In a press release published last week, the American Association for Laboratory Accreditation (A2LA) announced that they have successfully accredited East Coast Cannalytics (ECC) to ISO/IEC 17025:2017. ECC Labs, based in Blacksburg, Virginia, is an analytical and microbial testing lab.
The news is rather timely given Virginia’s recent efforts to reform their cannabis laws. Earlier this year, the state passed legislation legalizing medical cannabis and the very first dispensary in the state opened its doors in Bristol, VA last week.
According to Becky Hobden, CEO of ECC, their mission is to support the rapidly growing cannabis industry in Virginia and the greater Southeast. “ECC is thrilled to be ISO/IEC 17025 accredited! In the cannabis industry ISO/IEC 17025 is a beacon for labs that have rigorously validated methods and hold the highest standards for quality,” says Hobden. “As a leading cannabis lab in the southeast, we are honored to work with A2LA and demonstrate that we meet the quality standards set forth in ISO/IEC 17025. Thank you!”
As a medical cannabis professional, I, like most industry leaders, have been left out of the conversation around the Governor’s call to legalize recreational cannabis. Much like flying a plane without the advice of the pilot, those of us who are rooted in this space should be given a seat in the cockpit if we’re headed in this direction.
While Governor Wolf has called for legalization, which is absolutely necessary, those who understand where legislation has gone wrong and what works well – including business owners and most importantly, patients – have been largely left out of the conversation.
I meet regularly with legislators and unlike many, I speak and listen to both sides. I applaud the call for legalization by Governor Wolf, however, I question his true intentions. Is this political posturing to make Republicans look out of touch? Any political strategist would say that if you actually want something done, you must work with the opposition. Like many issues today, change can only be created once we come together. This is no different.
Few people understand that cannabis was used as medicine for thousands of years and legal in the U.S. until 1969. In 1971, Nixon told us that cannabis was “bad” and drug abuse was public enemy number one, so Americans listened. Nixon then goes on to break American law, be impeached, resigns, and yet, Americans continue to follow his lead, vilifying cannabis users, 46 years later. As a society, we are taught to conform to what we are told by elected officials and community leaders as truth.
Act 16 legalized cannabis – a term illegal to use by someone like me, who has been mandated by The Commonwealth of Pennsylvania, to use ONLY the racist term “marijuana” – but in a way that shames users. The system fails our patients at every turn leaving business owners hostage to an unmanageable “seed to sale” platform, leaving many patients without access to their medicine. Low income patients have been left out of our program by high prices and have not received any of the subsidies they were promised, even though the program has produced hundreds of millions of dollars.
Pennsylvania law strictly prohibits anyone charged with the use of cannabis to work in the industry. You cannot own a cannabis business or work for a cannabis company if you have been arrested for possessing a $10 joint. Yet, my customers skip to their cars with hundreds of dollars of weed in their bags and go about their day. Meanwhile, a 19-year-old black kid’s life just ended after he was pulled over, driving while black and the officer finds a joint. He can never receive financial aid for college or get a job because he has “a record.” The reality is, the black teen’s life will most definitely come to an end because of a joint while others can smoke walking down Broad Street and no one blinks.
Pennsylvanians want legal cannabis. It has a consistent history of reducing opioid deaths, state by state, by 25%. How many lives would be saved if we allowed those who cannot afford legal cannabis but fear prosecution for illegal use, to grow their own?
I have no judgement against those who have been conditioned to believe cannabis is an “illicit drug” because this is how we’ve been programmed. Cannabis has healed but has killed no one. We must educate our legislators before we vilify them. There are more Republicans quietly for legalization than against, but they need information, not shaming.
Legalization of cannabis is necessary to preserve our health and welfare, because we’ve become a society addicted to chemically derived pharmaceutical drugs designed to cause dependence. Cannabis is not physically addicting. It can prevent and eliminate seizures, shrink and even kill cancer tumors, settle the nervous system from diseases like Parkinson’s and MS and help those with anxiety, depression and PTSD. Legalize cannabis and clean up our homelessness, allow people of color to profit from an industry which has capitalized on them, allow low income people and all people to grow their own medicine, and reduce the violence in our streets caused by prohibition.
Pennsylvania needs a legalization law that includes real, hard-working Americans. I am one of the few, born and bred small business cannabis owners in Pennsylvania and I want opportunity for my neighbors and fellow Pennsylvanians in this space. We need legalization to save our communities, but we need two separate application processes – one that is directed toward those disproportionately impacted by the war on drugs which should be crafted to protect applicants who cannot afford thousands of dollars of application fees and the uncertainty of losing hundreds of thousands of dollars via legislative delays. The system is broken. There must be two points of entry.
