Gretchen Gailey, Author at Green Market Report

Gretchen GaileyGretchen GaileyDecember 23, 2020
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5min2750

Editors Note: This is the final story in a three-part series.

Pests and contaminates are a given in the cultivation of cannabis, and most standards developed to control these on other agricultural products don’t apply. This is why the U.S. Pharmacopeia has stepped in to provide analytical methods and risk-based limits for the industry to help protect public health, including looking at how cannabis is grown, not just at how it hits the shelves.

“Cannabis is susceptible to pest infestation whether grown indoors or outdoors, which means cultivators often turn to pesticides to ensure their harvest. However, pesticides can be quite dangerous if not used appropriately to make sure residue levels are not higher than they should be. This could be especially true if consumed by someone with a health condition who may be taking the plant for medicinal purposes” said Robin Marles, Ph.D., chair of the U.S. Pharmacopeia (USP) Botanical Dietary Supplements and Herbal Medicines Expert Committee.

USP has assembled an expert panel of clinicians, scientists and industry representatives from around the world to provide necessary information and guidance all laid out in the Journal of Natural Products, Cannabis Inflorescence for Medical Purposes: USP Considerations for Quality Attributes.

Recent cases in the U.S. and Canada of consumers being exposed to residues of pesticides unauthorized for use or used off-label on cannabis have resulted in recalls and increased public and regulatory concerns. In the U.S., crop-specific pesticide limits are established by the U.S. Environmental Protection Agency (EPA) for foods, but no approved pesticide or pesticide limits exist for cannabis. And levels of pesticides deemed appropriate to protect public health and safety for food products may not necessarily apply to cannabis, since cannabis is typically smoked or vaped.

Although U.S. state requirements may provide some guidance to control specific pesticide contaminants, additional pesticide residues that are not expressly permitted by these states may also be detected on cannabis due to environmental drift or persistence or through incidental contamination. 

“Even if you do not apply pesticides, you might find pesticide contamination from neighboring agricultural fields through environmental drift,” said Nandu Sarma, Director, Dietary Supplements and Herbal Medicines at USP. 

To date, Canada has the strictest requirements for pesticides among countries and U.S. states that regulate the use of cannabis. USP has pesticide standards for oral botanical drugs, but they are not exhaustive. Many of the pesticides used to control pests for cannabis such as powdery mildew, botrytis or spider mites are not listed in USP’s general chapter that describes pesticide levels for botanical dietary supplements.

Based on the multiple possibilities for contamination for pesticides, USP recommends  a cautious approach, with maximum acceptable exposure limits for each pesticide that are 1,000 fold lower than the acceptable daily intake limits established by the Food and Agriculture Organization of the United Nation (FAO) and World Health Organization (WHO).

“It is important that USP guidelines address the quality controls for actual plant material as the starting point, besides the quality controls for the finished product” said Ikhlas Khan, Ph.D., USP Cannabis Expert Panel chair. 


Gretchen GaileyGretchen GaileyDecember 22, 2020
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4min3241

Editors Note: This is part two of a three-part series.

Blue Dream, Purple Haze, Girl Scout Cookies, Red Headed Stranger, Acapulco Gold, Fruity Pebbles or Pineapple Express… all classic strain names and all of them meaningless.

“Strain names are absolutely misleading with considerable variation in the same cannabinoid content among different specimens of the same strain. You can get the same color and the same smell, but actually levels of the THC and CBD and some of the other compounds could be quite different,” says Robin Marles, Ph.D., chair of the U.S. Pharmacopeia (USP) Botanical Dietary Supplements and Herbal Medicines Expert Committee.

USP has assembled an expert panel of clinicians, scientists and industry representatives from around the world to provide necessary information and guidance on critical quality attributes, including recommendations for naming , all laid out in an article in the Journal of Natural Products, Cannabis Inflorescence for Medical Purposes: USP Considerations for Quality Attributes.

“USP recommendations are entirely focused on the inflorescence of the cannabis plant, popularly known as the flower or ‘the bud.’ And as with any plant product, the first challenge was to determine how to classify the various varieties and subtypes that are currently in use.” said Ikhlas Khan, Ph.D., USP’s Cannabis Expert Panel chair.

USP has elected to recognize cannabis as a single plant species, Cannabis sativa L., with different varieties or subtypes that can then be classified based on their THC and CBD content. The expert panel provided guidance for organizing the plant material into three “chemotype” categories: THC-dominant, CBD-dominant, or intermediate varieties that contain physiologically meaningful levels of both – intending to give prescribers or consumers greater clarity about what substances they are using.

In order to properly identify and quantify these cannabis varieties, USP’s expert panel recommended the use of science-based analytical procedures for the industry to employ.  This entails the use of high-performance liquid chromatography (HPLC) and gas chromatography (GC) to separate and quantify not just THC and CBD, but also 11 other cannabinoids that are less studied, but may also have an impact on the effect of cannabis products.

