New hemp-derived CBD regulations in Colorado

The Colorado Department of Public Health and Environment (CDPHE) has finalized state testing requirements for hemp. The new regulations take effect on October 1 and include all hemp-derived goods intended for human consumption, including hemp-infused CBD products.

“We don’t want to burden the industry,” Jeff Lawrence, CDPHE director of environmental health and sustainability, told Westword. “But what we’ve learned is that there are things in hemp products that we obviously need to be considerate of. Since the inception of hemp, Colorado has been a leader in this industry. This will provide some better guidance.”

Testing will screen for things like pesticides, heavy metals, and residual solvents.

Hemp-infused products like foods, drinks, nutritional supplements, cosmetics, and pet products will be subject to the new testing requirements. Industrial hemp products like textiles, fuel, and building materials, are excluded from the testing requirements. Hemp-derived smokable products, including those with modified cannabinoids like Delta-8 THC, are also excluded from the new regulations.

“Ultimately, this is a public-health issue. In 2018, when, statutorily, these products were allowed, we said it would be treated like every other food and dietary supplement requirement,” Lawrence said.

DEA-approved medical marijuana research facility coming to Denver

A Denver-based marijuana research and cultivation firm received approval from the Drug Enforcement Agency (DEA) to begin federally-approved medical marijuana studies.

The research license will allow MedPharm to study all of the molecules known to be made by the cannabis plant—more than 400 so far. The company will also be studying the interaction between phytocannabinoids and different brain cells.

“Access to the diversity of chemicals produced by cannabis has never been greater, and we are excited to unlock the medical potential of these compounds,” said Dr. Tyrell Towle, MedPharm’s director of chemistry and research.

Although MedPharm is licensed to grow medical marijuana for research purposes at the city and state levels, they’re still waiting on the DEA to approve federal licensing. That means that the company won’t be using its own marijuana for research. Currently, the University of Mississippi is the only federally licensed medical marijuana research supplier.

Colorado Cannabis Business Office focuses on social equity

Governor Jared Polis announced the creation of a new office aimed at supporting cannabis businesses and promoting social equity.

The Cannabis Business Office (CBO) was created as part of a bill passed earlier this year. $4 million was set aside for the program for the 2022-’23 fiscal year from the state Marijuana Tax Cash Fund.

According to the CBO, the office will:

“This office will offer tools like technical help and improve access to money for businesses. Where the federal government has fallen behind, Colorado will lead. Colorado is, and always has been, the best place to live, work, grow and sell cannabis,” Polis said in a press release.

The U.S. Department of Agriculture (USDA) announced last week that they would not be making changes to the allowable THC limit for legal hemp. While the 2018 Farm Bill passed by Congress legalized hemp, it came with the requirement that THC content must be under 0.3%, and any hemp found to exceed that amount must be destroyed. The USDA says that it’s up to Congress to make changes.

“The Farm Bill set forth these requirements,” Bruce Summers, acting administrator of USDA’s Agriculture Marketing Service, said on a call with reporters. “Any changes to these requirements require legislative action.”

“To go from 0.3 to one percent would have to be a statutory change,” he said. “In other words, Congress would have to take action. We couldn’t do that by regulation.”

While the THC limit will remain the same for hemp, the USDA is open to other changes to their rules. The USDA says it will use the 2020 growing season as a chance to “test drive the interim rule to help guide any adjustments that are made in the final rule.” After the 2020 harvest, the USDA will open a second public comment period before final regulations are set. The interim final rule will expire Nov. 1, 2021, after which the USDA will then deliver the final regulations.

One potential change could involve the disposal practices for “hot hemp.” Hemp that tests above regulated THC levels cannot be sold and must be destroyed. According to Summers, “there’s probably some flexibility there, and we hope to get some additional guidance on that out shortly.”

“Hot hemp” is ineligible for federal crop insurance programs, including the two new federal hemp insurance programs the USDA announced earlier this month.

Summers also said that there could be changes to the requirement that testing facilities must be certified by the Drug Enforcement Administration (DEA). Hemp farmers have been concerned that there are too few certified labs, which will cause backlogs and delays in hemp testing.

“It’s something we’ve heard loud and clear. It’s something we’re dealing with and something we’re hoping to have more information out about shortly,” Summers said about the lab shortages.

The Farm Bill gives states the right to submit their own proposed hemp regulations. The Colorado Senate has urged the USDA to loosen some of its hemp regulations.

“As presented by the U.S. Department of Agriculture…members, there will not be a hemp industry in Colorado,” said Colorado Sen. Don Coram (R-Montrose). “The rules and regulations are so onerous that we as farmers cannot comply, and the state cannot afford to comply.”

The state Senate adopted a resolution in January, pledging their support for regulatory revisions.