Pennsylvania Republicans will legalize cannabis. Pennsylvania Democrats will not. Democrats hold no power or authority in our Republican controlled state, and they have shown no attempt to educate. Cannabis legalization is necessary to save the state, but money should not be the reason. Pennsylvanians deserve the education to understand what they do not understand.
Instead, lets legalize and allow 50% of the licenses to be awarded to social equity applicants (those disproportionately affected by the war on drugs) with a bill that is written in the best interest of the social equity applicant and the consumer. The other 50% of the applications should be open to current license holders (who should be grandfathered in with a high price license acceptance fee) and small business owners from Pennsylvania. (It is federally illegal to require residency requirements).
We must not eliminate the Multi State Operators (MSOs) because a free market depends on expertise and stability – and whether anyone wants to hear it or not, being disadvantaged is not enough to be a successful businessperson. We need a balance, but more importantly, as with our nation in crisis, we need to come together.
Provide affordable, non-addictive medicine to patients.
Allow people to grow their own cannabis.
Create BILLIONS in tax revenue nationally by taxing adult use cannabis.
Demand social equity reform where anyone can profit from the plant.
Free Americans from prisons and parole and expunge records.
All of this is a cry for peace. As a wise person once said, “Drunk men in a bar start a fight, high men start a band.” Spread peace not hate. Thousands die from excessive alcohol consumption every year, but legalization of cannabis does not increase usage. No one has ever died from cannabis. Tell me again why we shouldn’t legalize? Those who believe we should not might as well push for alcohol prohibition again – it has no medicinal properties and kills.
Hopes and dreams will not help our humanitarian crisis – but action and education just might…
Georgia doesn’t have a hemp market yet, but that is about to change. In 2019, the Georgia state legislature passed two bills: HB 213, the Georgia Hemp Farming Act and HB 324, the Hope Act, which legalized low-THC oil. While the regulatory framework for the program is still being decided, the market in the state is now beginning to materialize.
Kevin Quirk, CEO of Harvest Connect LLC, wants to be a pioneer for the hemp industry in the Southeast. With a strong focus on local economic growth, Quirk is moving quickly to corner the market and establish a thriving enterprise. His background is in consumer packaged goods (CPG). He’s worked for Anheuser-Busch, Coca Cola and Minute Maid before becoming an entrepreneur in the CPG space. He started White Hat Brands, a children’s health and wellness company, where they worked with the Juvenile Diabetes Research Foundation to co-develop wellness brands for children.
During that time, he saw two major trends unfolding in the CPG arena: organic health and wellness products and hemp-derived CBD products. “Every year we’d see more and more CBD products on the market,” says Quirk. “Almost a year ago, we decided to get into the hemp space coinciding with Georgia’s push around the hemp and medical cannabis market.” That’s when Georgia’s state legislature introduced those two bills.
In October of 2018, Hurricane Michael wiped out an entire season of crops for Georgia farmers, an almost $3 billion hit to the local agricultural economy. Farmers in Georgia were devastated, taking massive losses. “That put momentum behind the hemp program and gave Governor Kemp the impetus to move forward right after the 2018 Farm Bill passed,” says Quirk. With the launch of his newest venture, Harvest Connect LLC, a Georgia-based hemp-derived CBD extraction and retail company, he saw a way to help some farmers get back on their feet.
Quirk says he expects the state will have applications ready for submittal in the next 60-90 days. The state is going to issue permits to processors and farmers. For farmers, the barriers to entry are pretty low- just $50 per acre for a hemp farming permit with a $5 thousand dollar cap. For a processing permit, the barriers are higher and include an application fee, a surety bond and a minimum of at least five Georgia farmers committed to process in a permitted facility. According to Quirk, it is also critical to understand how to manufacture quality products in a highly regulated environment. Quirk has experience in building and running food-grade USDA and FDA manufacturing facilities and already has a number of farmers signed up to process with them once the program gets off the ground. Many of them are tobacco and cotton farmers hit hard in the aftermath of Hurricane Michael.
Harvest Connect, through its subsidiary Graceleaf, is planning to launch a series of retail CBD stores throughout the state. “This will help us meet the demand in Georgia, which will help patients in Georgia and which will then help farmers in Georgia,” says Quirk. Georgia hasn’t launched a new agricultural product in decades at least, so for Quirk and Harvest Connect, this is about putting Georgia farmers first. “We plan to work very closely with our growers as partners to make sure everyone succeeds,” he added.
