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.
Colorado Governor Touts Marijuana Legalization’s Benefits
After the 2012 election, which saw Colorado become the first state to legalize marijuana, Gov. John Hickenlooper (D) said he probably would have reversed the vote if he had a magic wand.
But with the perspective of a few years post-legalization, today he says he’d put that wand “back in the drawer.”
“I’m not quite there to say this is a great success, but the old system was awful,” Hickenlooper said at a forum hosted by the Economic Club of Chicago on Wednesday.
What’s more, “the things that we most feared—a spike in teenage consumption, a spike in overall consumption, people driving while high—we haven’t seen them,” he said.
“We had a little increase in teenage consumption, but then it went down. We do think that some of the teenage consumers are using it a little more frequently than they were five years ago before legalization. We have in many ways seen no demographic where there’s an increase in consumption, with one exception: senior citizens. I leave you to draw your own conclusions.”
Hickenlooper, who’s been floated as a potential 2020 presidential candidate, described the challenges his administration faced when Colorado voters approved an adult-use legalization measure. Elected officials and advisors were opposed to it, he said, and plus, “it’s no fun to be in conflict with federal law.”
But he pushed forward with implementation, recruiting the “smartest people” he could find to figure out the best approach to regulation and taxation. And Illinois, which recently elected pro-legalization J.B. Pritzker for governor, will likely be better off if they pursue reform because they can learn from the successes and failures of Colorado’s system, Hickenlooper said.
“Ultimately, I haven’t come to a final conclusion yet, but I think it’s looking like this is going to be—for all of the flaws and challenges we have—a better system than what we had. You guys are going to benefit, I think, having let us make a bunch of the mistakes and deal with it, I think you’re going to be able to have a much better system if indeed that is the direction that the state wants to go.”
Asked what advice he’d give to Pritzker if Illinois does elect to fully legalize cannabis, Hickenlooper offered three tips: 1) don’t overtax marijuana, or else the illicit marketplace will persist, 2) get data from law enforcement on the presence of cannabis metabolites in the blood after highway fatalities to establish “good baselines” for comparison and 3) set limits on THC concentrations in edibles.
“What they’re selling now, they tell me it’s 10-to-12 times more intense than what allegedly I smoked in high school,” Hickenlooper said, pausing before conceding, “I smoked pot in high school and I inhaled, but it was a fraction of the intensity of what these kids are getting now.”
Photo courtesy of YouTube/Economic Club of Chicago.
The DEA Just Got Scolded Over Its Marijuana Eradication Program
The Drug Enforcement Administration (DEA) got a slap on the wrist from a federal watchdog agency over its management of a multi-million dollar marijuana eradication program.
In a report released on Wednesday, the non-partisan Government Accountability Office (GAO) said the DEA had failed to adequately collect documentation from state and local law enforcement partners that received funds through the federal program. And that lapse could prevent the agency from being able to accurately assess “program performance.”
What’s more, the DEA “has not clearly documented all of its program goals or developed performance measures to assess progress toward those goals,” according to the report.
In other words, the agency expends about $17 million in funds to partners across the U.S. each year to help them get rid of illegal cannabis grows. That includes fully legal states like California, where enforcement efforts are generally limited to public lands—namely national forests. But due to inadequate record keeping, the DEA doesn’t really know if that money is serving its purpose.
To fix the problems, the GAO issued four recommendations:
1. The DEA Administrator should develop and implement a plan with specific actions and time frames to ensure that regional contractors are implementing DEA’s requirement for collecting documentation supporting participating agencies’ Domestic Cannabis Eradication And Suppression Program (DCE/SP) program expenditures in the intended manner.
2. The DEA Administrator should clarify DCE/SP guidance on the eradication and suppression activities that participating agencies are required to report, and communicate it to participating agencies and DEA officials responsible for implementing DCE/SP.
3. The DEA Administrator should clearly document all DCE/SP program goals.
4. The DEA Administrator should develop DCE/SP performance measures with baselines, targets, and linkage to program goals.
The DEA was able to review a draft of the GAO report ahead of its release and, in an October 17 letter, a Justice Department official said the agency concurred with all four of the recommendations and would take steps to address them.
