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.
The post Medical Cannabis in Georgia: Federal Policy Effects on State Industries appeared first on Cannabis Industry Journal.
1. What is CBD? What is CBD Oil?
Cannabidiol (CBD) is a naturally occurring constituent of industrial hemp/cannabis. Its formula is C21H30O2 and it has a molecular mass of 314.4636. It is the most abundant non-psychoactive cannabinoid found in cannabis, and is being scientifically investigated for various reasons.
CBD oil is a cannabis oil (whether derived from marijuana or industrial hemp, as the word cannabis is the latin genus name for both) that has significant amounts of cannabidiol (CBD) contained within it. Our CBD products and extracts are derived from industrial hemp, so they could be considered CBD-rich hemp oil, hemp derived CBD oil, CBD-rich cannabis oil, or plainly “hemp extracts” since they typically contain much more than just CBD. Again, cannabis doesn’t mean marijuana, but is the genus name, and general umbrella term which all forms of marijuana and hemp fall under. The form of cannabis we use for our CBD and hemp extracts is industrial hemp; we do not sell marijuana.
2. If a hemp extract is 40% cannabinoids, what’s the other 60%? What’s in your hemp extracts besides the naturally occurring cannabinoids?
Our Kentucky hemp extracts contain over 80 different phyto-cannabinoids such as cannabidiol (CBD), CBC, CBG, CBN, etc.. In addition to the cannabinoids naturally present in our agricultural hemp extracts, there are also many other types of natural molecules and phyto-chemical compounds such as amino acids, carbohydrates, vitamins (including B1, B2, B6, D), fatty acids (including omega 3 & 6), trace minerals (including iron, zinc, calcium, magnesium, potassium), beta-carotene, chlorophyll, flavanoids, ketones, nitrogenous compounds, alkanes, glycosides, pigments, water, and terpenes. The most common terpenes in our hemp extracts are Myrcene, Beta-caryophyllene, Terpinolene, Linalool, alpha-Pinene, beta-Pinene, Nerolidol og Phytol, trans-alpha-Bergamotene, Limonene/ beta-Phellandrene (Co-elution), and alpha-Humulene.
3. What’s the difference between Hemp and Marijuana?
Scientifically, industrial Hemp and Marijuana are the same plant, with a genus and species name of Cannabis Sativa. They have a drastically different genetic profile though. Industrial Hemp is always a strain of Cannabis sativa, while marijuana can be Cannabis sativa, Cannabis indica, or Cannabis ruderalis. The major difference is how industrial hemp has been bred compared to a marijuana form of Cannabis sativa. Typically speaking, industrial hemp is very fibrous, with long strong stalks, and barely has any flowering buds, while a marijuana strain of Cannabis sativa will be smaller, bushier, and full of flowering buds. However, newer industrial hemp varieties in the USA are being bred to have more flowers and higher yields of cannabinoids and terpenes, such as our Kentucky hemp we’re now using!
99% of the time marijuana has a high amount of THC and only a very low amount of CBD. Hemp, on the other hand, naturally has a very high amount of CBD in most instances, and only a trace amount of THC. Fortunately, the cannabinoid profile of hemp is ideal for people looking for benefits from cannabis without the ‘high.’ Hemp is used for making herbal supplements, food, fiber, rope, paper, bricks, oil, natural plastic, and so much more, whereas marijuana is usually used just recreationally, spiritually, and medicinally. The term cannabis oil can refer to either a marijuana or hemp derived oil, since marijuana and hemp are two different forms of cannabis.
In the USA the legal definition of “industrial hemp,” per Section 7606 of the Agricultural Appropriations Act of 2014, is “INDUSTRIAL HEMP — The term ‘‘industrial hemp’’ means the plant Cannabis sativa L. and any part of such plant, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.”
4. Are hemp derived cannabinoids such as CBD as good as CBD from marijuana?
The short answer is yes. CBD is CBD, whether from marijuana or hemp. Most marijuana has a very low non-psychoactive cannabinoid profile (like CBD, CBC, CBG), so most of the time hemp would be much more preferable for anything besides THC. Marijuana is usually very high in THC (gives people the high) but usually very low in other non-psychoactive cannabinoids.
