The Food and Drug Administration (FDA) submitted a report to Congress on the state of the CBD marketplace on Wednesday, and the document outlines studies the agency has performed on the contents and quality of cannabis-derived products that it has tested over the past six years.
The report, which is responsive to a mandate attached to congressional appropriations legislation last year, shows significant inconsistencies between cannabinoids concentrations that are listed on labels and what the products actually contain. At the same time, it found negligible evidence that dangerous metals and minerals are added to these products.
Reform advocates have emphasized the need for FDA to develop regulations to ensure quality control in the market. The agency is in the process of creating those rules, but in the meantime it is generally allowing CBD to be sold while prioritizing enforcement action against companies that make particularly outlandish claims about the medical benefits of their products.
“FDA recognizes the significant public interest in CBD products,” the agency wrote. “However, there are many questions about the characteristics of currently marketed CBD products because the Agency lacks significant information on what CBD-containing products are on the market and there are little data available on those products themselves.”
“FDA believes that understanding the characteristics of marketed CBD products is critical to making informed decisions about how best to protect public health in the current marketplace,” the report states.
While the agency has previously conducted sampling studies for CBD, a spending bill that provided funds for FDA requires it to perform another, especially since hemp and its derivatives were legalized under the 2018 Farm Bill. The legislation stipulated that FDA had 180 days to “perform a sampling study of the current CBD marketplace to determine the extent to which products are mislabeled or adulterated.”
“Together, this information will provide the Agency with a better understanding of product characteristics in the current CBD marketplace and will help protect and promote public health,” the report said.
FDA described the three phases of CBD testing it has overseen since 2014.
During the first period, from 2014 to 2018, it looked at a sample of 78 cannabis products marketed to humans and pets. They found that 67 of them (86 percent) contained CBD. Of the 23 products FDA analyzed in 2014, only eight (35 percent) had CBD concentrations that were consistent with their labeling.
In 2019, the agency tested 34 additional CBD products for a wide range of potentially dangerous materials such as arsenic and lead. They determined that the “levels found in these 34 products did not raise significant public health concerns.”
Among 31 products that were tested for cannabinoids, 21 had labels that specified a CBD concentration. Only seven of them (33 percent) ultimately contained CBD within 20 percent of what was noted on the label.
For 2020, the agency said, “Given the extensive data gaps regarding the current CBD marketplace, the results from previous product testing, and in response to the congressional directive…FDA is undertaking a more extensive CBD product sampling effort.”
That effort involved a short-term plan to 147 products for cannabinoids, 138 of which contained CBD.
“Of the 102 products that indicated a specific amount of CBD, 18 products (18 percent) contained less than 80 percent of the amount of CBD indicated, 46 products (45 percent) contained CBD within 20 percent of the amount indicated, and 38 products (37 percent) contained more than 120 percent of the amount of CBD indicated,” the report states. Only one of 133 samples had potentially hazardous materials, however.
Looking ahead, the agency has long-term testing plans that will involve using “a sampling methodology to create a representative, random sample of the current CBD product marketplace.”
“The Agency is purchasing data on brands, product categories, and distribution channels for CBD products,” it said. “FDA is also in the process of developing its own comprehensive list of brands operating in the CBD market space by assembling data from targeted internet searches and analytics. FDA intends to leverage both data sets to randomly sample products across brands, product categories, and distribution channels, while favoring products with a higher market share.”
The sampling is expected to cover cannabis tinctures, oils, extracts, capsules, powders, waters and other beverages, food items, cosmetics, personal lubricants, tampons, vape cartridges and products sold for pets.
Interestingly, FDA also revealed in the report that it is working with the nation’s only federally authorized marijuana cultivation facility at the University of Mississippi to develop techniques to test for hemp and its derivatives in cosmetics.
The advocacy group U.S. Hemp Roundtable said in an email blast that “there’s not much news” in FDA’s report.
“Citing previous testing data and some more recent but limited random sampling, the FDA revealed what we already knew: While more work needs to be done to ensure CBD products consistently meet label claims, the majority of products do not contain unsafe contaminant levels, specifically heavy metals,” it said. “As an industry that holds itself to the highest standards, we would like to rid the marketplace of all improperly labeled products and unsafe products.”
“It’s high time for the FDA to regulate CBD as a dietary supplement and food additive,” the industry group said. “The agency’s current public stance not only impairs hemp farmers and small businesses; an unregulated marketplace poses real health and safety concerns.”
The Consumer Brands Association (CBA), for its part, said that the FDA data “further affirms the need for federal regulatory clarity.”
“Allowing bad actors to continue to put products on the market, unchecked, is a threat to consumer safety everywhere,” Betsy Booren, CBA’s senior vice president for regulatory and technical affairs, said.
