Tag Archives: FDA

January 15, 2016

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

By Aaron G. Biros, Matthew A. Karnes, CPA

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.

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.’

November 11, 2015

Cannabis Coaching & Compliance

Keep It Professional~Food Safety Musts!

By Maureen McNamara

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There are many aspects to the cannabis industry that demand an owner’s attention: Compliance, great products, great people, great location, finances…. So is a focus on food safety a priority?

Yes, yes it is. And not just for infused products.

For starters, in some states like Colorado, it is required. In other states it will be required in the foreseeable future, and generally speaking, it is a vital component for a professional industry that continues to show the community that you are committed to creating safe products.

Have you ever had a foodborne illness? I’m going to assume you just nodded your head or thought yes. Check out this statistic: according to the Center for Disease Control there are about 48 million cases of foodborne illnesses (and 3000 people die) every year in the United States.

A quick reminder about the typical symptoms of foodborne illness: vomiting, diarrhea, headaches and nausea. Experiences we would all like to avoid.

What I know for sure… you do not want your product or your company to ever be associated with making people sick.

Take into account that for medical marijuana patients, they may already have compromised immune systems. This puts them at an even greater risk for foodborne illness. We need to ask questions like “Are my employees doing everything possible to ensure a safe, wholesome product?”

A properly trained staff is a critical necessity in the cannabis industry. Whether it is currently required or not, your commitment to safety for your patients and consumers show that you care and are committed to high standards. Additionally, you may avoid fines, closures and recalls. These all create a drain on your finances… as well as your reputation.

The FDA has identified five key factors that often contribute to outbreaks:

Purchasing Food from Unsafe Sources
Improper Holding Time and Temperature
Inadequate Cooking
Improper Cleaning and Sanitizing
Poor Personal Hygiene

Safe Purchasing:

Be aware of starting with high quality ingredients. Ask your suppliers questions about their inspections and quality controls. If possible conduct a tour of the supplier facilities to verify they meet necessary standards. Are you impressed with their food safety standards and protocols?

Avoiding Time & Temperature Abuse:

Bacteria needs an ideal temperature (between 41°-135°) and a bit of time (4+hours) to grow to harmful levels. Keep your cold food cold and cool your heated foods quickly.

Inadequate Cooking:

If you are infusing oil, I strongly encourage you to work with your local health department for a procedure that will ensure the oil is cooked to a safe temperature (while not interfering with your chemistry) to eliminate potential pathogens or microbials.

Cleaning and Sanitizing:

Microorganisms grow well at room temperature. Cleaning and sanitizing is important to ensure microorganisms are reduced or eliminated. Certainly all of your food contact surfaces must be cleaned and sanitized whenever you change tasks and at least every four hours. This is not just for making infused products, please keep this in mind at the retail level as well. Think of how many hands (both employees and customers) may be touching the product containers. Avoid cross-contamination by cleaning and santizing thoroughly and often.

Personal Hygiene:

In each food safety class I have facilitated in the last 18 years, everyone admits they or their team could improve personal hygiene. Shout out to any bearded folks… did you know that the FDA food code requires facial hair that is 1-inch or longer to be restrained? Got a beard net?

Because most of the foods manufactured in the cannabis industry are “ready to eat” foods, great personal hygiene and frequent, thorough handwashing is essential. The FDA reccommends a 20 second handwashing procudure with hot water (≥100°), a soapy lather, vigoursly rubbing hands for at least 10-15 seconds, rinsing well and using a single-use towel to dry your hands.

I know… it sounds very basic. However, when I observe people washing their hands it is often for less than 8-seconds. Not only is handwashing a great way to stay healthy ourselves, it is a key way to ensure your products are safe and not putting public health in jeopardy.

I’ll throw down a challenge for you! This month: focus with your team on personal hygiene and hand washing. Whether you are growing, infusing or selling this is a vital component for a professional, responsible industry. When it comes down to it, you make things that go right into your customer’s and patient’s bodies. Create those products on a foundation of food safety and you will more easily create a thriving business.

Cannabis Trainers provides ServSafe® food safety training for edible makers and Sell-SMaRT™ the responsible cannabis vendor program for sellers. (www.CannabisTrainers.com)

We would love to hear from you! Comment below and let us know what your team does to ensure you are making and selling safe products.

August 12, 2015

Federal Marijuana Policy: A Q&A with Stephen Goldner

By Aaron G. Biros

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Ahead of the launch of our newest publication, CannabisIndustryJournal.com, I interviewed Stephen Goldner, President of Regulatory Affairs Associates, regarding the possibility of federal oversight in the cannabis industry, namely direct FDA involvement via regulations.

With experience as a forensic toxicologist and attorney, Stephen Goldner has worked over 35 years as a regulatory professional in the healthcare space. He has contributed to the approval of 230 drugs and medical devices serving as an FDA advisor. Steve is credited with the development of the liquid dose form of methadone and various screening tests for drug abuse.