Nowadays in the USA, many farmers are growing industrial hemp flowers that are just as beautiful, odor-producing, and terpene rich as the best marijuana strains, such as our partnered farmers in Kentucky.
5. Why don’t you source your Hemp and CBD from within Colorado?
We feel that the hemp program in Kentucky is more well suited for our company in regards to growing hemp, and that because it’s 100% compliant with Section 7606 of the 2014 Farm Bill (and the 2016 Agricultural Appropriations Act), procuring it from there is perfectly legal at the federal level. Kentucky’s ecology is perfect for hemp just as it is for tobacco. The growing season is longer than in Colorado, and the soil is richer, so the quality of the hemp and the yields are better.
6. What’s the percentage of cannabinoids and CBD in your product?
Our raw extracts have varying percentages of cannabinoid and cannabidiol (CBD) content, the range being 10%-99%. Each product has a unique formulation and uses varying ratios of our extract types. Our CBD Isolate is over 99% pure CBD.
7. What is the best method of use?
For our dietary supplements we can only recommend them for internal consumption. Our CBD isolate is for research purposes only. If you don’t like the flavor of the oil supplements, you can mix with something sweet like apple sauce or honey to cut through the flavor.
8. What’s the ideal serving size for me, and how often should I take it?
There is no easy answer to this. Our starting recommended serving size is 15 drops but we generally recommend experimenting to see what feels best to you. Some prefer 5 drops, some prefer over 50 drops per day.
9. What is the safety of your hemp extracts? Are there negative side effects?
Hemp is considered by many to be generally safe. We’ve never seen or heard of any significant or negative side effects in our years in the industry. That said, we can’t rule them out. Please consult with your physician before using any dietary supplement including Hemp extract supplements.
10. Which of your CBD and hemp products should I get?
As a company who sells various dietary and food supplements, we can’t suggest any of our products for the prevention, treatment or cure of any disease or ailment.
When considering our different dietary hemp products, know that they all come in two strengths. Our Original Hemp blends (Classic Hemp Blend, Hemp Complete, Brainpower oil, & Signature Blend) all have 250+mg of cannabinoids per fluid ounce, and our concentrated blends have 1,500+mg per fluid ounce, six times the potency of our traditional oils. We’ve found that sometimes less is more, but nevertheless, some people like to take very large serving sizes of our hemp extracts.
The main difference between the four Original Blends is the additional herbal ingredients besides hemp. We suggest you research the separate components of each blend to determine which product may be most appealing to add to your dietary regimen. If you know it’s solely the hemp extract that you are looking for, with no additional ingredients, then Classic Hemp Blend or Classic Hemp 6x is what you’re looking for.
For dabbing and vaporizing or for research you can try our CBD Isolate.
THOSE WHO SUSPECT THEY MAY HAVE A DISEASE OR ARE SEEKING HELP FOR A DISEASE SHOULD CONSULT A QUALIFIED MEDICAL PROFESSIONAL.
11. Why do people use Hemp Extracts and CBD? What are the benefits and uses of CBD?
In accordance with federal regulations we cannot make health claims regarding our dietary supplement products. We can only recommend our products for general wellness.
12. Is a standard hemp seed oil the same as a high-CBD hemp extract?
Absolutely not. Standard hemp oil, which can be found very cheaply at a grocery store, is a much different product than our CO2 hemp extracts (not from seed). Standard hemp oil is produced by cold pressing the seeds, whereas our hemp extract is a supercritical CO2 extraction of the hemp plant itself, not the seeds. Hemp seed oil is considered to be a great nutritive food, but it doesn’t have the naturally occurring terpenes, cannabinoids and other components that our extracts do have.
