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Sustainability in Packaging: A Q&A with Dymapak CEO Ross Kirsh

By Aaron G. Biros
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Ross Kirsh launched Dymapak in New York City in 2010. Born into a family with a storied history in manufacturing, he founded the company after working for several years in Hong Kong where his interests, skills and passions for product development took shape.

Filling a niche for smell-proof bags in smoke shops, the business grew as he immersed himself in cannabis markets around the country. After designing and inventing a patented, first of its kind child-resistant pouch for Colorado’s first adult use sale in 2014, the business has continued to achieve global scale and today is recognized as the worldwide leader in cannabis packaging.

While the cannabis industry has long drawn the ire of environmentalists because of its energy problem when it comes to cultivation, the packaging side of the business faces very similar issues; the cannabis industry also has a plastic problem. In most states where cannabis is legal, state regulations require producers and dispensaries to package all cannabis products in opaque, child-resistant packaging, with several states requiring dispensaries to place entire orders inside large, child-resistant exit bags prior to customers leaving with their purchase.

Dymapak, led by Kirsh, is working on initiatives to help address environmental sustainability in cannabis packaging and turn interest into action industry wide. Ross will offer insights and the business’s action plan at the upcoming Cannabis Packaging Virtual Conference December 1. And ahead of that chat, we caught up with him to learn more.

Aaron G. Biros: Tell me a bit about yourself and how Dymapak came to be. What brought you to the cannabis space and where you are today?

Ross Kirsh, CEO of Dymapak

Ross Kirsh: My family has deep roots in manufacturing. Back in the mid 1970s, my uncle and his brothers all launched separate manufacturing businesses after one of the brothers moved to Hong Kong to open a handbag and luggage factory. The 70s happened to be a unique time to work abroad in Hong Kong given few US companies were operating there when China first announced its open-door policy around 1979. And as you can expect, he became a sourcing agent for many large companies in the US who needed trustworthy boots on the ground.

I went to college, pursued IT and in the back of my mind always knew product development and the manufacturing process was too interesting not to follow. I already knew Hong Kong was ripe for learning entrepreneurship so I went abroad to learn more, and fell in love with the culture, the opportunity and the people.  Immediately after graduation, I moved to Hong Kong. I began working with my family, who taught me the trade – end to end. I helped develop several product lines and lived next to one of our factories in southern China to immerse myself.

After 3.5 years abroad, I began running sales operations back in the US. Fast forward a year back in the states, I had unique customers that owned tobacco and smoke shops telling me that cannabis packaging existed in the market, but not really what everyone was looking for. In truth, the business was born the minute a customer said, “Can you make me a retail ready smell-proof bag?” I figured I could, and the rest – as they say – is history.

What began and was established in 2010 truly took shape at an accelerated pace in 2013, when my relationship with one of the first dispensary owner/operators in Denver – Ean Seeb of Denver Relief – came with a golden opportunity; Invent a child resistant package for cannabis, one did not exist but it was mandated under Colorado’s first-ever recreational cannabis regulations. I spent 7 out of the next 8 weeks in China developing a solution and am proud to say our bag was used in the first recreational sale when Colorado went legal in January 2014. From there, the business grew rapidly, and organically throughout the industry.

Biros: Environmental sustainability is a big issue for cannabis. Not just on the energy intensive side, but particularly when it comes to packaging and its plastic problem. How is your company approaching this issue and are you working on any initiatives to eliminate or reduce plastic waste?

Kirsh: We recognize firsthand the issues that plastic presents. While the material is full of advantages, the disadvantages are both imminent and critical to understand.

What many don’t realize is, for most cannabis packaging that’s recyclable to actually BE recycled, the customer must first find a drop off location, either at a dispensary or elsewhere that accepts the material. The process relies exclusively on the consumer to take action because the products cannot be recycled curbside. And unfortunately, the stats show that very few consumers take the time to bring the packaging back in order to recycle it.