USP  has also looked at the composition of terpenes, which are largely responsible for the flavor and odor of cannabis. They identified five different terpenes that are especially abundant in cannabis that could also help with classification: myrcene, limonene, terpinolene, pinene and caryophyllene. Terpenes may form the basis for further subcategorization of cannabis chemotypes to establish the impact of these substances on the pharmacological effects of cannabis products when used in clinical practice. 

“Naming cannabis varieties based on detailed profiles of cannabinoid and terpene content can also help guide prescribers and help ensure that patients are consistently receiving the cannabis varieties that they intended,” said Nandu Sarma, Director, Dietary Supplements and Herbal Medicines at USP.

 


Gretchen GaileyGretchen GaileyDecember 21, 2020
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5min4890

Editors Note: This is part one of a three-part series of articles.

The U.S. Pharmacopeia (USP) has decided to bring cannabis back into the fold and has provided guidelines for labs and cultivators around the globe to utilize to help provide consumers with quality cannabis products.  

“There is a critical and growing need for the scientific articulation of quality attributes for cannabis and related products to help protect patients and consumers from harm. As more products become available and sourced more broadly, and states continue to adopt initiatives allowing the use of cannabis for medical purposes, potential exposure to and associated risk of harm from contaminated, substandard, or super potent products is increasing and we must do what we can to mitigate that risk,” said Jaap Venema, Ph.D., Chief Science Officer at USP.

The organization’s goal in this area is to provide suitable methods and reference standards that can help the industry and regulators ensure cannabis quality, laid out in an article in the Journal of Natural Products, Cannabis Inflorescence for Medical Purposes: USP Considerations for Quality Attributes.  Nomenclature is at the top of USP’s “to-do list,” an important quality attribute for labeling the ingredients, to help patients and healthcare professionals assess whether a product is suitable for particular needs. 

“The thousands of so-called ‘strains’ are not consistent in either morphological or chemical profiles and cannot be relied upon for consistent categorization of different kinds of cannabis. Identity of cannabis and cannabis-derived products should be linked with clear nomenclature, including reference to plant part, product, and/or herbal preparation,” said Robin Marles, Ph.D., chair of the USP Botanical Dietary Supplements and Herbal Medicines Expert Committee. 

USP has elected to recognize cannabis as a single plant species, Cannabis sativa L., with different varieties or subtypes that can be classified based on their THC and CBD content. The guidelines in the Journal of Natural Products article organize the plant into three ‘chemotype’ categories: THC-dominant, CBD-dominant, or intermediate varieties that contain physiologically meaningful levels of cannabinoids. 

USP is an independent, scientific, nonprofit public health organization devoted to improving health through the development of public standards for the quality, safety, and benefit of medicines and foods. The organization is comprised of over 450 academic institutions, healthcare practitioner organizations, industry groups and government representatives. USP standards are enforced by the FDA in the U.S., but since cannabis is still generally illegal under federal law, USP has not created formal compendial standards at this time. They have published a scientific paper instead of creating a conventional USP monograph. However, they still employed their rigorous process for creating the guidelines.

“This document is just a first step. Much remains to be learned about the clinical utility of this plant and it’s likely that future research will generate greater complexities in classification as we gain a greater understanding of its physiological effects,” said Ikhlas Khan, Ph.D., USP Cannabis Expert Panel chair.

The guidelines in the article also recommend best practices for sampling, strength and composition, and contaminant identification and limits. The hope is that they outline core quality attributes and tools that may serve as resources for quality control of the plant.


Gretchen GaileyGretchen GaileySeptember 2, 2020
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4min12830

Editors Note: This is an opinion piece.

I would like to say kudos to Pennsylvania Governor Tom Wolf for finally calling on the Pennsylvania General Assembly to legalize adult-use cannabis. It would have been better if he had actually thought through what he was proposing and meant it.

Last week, the governor said that he would like to legalize cannabis in order to bring in more revenue for the state and he thinks that selling cannabis in the state liquor stores is the way to do it.

“My hope is that with the pandemic and the hit that we have taken to revenues that there might be a little more interest in it now. And I think that we have had a little more time to see what’s happening in places like Colorado with revenues for example. This might be one way to plug a hole….We have a state store system that would be an ideal way to distribute it,” said Wolf.

Wolf spoke about how he would like funds left over from the CARES Act and tax revenue from cannabis sales to help turn the tide of the pandemic induced recession that has hit the commonwealth, but Senator Daylin Leach the sponsor of SB350 known as the “gold standard” for adult use legalization calls the governor’s plan a nightmare.

“I think it would be unresponsive to the consumer, a bureaucratic nightmare, discourage innovation and kill large parts of the industry right off the bat. Sure, we could do it. We could do it in a way that is less profitable, less advantageous, we can do it in a way that is lesser all around. I don’t know why we would do this,” said Leach.

