Government
FDA takes another look at CBD, but insiders are skeptical much will change
U.S. health regulators are taking their closest look in more than three years at the idea of incorporating cannabinoids into dietary supplements.
But hopes are dim that Tuesday’s daylong review by the U.S. Food and Drug Administration’s Science Board will finally deliver a path to treating CBD like other dietary supplements – regulated but sold without prescriptions.
“It’s hard to get too excited about anything anymore,” said Vince Sanders, a CBD manufacturer and retailer in Missouri who traveled to Maryland in 2019 to attend the FDA’s first CBD hearing and has since seen the agency take little action to guide how CBD can be made outside pharmaceutical channels.
Tuesday’s meeting is an informational discussion by the FDA’s Science Board, an advisory panel made up of outside nutrition and drug-safety experts.
The panel meets intermittently, and the virtual daylong discussion Tuesday focuses on “challenges in evaluating the safety of dietary supplement and food ingredients with predicted pharmacological activity, utilizing cannabinoids as a case study.”
The hearing notice doesn’t mention CBD.
Still, several CBD manufacturers have submitted comments in hopes of seeing federal health regulators acknowledge that CBD is widely available and in need of guidelines.
“The majority of our industry either regulates itself with food and dietary supplement GMPs (Good Manufacturing Practices), or you have players that aren’t regulating themselves at all. It’s terrifying,” said Laura Eder, director of regulatory affairs and quality assurance for Vantage Hemp, which makes hemp-derived CBD in Greeley, Colorado.
How we got here
The FDA has been ostensibly considering CBD regulations ever since the agency was directed by Congress in 2018 to oversee how hemp products could be sold.
But the agency has repeatedly said it can’t set any regulations for over-the-counter hemp products because it doesn’t have enough data to say they’re safe.
The FDA also says that because CBD is an active ingredient in a prescription drug, Epidiolex, it can’t regulate nonpharmaceutical CBD.
Instead, the FDA has confined its cannabinoid enforcement activity to issuing warning letters to companies making egregious health claims.
At the same time, the agency has repeatedly discounted industry-funded research on the safety of CBD products as insufficient.
Last year, the FDA rejected efforts from two companies to market full-spectrum CBD as a new dietary ingredient.
So the fact that an advisory board is even talking about how to evaluate the safety of things such as cannabinoids in foods and dietary supplements could offer clues for companies trying to set themselves up for the day when FDA’s posture might change.
The Science Board meeting is “a peek behind the curtain,” said Emily Leongini, an attorney who specializes in FDA regulations for Arent Fox in Los Angeles.
“Is this meeting going to be the watershed moment where FDA announces that they’re going to allow a certain amount of CBD in food? No. But is it an important meeting in the grand scheme of things? I think so.”
Cynicism abounds
Leongini’s prediction that Tuesday’s meeting won’t immediately break FDA resistance to nonprescription CBD mirrors what several industry insiders told MJBizDaily.
In fact, many question why the Science Board is even taking up cannabinoid safety when the agency repeatedly says it isn’t safe without a prescription.
“I don’t view this as an attempt by FDA to try to move the needle. I just see this as them kind of building up their dossier of why they’re not going to be easing the burdens for industry,” said Jonathan Havens, a Washington DC-based cannabis attorney with Saul Ewing Arnstein & Lehr.
“It will probably result in more of the same, which is FDA saying, ‘We don’t have a sufficient basis or sufficient data to change our position that CBD is not a permissible dietary ingredient.’”
So far he FDA has dismissesed industry-funded safety research.
The silence exasperates manufacturers such as Sanders, owner of Kansas City, Missouri-based CBD American Shaman, a retail chain with more than 300 locations in 38 states.
“If you present (the FDA) with facts, they don’t pay any attention. … It just gets shelved.”
Next steps
The agency’s silence on over-the-counter CBD means companies are left to guess the best ways of making products.
“You just keep pounding away, doing it right every day, day in and day out, trying to raise the bar and do the best you can,” Sanders said.
“You just count on the fact that at some point in time, the opportunity is going to be there. You’re going to get the right people in the FDA, or the right situation, or Congress will pass a law where we can actually regulate this and move on with real business.”
For Vantage Hemp’s Eder, a 20-year pharmaceutical industry veteran who also made the trek to that 2019 hearing, skepticism about Tuesday’s hearing was overcome by her belief that consumers need better regulation of CBD.
“The common person who’s purchasing this has no idea if what they’re buying is safe,” Eder said.
She hopes the FDA will acknowledge that its opposition to CBD regulation hasn’t stopped folks from selling it.
“The cat is out of the bag. If you go to any store, any gas station, any salon, there are CBD products on the shelf, down to your local mom-and-pop store, not to mention the online presence,” Eder said.
“There is no way to pull back what is already there and try to enforce taking products off the shelf, when we all know that FDA does not have the manpower to enforce that.
“So the critical need right now is to implement a guidance for industry … because it’s critical for the safety of our consumers at this point.”
Hemp Editor Kristen Nichols can be reached at kristen.nichols@mjbizdaily.com.
Source: https://mjbizdaily.com/fda-takes-another-look-at-cbd-but-insiders-are-skeptical-much-will-change/
New Mexico regulators fined a cannabis operator nearly $300,000 and revoked its license after the company allegedly created fake reports in the state’s traceability software.
The New Mexico Cannabis Control Division (CCD) accused marijuana manufacturer and retailer Golden Roots of 11 violations, according to Albuquerque Business First.
Golden Roots operates the The Cannabis Revolution Dispensary.