So, yes, we produce recyclable bags in our portfolio, but we really want to get to the source of the problem here – pollution. We looked in a few different areas. And we developed a different bag made with 30% post-consumer resin, meaning 30% is made from reused plastics.

Even more, we recently partnered with a socially conscious, industry leader in the space, Plastic Bank, which builds regenerative, recycling ecosystems in under-developed communities. They work to  collect plastic waste from the ocean – extracting it to ensure its opportunity to enter the recycling ecosystem. Through our partnership with Plastic Bank, we’ll help prevent more than six million plastic bottles from entering the ocean this year alone. And I’m really proud of that.

Biros: Where do you see the cannabis packaging industry going in the next five years?

Kirsh: I think that’s a fascinating question. Sustainability will play a huge role in the future of this market. Just like we are seeing single use plastic bags being phased out across the country, we’ll see that happen to other areas too as part of this larger trend.

I predict more on-time and on-demand needs in the future; the ability to see traceability in real time, similar to the pharmaceutical industry. People will expect batch numbers and lot numbers, with data, in real time. It’ll become central to the business.

Gaining and cultivating trust will be another big hurdle for companies in this sector soon. With federal legalization comes a greater sense of professionalism and more sophistication for the market.

Yet, the continued pressure on environmental sustainability will be the biggest change in the next five years. When you look at sustainability in the packaging industry, paying attention to the format or choice of material should be top of mind. For example, if you’re shipping a glass jar, the amount of space that takes up in a shipping container has a huge impact on the environment, what’s called a hidden impact. One shipping container can hold millions of bags, but you need eight shipping containers for glass jars to get the same amount of storing capacity. That’s about efficiency, which is a bit more hidden, and I hope that consumers will become more and more knowledgeable about what companies are doing to stay environmentally sustainable.

Biros: Ross, thank you very much for your time today.

Kirsh: My pleasure, Aaron.

PlantTag

Quality Systems 101: CAPA Programs Drive Improvement & Prevent Costly Mistakes

By David Vaillencourt
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PlantTag

No business is perfect, especially when humans are part of the equation. But, how do you tackle fixing quality issues as they arise? The goal of this article is to shed some light on the value of a CAPA program and why many states are making them mandatory for cannabis businesses.

Let’s consider the following situations:

  • Analytical lab results for a production batch test above the limit for a banned pesticide or microbial contamination
  • You open a case of tincture bottles and some are broken
  • A customer returns a vape pen because it is leaking or ‘just doesn’t work’

Do you…

  • Document the issue?
  • Perform some sort of an investigation, asking questions of the people involved?
  • Ask for a retest? Then, if the test comes back positive, move on?

Let’s go through each one of these and understand why the suboptimal answer could be costing your business money:

You don’t document the issue

I hear excuses for skipping on documentation all the time.

  • “It’s not a big deal”
  • “It was a one off”
  • “The glasses probably broke in transit”
  • “They are cheap and easily replaceable”
  • “It’s not worth the time”
Tracking and documenting supplier shipments can help you identify supply chain issues.

In the situation of a couple of broken bottles in a shipment, what if it was the seventh time in the last two months? If you haven’t been documenting and tracking the issue, you have no way of knowing if it was a single occurrence. Remember when you were surprised that your filling team did not have enough bottles? Those broken bottles add up. Without documenting the incident, you will never know if it was truly a one-time mistake or the sign of a deeper issue. The reality is, it could be sloppy handling on the production line, issues with the shipper or even a sign of poor quality coming from the supplier.

Have you ever compared the number of fills vs the number of bottles ordered? How much money have you already lost due to those broken bottles adding up? Do you have the ability to answer this question?

You perform an investigation

Let’s say a customer returns a leaky vape pen. You perform an investigation by asking the production workers what they think went wrong. They say that it’s very difficult to get the seal for the cartridge into place. Their supervisor tells them to try harder, refunds the customer and moves on. But, why is it difficult to get the seal into place? Is it a design flaw? Should a special tool be used to assemble the cartridge properly? Without getting to the root cause of why the seals are leading to leaking cartridges, you are doomed to have repeat issues. Numerous studies have found that less than one in twenty dissatisfied customers will complain, and that approximately one in ten will simply leave for another brand or provider. How much is this unresolved issue truly costing your business?