You can listen to a podcast about the GAO report here:
Just because it’s the DEA’s program doesn’t mean it’s the only agency dropping the ball on marijuana eradication efforts. In April, a report from the inspector general for the U.S. Department of Agriculture found that agents weren’t adequately cleaning up public lands after cannabis busts, which can pose threats to humans, animals and the environment.
Photo courtesy of Chris Wallis // Side Pocket Images.
Here’s How Much Legal Marijuana Supporters And Opponents Spent Per Vote In Last Week’s Election
Political committees concerned with marijuana law reform in four states have waged an information war over the past year, first to qualify cannabis initiatives for the ballot, and then to support or oppose those measures in the lead-up to last week’s midterm elections. In total, over $12.9 million in cash and in-kind services was spent attempting to convince voters about these marijuana ballot measures.
Now that voters have had their say, Marijuana Moment decided to calculate how much each “yes” and “no” vote cost the committees on either side of the debate. Our calculations are based on dollars raised and disclosed before the election, since final totals of actual expenditures won’t be available until December or January reports required in the states that voted on cannabis.
In Michigan, where voters approved marijuana legalization, our calculations show that the two anti-legalization committees spent about $1.28 per “no” vote, as they raised $2.37 million for the 1.85 million votes against the measure. The proponents spent 19 percent more per vote, or $1.52 for each of 2.35 million “yes” votes.
In Missouri, three separate medical cannabis initiatives competed in the run-up to Election Day, resulting in the highest funding levels of the four states we looked at. There, committees raised a total of $5.4 million dollars to influence voters. Across all the committees, the average cost per “yes” vote was $1.82.
Amendment 3, which was supported by Find the Cures PAC, spent $2.91 for each of its 747,977 votes. Proposition C, supported by Missourians for Patient Care, spent $1.44 for each of its 1.03 million votes. New Approach Missouri, which supported winning Amendment 2, which garnered the support of 1.57 million voters, spent the least, at $1.10 per vote. Only Amendment 2 received a majority and was approved.
Given that there were three competing measures on the ballot, vote costs cannot be parsed in the same binary “yes” or “no” on marijuana reform that is possible for initiatives in the other states. A “no” vote for one measure in Missouri was often paired with a “yes” vote for another.
In North Dakota, there were many fewer votes cast on the state’s marijuana legalization initiative as compared to cannabis measure elsewhere, a total of 324,550. The two committees that opposed Measure 3 heavily outspent the pro-reform committees, to the tune of $629,648 to $94,308. With 131,585 people voting for the initiative, the cost per “yes” vote was 72 cents. On the opposing side, winning came at a high price: Each “no” vote cost four and a half times as much, or $3.26, the most costly per-vote expense on a marijuana ballot measure in the nation this year.
In Utah, a relatively state where proponents of medical cannabis measure Proposition 2 were narrowly outspent by opponents, the cost per vote was higher. Votes are still being counted more than a week after Election Day, but preliminary vote totals show opponents spent $908,464, or $1.99 for each of the 455,879 votes against the initiative. The prevailing “yes” committees spent $831,471 for 493,060 votes, or $1.69 each. About 8 percent of precincts are yet to be counted, so both of these figures will decrease as more votes are added to both the support and opposition tallies.
Overall in the three states that had a straight up-or-down vote (Michigan, Utah and North Dakota), the average cost per “no” vote was slightly more than each “yes” vote, with prohibitionist committees spending an average of $1.56 for each “no” vote, versus $1.51 spent on average for each “yes” votes. It should be noted that those costs include millions of dollars in in-kind services. In Michigan, for example, The Coalition to Regulate Cannabis like Alcohol reported $706,900 in in-kind services, or 23 percent of their total fundraising.
Looked at another way, the average per state cost (rather than total votes average) for “yes” votes was $1.31 while “no” votes cost 67 percent more: $2.18. And with the total number of “yes” votes in those states outnumbering “no” votes by 19 percent, it would seem that in the state-by-state marijuana legalization battle, you don’t always get what you pay for.