“Colorado has been a national leader in developing public policies that support hemp production, protect farmers and consumers, and treat hemp as an important agricultural product and not a controlled substance,” the resolution reads. “The State’s written comments on the interim rule present thoughtful and compelling recommendations on how the USDA’s rules could be improved to allow for greater flexibility and equity in state regulation of hemp production in a manner that protects farmers and consumers and promotes growth of the industry.”

After years of delay, researchers may soon have access to potent, high-quality cannabis for research and testing. A lawsuit brought by cannabis researcher Dr. Sue Sisley has forced the Drug Enforcement Administration (DEA) to move forward with processing applications to cultivate marijuana for scientific research.

More than 30 organizations have filed applications to grow cannabis for research purposes since August 2016. Sisley filed one of those applications three years ago, but since then it’s been lost in bureaucratic limbo. None of the applications submitted to the DEA have even been processed, much less approved.

Under the Controlled Substances Act, the U.S. Attorney General is required to publish a notice of application within 90 days of receiving an application and the associated fee. In Sisley’s lawsuit, her attorneys argue that the DEA is violating the law by holding up the process.

“We are also suing the Attorney General, not just the DEA because my gut tells me that the DEA is not responsible for impeding this,” said Sisley, who leads the Scottsdale Research Institute in Arizona.

Cannabis research has been difficult, if not impossible, for researchers who want to study marijuana’s effects in controlled experiments and clinical trials.

“On the one hand, you can’t do the research with good, high-quality cannabis because it’s a Schedule 1 drug. On the other, it’s a Schedule 1 because nobody can really do the research,” said Matt Zorn, who represents the Scottsdale Research Institute in the lawsuit.

Since 1968, the only way researchers have been able to gain access to cannabis was through the University of Mississippi, which is notoriously bad. It’s moldy, full of seeds and stems, and less potent than cannabis available through the medical or recreational markets.

“Scientists need access to options and we are handcuffed by a government-enforced monopoly that has only allowed me to study this really suboptimal study drug from Mississippi,” said Sisley. “The scientific community is concerned this is harming our data — our outcomes.”

The news that the DEA will begin processing applications for clinical-grade cannabis is welcome news, but many in the cannabis community are skeptical that the DEA will follow through.

“We’re cautiously optimistic, and this is a positive first step,” said Zorn. “But it took Dr. Sisley three years and a lawsuit just to get to this point, so I wouldn’t say the case is closed.”

Even if the DEA picks up the pace on approving research-grade cannabis grows, it will likely be several years before researchers have access to it.

“We haven’t really won anything until scientists are finally utilizing real-world cannabis flower in their clinical trials,” Sisley said.

Another year, more legal cannabis! 2018 saw a ton of changes in the cannabis industry and support for legalization is at an all-time high.

These were some of the biggest cannabis stories of 2018:

California Adult-Use Sales

On January 1, recreational marijuana sales officially began in California. The state is home to nearly 40 million people, and the potential cannabis revenue is in the billions. Changing regulations, licensing delays, high taxes, local cannabis bans, and testing snafus caused a less than smooth roll-out of adult-use sales in the state. California’s Bureau of Cannabis Control (BCC), charged with issuing licenses to retailers and distributors, initially issued businesses licenses to eighty-eight stores in 34 cities. As of December, the BCC has issued 547 temporary licenses to recreational marijuana dispensaries, still on the low end to supply the market adequately. Only 70 of California’s 482 cities allows recreational cannabis retail stores, but recent changes in regulations will allow cannabis deliveries throughout the state.

Massachusetts also began adult-use sales this year, with the first recreational dispensaries opening in November.

FDA Approves Cannabis Epilepsy Medication, Pushes to Deschedule CBD

The U.S. Food and Drug Administration (FDA) approved Epidiolex, a cannabis-derived medication used to treat certain forms of epilepsy, in June. Epidiolex, developed by UK-based GW Pharmaceuticals, is made from CBD and contains no THC.

In October, the FDA released a memo advising the U.S. Drug Enforcement Agency (DEA) that CBD has “negligible potential for abuse,” “currently accepted medical use in treatment,” and that any abuse “may lead to limited physical dependence.” As a result, the FDA recommended that the DEA reschedule CBD under its least restrictive category, Schedule 5.

Canada Legalizes Marijuana Nationwide

On October 17, Canada became the second country in the world to legalize adult-use cannabis. Uruguay was the first country to legalize cannabis in 2013. In June, the Senate and House of Commons passed the Cannabis Act, making it legal for adults 18 years-and-older to purchase, possess, and grow cannabis. Canadians will be able to cultivate up to four plants and possess up to 30 grams of cannabis in public. There’s no limit to the amount of cannabis residents can possess in their homes.