Asking for a retest and if it passes, releasing the product and moving on.

labsphoto
In Colorado, 15% of the final tested cannabis flower products continue to fail.

Suppose a major producer of cereal received test results for its most popular cereal that were positive for levels of heavy metals that research has shown to be linked to cancer or developmental issues in children. Now, suppose the company stated that it was an isolated incident and a retest showed that the product met acceptable limits. Further investigation showed no paperwork, save for a couple of emails and a phone call between the lab and the producer. Would that give you peace of mind? This is known as “testing into compliance” and was the subject of a landmark lawsuit in 1993 that Barr Laboratories lost.

For many the answer would be a hard NO. But this happens every day. In Colorado, 12.5% of cannabis batches failed final product testing in 2018 and 2019. That’s one in eight batches! What happened to those products? Good question.

Enter: CAPA (Corrective Action and Preventive Action) programs! For people with a background in quality and GMPs (Good Manufacturing Practices), CAPA is a household name. And, it’s quickly becoming a requirement that cannabis regulatory bodies are looking at. Colorado was the first state to explicitly require CAPA programs for all license holders effective January of this year and has provided a free resource for them. But, for the large majority of people, including those in the cannabis industry, it’s just another acronym.

What does a CAPA program do?

The benefits are numerous but two major ones are:

An effective tool for investigating the true root cause

First of all, a CAPA program provides the framework for a tool for investigation – as Murphy’s Law posits – things go wrong all of the time. Whether you have a manual, labor-intensive process or a highly automated operation, the equipment is programmed, maintained and monitored by humans. The logical sequence of problem solving within a CAPA program allows you to thoroughly investigate and determine the root cause of the issue. With a complete understanding of root cause, you are then able to eliminate it and prevent future occurrences – not just in the one area investigated, but in all similar situations throughout the company.

System for continuous improvement

Gathering info from a customer complaint like batch or product IDs can be crucial in a CAPA system

Anyone who is in the market for a new car lately can appreciate the technological advances. In the 1980s, it was air bags and ABS brakes (those of you that drive in snowy climates and remember having to pump your brakes can appreciate technological advancements). Bluetooth technology for hands-free communication and radio control is another example of continuous improvement in cars.

This is one of the biggest predictors and differentiators between profitable and successful companies with satisfied clients and one that is barely scraping by. The cost of poor quality adds up!

Key inputs in a CAPA system 

If the output is an improved system and lower cost of quality, we need to make sure we’re considering the potential inputs. 

Information that feeds into your CAPA system:

Customer complaints

Every complaint must be recorded. Gather as much information as possible, but at a minimum: the product type/SKU, the customer name and date of purchase. If possible, the batch or product ID.

This is not necessarily to identify products for a recall, but to prevent…

Laboratory test results

This should not be restricted to final product testing, but include any in-process inspections. Say you have a product repeatedly failing final testing, what if it’s actually been consistently failing or very close to failing at the very first in-process inspection? It’s also important to work with your laboratory to understand their method validation process, including the accuracy, precision, robustness, etc.

Infrastructure & environmental controls/monitoring

Most people consider “environmental controls” to be things like temperature and humidity control. While that is true, it can also include pest and contamination control. Poorly designed infrastructure layouts are major contributors to product cross contamination as well.

Supplier information

Undetected supply chain issues (remember the broken bottles?) can add up fast! CAPAs for suppliers cannot just include supplier monitoring, but improvement in how you communicate your needs to your suppliers. It’s easy to overlook non-cannabis raw materials as sources of microbiological and chemical contamination. Conduct a risk assessment based on the type of contact with your product and the types of contamination possible and adjust your supplier qualification program accordingly.

Are you ready to recognize the benefits of a CAPA program?