Wolf’s proposal would make Pennsylvania the only state-run cannabis market in the country and we all know how well things go when the government takes over. If the state runs cannabis sales, it eliminates the retail market opportunity, a key driver of market competition, which means consumers will be the ones taking the hit in their pocketbooks. It will also constrain the product market, keeping out the smaller less capitalized brands, less flexibility in what brands will be sold and less chance of innovation.

Leach says that the governor’s plan is a political nonstarter and his state store announcement did more damage than good.

“He has made it (legalization) far less likely to pass. Republicans hate the state system, they are looking to shut down the state system, not expand their portfolio. Other than sign medical, he did nothing to help us pass medical. Wolf’s efforts to pass legalization have been clumsy and ham-handed enough.”

Knowing that Republicans are opposed, and every other state has passed on a government takeover of their cannabis markets, doesn’t it seem obvious that his proposal is a poison pill? Does it not seem intentionally designed to fail? There is plenty of precedents that makes it clear from every state why no government in its right mind would take this approach.


Gretchen GaileyGretchen GaileyMarch 16, 2020
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4min10250

With news coverage of the Coronavirus pandemic prepping Americans for the impending health crisis, many are taking extreme precautions with whom they interact, where they are going, and the businesses that they frequent. According to The Washington Post, “consumer spending – which supports 70 percent of the economy – is grinding to a halt,” and cannabis businesses are not immune.

The only way to shore up your business and maintain your customer base is through public relations and communication, internally and externally. A lack of information breeds fears and anxiety.  You have the power to alleviate those concerns and navigate this health crisis.

Communicate with your Customers: No one in this country has dealt with this kind of crisis in recent years, so there are questions all around on how to deal with it. Tell your customers about the extra precautions that you are taking in your dispensary to maintain a hygienic environment. CEO Wanda James of Simply Pure did a great job of this recently in an online video posted to Instagram, where she informed her customers of the precautions that they have always taken and are currently taking to ensure customer safety.

Make company announcements across multiple platforms: This will show your customers, employees, and stakeholders that you have a firm grasp of the situation and that you are covering all of your bases. By having one standard message across all platforms it also leaves no room for miscommunication.

Communicate with your suppliers: Around the country, quarantines may go into place, impacting your supply chain. Or perhaps you are a vape pen manufacturer waiting on parts to come in from China. You need to be aware of what strains and products may not be coming into your store so you can inform your patients and your budtenders. With this knowledge in hand, you can determine alternative product recommendations for your patients and have your workers prepared to offer that advice.

Have in Place Emergency Preparedness Plan: Make sure all employees are aware of contingency plans when they may call in sick, have childcare issues when their children are kept home from school, or you run out of product. You don’t want your business to be impacted because your employees don’t know how to react to internal conflicts.

Educate the media: In this 24-hour news cycle, reporters are going to need to fill every angle possible in their broadcasts to inform the public about what is going on in their communities and they will eventually look at what is going on in the cannabis industry. You want your organization to be known for the care, calm, and professionalism that the cannabis industry is bringing to this health crisis. If reporters have medical questions about what impact cannabis might have on the virus, bring in a doctor that you trust to speak on your behalf. Since COVID-19 is a respiratory illness, speak to reporters about products you may be advising patients to take that are not consumed through the lungs. Don’t wing it and don’t make unfounded claims about your product being able to cure it.

Above all, take care of yourselves and your loved ones. Our industry is still in its infancy, now is not the time for martyrs. We need everyone healthy and an “abundance of caution” is not cowardice, it’s the best science available.

 


Gretchen GaileyGretchen GaileyJanuary 29, 2020
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3min7570

Governor Andrew Cuomo (NY) announced his plans to legalize cannabis for adult use in his state budget speech last week. He made the announcement with such enthusiasm some think legalization is an actual possibility this year. A major stumbling block in 2019 was sorting out the social and criminal justice issues that come with cannabis legalization, it will be so again this year.

Can the Empire State overcome the usual pitfalls and set up a market that will finally address those disproportionately affected by the War on Drugs?  Unlikely.

If we look closely at the Cuomo cannabis plan there are red flags. According to Cuomo’s budget, “the program will limit the number of producers and retail dispensaries to guard against a market collapse.” 

That may sound good but time and again states that have limited licensing markets face serious product shortages, increased consumer cost, and greater startup expenses that ultimately keep illicit markets going. 

Fewer licenses at higher costs mean fewer entrepreneurs. In many markets the initial capital requirements are so high minority entrepreneurs can’t compete. 

