Tag Archives: policy

DEA To Consider Rescheduling Cannabis, Could Mean Policy Shift

By Aaron G. Biros
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In a letter sent to lawmakers last week, the Drug Enforcement Agency (DEA) announced plans to make a decision on rescheduling cannabis by mid-2016. The announcement could represent the culmination of a shift in the federal government’s attitude toward cannabis legalization.Dea_color_logo

Currently, cannabis is a Schedule I narcotic, meaning the government views it as lacking medical benefits and have a high potential for abuse. The rescheduling of cannabis has the potential to open the floodgates for research, including much needed clinical trials.

Derek Peterson, chief executive officer at Terra Tech, a cannabis-focused agriculture company, believes this bodes well for the growth potential of the cannabis industry. “From the perspective of quality and safety standards, I find it unlikely that rescheduling it would negatively impact the degree to which cannabis is examined,” says Peterson. “It’s unnecessarily high position on the DEA drug schedule does nothing but limit the industry’s potential for growth, stall any meaningful pharmaceutical testing and increase law enforcement’s ability to prosecute non-violent drug offenders,” adds Peterson.

The rescheduling could also potentially allow for the prescribing of cannabis for patients. Stephen Goldner, founder of Pinnacle Labs and president of Regulatory Affairs Associates, is hopeful this will lead to a greater shift in public attitude towards cannabis. “The DEA’s announcement is a clear message to all States and possibly even to United Nations policy makers: even the DEA is willing to reconsider cannabis,” says Goldner. “Since the DEA is reconsidering cannabis, state politicians and local police departments can also be flexible and move away from prohibition, towards the regulation of cannabis.”

The rescheduling of cannabis could have a tremendous impact on the growth of the cannabis industry, including more clinical trials, medical research and physician participation. It could also open the door for more federal agency involvement, as the Schedule I status inhibits any EPA research on cannabis pesticide use or FDA guidance on food and drug good manufacturing practices. When reached for comment, the FDA’s press office said they could not speculate on any involvement in the matter.

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Health Care Industry Cannot Ignore Cannabis Any Longer

By Robert T. Hoban, Esq.
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Twenty-four U.S. states now have some form of medical marijuana legalization on the books. These states allow patients with a variety of qualifying conditions to possess and cultivate cannabis lawfully as a treatment for such medical conditions. The number of states allowing medical cannabis is set to increase dramatically, as various additional state legislatures have bills or ballot measures pending on this topic. You can read more about this topic here.

The federal government surprisingly already has their hands in medical marijuana. The federal government sends free, pre-rolled cannabis cigarettes to a special, albeit dwindling, group of patients on a regular basis and they have been doing so since 1976. This is a product of the 1976 federal Investigational New Drug Program (Compassionate Access I.N.D.), which still operates, but was closed in 1992 to any new patients. 

The U.S. Government holds a federal patent for therapeutic cannabinoid use (US6630507 B1). The patent, “Cannabinoids as antioxidants and neuroprotectants,” (LINK) covers a method of treating diseases by applying a therapeutically effective amount of cannabinoids derived from marijuana. In addition, the White House website provides links to government-funded research projects involving medical marijuana. Presently, the links show 219 completed projects and 95 projects in progress.

On June 23, 2015, the American Medical Association adopted the formal position that marijuana is a form of medicine. Reliable scientific studies address the medical efficacy of the use of medical cannabis for an increasing number of conditions. Medical cannabis is here to stay and the health care industry needs to pay close attention.

 Simply put, the health care industry has been resistant to beginning the study of medical marijuana. This does not bode well for health care systems that will see more patients utilizing various forms of medical cannabis. Moreover, this is not a sustainable health care business model. With an increased focus on alternative forms of medicine and treatment both by practitioners and health care insurance providers, it is imperative that the health care industry studies the facts.

The New Mexico Workers’ Compensation Administration began requiring employers and insurers to reimburse injured workers for medical marijuana when the state’s health care provider fee schedule took effect January 1, 2016. Workers compensation claimants can be reimbursed up to $12.02 per gram of marijuana for up to 226.8 grams of marijuana per year, according to the fee schedule. Such reimbursements were ordered after the New Mexico Court of Appeals had ruled three times since May, 2014 that medical marijuana should be classified as reasonable and necessary medical care for injured workers.

The same momentum is impacting Latin America. Brazil’s governmental health care agency, ANVISA, recently removed a component of cannabis, cannabidiol (CBD), from the list of banned substances, meaning the marijuana molecule can now be prescribed by physicians for treating seizures, multiple sclerosis, schizophrenia and other ailments. As such, ANVISA has approved the importation of CBD from the United States.

