By Melissa Kuipers Blake, Osiris Morel No Comments
After nearly a decade of conversation and education on the Hill, the Senate Banking, Housing and Urban Affairs Committee finally held a markup on the Secure and Fair Regulation (SAFER) Banking Act. Previously known as the SAFE Banking Act, the “R” was included to account for Sen. Jack Reed’s (D-RI) concerns with Section 10. The senator shared his concerns publicly on May 11 during the “Examining Cannabis Banking Challenges of Small Businesses and Workers” hearing. Sen. Reed said that Section 10’s language “would make it more difficult for federal regulators to raise the alarm about relationships with any customer that presents significant risks to the bank” and shared that such a provision is “not limited to the marijuana industry or the cannabis industry,” but that it “could allow pyramid schemes or all sorts of other interesting activity to go on without an effective response by the regulator.” Since then, he and a group of bipartisan members, including Majority Leader Chuck Schumer (D-NY), Senate Banking Committee Chair Sherrod Brown (D-OH), and Sens. Steve Daines (R-MT), Cynthia Lummis (R-WY), Kevin Cramer (R-ND) and Kyrsten Sinema (I-AZ), have worked endlessly to develop language to resolve such concerns while maintaining GOP support, leading to the SAFER Banking Act.
Number of Depository Institutions Actively Banking Cannabis-Related Businesses in the United States (Reported in SARS)
The difference between the SAFE Banking Act and the SAFER Banking Act can mainly be found in Section 10. Changes focus on and determines:
How regulators terminate bank accounts;
How the Federal Deposit Insurance Corporation (FDIC) develops guidance for financial institutions serving state-licensed cannabis businesses;
How income derived from state-legal cannabis business activity is managed;
That personal and political beliefs cannot impact a financial regulator’s decision making;
That federal banking regulators and state banking supervisors and their secretaries of Commerce and Treasury would create rules to increase access to deposit accounts and how such individuals would enhance customer relationships with rural, low- and moderate-income, unbanked and tribal communities; and
How the FDIC would conduct a biennial survey and report on barriers for small- and medium-sized businesses.
During the markup on Wednesday, members introduced and discussed a range of amendments related to criminal justice reform, the racial wealth gap, federal regulators and their processes, rescheduling and the opioid epidemic. In total, there were six amendments, one by Chairman Brown, as well as Sens. Mike Crapo (R-ID), Bill Hagerty (R-TN), Mike Rounds (R-SD) and two by Sen. Raphael Warnock (D-GA). Sen. Brown’s amendment, which would make technical changes to the bill, was the only amendment to prevail on a 17-6 vote.
Senate Majority Leader Chuck Schumer (center), Senate Finance Committee Chair Ron Wyden (right) and Senator Cory Booker (left)
To begin the markup, Chair Brown said that propelling this legislation is a critical step in reversing the damage done by the war on drugs and clarified that the SAFER Banking Act would create a better financial system for small and medium-sized cannabis businesses that lack access to such traditional banking services. Sen. Daines, who served as the committee ranking member in place of Sen. Tim Scott (R-SC), who was in California preparing for the Republican presidential debate, shared that although he opposes legalization or decriminalization, he agreed to sponsor and support the SAFER Banking Act because it would fix the current banking system for cannabis businesses nationwide. After hearing remarks from Sens. Lummis, Catherine Cortez Masto (D-NV) and Sinema, the committee voted on the bill, and approved its passage to the Senate floor on a 14-9 vote. Senators voting in favor of the bill were Brown, Tester, Warren, Reed, Menendez (by proxy), Smith (by proxy), Warner, Fetterman, Cortez-Masto, Sinema, Van Hollen, Lummis, Cramer and Daines, and voting against the measure were Sens. Warnock, Scott (by proxy), Crapo, Tillis, Kennedy, Haggerty, Vance and Britt.
After the vote, Sen. Jeff Merkley (D-OR) thanked Sen. Rand Paul (R-KY) and former Republican Sen. Cory Gardner (CO) for their early efforts and for bringing the legislation and issue to the chamber’s attention and concluded that he hopes to have a robust discussion with the full Senate chamber.
With the bill out of committee, it heads to the Senate floor for additional input, discussion and potentially a vote. Majority Leader Schumer has said he intends to bring the SAFER Banking Act to the floor “with all due speed” and noted that he is committed to attaching Rep. Dave Joyce’s (R-OH) Harnessing Opportunities by Pursuing Expungement (HOPE) Act and Rep. Brian Mast’s (R-FL) Gun Rights and Marijuana (GRAM) Act to the final legislation. Sen. Schumer also shared that such provisions would address the war on drugs, bolster social equity and criminal justice reform and protect Second Amendment rights for medical cannabis patients.