Cuomo says that he wants to “encourage equity through craft growers and cooperatives, and provide training and incubators to ensure meaningful and sustained participation by communities disproportionately harmed by cannabis prohibition.” If you read between the lines, that means the minorities who cannot meet the state’s high standards for a license will be thrown a bone and be allowed into a collective of other potential unworthy license holders who won’t be able to compete with the deep pockets of more established brands. None the less, come election day, it may seem to some that the Governor kept his promise for social and criminal justice.

The budget also says, “the Office of Cannabis Management will administer social equity licensing opportunities, implement an egalitarian adult-use market structure….” 

The fastest way to develop an egalitarian cannabis model is unlimited licensing, low barriers to entry, access to capital, ending “grandfathering” of medical market license holders, and a strict government agency that ensures access to minority entrepreneurs and polices abuse like shell companies scooping up licenses. 

While a truly free market is the American way, that free market needs to be tempered with reasonable regulation.  However, that regulation should not limit the number of licenses, or make licenses inaccessible to less established entrepreneurs.


Gretchen GaileyGretchen GaileyJanuary 15, 2020
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3min5660

Editor’s Note: This is an opinion guest post. 

In my last post, I promised a whole other can of worms on how impeachment will impact cannabis and I am a woman of my word. As I stated before, once the trial begins in the Senate, all Senators must be in their seats for the duration of the trial to hear the entirety of the case. This means that several the pro-cannabis Democratic candidates are going to be sitting on the sidelines for the earliest races in the primary calendar which often decides who is going to be the presidential nominee.

Four of the remaining candidates and a few frontrunners, Senators Bernie Sanders, Elizabeth Warren, Michael Bennet, and Amy Klobuchar, will not be able to campaign and participate in the Iowa Caucus or the New Hampshire and South Carolina primaries because they will be sitting in their seats listening to arguments on abuse of power and obstruction of Congress. 

While all those races could be cause for concern, we truly need to just look at Iowa to determine the possible fate of cannabis.  Iowa has been a strong indicator of who will be the Democratic nominee and it will be impacted by the upcoming hearing. The latest Real Clear Politics poll has the race neck and neck between former Vice President Joe Biden, Senator Bernie Sanders, Mayor Pete Buttigieg, and Senator Elizabeth Warren. 

If Senators Warren and Sanders are unable to campaign in Iowa then that leaves the door open for Biden and Buttigieg to pick up the momentum they need for the win. Buttigieg had not said much on the cannabis issue, which I’m sure is tactical given his hopes of winning over more conservative voters in the Midwest. Time will tell with his campaign.

Meanwhile, Biden is by far the worst possible nominee for the cannabis movement. He has been a staunch opponent to legalization for years and helped to create the Office of National Drug Control Policy and drafted the legislation, The Violent Crime Control, and Law Enforcement Act of 1994 which has led to massive numbers of incarcerations, not to mention that the term “gateway drug” is still in his vocabulary.

According to polling site FiveThirtyEight, Biden will take Iowa and if that’s the case, then that’s the federal ballgame for cannabis – if Biden beats Trump.  If Trump comes back around for another term, that’s a whole case of worms for cannabis.

 


Gretchen GaileyGretchen GaileyJanuary 7, 2020
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3min15581

With the start of a new legislative session kicking off this week, cannabis enthusiasts are hopeful for a year of progress on cannabis bills like the SAFE Act to jumpstart the industry out of its current lull and bring more legitimacy to its legalization movement. Well, keep waiting.

Despite Congress’ holiday break, President Donald J. Trump has been impeached by the House of Representatives and the Senate is going to have to act at some point, leaving cannabis and every other possible issue on the back burner. I take that back, cannabis won’t be on the back burner, it won’t even be in the kitchen.

When Speaker of the House Nancy Pelosi’s stops stonewalling Senate Majority Leader Mitch McConnell and turns over the Articles of Impeachment, which many expect will happen this week, Senate rules state that the trial must commence the next day by 1 pm and all Senators must be in their seats for the entirety of the trial. Meaning – all other legislative business in the Senate comes to a standstill and cannabis is an afterthought.

If the Senate trial is anything like President Clinton’s trial which went for six weeks, all of January will be sucked up and run us deep into February, (which opens a whole other can of worms for cannabis that I’ll come back to in a later post, stay tuned.) Congress will want to get back to its actual legislative priorities, the U.S.-Mexico-Canada Agreement, surveillance reform, funding the government and not to mention, now a potential war with Iran. Cannabis is nowhere on this list, especially in the Senate where it needs to find support.

While it may seem that Trump and McConnell want to bring the Senate trial to a quick close and end this “witch hunt,” it’s in the President’s and the Republicans’ best interest to drag it out and use it for every ounce of PR fuel that it’s going to provide for the upcoming election. In the meantime, cannabis bills will be set aside, and their fate sealed like 96% of all other legislation introduced during a Congress – a slow, quiet, unnoticed death.

All legislative actions can be followed at no cost under the Legislation tab on the home page of the Green Market Report.



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