Government
What’s Up with the FDA’s Delay on CBD Rules? (2022 Update)
When will the FDA get around to doing what they said on CBD?
The hemp industry was shocked to its core when the 2018 Farm Bill passed. It’s not that the changes hadn’t been expected. In 2014, a similar bill was signed into law that started the process of re-legalizing hemp.
The possibilities were just suddenly staggeringly enormous. With “industrial hemp” CBD products containing less than 0.3% THC now essentially legal in all 50 states, the hemp market found itself with ample room to grow.
Over the last year or so, though, hemp industry stakeholders have started to feel themselves hit something of a wall. Comprehensive regulation issued by the FDA (CBD’s new federal overseer) has been expected since 2020 but still hasn’t arrived, leading to a general sense of uneasiness.
The pandemic slowed things down, but there are other factors at play here as well. Find out exactly why it’s 2022 already and the FDA still hasn’t properly regulated CBD.
The Current Status of CBD
Under the 2018 Farm Bill, most hemp-extracted CBD products containing less than 0.3% delta-9 THC are considered industrial hemp, a legal category that is entirely separate from the Controlled Substances Act’s definition of “marijuana”. As a result, CBD oil for pain and a vast variety of other CBD products are now sold widely on the internet and shipped to all 50 states.
CBD is not exactly legal in the sense of an over-the-counter drug, a supplement, or even a prescription drug in the majority of cases. The DEA may no longer have any jurisdiction over CBD, but for the most part, the FDA has failed to pick up the reins.
The FDA’s Position
In June of 2022, hopes briefly surged that the FDA might be getting close to releasing some definitive CBD guidance. The federal agency announced that it would be convening its Science Board to discuss the challenges related to regulating cannabinoids as dietary supplements or food ingredients.
Before it even took place, though, industry insiders were already confident that this meeting wouldn’t result in any major changes to the status quo of CBD regulation in the United States. Recent FDA statements make it clear that the agency is facing significant challenges as it develops regulatory frameworks that properly encompass CBD as an easily accessible online ingredient.
The FDA has at least one legitimate reason for taking its time on CBD: There’s still a serious lack of definitive safety data regarding the cannabinoid itself and the types of products in which it is commonly included. The FDA has commissioned various studies to determine the CBD’s safety, but it takes a while for that sort of research to come in.
Lack of safety data isn’t the only factor holding the FDA back, though. A decision the agency made regarding CBD back in 2018 has returned to haunt it in the here and now.
The Epidiolex Dilemma
Epidiolex is a CBD-based prescription drug developed by UK cannabis giant GW Pharmaceuticals. The FDA approved Epidiolex in 2018 for certain types of intractable epilepsy (including Dravet syndrome) and has since expanded the CBD drug’s accepted uses.
Though it’s called a “CBD-based drug” in regulatory contexts, the sole active ingredient in Epidiolex is hemp-derived CBD: The same hemp-derived CBD, for all intents and purposes, as you can find in hemp products sold on the internet.
The FDA has a long-standing precedent of not approving substances as supplements or over-the-counter drugs after they’ve already been approved as prescription medications. Though additional variables, such as federal cannabis legislation, may also sway the FDA’s decision on the matter, the fact that CBD is available on a prescription basis in Epidiolex is making it very hard for the agency to approve or regulate the cannabinoid in other contexts.
Possible Solutions on the Horizon
In May of 2022, the Democrat-controlled US House of Representatives passed a bill that would remove cannabis from the Controlled Substances Act. If the bill carries through the Senate and reaches the President’s desk, it could be the trigger the FDA needs to finally resolve the paradoxes surrounding federal CBD regulation.
Due to considerable political failures since gaining the majority in 2020, though, it’s possible the House and Senate will return to Republican control during the midterm federal elections, potentially stalling cannabis reform. Over time, ongoing research regarding CBD’s safety will continue to come in, and the FDA will eventually resolve regulatory conflicts between Epidiolex and other forms of CBD. The near future of the American hemp industry remains murky, however.
Summary: When Will the FDA Move on CBD?
In mid-2019, practically every industry expert predicted that comprehensive federal cannabis reform — accompanied by FDA clarity on CBD — would arrive in 2020. Then, the pandemic hit, and non-essential federal government activity was mostly shut down.
Now, political ambiguity is combining with regulatory tangles that are harder than expected to solve, making the exact path American CBD takes from here unsettlingly uncertain. What we know for sure, though, is that CBD industry leaders are committed to building a better tomorrow for hemp one day at a time.
Source: https://cannabis.net/blog/news/whats-up-with-the-fdas-delay-on-cbd-rules-2022-update
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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