-ed, at least one other Democratic congressman raised the issue during the party’s House Steering and Policy Committee on Thursday, a lawmaker who was in the room, but wished not to be named, told me.
“Pure bad karma and politics,” the legislator said, of the DCC tweet.
Indeed, beyond just Democrats, a growing majority of voters overall, as well independents and even Republicans specifically now support legalization.
California’s 2016 legal cannabis measure won by a significant margin in Rohrabacher’s district, so it’s somewhat of a mystery as to why Democrats thought attacking him over his leadership on the issue was a smart strategy to win back the seat.
Rohrabacher himself seemed to revel in the Democrats’ stepping in it and having to walk back their attack.
Rouda/Pelosi allies scramble 2 delete false attack on my record, as they struggle to sell their big gov/high tax agenda #ca48
— Dana Rohrabacher (@DanaRohrabacher) July 12, 2018
GOP pollster Frank Luntz chimed in, too.
— Frank Luntz (@FrankLuntz) July 12, 2018
American support for marijuana legalization:
• 57% of Republicans
• 77% of Democrats
• 62% of independentshttps://t.co/xfThxjhe11
— Frank Luntz (@FrankLuntz) July 12, 2018
One fun note that I didn’t have space to include in my LA Times op-ed is the fact that DCCC’s own chairman, Congressman Ben Ray Luján (D-NM), himself voted three times on the House floor in favor of Rohrabacher’s medical cannabis amendment and even backed a broader measure from Congressman Tom McClintock (R-CA) that would have protected state recreational marijuana laws from federal interference.
Democrats should be campaigning on, instead of attacking, marijuana law reform.
Unless they want to remain the minority party.
Major Alcohol Association Endorses States’ Rights To Legalize Marijuana
For the first time ever, a major alcohol association has come out in support of ending federal marijuana prohibition so that states can legalize cannabis without interference.
The Wine & Spirits Wholesalers of America (WSWA) announced “an official policy position in favor of a state’s right to establish a legal, well-regulated, adult-use cannabis marketplace,” in a press release on Thursday.
Today, we became the first and only beverage alcohol association to announce our position in favor of a state's right to establish a legal, well-regulated, adult-use #cannabis marketplace. Read our full statement: https://t.co/0rHHN3aEzU
— WSWA (@WSWAMedia) July 13, 2018
The announcement represented a significant departure from the association’s past statements on marijuana reform. Just two years ago, WSWA said in a sponsored advertisement that it was “neutral on the issue of legalization,” going on to caution congressional officials about the “dangers associated with the abuse and misuse of marijuana,” including drug-impaired driving.
Now the alcohol trade group is singing a different tune.
“The legal cannabis market continues to expand in the United States, generating $7.2 billion in economic activity in 2016,” Thursday’s press release reads. “WSWA believes that, similar to alcohol, the federal government should give states the power to legalize cannabis, but should ensure they meet an appropriate regulatory threshold.”
“Eight decades ago, Americans acknowledged that the Prohibition of alcohol was a failed policy. The state-based system of regulation, adopted after Prohibition, created a U.S. beverage alcohol market that is the safest, most competitive and best regulated in the world.” — WSWA Acting Executive Vice President for External Affairs Dawson Hobbs
WSWA went on to outline 13 policies it recommended for states that legalize recreational marijuana.
- A minimum age of 21 for purchase, possession and use, along with penalties for providing cannabis to minors;
- Establishment of Driving Under the Influence impaired driving standards;
- Licensing of producers, processors, distributors and retailers; Policies to prevent vertical monopoly/integration;
- Hours and days of sale parity with beverage alcohol;
- Tax collection and enforcement; Measures to prevent diversion of cannabis to other states;
- Restrictions on sale/common carrier delivery;
- Labeling requirements that include potency and health requirements;
- Testing of formulas to ensure product purity and consistency;
- Advertising restrictions designed to discourage underage access and promote responsible consumption;
- Restrictions on health claims on packaging;
- Establishment of a designated agency overseeing cannabis industry regulation in each state;
- Penalties for licensee violations on par with the state’s alcohol regulations;
- and Regulations that ensure all products in market can be tracked/traced to source processor/producer.
So what changed from two years ago?
While the group’s sudden embrace of local cannabis legalization efforts might strike some as odd given the intrinsic, competitive dynamic that’s developed between alcohol and marijuana interests, one aspect of the press release reveals how the broader booze industry could stand to profit:
“Legalization should include regulations that set age restrictions on buyers, as well as license and regulate the supply chain of cannabis, including growers, distributors, retailers and testing laboratories.” [Emphasis added.]
In other words, marijuana legalization might take a bite out of alcohol sales—as recent studies have shown—but the cannabis industry has diverse roles for various players to fill. Ancillary operators such as distributors now working under the current three-tier model for alcohol could be used in states with legal, regulated marijuana markets.
Hobbs denied that the association was trying to help the alcohol industry cash in on legal cannabis during an interview with Fox Business on Thursday.
“No, what we’re talking about is just creating a pathway for states to have federal recognition of legalization by enacting appropriate regulation that creates a safe and reliable marketplace,” Hobbs argued. He also said that the association wouldn’t be lobbying Attorney General Jeff Sessions to take action on federal marijuana policy, but rather the group’s focus would be on Congress.
Marijuana Moment reached out to WSWA for comment, but a representative was not immediately available.
What remains to be seen is whether other alcohol associations will follow suit. After all, a handful of alcohol interests, including the Arizona Wine and Spirits Wholesale Association and the Boston Beer Company donated to campaigns opposing legalization efforts during the 2016 election.
With this latest development from a major alcohol association, it seems the industry is conceding: If you can’t beat ’em, join ’em.
Another encouraging signal of cannabis becoming ever more established and mainstream. https://t.co/uJtNBiTd9k
— Earl Blumenauer (@repblumenauer) July 14, 2018