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DEA Backs White House Plan To Research Cannabis, Psychedelics

DEA Backs White House Plan To Research Cannabis, Psychedelics

DEA approves of more cannabis and psychedelic research
The Drug Enforcement Administration (DEA) and National Institute On Drug Abuse (NIDA) say they are in favor of a White House proposal to streamline the process of researching Schedule I drugs like marijuana and certain psychedelics.

The agencies testified at a House Energy and Commerce subcommittee hearing on Thursday, expressing support for the Office of National Drug Control Policy (ONDCP) research plan. While the focus of the meeting was mostly on a controversial move to strictly classify fentanyl-related substances, the Biden administration proposal’s research components would also help address concerns within the scientific community about the difficulty of studying other Schedule I drugs.

DEA said in written testimony that “expanding access to Schedule I research is a critical part of DEA’s mission to protect public safety and health.”

“It is critical that the scientific and medical community study Schedule I substances, as some may turn out to have therapeutic value,” DEA Principal Deputy Administrator Louis Milione said. “DEA supports the administration’s legislative proposal’s expansion of access to Schedule I research. DEA looks forward to continuing to work with the research community and our interagency partners to facilitate Schedule I research.”

In general, what the administration is proposing is to align the research requirements for Schedule I drugs with those of less-restricted Schedule II drugs. Scientists and lawmakers have consistently pointed out that the existing rules for studying Schedule I controlled substances are excessively burdensome, limiting vital research.

Rather than having each scientist involved in a Schedule I drug study obtain DEA registration, ONDCP wants to make it so multiple researchers at a given institution would be allowed to participate under a single registration. The administration also proposed a policy change where a research institute with studies taking place over multiple locations would only require one overall registration instead of needing to have a specific one for each site.

Another change would allow certain researchers to move ahead with conducting their studies after submitting a notification to the Department of Justice instead of waiting for officials to affirmatively sign off on their proposals. ONDCP’s plan would also waive the requirement for additional inspections at research sites in some circumstances and allow researchers to manufacture small amounts of drugs without obtaining separate registrations. The latter component would not allow cultivation of marijuana, however.

Michigan Cannabis Recall May Affect $200M In Cannabis Products

Michigan Cannabis Recall May Affect $200M In Cannabis Products

Michigan cannabis regulatory agency has recalled products impacting 400 retail locations across the state

In the largest product recall since the state legalized cannabis in 2019, the Michigan cannabis regulatory agency (Marijuana Regulatory Agency) has recalled enough products to impact over 400 retail locations around the state.

While the exact amount of products that are being recalled hasn’t been specified, the Marijuana Regulatory Agency (MRA) recalled all marijuana flower product that passed safety testing at Viridis Laboratories between Aug. 10 and Nov. 16. The agency released a full list of all locations impacted by the recall after calling lab test results “inaccurate and/or unreliable” in a notice issued just before 5 p.m. on Wednesday November 17, but provided no further explanation.

The recall Michigan cannabis recall only impacts flower products

“While we strongly disagree with this decision and firmly stand by our test results, we are fully cooperating with the MRA and working closely with our customers to minimize interruptions and retest affected products at no cost,” Viridis said in a prepared statement. “We have been cleared to continue testing at both of our state-of-the-art facilities. We look forward to continuing to serve our amazing customers using the best, most cutting-edge scientific methods available so we can fulfill our mission of promoting the health and safety of patients and adult-use consumers.”

According to a notice sent out by the MRA, customers who have the recalled product should return it to the retailer they purchased it from “for proper disposal.” “Consumers with weakened immune systems or lung disease are at the highest risk for health-related incidents such as aspergillosis, which can impact lung function, if these potentially harmful products are consumed,” the agency said Wednesday evening.

All Michigan cannabis products are required to have safety labels that contain the date product passed testing and the lab where it was tested. Viridis Laboratories, founded by former Michigan state police forensic scientists, operates labs in Bay City and Lansing. The license identification numbers for Viridis labs that should appear on labels are: “SC-000009, AU-SC-000113″ and “SC-000014, AU-SC-000103.”

The MRA is giving retailers holding the defective product three options: destroy the product and send the agency proof, resubmit the products for testing, or send the products back to the original source to be retested as part of a larger batch.

DEA may allow companies to grow cannabis for scientific research

DEA may allow companies to grow cannabis for scientific research

DEA cannabis may be getting better for scientists

After years of delay under the Trump administration, the federal government is preparing to award the first new licenses for cultivating cannabis for scientific research, giving U.S. marijuana operators a crack at entering a business that has been dominated by the University of Mississippi for more than 50 years.

The U.S. Drug Enforcement Administration late last week signaled it would award the licenses soon by issuing a “Memorandum of Agreement” (MOA) to “a number” of organizations that applied for the opportunity, according to an agency news release. The move will allow greater research into marijuana and its potential medicinal properties. That, in turn, could spur more doctors to recommend medical cannabis, which likely would boost sales.

“We expect to receive our registration number this afternoon,” said Dr. Steven Groff, founder of Groff North America in Red Lion, Pennsylvania, one of three entities that on Friday received an MOA from the DEA.

The recipients are supposed to review the MOAs and return them to the DEA with comments or suggestions. Groff already returned its MOA, and two other recipients told MJBizDaily they’d return their paperwork in the coming days or weeks.

Besides Groff, at least two other organizations confirmed they’d received an MOA:

  • Scottsdale Research Institute in Arizona.
  • Biopharmaceutical Research Co. (BRC) in Castroville, California.

A DEA spokesperson declined to answer if any other MOAs were issued. It’s also unclear when, or if, the DEA intends to issue more MOAs.