13. Do I need to move to Colorado to get your Hemp Extracts and CBD? Where do you ship?
No. We actually source our hemp from Kentucky, as it’s legal to ship across state lines. Many people are under the impression that the only way to acquire hemp extracts and CBD for themselves or a loved one is to move to Colorado or another cannabis-friendly state. Many major news outlets are misinformed and are unfortunately spreading the idea that you can only get CBD oil in the states where medical marijuana has been legalized. This is simply not the case though. Because our extracts comes from hemp instead of marijuana, we can and do ship to all fifty states, and no medical marijuana card is needed. There are some exceptions, like with Indiana, Missouri and South Dakota we can’t sell our concentrated products due to state legislation.
We also ship to Japan, Australia, the EU, Switzerland, and Brazil. For all EU orders contact our exclusive distributor there, Cannawell.
14. Is your Hemp Extract Oil similar to Rick Simpson Hemp Oil?
Not quite. Ours are from hemp and RSHO is usually using marijuana, a different form of cannabis than industrial hemp. Our industrial hemp extracts are more standardized and will usually have a much higher content of non-psychoactive cannabinoids like CBD than one produced through the Rick Simpson method. And oils produced through his method will usually have a much higher THC content, as it’s typically marijuana that is used for RSHO.†
Generally speaking, most marijuana producers and sellers (especially on the black market) don’t test for contaminants (metals, pesticides, bacteria, etc.). Rick Simpson Hemp Oil is actually more a method of extraction than it is a specific product. People use the Rick Simpson method with hundreds of different strains of marijuana, so the THC, CBD and other cannabinoid content of the final oil is always varying greatly, depending on the cannabis the consumers are acquiring. Usually what’s used for Rick Simpson oil is a strain with an inferior CBD content (and high THC), because that’s what the vast amount of marijuana is nowadays.
15. Where do you source your hemp and CBD from?
We have partners in Kentucky who grew a dedicated plot for us this year (2016) which is being used in our products now. We also currently source from Europe but we’ll be changing that soon.
16. What kind of testing/analysis is performed on your products?
We have an industry leading quality control system, and we have third party laboratories analyze all of our hemp extracts and our final products for cannabinoid potency, heavy metals, bacterial and microbial life, mycotoxins (fungus), and pesticides.
17. What is CO2 extraction? What’s the difference between subcritical and supercritical CO2 extractions?
CO2 extraction is an extraction process that uses pressurized carbon dioxide to extract phyto-chemicals (such as CBD, CBG, or terpenes, flavonoids, etc.) from a plant. CO2 at certain temperatures and pressures acts like a solvent, without the dangers of actually being one. It is the most expensive extraction method, and is widely considered the most effective and safest plant extraction method in the world.
Many hemp and CBD companies boast about their supercritical CO2 extractions, but that’s actually only one (and perhaps an inferior) method of using a CO2 extraction machine. There are also subcritical CO2 extractions, and ‘mid-critical’, a general range between subcritical and supercritical. Subcritical (low temp, low pressure) CO2 extractions take more time and produce smaller yields than super-critical, but they retain the essential oils, terpenes, and other sensitive chemicals within the plant. Supercritical, on the other hand, is a high pressure and high temperature process that damages most terpenes and heat sensitive chemicals, but can extract much larger molecules such as lipids (omega 3 and 6), chlorophyll, and waxes. A truly full-spectrum CO2 extract includes first performing a subcritical extraction, separating the extracted oil, and then extracting the same plant material using supercritical pressure, and then homogenizing both oil extracts into one. In the essential oil industry, an extract made using this specific process is referred to as a CO2 Total.
18. What is the endocannabinoid system (ECS)?
“The endocannabinoid system (ECS) is a group of endogenous cannabinoid receptors located in the mammalian brain and throughout the central and peripheral nervous systems, consisting of neuromodulatory lipids and their receptors.” Wikipedia
There are two main types of receptors in the ECS, CB1 and CB2. CB1 receptors are primarily located in the central nervous system and brains of mammals, and CB2 are generally found in the peripheral nervous system. There are two main cannabinoids mammals produce- 2AG and Anandamide (named after the Sanskrit term “ananda” which translates to “peace”).
For hundreds of millions of years every vertebrate on Earth has been equipped with this ECS, a crucial system in the body, and it has been known about in the scientific and medical communities since the 1980’s. However, it’s still not taught about in most medical schools.