One more major benefit of CAPA programs to mention before we go is … Preventive via predictive analytics.

In Colorado, 15% of the final tested cannabis flower products continue to fail, mostly due to mold and mildew. A quality system, with effective data capture that is funneled into a CAPA program can easily reduce this by 75%. For even a small business doing $2M per year in revenue, that equates to a revenue increase of nearly $200,000 with no additional expenses.

Whether you are operating in the State of Colorado or elsewhere, a CAPA and Recall program will provide immense value. In the best case, it will uncover systemic issues; worst case, it forces you to fix mild errors. What are you waiting for?

Pesticide Testing: Methods, Strategies & Sampling

By Charles Deibel
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Editor’s Note: The following is based on research and studies performed in their Santa Cruz Lab, with contributions from Mikhail Gadomski, Lab Manager, Ryan Maus, Technical Services Analyst, Dr. Laurie Post, Director of Food Safety & Compliance, Andy Sechler, Lab Director, Toby Astill, Senior Business Development Leader at Perkin Elmer and Charles Deibel, President of Deibel Cannabis Labs.


Pesticides represent the leading cause of batch failures in the cannabis industry. They are also the hardest tests to run in the laboratory, even one equipped with state-of-the-art equipment. The best instruments on the market are HPLC and GC dual mass spectrometer detectors, called “HPLC-qqq”, “GC-qqq,” or just triple quads.

As non-lab people, we envision a laboratory that can take a cannabis sample, inject it into a triple quad and have the machine quickly and effortlessly print out a report of pesticide values. Unfortunately, this is far from reality. The process is much more hands on and complex.In the current chemistry lab, trained analysts have to first program the triple quads to look for the pesticides of concern; in cannabis pesticide testing, this is done by programming the first of two mass spectrometers to identify a single (precursor) mass that is characteristic of the pesticide in question. For BCC requirements in California, this has to be done for all 66 pesticides, one at a time.

Next, these precursor ions are degraded into secondary chemicals called the “product” ions, also called transition ions. The second of the two mass spectrometers is used to analyze these transition ions. This process is graphed and the resulting spectrum is analyzed by trained chemists in the lab, pesticide by pesticide, for all the samples processed that day. If the lab analyzes 10 samples, that translates to 660 spectra to analyze (66 pesticides x 10 samples). When looking at the spectra for each pesticide, the analysts must compare the ratios of the precursor ions to the product ions.

Confirmation Testing

If these spectra indicate a given pesticide may be present, the chemists must then compare the ratios between the precursor and the products. If these ratios are not what is expected, then the analyst must perform confirmation testing to prove the precursor mass either is or is not the pesticide of concern. If the ratios are not what is expected, it means the molecule is similar to the pesticide in question, but may not be that pesticide. This confirmatory testing is key to producing accurate results and not failing batches when dealing with closely related chemicals. This process of analyzing spectra is done in all labs that are performing pesticide testing. In this fledgling industry, there are few published cannabis pesticide methods. 

The need for this type of confirmation testing doesn’t happen all of the time, but when it does, it will take longer than our targeted three-day turn-around time. In the picture above, one precursor mass is ionized into several product masses; but only two are large enough to be used for comparison. In this hypothetical situation, two product masses are produced for every one precursor, the expected ion abundance ratio should be less than 30%. When performing any confirmatory testing, if the ion abundance ratio is >30%, it means the original precursor molecule was not the pesticide of concern. For example, if the ion abundance ratio was 50%, then the original molecule broke down into too many parts; it was not the pesticide we were looking for. This ion abundance ratio threshold was established by FANCO, the international organization that sets guidelines for all pesticide testing.

Testing Strategies

Methodology: In this fledgling industry, there are few published cannabis pesticide methods. The identification of the precursor mass and product ions are not always published, leaving labs to research which ions should be used. This adds to the potential for differences between lab results. Once selected, labs should validate their research, through a series of experiments to ensure the correct precursor and transition (product) ions are being used in the method.