“This has the potential to create a renaissance of cannabis research for decades,” Dr. Sue Sisley, president of the Scottsdale Research Institute, said in a phone interview. Sisley, a longtime cannabis advocate, has been studying marijuana’s potential therapeutic benefits.

George Hodgin, the CEO of BRC, echoed Sisley, saying in a phone interview: “This is a massive regulatory step.”

Currently, the University of Mississippi, or Ole Miss, is the only institution in the United States with DEA permission to cultivate cannabis for federally approved research, having been awarded its license in 1968.

Critics complain that the cannabis grown there doesn’t reflect what’s being sold in the marketplace today.

To expand the number of entities with federal licenses for cultivating marijuana for research, the Obama administration announced an application process in its final year. Nearly 30 businesses, research institutes, universities and other entities applied.

Feds Announce New Standard THC Dose for Cannabis Research

Feds Announce New Standard THC Dose for Cannabis Research

cannabis research by the government

The National Institute on Drug Abuse (NIDA) announced on Friday it was setting the new standard THC dose for cannabis research at five milligrams, Marijuana Moment reports. The requirement took effect immediately.

Inconsistency in the measurement and reporting of THC exposure has been a major limitation in studies of cannabis use, making it difficult to compare findings among studies. A standardized measure of THC in cannabis products is necessary to advance research by providing greater comparability across studies of both its adverse effects and potential medical uses. — NIDA Notice of Information excerpt

NIDA said the five-milligram standard unit was selected following extensive stakeholder input, expert consultation, and a request for information from the general public.

In its notice, NIDA recognized that “the same quantity of THC may have different effects” depending on a number of variables, including the method of administration, other ingredients in the product, an individual’s genetic make-up and tolerance levels, and more. Additionally, the notice clarified that the newly standardized THC unit does not limit the quantity of THC permissible in cannabis research, only the way in which investigators must record and report their work.

While cannabis remains a Schedule 1 substance under federal law, research efforts are difficult but not completely blocked: a 20-year study by the University of Minnesota recently revealed that long-term cannabis use has little to no effects on cognitive abilities, while another recent study found cannabis use to be associated with increased rates of exercise and physical activity.

Lack of standards, dubious business practices threaten to upend cannabis testing industry

Lack of standards, dubious business practices threaten to upend cannabis testing industry

cannabis testing labs are suffering from issues.

A lack of standards is among the factors plaguing the cannabis testing industry, threatening to undermine consumer confidence in marijuana products and making it harder for some testing businesses to operate, according to industry insiders.

But the problems don’t stop there, testing lab officials and regulators contend.

Some marijuana businesses – such as growers, processors and manufacturers – are shopping around for labs that will give them the results they want to see in the way of THC potency and contaminants, according to industry officials.

Other cannabis businesses are said to be sending in samples of their marijuana that have been adulterated with spray-on cannabis oil or dusted with THC crystals to give the impression of a higher THC content, among other practices.

Regulators, meanwhile, are shuttering testing labs for allegedly reporting results that don’t match up with audits.

Earlier this month, the Washington State Liquor and Cannabis Board (LCB) suspended the license of Praxis Laboratory for allegedly falsifying testing data on more than 1,200 samples of cannabis by providing higher THC numbers than tests actually found.

As it stands now, the Centralia, Washington-based lab is suspended for 180 days effective Dec. 10. While the lab is shuttered, state regulators will seek to permanently revoke its license.

According to an LCB release, “during the investigation the lab owner attempted to destroy evidence of falsified data in an effort to obstruct (the agency’s) ability to conduct a complete investigation.”

Praxis said in a statement to Marijuana Business Daily that the LCB’s decision was “in error and based on inaccurate information.” The lab is appealing the ruling.

In a separate statement to the Washington state cannabis community that was shared on social media, the company said, “This is a clear cut case of agency overreach and libel and we will be pursuing legal action immediately.”

The statement also noted that a disgruntled former employee stole data from the lab, then contacted the regulators.

Regulators elsewhere have shuttered cannabis labs for inaccurate or misleading test results.

In September 2019, the Nevada Tax Commission launched an investigation into marijuana testing labs in the state.

In February 2020, state regulators suspended the license of Certified Ag Labs and fined the business $70,000 for what was described as “inaccurate and misleading” potency in cannabis products that boosted THC levels by as much as 10%.

The lab was allowed to reopen.

A Certified Ag representative told MJBizDaily the company “had some bumps, but our data was plus or minus 10% and we stand behind it.”

Lab shopping

The practice of lab shopping – where cannabis growers or product makers look for a facility that will provide favorable results – has almost put Keystone State Testing out of business, said Dr. Kelly Greenland, CEO of the Harrisburg, Pennsylvania-based marijuana testing lab.

“We have clients who test with us and never come back because their numbers are higher elsewhere,” she said.

In addition to higher potency levels, some cannabis businesses also seek favorable results for contaminants, including microbials and heavy metals.

“There are a few labs out there saying, ‘Tell me what you want it to say, and I’ll put it on the label,’” Greenland said.

Pennsylvania’s regulations are adequate, she said, but they’re not being enforced.

“If you want to make sure this market is safe, you need to have safe regulations and you need to have your enforcement enforce the regulations that you’ve made,” Greenland said.

Testing labs promising quick turnaround times – less than 48 hours, for example – might be cutting corners. Greenland said it’s normal for a lab to take up to 72 hours to return results.

Growers and processors don’t have to try that hard to find good testing labs, according to Greenland.

But she added that often it doesn’t make good business sense to play by the rules, “as messed up as this sounds.”