Quirk predicts the Southeast will be a leading producer of hemp for years to come. “I think it’s going to be huge,” says Quirk. “With just the pure amount of agricultural land mass that we have, plus the ideal climate, we’ll be able to turn 2-3 crops a year in the southern parts of Georgia. We actually think Georgia could be one of the most significant producers of hemp in the country.”
While the state is working on promulgating the rules, establishing the licensing process and rolling out the hemp program, Quirk is working to iron out the details of his business so they are ready as soon as the time comes. “We expect to be up and running with our processing facility by Q2 of 2020.”
Under the U.S. Drug Enforcement Administration’s (DEA) Controlled Substance Act (CSA), drugs are classified into five distinct schedules depending upon their acceptable medical use and their overall potential for abuse or dependency. The DEA currently lists cannabis as a Schedule I drug, which the CSA defines as drugs having no currently accepted medical use and a high potential for abuse. It appears, however, that the DEA may soon reconsider its current Schedule I classification of cannabis.
This article considers how the DEA’s potential reclassification of cannabis potentially could affect Georgia’s medical cannabis industry. Specifically, the article discusses: (1) how Georgia medical cannabis distributors would operate within this new regulatory framework; (2) how this change would affect registered Georgia patients who are either currently purchasing medical cannabis or are planning to do so; and (3) whether this reclassification would cause big pharmaceutical companies to enter Georgia’s medical cannabis market, and if so, how.
The DEA’s Reclassification of Cannabis Would Likely Affect the Regulatory Framework of Georgia’s Medical Cannabis Industry
On April 2, 2019, Georgia became the 34th U.S. state to legalize cannabis for medicinal use when the Georgia Legislature passed House Bill 324 (“HB 324”), which recently took effect on Monday, July 1, 2019. In Georgia, medical cannabis is defined as a “low-THC oil” that contains 5% or less of tetrahydrocannabinol (THC)—the psychoactive chemical in cannabis that causes a “high.”
If the DEA reclassifies cannabis, the regulatory framework of Georgia’s medical cannabis industry under HB 324 would likely be affected. For instance, depending on how the DEA elects to reclassify cannabis, low-THC oil products manufactured and sold in Georgia could become subject to the U.S. Food and Drug Administration’s (FDA) costly, complicated and time-consuming drug approval process. Then, any low THC oil products that the FDA approves will be subject to federally mandated quality, efficacy and potency standards for FDA-approved drugs. Also, any federal standards that stem from the DEA’s reclassification of cannabis will trump any conflicting provisions in HB 324 or any other conflicting rules, regulations or procedures established by the Georgia Access to Medical Cannabis Commission (GAMCC), the seven member state agency responsible for promulgating and implementing the state-based rules, regulations and procedures necessary to produce and distribute low-THC oil in Georgia, and the Georgia State Board of Pharmacy (Pharmacy Board). However, even if the DEA reclassifies cannabis, the following state regulatory framework established by HB 324 will remain unaffected:
The GAMCC will likely continue to oversee the state’s medical cannabis industry.
The following two different types of dispensary licenses issued under the legislation will still likely remain: retail outlets (issued by the GAMCC) and pharmacies (issued by the Pharmacy Board).
Licensed dispensaries will still likely not be located within a 1,000-foot radius of a school or church, and licensed production facilities will still not be located within a 3,000-foot radius of a school or church.
Pharmacists who dispense low-THC oil will still likely have to review each registered patient’s information on the state’s Prescription Drug Monitoring Program (PDMP) database to confirm that they have been diagnosed with one or more of the 17 approved conditions and diseases. The legislation does not require retail outlet dispensaries to review patient information on the PDMP database or employ a pharmacist to dispense the drug.
Registered patients will still likely be prohibited from vaping low-THC oil or inhaling it by any other electronic means. The legislation does not expressly prohibit the use of other, non-electronic delivery methods of low THC oil such as pills or nasal spray.
All licensed dispensaries (and all licensed production companies) will still likely be subject to an “on-demand” inspection when requested by the Georgia Bureau of Investigation (GBI), the GAMCC, the four-member Medical Cannabis Commission Oversight Committee (MCCOC), or local law enforcement. The GAMCC and the Georgia Drugs and Narcotics Agency (GDNA) will also still likely be able to conduct one, annual inspection of dispensary locations. And, upon request, licensed dispensaries will still likely be required to immediately provide a sample of their low-THC oil for laboratory testing to the GBI, GAMCC, MCCOC, GDNA or local law enforcement.