We discussed the current regulatory frameworks in place for legal marijuana in the United States and found that there are some gaps in understanding when it comes to regulating the plant. Here is a snapshot of our conversation discussing federal involvement in the cannabis industry:

Food Safety Tech: Are state governments and marijuana businesses working jointly to handle the regulatory framework succeeding? Can you see, in the handful of states that have already legalized marijuana, a need for FDA regulatory guidance?

Steve Goldner: To many people’s surprise, the states that have legalized marijuana are doing very well setting up a regulatory framework. Plus, the legitimate operations really want to succeed in business and provide safe and effective recreational and drug products. I’m surprised to hear myself say it, but FDA might be best served if it stayed out of this issue for a while.

FST: What are some reasons why the FDA might want to get involved in the cannabis industry?

Steve: Certainly if there were reports of injuries, but so far the marijuana products seem to be much less hazardous than other common recreational substances like beer and wine. But FDA also gets involved when there are outrageous claims that products cure diseases like cancer. I expect FDA will act against cannabis distributors who make those claims, even if they only distribute their marijuana within one state.

FST: What are some reasons why the FDA might want to let this social experiment run a little longer?

Steve: Thousands of people have gone to jail or otherwise had their life ruined because of small amounts of this product being used or being sold. If it turns out, as the data appears to show, that marijuana is not a ‘gateway drug’ to other drugs, and it’s use is fairly harmless, then FDA stepping in will probably just send most of the users and growers into the black market and then nothing will have been gained.

FST: What actions might you suggest the FDA take in the near future as more states continue to legalize marijuana?

Steve: Great question! FDA is excellent at monitoring data, along with the CDC. If FDA sees a real health hazard problem, it can convene a panel of experts to offer solutions. And then monitor the situation to see if growers and producers of marijuana edibles can adopt those solutions into their business practices.

Ahead of a number of state reforms and initiatives to legalize the recreational use and sale of the plant in 2016, The New York Times published an op-ed by The Editorial Board in favor of removing marijuana from the Controlled Substances Act. While Goldner, along with many others, believe that states are making great strides with regulatory measures, The New York Times believes “State legalization efforts are not uniformly well thought out, which is another reason for Congress and the president to act.”

With the 2016 elections fast approaching, we hope to see major changes coming soon in the federal government’s position on marijuana.

We want to hear your thoughts! Do you think the federal government should step up their involvement? What actions or inactions would you like to see the federal government take? Do you think the FDA should chime in? Post your questions or thoughts in the comments section below.

August 3, 2015

Hemp-Infused Beverages: FDA Compliance and the Cannabis Industry

By Aaron G. Biros

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With cannabis-infused edibles gaining a bigger market share in 2014 (See the marijuana edibles regulatory update here), it comes as no surprise that cannabis-infused beverages are growing in popularity. Some of these beverage manufacturers operate in a very interesting legal environment because of the differentiation between compounds found in hemp and marijuana, two different varieties of cannabis.

“Under federal legislation, there is an exemption for hemp and as long as we process our CBD (Cannabidiol) molecules from the hemp plant, we are allowed to sell our products federally,” says Chris Bunka, CEO of Lexaria, a company that makes a hemp-infused tea.

A number of scientific research studies have suggested that the compound CBD has medical properties that can help mitigate symptoms like inflammation, anxiety, chronic pain, and much more.

Because of the federal exemption for hemp, Lexaria can enjoy interstate commerce and other freedoms that manufacturers using marijuana flowers do not, such as access to banking services. Dried marijuana flowers contain the psychoactive compound, Tetrahydrocannabinol (THC). This compound is responsible for the regulatory and legal schism between the states that have legalized marijuana and the federal government, which still considers it to be a Schedule I narcotic.

Much unlike a number of marijuana edibles manufacturers operating in states where marijuana is currently legal, hemp-infused beverage manufacturers operate in full FDA compliance.

Michael Christopher, founder of Loft Tea, is working with a laboratory and bottler that are both 100% FDA compliant. “We definitely operate up to and abide by all FDA best practices with our laboratory and as far as producing and handling material we use best manufacturing practices and processes,” says Christopher.

“We have to partner with a bottler and laboratory who have the reputation to build trust with our brand as an industry leader in safety and quality,” says Christopher. “Until the FDA gives us complete guidelines on cannabis-infused products, we will continue to operate above and beyond best manufacturing practices with our infusions.”

Because these manufacturers view their hemp tea as a health and wellness product, it is only a matter of time before we see these types of products lining the shelves of health-food stores nationally. However, before this happens, an FDA regulatory framework specific to hemp-infused products is needed to address this growing industry.

“The hemp infusion industry has a lot of opportunity when presented in the right framework,” Christopher says. “There is still education needed in the marketplace to get it to the point where it will be on the shelves in stores like Whole Foods.”

Until that time comes, expect to see a steady growth of interest and inquiry from consumers, manufacturers, and regulators alike in the cannabis industry, whether federally legal or not.