When the SAFER Banking Act will receive floor time remains unclear, but Leader Schumer has made numerous representations that he would like to see it done this year.
Imagine this: you are taking medication for cancer pain. One day, it works perfectly. The next, you feel no relief. On some days, you need to take three doses just to get the same effect as one. Your doctor can’t be completely positive how much active ingredient each dose contains, so you decide for yourself how much medication to take.
Doesn’t seem safe, right? It is crucial that doctors know exactly what they are prescribing to their patients. They must know that their patients are receiving the exact same dose of medication in their prescription each time they take it, and that their medication contains only the intended ingredients.
consistency is key to creating products that are safe for consumers.In the cannabis industry, lack of certainty on these important factors is a major problem for drug manufacturers as they attempt to incorporate cannabidiol (CBD), a compound found in cannabis that has no psychoactive effects but many medical benefits, into pharmaceutical drugs.
When using these compounds as medications, purity is essential. Cannabis contains a wide variety of compounds. Delta-9 tetrahydrocannabinol (THC) is the most well-known compound and its main psychoactive one1. Safety regulations dictate that consumers know exactly what they are getting when they take a medication. For example, their CBD-based medications should not contain traces of THC.
The cannabis industry greatly needs a tool to ensure the consistent extraction and isolation of compounds. In 2017, the cannabis industry was worth nearly $10 billion, and it is expected to grow $57 billion more in the next decade2. As legalization of medical cannabis expands, interest in CBD pharmaceuticals is likely to grow.
If compounds such as CBD are going to be used in pharmaceutical drugs, consistency is key to creating products that are safe for consumers.
CBD’s Potential
CBD is a non-psychoactive compound that makes up 40 percent of cannabis extracts1. It is great for medical applications because it does not interfere with motor or psychological function. Researchers have found it particularly effective for managing cancer pain, spasticity in multiple sclerosis, and specific forms of epilepsy3.
Figure 1: The chemical structure of cannabidiol.
Other compounds derived from cannabis, such as cannabichromene (CBC) and cannabigerol (CBG), may also be beneficial compounds with medical applications. CBC is known to block pain and inflammation, and CBG is known for its use as a potential anti-cancer agent1.
Along with these compounds that provide medical benefits, there are psychoactive compounds that are used recreationally, such as THC.
“It will definitely be an advantage to have cannabis-based medications with clearly defined and constant contents of cannabinoids,” says Kirsten Müller-Vahl, a neurologist and psychiatrist at Hannover Medical School in Germany.
Creating a Standard Through Centrifugal Partition Chromatography
To obtain purified compounds from cannabis, researchers need to use technology that will extract the compounds from the plant.
Many manufacturers use some sort of chromatography technique to isolate compounds. Two popular methods are high performance liquid chromatography (HPLC) and flash chromatography. These methods have their places in the field, but they cannot be effectively and cost-efficiently scaled to isolate compounds. Instead, HPLC and flash chromatography may be better suited as analytical tools for studying the characteristics of the plant or extract. As cannabis has more than 400 chemical entities4, compound isolation is an important application.
This method is highly effective for achieving both high purity and recovery.Although molecules such as CBD can be synthesized in the lab, many companies would rather extract the compounds directly from the plant. Synthesized molecules do not result in a completely pure compound. The result, “is still a mixture of whatever cannabinoids are coming from a particular marijuana strain, which is highly variable,” says Brian Reid, chief scientific officer of ebbu, a company in Colorado that specializes in cannabis purification.
Currently, there is only one method available to researchers that completely allows them to isolate individual compounds: centrifugal partition chromatography (CPC).
The principle of CPC is similar to other liquid chromatography methods. It separates the chemical substances as the compounds in the mobile phase flow through and differentially interact with the stationary phase.
Where CPC and standard liquid chromatography differs is the nature of the stationary phase. In traditional chromatography methods, the stationary phase is made of silica or other solid particles, and the mobile phase is made of liquid. During CPC, the stationary phase is a liquid that is spun around or centrifuged to stay in place while the other liquid (mobile phase) moves through the disc. The two liquid phases, like oil and water, don’t mix. This method is highly effective for achieving both high purity and recovery. Chemists can isolate chemical components at 99 percent or higher purity with a 95 percent recovery rate5.