The majority of the violations are related to the Albuquerque company’s improper use of BioTrack, which has been New Mexico’s track-and-trace vendor since 2015.
The CCD alleges Golden Roots reported marijuana production only two months after it had received its vertically integrated license, according to Albuquerque Business First.
Because cannabis takes longer than two months to be cultivated, the CCD was suspicious of the report.
After inspecting the company’s premises, the CCD alleged Golden Roots reported cultivation, transportation and sales in BioTrack but wasn’t able to provide officers who inspected the site evidence that the operator was cultivating cannabis.
In April, the CCD revoked Golden Roots’ license and issued a $10,000 fine, according to the news outlet.
The company requested a hearing, which the regulator scheduled for Sept. 1.
At the hearing, the CCD testified that the company’s dried-cannabis weights in BioTrack were suspicious because they didn’t seem to accurately reflect how much weight marijuana loses as it dries.
Company employees also poorly accounted for why they were making adjustments in the system of up to 24 pounds of cannabis, making comments such as “bad” or “mistake” in the software, Albuquerque Business First reported.
Golden Roots was fined $298,972.05 – the amount regulators allege the company made selling products that weren’t properly accounted for in BioTrack.
The CCD has been cracking down on cannabis operators accused of selling products procured from out-of-state or not grown legally:
- Regulators alleged in August that Albuquerque dispensary Sawmill Sweet Leaf sold out-of-state products and didn’t have a license for extraction.
- Paradise Exotics Distro lost its license in July after regulators alleged the company sold products made in California.
Golden Roots was the first alleged rulebreaker in New Mexico to be asked to pay a large fine.
Source: https://mjbizdaily.com/new-mexico-cannabis-operator-fined-loses-license-for-alleged-biotrack-fraud/
Four marijuana companies, including a multistate operator, have filed a lawsuit against U.S. Attorney General Merrick Garland in which they allege the federal MJ prohibition under the Controlled Substances Act is no longer constitutional.
According to the complaint, filed Thursday in U.S. District Court in Massachusetts, retailer Canna Provisions, Treevit delivery service CEO Gyasi Sellers, cultivator Wiseacre Farm and MSO Verano Holdings Corp. are all harmed by “the federal government’s unconstitutional ban on cultivating, manufacturing, distributing, or possessing intrastate marijuana.”
Verano is headquartered in Chicago but has operations in Massachusetts; the other three operators are based in Massachusetts.
The lawsuit seeks a ruling that the “Controlled Substances Act is unconstitutional as applied to the intrastate cultivation, manufacture, possession, and distribution of marijuana pursuant to state law.”
The companies want the case to go before the U.S. Supreme Court.
They hired prominent law firm Boies Schiller Flexner to represent them.
The New York-based firm’s principal is David Boies, whose former clients include Microsoft, former presidential candidate Al Gore and Elizabeth Holmes’ disgraced startup Theranos.
Similar challenges to the federal Controlled Substances Act (CSA) have failed.
One such challenge led to a landmark Supreme Court decision in 2005.
In Gonzalez vs. Raich, the highest court in the United States ruled in a 6-3 decision that the commerce clause of the U.S. Constitution gave Congress the power to outlaw marijuana federally, even though state laws allow the cultivation and sale of cannabis.
In the 18 years since that ruling, 23 states and the District of Columbia have legalized adult-use marijuana and the federal government has allowed a multibillion-dollar cannabis industry to thrive.
Since both Congress and the U.S. Department of Justice, currently headed by Garland, have declined to intervene in state-licensed marijuana markets, the key facts that led to the Supreme Court’s 2005 ruling “no longer apply,” Boies said in a statement Thursday.
“The Supreme Court has since made clear that the federal government lacks the authority to regulate purely intrastate commerce,” Boies said.
“Moreover, the facts on which those precedents are based are no longer true.”
Verano President Darren Weiss said in a statement the company is “prepared to bring this case all the way to the Supreme Court in order to align federal law with how Congress has acted for years.”
While the Biden administration’s push to reschedule marijuana would help solve marijuana operators’ federal tax woes, neither rescheduling nor modest Congressional reforms such as the SAFER Banking Act “solve the fundamental issue,” Weiss added.
“The application of the CSA to lawful state-run cannabis business is an unconstitutional overreach on state sovereignty that has led to decades of harm, failed businesses, lost jobs, and unsafe working conditions.”
Alabama regulators are targeting Dec. 1 to award the first batch of medical cannabis business licenses after the agency’s first two attempts were scrapped because of scoring errors and litigation.
The first licenses will be awarded to individual cultivators, delivery providers, processors, dispensaries and state testing labs, according to the Alabama Medical Cannabis Commission (AMCC).
Then, on Dec. 12, the AMCC will award licenses for vertically integrated operations, a designation set primarily for multistate operators.
Licenses are expected to be handed out 28 days after they have been awarded, so MMJ production could begin in early January, according to the Alabama Daily News.
That means MMJ products could be available for patients around early March, an AMCC spokesperson told the media outlet.
Regulators initially awarded 21 business licenses in June, only to void them after applicants alleged inconsistencies with how the applications were scored.
Then, in August, the state awarded 24 different licenses – 19 went to June recipients – only to reverse themselves again and scratch those licenses after spurned applicants filed lawsuits.
A state judge dismissed a lawsuit filed by Chicago-based MSO Verano Holdings Corp., but another lawsuit is pending.
Source: https://mjbizdaily.com/alabama-plans-to-award-medical-cannabis-licenses-dec-1/
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