More and more research studies are published every year. In the National Center for Biotechnology Information database of biomedical literature, 4,516 medical abstracts reference both cannabis and cannabinoids. Still the vast majority of medical schools do not educate students about the human endocannabinoid system.

Denis Petro, a neurologist and pharmacologist, researches cannabis as a treatment for multiple sclerosis. He founded Patients Out of Time, a non-profit organization dedicated to research and education on the endocannabinoid system. “At present, conventional treatments for spasticity are unsatisfactory,” Dr. Petro wrote, in an article, Indications for Therapeutic Use of Cannabis. “Based on scientific evidence, cannabis is a safe and effective alternative when compared to conventional treatments.”

Physicians in Colorado can recommend marijuana and the Colorado Constitution legally protects them (Article XVII, Section 14). The Colorado Constitution gives physicians immunity for advising a patient about the risks and benefits of medical marijuana for a debilitating medical condition, and for recommending medical marijuana to a patient.

Moreover, physicians have a duty to care for their patients, and that includes considering medical marijuana if it would help that patient. Consequently, by understanding the health benefits and the particularized sources of liability, physicians can lend clarity to the medical marijuana industry.

While medical marijuana policy changes may lead to uncertainty, most questions about the marijuana industry, including the risks and its related legality, have answers. The problem is that health care providers and insurance companies do not know where to turn for this information.

I delivered a number of presentations concerning this topic to various provider and insurance-related entities across the country serving our health care system. It is evident that many of these health care related entities can move forward with a better understanding of the risk implications and devise better informed strategies to incorporate medical cannabis into their operational plans, whether for now or in the near future.

An understanding of the researched health benefits of medical marijuana is increasingly necessary for physicians and other members of our health care system. A conservative approach is certainly advisable, but it is more than just a good thing to learn about; it is a necessity in this day and age to remain relevant and informed. This needs to happen now. And the providers that take appropriate steps soon will be better positioned to deal with these issues as they become increasingly prevalent.

Analyzing National Trends for Marijuana Policy: Q&A with Matt Karnes

By Aaron G. Biros, Matthew A. Karnes, CPA
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According to Matthew Karnes, founder and managing partner of GreenWave Advisors, LLC, looking toward the growth of the cannabis industry requires analysis of the changes in state and federal laws. “Eventual rescheduling or de-listing of marijuana as a federally prohibited drug, will hopefully lead to consistent and uniform national regulation and taxing authorizations that will ultimately change the structural and economic landscape of the industry,” says Karnes in an article here.COLOR-PIC-200x300

Looking at the sales trends in current legal states is a viable option to make financial projections, but much of that relies on the changing legal and political landscape of our country. According to Karnes, because it is impossible to accurately predict federal rescheduling or full legalization, investors must look at short, medium and long term trends to guide their decision making process. Cannabis Industry Journal sat down with Matthew Karnes to discuss some of the foreseeable trends.


 

Cannabis Industry Journal: What are some of the trends happening presently, that you can expect to continue?

Matthew Karnes: Just as states continue to pass legislation in some form of legalization measure, there is talk at the federal level of minimizing interference with state policies and removing prohibition statutes. We can see this national progression continuing until rescheduling cannabis eliminates the current obstructions that have limited industry growth.

Where states continue to roll out legislation to legalize cannabis, the rate of retail and cultivation license granting will have a large effect on the growth rates for each given state. Free market approaches as seen in Colorado and California will allow for faster growth rates than more restrictive states.

Recreational and adult use measures being introduced are notable disruptions in the medical sector that once fueled legalization. Medical research and development of strains for specific ailments is still in its early stages due to the impact of federal policy on research.

With an eye forward to eventual federal rescheduling or possible de-listing it is reasonable to assume that uniform national testing and operational standardization protocols will eventually be implemented at least as a baseline binding thread that will steadfastly assure consumers of an expectant consistency of product.

CIJ: Where do you see medium term trends taking the industry?

Matt: With more and more states legalizing cannabis in some form, we can expect the federal government to make a policy change. This will be accomplished via a DEA policy change or through congressional avenues in conjunction with federal agencies like the FDA, USDA and Department of Agriculture administering regulations.

With FDA or Department of Agriculture implementing cannabis policies, we can expect increased interest from outside the industry in research and development of cannabis-based drugs. This will lead to a medical market with more targeted medicine with precise dosing. We can expect more physicians to gain comfort in treating ailments with cannabis as well.

The recreational market will expand greatly with normalized commerce, enabling larger cultivation operations and infused products brands could grow to the national scale with interstate commerce.

CIJ: Where do you see the industry going long term?

Matt: When the cannabis industry matures down the road, we can expect multiple offshoots occurring. The recreational industry will involve local, regional and national policy much like the alcohol industry, and will likely resemble a liquor store model with individual “mom and pop” type businesses.