State Legalization

November’s mid-term elections resulted in huge wins for adult-use and medical marijuana legalization. Michigan was the first state in the Midwest and the 10th in the country to approve recreational marijuana. The first recreational dispensaries are expected to open in 2019 or 2020.

In Missouri and Utah voters were in favor of medical marijuana, a watershed moment in states that have traditionally opposed marijuana use. Missouri had three medical marijuana initiatives on the ballot, but Amendment 2 was the only one to pass with 65 percent approval. In Utah, Proposition 2 met voter approval, despite opposition from the Mormon Church.

Farm Bill Legalizes Hemp

The 2018 Farm Bill removed industrial hemp from the federal government’s list of controlled substances, legalizing its use as an agricultural product. While the bill didn’t deschedule CBD, it did legalize CBD extraction from hemp. The bill will enable farmers to grow, sell, and export industrial hemp, and opens the door for researchers studying CBD and other cannabinoids. Moving hemp to legal status will make banking and advertising in the industry more accessible, and this could be another step closer to nationwide cannabis legalization.

A year after the US Drug Enforcement Agency (DEA) began accepting applications to grow cannabis for research it appears that the Department of Justice (DOJ), with the pressure of Attorney General Jeff Sessions, are blocking researchers from moving ahead with their proposals.

The DEA has received 25 research proposals, but so far none of them have been able to move forward. As part of the approval process, researchers must get final sign-off from the DOJ–and it’s no secret that Sessions is not a fan of weed.

“They’re sitting on it,” one law enforcement official told the Washington Post, “They just will not act on these things.”

A senior DEA official said that, “the Justice Department has effectively shut down this program to increase research registrations.”

The marijuana that researchers currently have access to is not what most people would consider weed. Since the late 1960s, all marijuana used in clinical research is required to come from a single government-run marijuana farm at the University of Mississippi. The problem is that the marijuana grown there doesn’t even really resemble the weed that’s sold at dispensaries, making it difficult for researchers to reach conclusions that are applicable to real-world use.

The quality of the government grown cannabis was so bad that Johns Hopkins University, which planned to begin a multiyear clinical trial studying cannabis and PTSD, backed out of the study.

One of the researchers who submitted a proposal to the DEA is Lyle Craker, a professor at the University of Massachusetts at Amherst. Craker submitted his last application in February but hasn’t heard back on his yet. He’s hoping to do research into whether other parts of the cannabis plant have medicinal value.

“I’ve filled out the forms, but I haven’t heard back from them. I assume they don’t want to answer,” said Craker. “They need to think about why they are holding this up when there are products that could be used to improve people’s health. I think marijuana has some bad effects, but there can be some good and without investigation we really don’t know.”

The U.S. Drug Enforcement Agency has denied a petition that would have reclassified cannabis under the Controlled Substances Act. The petition was filed by two former state governors, Rhode Island Gov. Gina Raimondo, Washington Gov. Jay Inslee, and New Mexico nurse practitioner Bryan Krumm.

Cannabis is currently a Schedule I drug, classified as a substance that has no medical use and a high likelihood of abuse and dependence. Other Schedule I drugs include LSD, heroin, and mescaline. Possessing any one of these drugs is considered a criminal act under federal law.

Schedule II drugs–deemed to have medicinal value–include highly addictive methamphetamine and opioids like morphine and oxycodone. Opioid addiction kills 80 Americans every day, yet the FDA and DEA maintain that marijuana is less medically useful and more addictive.

In an interview with NPR, Drug Enforcement Administration chief Chuck Rosenberg said that, “This decision isn’t based on danger. This decision is based on whether marijuana, as determined by the FDA, is a safe and effective medicine,” he said, “and it’s not.”

The DEA’s report stated that there is “no currently accepted medical use in treatment in the United States,” and that there’s “high potential” for marijuana abuse that can lead to “severe psychological or physical dependence.”

However, there’s a growing amount of anecdotal and scientific evidence that marijuana has the potential treat symptoms of a variety of medical conditions and to serve as an “adjunct to or substitute for opiates in the treatment of chronic pain.” Cannabis is also being used to treat heroin and opioid addiction.

Tom Angell, chairman of the lobbying group, Marijuana Majority, released a statement following the DEA’s announcement. “President Obama always said he would let science — and not ideology — dictate policy, but in this case his administration is upholding a failed drug war approach instead of looking at real, existing evidence that marijuana has medical value,” he wrote.

Although state and federal law grow increasingly apart, most everyday Americans have reached consensus on the issue. 61 percent of Americans support marijuana legalization, and it is currently legal for medical and recreational use in four states; 20 states have medical marijuana programs, with more expected after November’s elections.