Will the FDA/DEA Epidiolex Rulings and the 2018 Fa
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Posted On: 10/04/2018 11:40:25 AM
Will the FDA/DEA Epidiolex Rulings and the 2018 Farm Bill Change the Industry?
October 4, 2018 by Courtney Elder
In late June 2018, the Food and Drug Administration announced approval for a new medication that could potentially change the way the world views cannabis. Epidiolex is a CBD-based oral solution that is prescribed to treat two forms of rare epilepsy. Patients who suffer from Dravet syndrome, as well as Lennox-Gastaut syndrome, may find that this treatment dramatically helps to manage their seizures and offers them a better quality of life. Only after undergoing rigorous clinical trials and spending enormous amounts of money on their research and development was Epidiolex able to pass through the complex hoops required to receive approval from this bureaucratic agency.
FDA Commissioner Scott Gottlieb acknowledged that the organization has been aware and supportive of the benefits of marijuana-derived medications for quite some time, but also included the caveat that they will be heavily scrutinizing the drug’s potential for abuse. While it’s clear that this change does not give a green light to any and all entities looking to promote CBD remedies in a non-dispensary setting, it does shine light on the path that’s being forged in the industry. This news is huge for the cannabis world, as the individuals who for years have been singing the praises of both THC and CBD are now getting at least a little more of validation from the powers that be.
Opening Minds
The FDA approval might help people to pay attention a little bit more, and change their assumptions away from the idea that people are just trying to get stoned. People may not think it is such a bad thing anymore. Dispensaries who do not make CBD items a priority may fall by the wayside, as more and more customers are looking for other methods of using these products. The demand for topicals and concentrates often outweighs current supply in most area locations, making it difficult for patients to find everything they need in one place.
Getting Ahead Of The Issue
While it’s certainly anyone’s guess where the cannabis industry is headed, and quite honestly, many may be surprised that we’re already as advanced as we are, dispensary owners and even investors may want to reevaluate the long-term implications of the FDA’s recent change in heart. Where CBD was once lumped into the negative connotation that marijuana often carries with it, the compound is now being given the appropriate time and attention it deserves.
Steps In The Right Direction
Dispensary owners would be smart to realize that the FDA will probably never fully utilize the term ‘medical marijuana,’ but instead what will occur is continued approval for CBD in a pharmaceutical setting. Given that the approval process for any new drug is incredibly costly and time-consuming, it will take a while before we see more alternative therapies come to market, but that doesn’t mean a little proactivity in stocking the shelves with a wide range of CBD based products is too optimistic either.
Seeing the ways in which the cannabis industry may be affected “[Reclassifying marijuana] changes the game completely. Big companies are looking into growing facilities and seeing what they can do. They recognize that they are going to make less money because people will want to turn to a legalized route if marijuana is approved, and they may lose a large part of people who turn to them for help. You can either grow with it or you can stay behind – The idea of reclassification for all marijuana products would be a welcome change, but ultimately those in the industry are waiting for the day when declassification as a whole comes to pass. Progress is slowly being made through proposed legislation like the STATES Act, which would open up new opportunities to dispensary owners who are currently impeded by banking and tax regulations. Separating industrial hemp from the marijuana classification itself also begins to demonstrate just how different medical CBD use is from recreational marijuana consumption.
Additional legislation is also paving the way for viewpoints on hemp as well as CBD to shift dramatically. The 2018 Farm Bill proposed by Kentucky Senator Mitch McConnell demonstrates that the benefits of cultivating hemp have far outweighed the perceived negative connotations associated with the plant. Lezli Engelking, founder and CEO of FOCUS: The Cannabis Health and Safety Organization, explains one of the major proponents of the Farm Bill: “In addition to establishing a formal definition of hemp, the legislation will remove hemp as a controlled substance and move hemp regulatory authority from the DEA to the USDA, making hemp an agricultural commodity.”
https://www.cannabisbusinessexecutive.com/201...-264326777
October 4, 2018 by Courtney Elder
In late June 2018, the Food and Drug Administration announced approval for a new medication that could potentially change the way the world views cannabis. Epidiolex is a CBD-based oral solution that is prescribed to treat two forms of rare epilepsy. Patients who suffer from Dravet syndrome, as well as Lennox-Gastaut syndrome, may find that this treatment dramatically helps to manage their seizures and offers them a better quality of life. Only after undergoing rigorous clinical trials and spending enormous amounts of money on their research and development was Epidiolex able to pass through the complex hoops required to receive approval from this bureaucratic agency.
FDA Commissioner Scott Gottlieb acknowledged that the organization has been aware and supportive of the benefits of marijuana-derived medications for quite some time, but also included the caveat that they will be heavily scrutinizing the drug’s potential for abuse. While it’s clear that this change does not give a green light to any and all entities looking to promote CBD remedies in a non-dispensary setting, it does shine light on the path that’s being forged in the industry. This news is huge for the cannabis world, as the individuals who for years have been singing the praises of both THC and CBD are now getting at least a little more of validation from the powers that be.
Opening Minds
The FDA approval might help people to pay attention a little bit more, and change their assumptions away from the idea that people are just trying to get stoned. People may not think it is such a bad thing anymore. Dispensaries who do not make CBD items a priority may fall by the wayside, as more and more customers are looking for other methods of using these products. The demand for topicals and concentrates often outweighs current supply in most area locations, making it difficult for patients to find everything they need in one place.
Getting Ahead Of The Issue
While it’s certainly anyone’s guess where the cannabis industry is headed, and quite honestly, many may be surprised that we’re already as advanced as we are, dispensary owners and even investors may want to reevaluate the long-term implications of the FDA’s recent change in heart. Where CBD was once lumped into the negative connotation that marijuana often carries with it, the compound is now being given the appropriate time and attention it deserves.
Steps In The Right Direction
Dispensary owners would be smart to realize that the FDA will probably never fully utilize the term ‘medical marijuana,’ but instead what will occur is continued approval for CBD in a pharmaceutical setting. Given that the approval process for any new drug is incredibly costly and time-consuming, it will take a while before we see more alternative therapies come to market, but that doesn’t mean a little proactivity in stocking the shelves with a wide range of CBD based products is too optimistic either.
Seeing the ways in which the cannabis industry may be affected “[Reclassifying marijuana] changes the game completely. Big companies are looking into growing facilities and seeing what they can do. They recognize that they are going to make less money because people will want to turn to a legalized route if marijuana is approved, and they may lose a large part of people who turn to them for help. You can either grow with it or you can stay behind – The idea of reclassification for all marijuana products would be a welcome change, but ultimately those in the industry are waiting for the day when declassification as a whole comes to pass. Progress is slowly being made through proposed legislation like the STATES Act, which would open up new opportunities to dispensary owners who are currently impeded by banking and tax regulations. Separating industrial hemp from the marijuana classification itself also begins to demonstrate just how different medical CBD use is from recreational marijuana consumption.
Additional legislation is also paving the way for viewpoints on hemp as well as CBD to shift dramatically. The 2018 Farm Bill proposed by Kentucky Senator Mitch McConnell demonstrates that the benefits of cultivating hemp have far outweighed the perceived negative connotations associated with the plant. Lezli Engelking, founder and CEO of FOCUS: The Cannabis Health and Safety Organization, explains one of the major proponents of the Farm Bill: “In addition to establishing a formal definition of hemp, the legislation will remove hemp as a controlled substance and move hemp regulatory authority from the DEA to the USDA, making hemp an agricultural commodity.”
https://www.cannabisbusinessexecutive.com/201...-264326777
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