We anticipate that the medical market will recalibrate as more targeted products with precise dosing and efficacy are developed. At that point it will experience increased competition and consolidation. Without medical research and clinical trials, we cannot accurately project the growth of the medical sector.

Regulations involving tax revenue will most likely use a similar mechanism that states use for alcohol and tobacco taxation. Entities like state liquor control boards will oversee cannabis regulations. When that time comes, the cannabis industry will no longer be a novel idea and will become another conventional ‘consumer staple.’

Steve Goldner
Marijuana Matters

Food Processing & Cannabis Policy

By Stephen Goldner J.D.
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We have not seen food processing opportunities in the 45 years I’ve been in the industry like we are seeing in the cannabis food segment. There are still many legal, regulatory and policy misconceptions and this column is devoted to giving you some clarity. I hope this helps you make sensible business plans based on sound marketing opportunities.

It’s hard for many people to make the leap from thinking marijuana is illegal to knowing that food infused with marijuana is legal in 50% of the US, and quickly moving toward national legality. Any food processor that does not consider this opportunity to meet changing market dynamics risks losing a huge opportunity.

23 states, the District of Columbia and Guam now have comprehensive cannabis programs in place and many more are expected through Q4 of 2016. The voter approval, tax aspects and improved law enforcement profiles are highly favorable towards legalization and regulation. While marijuana itself can’t be shipped across state lines legally at this time, food-processing equipment is being sold, shipped, and installed every day of the week with no legal ramifications. The remaining problematic business aspects are rapidly moving through the solution phase, specifically labeling, tamper-evident and child resistant packaging, and payment methods.

Unlike other technology introductions, a mass market already exists and is clamoring for these food products. Therefore the ‘early movers’ are developing business relationships state by state to prepare food production lines that incorporate cannabis food production into cannabis processing companies. 

Essentially, any state that allows cannabis dispensaries to exist will require food-processing equipment. In addition, states like Michigan where I reside, there are over 200,000 medical marijuana licenses issued to individuals, and over 250 unlicensed dispensaries. Michigan is getting ready for dispensary licensing and food production. We should anticipate inquiries from companies applying for food production licenses from any and all states as they are carefully attuned to their local state rules.

You can always contact me at this publication by clicking here and I’ll do my best to answer you that day or visit my website, Regulatory Affairs Associates.

Jurisdictions with active cannabis food production in USA: Arizona, California, Colorado, Connecticut, Delaware, Washington, D.C, Guam, Illinois, Maine, Maryland, Massachusetts, Michigan [coming soon], Minnesota, New Hampshire, New Jersey, New Mexico, New York, Rhode Island, Vermont, Washington

The next few articles in this series will focus on making certain your food production equipment will meet cannabis food production regulatory standards, the unusual payment procedures in this new industry, and relationship building since many of the new companies and their advisors will be new to you. Plus you really want to know their expectations of you. 

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Legalize Marijuana and Regulate it Like Alcohol: Marijuana Policy Project

By Aaron G. Biros
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logo for MPP massachusetts

The Marijuana Policy Project (MPP) is a non-profit political organization, and has taken the leading role in several successful state-level marijuana policy reforms. Founded in 1995, MPP has most notably led the 2012 Amendment 64 initiative in Colorado to legalize marijuana for adults and regulate it like alcohol as well as the successful 2014 campaign under a similar name in Alaska.

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The Massachusetts MPP Campaign Logo

While MPP has been active at both the federal and state level, Matt Schweich, director of state campaigns for the organization, works in a handful of states to pass bills through state legislatures. In particular, Schweich’s work has put an initiative on the ballot in Nevada, and MPP is working with a coalition of groups on an initiative in California, both of which are scheduled for 2016.

In both Massachusetts and Arizona, Schweich and his team are leading the Regulate Marijuana Like Alcohol campaigns, where they manage political committees and lobby for legalization.

MPP campaign logo AZ
The Arizona MPP Campaign Logo

“We named the campaign [Regulate Marijuana Like Alcohol] because we want that to be the central message to the voter,” says Schweich. “We need to get the message across that marijuana is objectively less harmful than alcohol, and it makes no sense to punish users of marijuana.”

“It is common sense to understand that one is less harmful to the user and society in general, [and] in light of the fact that alcohol is legal, it makes no sense to keep marijuana illegal,” he adds.

According to Schweich, voters in their respective states should be given the independence to decide how to handle licensing and regulations, depending on the jurisdiction, just like state liquor laws.

On a national level, MPP has a federal policy team currently working on the fight for marijuana businesses to gain access to banking and financial services.