Sample Preparation: Beyond the time-consuming work that is required to develop sound pesticide methods, the extraction step is absolutely critical for credible results. If the pesticides aren’t fully extracted from the cannabis product, then the results will be lower than expected. Sample preparations are often not standardized between labs, so unless a given extraction technique is validated for accuracy, there is the possibility for differences between labs.

Getting a Representative Sample

The current California recommended amount of sample is one gram of product per batch. Batch sizes can vary greatly and it is entirely likely that two different one gram samples can have two different results for pesticides. Has the entire plant been evenly coated with exactly the same amount of pesticide onto every square inch of its leaves? No, probably not. That is why it is imperative to take a “random” sample, by taking several smaller samples from different areas of the entire batch.

Sampling Plans: We can learn a lot from the manufacturing and sampling best practices developed by the food industry through the years. If a food manufacturer is concerned with the possibility of having a bacteria pathogen, like Salmonella, in their finished product, they test the samples coming off their production lines at a statistically relevant level. This practice (theory) is called the sampling plan and it can easily be adapted to the cannabis industry. The basic premise is that the more you test, the higher your likelihood of catching a contaminate. Envision a rectangular swimming pool, but instead of water, it’s filled with jello. In this gelatinous small pool, 100 pennies are suspended at varying levels. The pennies represent the contaminates.

Is the pool homogenized? Is jello evenly represented in the entire pool? Yes. 

Is your concentrate evenly distributed in the extraction vessel? Yes. The question is, where are the pennies in that extraction vessel? The heavy metals, the microbial impurities and the pesticides should be evenly distributed in the extraction vessel but they may not be evenly represented in each sample that is collected. Unfortunately, this is the bane of the manufacturing industry and it’s the unfortunate reality in the food industry. If you take one random cup of jello, will you find the penny? Probably not. But it you take numerous 1 cup samples from random areas within the batch, you increase your chances of finding the contaminate. This is the best approach for sampling any cannabis product.

The best way to approve a batch of cannabis product is to take several random samples and composite them. But you may need to run several samples from this composite to truly understand what is in the batch. In the swimming pool example, if you take one teaspoon scoop, will you find one of the pennies? The best way to find one of the pennies is to take numerous random samples, composite them and increase the number of tests you perform at the lab. This should be done on any new vendor/cultivator you work with, in order to help establish the safety of the product.

Two Recalls Hit California Cannabis Market

By Aaron G. Biros
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Just weeks ago, the first voluntary cannabis product recall occurred under California’s new regulations. According to an article on MJBizDaily.com by John Schroyer, the recall for their vaporizer cartridges affects almost 100 dispensaries in California.

Bloom Brands, the company issuing the voluntary recall, mentioned in a press release that batches sold between July 1-19, 2018 were contaminated with the pesticide Myclobutanil and therefore does not meet the Bureau of Cannabis Control (BCC) standards. Below is an excerpt from the press release:

We are working closely with the BCC to remedy this issue and expect clean, compliant products to be back on shelves in three weeks…. At Bloom, we are continuing to work with the BCC and other partners to ensure that the space is properly regulated and safe for all customers. Transparency and safety remain our top concerns and we will provide updates as additional information becomes available. We apologize for any concern or inconvenience this serious misstep has caused. We thank you for your continued trust and confidence in our products.

Then, just days later, Lowell Herb Co. issued a voluntary recall on their pre-rolls. First reported by MJBizDaily.com, it appears the products initially passed multiple lab tests and was cleared for retail sales. Weeks after the batch passed tests, a laboratory reversed its decision, saying the products failed to pass the state’s testing standards. The contaminant in question was not mentioned.

The CCIA post calling out the BCC
The CCIA post calling out the BCC

Many seem to think these recalls are a product of the BCC’s unrealistic expectations in their lab testing rules. In a Facebook post days ago, the California Cannabis Industry Association called out the BCC for their unworkable rules. “The BCC has set testing standards that are nearly impossible to meet,” reads the post. “As a result recalls like this will be the norm and the industry will suffer a bottleneck in supply. Testing standards need to be realistic, not impossible.”