“CPC is ideal for ripping a single active ingredient out of a pretty complex mixture,” says Reid. “It’s the only chromatographic technique that does that well.”
The Need for Pure Compounds
High levels of purity and isolation are necessary for cannabis to be of true value in the pharmaceutical industry. Imagine relying on a medication to decrease your seizures, and it has a different effect every time. Sometimes there may be traces of psychoactive compounds. Sometimes there are too much or too little of the compound that halts your seizures. This is not a safe practice for consumers who rely on medications.“It’s hard to do studies on things you can’t control very well.”
Researchers working with cannabis desperately need a technology that can extract compounds with high purity rates. It is hard to run a study without knowing the precise amounts of compounds used. Reid uses a Gilson CPC 1000 system at ebbu for his cannabinoid research. With this technology, he can purify cannabinoids for his research and create reliable formulations. “Now that we have this methodology dialed in we can make various formulations —whether they’re water-soluble, sublingual, inhaled, you name it —with very precise ratios of cannabinoids and precise amounts of cannabinoids at the milligram level,” says Reid.
Kyle Geary, an internist at the University of Illinois at Chicago, is currently running a placebo-controlled trial of CBD capsules for Crohn’s disease. This consistent isolation is helpful for his research, as well. “Ideally, the perfect study would use something that is 100 percent CBD,” says Geary. “It’s hard to do studies on things you can’t control very well.”
The State of the Industry
While CBD is not considered a safe drug compound under federal law in the United States6, 17 states have recently passed laws that allow people to consume CBD for medical reasons7. Half of medicinal CBD users solely use the substance for treatment, a recent survey found8. As the industry quickly grows, it is crucial that consumer safety protocol keeps pace.
In June, the US Food and Drug Administration (FDA) approved the first drug that contains a purified drug substance from cannabis, Epidiolex9. Made from CBD, it is designed to treat Dravet Syndrome and Lennox-Gastaut syndrome, two rare forms of epilepsy. FDA Commissioner Scott Gottlieb said in the news release that although the FDA will work to support the development of high-quality cannabis-based products moving forward, “We are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”
The industry should be prepared to implement protocols to ensure the quality of their CBD-based products. The FDA has issued warnings in recent years that some cannabinoid products it has tested do not contain the CBD levels their makers claim, and consumers should be wary of such products10. It’s hard to know when or if the FDA will begin regulating CBD-based pharmaceuticals. However, for pharma companies serious about their reputation, there is only one isolation method that creates reliable product quality: CPC.
National Institute on Drug Abuse. (2015, June 24). The Biology and Potential Therapeutic Effects of Cannabidiol. Retrieved from https://www.drugabuse.gov/about-nida/legislative-activities/testimony-to-congress/2016/biology-potential-therapeutic-effects-cannabidiol
Atakan, Z. (2012). Cannabis, a complex plant: Different compounds and different effects on individuals. Therapeutic Advances in Psychopharmacology,2(6), 241-254. doi:10.1177/2045125312457586
Gilson. (n.d.). Centrifugal Partition Chromatography (CPC) Systems. Retrieved from http://www.gilson.com/en/AI/Products/80.320#.WzVB2lMvyMI
Mead, A. (2017). The legal status of cannabis (marijuana) and cannabidiol (CBD) under US law. Epilepsy & Behavior, 70, 288-291.
ProCon.org. (2018, May 8). 17 States with Laws Specifically about Legal Cannabidiol (CBD) – Medical Marijuana – ProCon.org. Retrieved from https://medicalmarijuana.procon.org/view.resource.php?resourceID=006473
Borchardt, D. (2017, August 03). Survey: Nearly Half Of People Who Use Cannabidiol Products Stop Taking Traditional Medicines. Retrieved from https://www.forbes.com/sites/debraborchardt/2017/08/02/people-who-use-cannabis-cbd-products-stop-taking-traditional-medicines/#43889c942817
U.S. Food & Drug Administration. (2017). Public Health Focus – Warning Letters and Test Results for Cannabidiol-Related Products. Retrieved from https://www.fda.gov/newsevents/publichealthfocus/ucm484109.htm
This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.
Strictly Necessary Cookies
Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings.
We use tracking pixels that set your arrival time at our website, this is used as part of our anti-spam and security measures. Disabling this tracking pixel would disable some of our security measures, and is therefore considered necessary for the safe operation of the website. This tracking pixel is cleared from your system when you delete files in your history.
We also use cookies to store your preferences regarding the setting of 3rd Party Cookies.
If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.