Today's findings are even more reason Congress must provide funding and resources to @US_FDA so it can create the regulatory framework consumers of #CBD products deserve. https://t.co/v6T1l8LeDQ pic.twitter.com/6gn4HlFWNO
— Consumer Brands (@consumerbrands) July 8, 2020
As FDA continues to conducts these tests and develop regulations for CBD to be marketed as food items or dietary supplements, it continues to issue warnings to cannabis businesses in certain cases—such as instances in which companies claimed CBD could treat or cure coronavirus—and provide public notices about recalls. It provided an update on its CBD enforcement guidance to guidance in March.
The agency also recently submitted guidance on marijuana and CBD research to the White House Office of Management and Budget, which is currently reviewing the proposal.
Read FDA’s report on CBD sampling below:
Photo by Kimzy Nanney.
New Initiative To Legalize Marijuana Sales Filed In D.C.
Activists recently filed a new proposed ballot initiative to legalize marijuana sales in Washington, D.C.
The measure—titled the “New Modern Day Cannabis Justice Reform Act”—would end prosecutions of cannabis cultivation, sales and consumption. It would also prevent marijuana from being the basis of police searches and provide for expungements of prior cannabis convictions.
District voters approved a measure to legalize low-level marijuana possession and home cultivation in 2014, but the city has been prevented from implementing a retail model due to a congressional rider barring it from using local tax dollars for such purposes. It stands to reason that the new proposal would run into the same problem, but activists say they plan to push ahead regardless.
Dawn Lee-Carty, executive director of the campaign behind this initiative, told Marijuana Moment in a phone interview that the currently unregulated cannabis system that’s in place has failed to address the problem of racially disproportionate enforcement, with arrests still occurring and putting people at risk of contracting the coronavirus.
“Our goal is to push hard and—if we have to take it to Congress, whatever levels that we have to take—to ensure that it is a different cannabis climate for the safety of the patient, for the economy, for those who run a participate and want to be store owners for cannabis, we should have access just like big moneyed interests have access without being washed out,” she said.
Lee-Carty said that, ideally, the measure would appear on the November ballot this year. It’s fairly late in the process at this point, but the Board of Elections is scheduled to meet to determine whether the initiative meets the standards of relevant subject matter for initiatives on September 2.
To qualify for the ballot, activists would have to collect 24,835 valid signatures from registered voters—just as a separate campaign to decriminalize a wide range of psychedelics successfully did. The marijuana campaign has not started formally gathering signatures, but it did circulate an independent petition that advocates say amassed about 40,000 signatures from individuals who would presumably be inclined to sign the official form.
“This initiative legalizes the possession, to the extent possible by current law the use, sale, and purchase of cannabis and CBD products for any person over the age of 21 or older,” text of the measure states. “Where not possible the initiative will make police enforcement and prosecution the lowest priority. Reverting to law automatically the soonest date possible in the future.”
The proposal also contains several noteworthy provisions such as requiring that, in order to obtain a marijuana business license, individuals must have resided in D.C. for at least two years. Those on parole would also be eligible, the measure states.
“We don’t want outsiders to come in and take over our business. It’s already happened. It’s already here,” Lee-Cary said, referring to the district’s existing medical cannabis program. “You have a lot of out-of-state, people that come in—big money interests that come in—and they sweep up the opportunities that people in our community could have.”
There’s also a ban on vertical integration included in the measure, preventing companies from multiple stages of production and sales so that the local industry would be more diverse and less at risk of monopolization.
Another unique provision would make it so police dogs “previously trained to detect cannabis will be retrained to detect explosives, weapons of mass destruction, and firearms so as to protect our schools, malls, mass gatherings, from foreign and domestic foreign terrorism.”
“Dogs are trained to sniff marijuana, but meanwhile we have bombs, we have school shootings, we have so many other things that are in play right now that I think that we should redirect the funding for dogs—once again removing police and all police-related things, including dogs—out of the cannabis industry or out of the cannabis climate if it’s legal,” Lee-Carty said.
Read the text of the proposed D.C. marijuana sales legalization measure below:
Photo courtesy of WeedPornDaily.
USDA Explains Why It’s Denying Hemp Farmers Access To Coronavirus Relief Benefits
The U.S. Department of Agriculture (USDA) has explained its reasoning for denying hemp growers access to federal coronavirus relief.
In a notice set to be published in the Federal Register on Thursday, the department said it was only providing benefits under the Coronavirus Food Assistance Program (CFAP) for producers of commodities that experienced a five percent price decline between January and April. Their analysis found that hemp did not meet that threshold.
“While the national price did decrease during the first quarter of 2020, it was only a 1 percent decrease, which did not meet the 5 percent or greater decrease in price for CFAP eligibility,” USDA said.
“The national price is represented by the average of 5 regional published hemp biomass benchmark midpoints,” the notice states. “USDA has determined hemp is not eligible for CFAP due to not meeting the 5 percent or greater price decline, nationally.”
USDA first announced that hemp and several other crops would not be eligible for the program in May. While the agency initially maintained it was not even open to reevaluating that decision when it comes to hemp—a determination for only that crop and tobacco—it changed course after Marijuana Moment reported on the blanket exclusion. The department then said that it would at least accept evidence of price declines to reconsider eligibility.