All licensed dispensaries (and all licensed production facilities) will still likely be required to utilize a GAMCC-approved seed-to-sale tracking software.
All licensed dispensaries (and all licensed production companies) will still likely be prohibited from advertising or marketing their low-THC oil products to registered patients or the public. However, they will still likely be allowed to provide information about their products directly to physicians, and upon request, physicians will still likely be allowed to furnish the names of licensed dispensaries (and licensed production companies) to registered patients or their caregivers.
The DEA’s Reclassification of Cannabis Would Likely Affect the Availability of Low THC Oil
To date, approximately 9,500 Georgians are registered with the state’s Low-THC Registry, which allows them to purchase low-THC oil from licensed dispensaries. Since the legislation’s passage, the number of registered patients has increased significantly and continues to steadily rise. If the DEA reclassifies marijuana, this patient number will likely increase at an even faster rate because the public will likely perceive reclassification as an acknowledgement by the federal government that marijuana possesses health and medicinal benefits. If that occurs, statewide demand for low THC oil could quickly outstrip the supply.
Under HB 324, the GAMCC is tasked with ensuring that the state has a sufficient number of retail outlet dispensaries across the state to meet patient demand but is limited to issuing only six production licenses. As the number of registered patients continues to grow, the GAMCC may be forced to recommend amendments to the statute allowing it to issue additional production licenses to increase the state’s supply of low THC oil, and depending on how many additional patients are added to the state’s Low-THC Registry, the GAMCC may also have to issue additional dispensary licenses to keep up with patient demand by relaxing the geographic limitations on locating dispensaries.
Thus, the DEA’s reclassification of cannabis likely would affect the amount of low THC oil available to registered patients in Georgia.
The DEA’s Reclassification of Cannabis Would Likely Cause Large Pharmaceutical Companies to Enter Georgia’s Medical Cannabis Market
Large pharmaceutical companies typically manufacture, market, sell and ship their products on a national and international scale. Given cannabis’ current status as a Schedule I drug under the CSA, these companies have largely steered clear of the burgeoning medical marijuana industry because of the inherent risk of violating federal law. If the DEA reclassifies cannabis, that risk will be diminished greatly, and the companies therefore will likely decide to enter the market by acquiring existing medical marijuana companies with established national or state-level medical cannabis brands.
If the DEA reclassifies cannabis, Georgia’s medical cannabis market will likely be affected in multiple ways.Depending on how the DEA reclassifies cannabis, low-THC oil in Georgia could be subject to stringent federal standards, including the FDA’s complex and expensive drug approval process. Georgia medical cannabis companies will likely not be accustomed to complying with such federal regulations. Large pharmaceutical companies, on the other hand, are very accustomed to dealing with the federal government, including FDA drug approval. So, if the DEA reclassifies marijuana, pharmaceutical companies will likely view reclassification as a tremendous opportunity to enter the Georgia market by leveraging their experience and institutional knowledge dealing with federal law to acquire or partner with a licensed Georgia cannabis company that has an established brand of low -HC oil.
Entering Georgia’s medical cannabis market won’t be easy, however, because HB 324 prohibits licensees from transferring their licenses for five years and requires that the original licensee be a Georgia business. But, HB 324 does not prohibit them from selling their businesses, which necessarily includes any licenses the business owns. Purchasing a licensed Georgia medical cannabis company requires payment of a production license business transfer fee. The fee for the first sale of a business with a Class 1 production license is $100,000 and the fee for a Class 2 license is $12,500. The fee for the second sale is $150,000 for a Class 1 production license, and $62,500 for a Class 2 license. The fee for the third and fourth sales is $200,000 for a Class 1 production license, and $112,500 for a Class 2 license.
If the DEA reclassifies cannabis, Georgia’s medical cannabis market will likely be affected in multiple ways. Specifically, depending on how the drug is reclassified, the regulatory framework for medical cannabis companies likely will change to include both state and federal requirements, potentially including the FDA’s complex drug approval process. Also, the amount of low-THC oil available for registered patients to purchase likely will be diminished precipitating the need for the GAMCC to modify the statute to allow for issuing additional production licenses and relaxing the geographic limitations on locating dispensaries. Finally, large pharmaceutical companies likely will attempt to enter Georgia’s medical cannabis market by purchasing existing, licensed Georgia companies that have established low-THC oil brands.
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