Government
Could the U.K. Eliminate Novel Food Regulations for Cannabis?
A Parliamentary group has proposed what so far has been the unthinkable in Europe—removing cannabis from the ongoing regulatory hell of “Novel Foods” approvals—as more delay looms for the industry.
In what would be a major boon to the regulated cannabis industry in the U.K., a Parliamentary group has now suggested that products containing cannabidiol should no longer be subjected to Novel Food regulations. Firms who wish to manufacture CBD-containing food products to date across Europe have all had to submit such applications to prove that cannabidiol is not hazardous to human health.
In both the U.K. and the E.U., this has been rocky territory.
On the British side, in March, the Food Safety Authority (FSA) gave 3,536 products preliminary approval before complaints caused the agency to expand that list to 6,000 with more to be added. Critics have said that the system is complex, costly, anti-competitive, and has no benefit for consumers.
Those wishing to amend that path to market also argue that submitting every CBD product to this process is like using an elephant gun to shoot a mouse. Here is why. Novel Food applications are usually required only of large corporations with international reach. There is almost no chance that smaller firms would have the wherewithal to perform such processes.
The British group has also suggested that the manufacturers of such products should be required to submit COAs—or certificates of analysis—to prove that they are not hazardous to human health.
This move would drastically speed up the development of this part of the industry, with implications for THC as well. COA analysis is also the standard used routinely in the backend of sourcing for the industry. People looking for bulk cannabis flower, distillate, or isolate share COAs before purchase agreements are signed—on both the medical and non-medical side.
These recommendations, as a result, are incredibly good news indeed, especially given the unbelievably bureaucratic and frustrating lack of progress so far on both sides of the Brexit divide.
In the U.K. at least, politicians appear to be listening.
The news is not so good on the E.U. side of the discussion. The fact that the European Food Safety Authority (EFSA) broke the news on Tuesday that they were delaying 19 pending applications is probably not coincidental. Even if it is, their decision puts the entire discussion about the process firmly in the spotlight within the E.U. too.
What Is Novel Food and Why Does This Matter to The E.U. Cannabis Industry?
For those outside of Europe, the idea of “Novel Foods” has never blighted the discussion about the acceptance of any cannabinoid. In fact, foreigners do not know what the fuss is about. This is also why edibles are now about half of the total U.S. market. They simply are not subjected to this analysis.
Those in Europe have had to face a bizarre series of regulatory hurdles—beyond the “normal” issues of legalization and certification—because CBD-containing products have been subjected to a regulation adopted at the beginning of the European Union. Novel Food regulation was implemented in 1997. The idea was to prevent food that is “foreign” and potentially hazardous to human health from entering distribution within the block. Approvals are an exceedingly long, arduous, and expensive process. On the U.K. side, after Brexit, the same structural regulatory process was also applied; it was just moved under the purview of a domestic agency, not a European one.
On one level of course this regulation (sans cannabis) makes a world of sense. In fact, similar regulation exists in the United States and Canada (as it does in most countries). Cannabis products, however, have not been subjected to this kind of scrutiny in either country because of the trajectory of cannabis reform. In Canada, the edibles business did not lead the discussion. In the United States, there has been no federal regulatory environment that applied to anything in the industry because so far, legalization has only existed on a state level.
In Europe that conversation has been very different.
This is unbelievably frustrating considering that hemp, much less extracted CBD, is not “novel”. It was widely consumed in the region long before there was an E.U.
Regulators, however, don’t share that perspective. Yet.
More Delays in Europe for Pending Applications
The new stance from the British Parliament is even more refreshing given current events on the ground.
On the E.U. side, as more delays were announced this week, according to Professor Dominique Turck, the chair of the Novel Foods and Food Allergens panel for the EFSA. “We have identified several hazards related to CBD intake and determined that the many data gaps on these health effects need filling before these evaluations can go ahead. It is important to stress at this point that we have not concluded that CBD is unsafe as food.”
The specific reason for the newest approval delay on the E.U. side is that the committee claims that there is insufficient data on the effect of CBD on the liver, gastrointestinal tract, endocrine, nervous system, and people’s psychological well-being.
As a small sop to companies with pending applications, Ana Alfonso, Head of Nutrition and Food Innovation at the agency said, “Stopping the clock on a novel food assessment is not unusual when information is missing. It’s the responsibility of applicants to fill data gaps. We are engaging with them to explain how the additional information can be provided to help address the uncertainties.”
The agency will hold an online session on June 28 which is open to applicants and other interested parties to discuss how applicants might provide information the agency claims is incomplete.
Source: https://hightimes.com/news/could-the-u-k-eliminate-novel-food-regulations-for-cannabis/
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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