USDA’s latest comments on hemp in the new Federal Register notice are part of a compilation of responses from the department to public feedback requesting aid for a variety of crops that were initially left out of the program.
CFAP is a $19 billion immediate relief program that “includes direct support to agricultural producers.” It was established as part of the first approved COVID-19 package passed by Congress.
Hemp industry advocates have expressed disappointment over USDA’s action, arguing that like any other industry, the hemp market is experiencing unique challenges amid the pandemic and shouldn’t be written off from this program.
They say because hemp is a newly legal crop, it’s more difficult to assess price declines based on traditional benchmarks.
The hemp exclusion by from USDA seemed unusual given that the department has seemingly made a significant effort to demonstrate that it is supportive of the industry and is actively working to ensure that the market has the resources it needs to expand since the crop’s federal legalization in 2018.
In the meantime, USDA is facing pressure from the top Democrat in the Senate and industry stakeholders to delay issuing final regulations for hemp until 2022, citing concerns about the challenges of state compliance that have arisen due to the COVID-19 pandemic.
The minority leader isn’t alone in requesting an extension; state agriculture departments and a major hemp industry group made a similar request to both Congress and USDA this week.
USDA has since approved numerous state, territory and tribal plans—most recently for Maryland and an Indian tribe last week.
Two senators representing Oregon recently expressed concerns that USDA appears positioned to reinstate two particular provisions of its interim final rule that stakeholders view as especially problematic. Those requirements, which the department temporarily suspended enforcement of, mandate that labs that test hemp be registered with the Drug Enforcement Administration and that law enforcement be involved in disposal of the crop if it contains excess THC.
Photo courtesy of Brendan Cleak.
Trump, Asked About Harris’s Marijuana Record, Says ‘She Lied’
President Trump weighed in on Sen. Kamala Harris’s (D-CA) prior comments on marijuana shortly after she was announced as Joe Biden’s vice presidential running mate on Tuesday.
While the president declined to explicitly discuss the senator’s cannabis policy positions after being pressed by New York Post reporter Steve Nelson, he said “she lied” and “said things that were untrue” when presented with details about an interview she gave last year in which she discussed smoking marijuana in college.
Harris, a former California prosecutor who has been widely criticized by advocates over he role in convicting people over marijuana and past dismissive comments about reform efforts, told The Breakfast Club that during her college days, she consumed cannabis and listened to rappers Tupac and Snoop Dogg. But as some quickly pointed out, the timeline didn’t match, as those artists hadn’t yet released their debut albums while she was in school.
President Trump, in his first remarks on Kamala Harris as Joe Biden's VP pick, tells me about her past remarks on marijuana:
'Well, she lied. I mean, she said things that were untrue. She is a person that's told many, many stories that weren't true.'https://t.co/VhKjB9G4yM
— Steven Nelson (@stevennelson10) August 11, 2020
Harris later conceded that she “definitely was not clear about what I was listening to” while consuming cannabis.
Nelson asked the president at a White House press briefing if he felt Harris’s “past on marijuana” is “a liability.”
“Well, she lied. I mean, she said things that were untrue. She is a person that’s told many, many stories that weren’t true,” Trump said before pivoting to criticism about her position on topics like taxes, fracking, military funding and health care.
The reporter followed up to ask whether “supporters of marijuana legalization should vote for you rather than her because she convicted so many people in the past.”
“I can’t tell you what she’s voting for. I don’t think she knows what. I think Joe knows even less than she does,” the president said without directly addressing the question.
It’s somewhat rare for Trump to comment on marijuana issues, but it’s notable that when presented with the opportunity to seize on Harris’s criminal justice record, he declined. It’s especially interesting given that his reelection campaign has been attacking Biden as an “architect” of the drug war who authored punitive laws during his time in the Senate and framing the incumbent president as the criminal justice reform candidate.
A majority of Americans support legalizing marijuana, which makes it all the more curious that neither Trump nor Biden have sought to embrace the issue. Harris, for her part, is now the lead sponsor of a bill to federally legalize cannabis.
In any case, Nelson, the New York Post reporter, has made a habit of pressing Trump on cannabis policy. Last year, he cited studies about reduced opioid overdoses in states with legalization on the books and the president replied that “right now we are allowing states to make that decision” with regard to cannabis policy.
And when the reporter previously asked about Sen. Cory Gardner’s (R-CO) legislation to allow states to set their own marijuana policies, the president voiced tentative support, saying “I really do” favor the proposal.
“I know exactly what he’s doing. We’re looking at it,” he said at the time. “But I probably will end up supporting that, yes.”
Both Trump and Biden are in favor of medical cannabis. And Biden has put forward plans to decriminalize marijuana possession, modestly reschedule the plant and facilitate expungements for prior cannabis convictions.
It remains to be seen whether Harris will push the former vice president to adopt a pro-legalization stance.