On July 13, California issued the first draft of their proposed permanent regulations, which would update and change the current emergency regulations. The proposed action levels for a batch to pass a pesticide test can be found on pages 105 and 106. The state’s regulatory bodies are holding public meetings on the proposed rules throughout August and stakeholders can also submit comments via email.

labsphoto

EVIO Labs Expands Ahead of California Testing Deadline

By Aaron G. Biros
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labsphoto

In a few short weeks, the regulations in California’s cannabis market will expand to include more laboratory testing. The previous exemption for selling untested product will be eliminated come July 1st, meaning that every product on dispensary shelves will have to be tested for a number of contaminants.

EVIO labs photo
Pesticide testing, expanded residual solvent testing and foreign materials testing will be added come July 1st.

According to William Waldrop, chief executive officer and co-founder of EVIO Labs, the state is currently finalizing a revision to the existing emergency rules, which is designed to target the potential supply bottleneck situation. “To help alleviate the bottleneck, the state is eliminating the field duplicate test on every batch of cannabis or cannabis products,” says Waldrop. “This will give the labs additional bandwidth to process more batches for testing.” So one test per batch is the rule now and batch sizes will remain the same. This, of course, is contingent on the state finalizing that revision to the emergency regulations.

William Waldrop, chief executive officer and co-founder of EVIO Labs
William Waldrop, chief executive officer and co-founder of EVIO Labs

In addition to that change, the state will expand the types of testing requirements come July 1st.  New mandatory pesticide testing, expanded residual solvent testing and foreign materials testing are added in addition to the other tests already required.

With July 1st quickly approaching, many in California fear the rules could lead to a major market disruption, such as the previously mentioned bottleneck. Waldrop sees the elimination of duplicate testing as a preventative measure by the state. “It is a good move for the industry because it allows labs to test more batches, hopefully reducing the bottleneck come July,” says Waldrop. Still though, with only 26 licensed laboratories in the state as of March, testing facilities will have to meet higher demand, performing more tests and working with more clients.

EVIO Labs is preparing for this in a number of ways. They already have a lab in Berkeley and are working to expand their capacity for more analyses. In addition to their lab in Berkeley, the company is working to get three more locations operational as quickly as possible. “Right now, EVIO Labs is expanding through the identification of new market locations,” says Waldrop. “We have announced the acquisition of a facility in Humboldt and we are outfitting it for state-mandated testing. We have secured a location in LA, and licensing for LA just began as of June 1stso we are going through the local licensing process at this time. We are still moving through the licensing process for our facility in Costa Mesa as well.”

EVIO Labs photo
Labs will soon have to deal with higher demand, meaning more samples and more clients

“In the meantime, we have expanded capacity of personnel in our Berkeley facility to support our client base until these other locations come online,” says Waldrop. “We are refining our business, bringing on additional equipment and more resources.” While the rules haven’t been implemented yet, Waldrop says he’s seen an uptick in business with licensed operators requesting more testing for the new July 1st standards.

While some might feel a bit panicky about how the new standards could disrupt the market, Waldrop says his clients are looking forward to it. “Our clients are very happy with the proposed new rules, because it reduces the cost of testing per batch, which will inherently reduce wholesale costs, making cannabis more affordable for patients and recreational users.”

Supplier Quality Audits: A Critical Factor in Ensuring GMP Compliance

By Amy Scanlin
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Editor’s Note: This is an article submission from the EAS Consulting Group, LLC team.


To Audit, or not to audit? Not even a question! Audits play a crucial role in verifying and validating business practices, ensuring suppliers are meeting their requirements for Good Manufacturing Practices (GMPs), and most importantly, protecting your interests by ensuring that you consistently receive a compliant and quality product. Audits can help ensure sound business procedures and quality systems, including well-established SOPs, verification and documentation of batch records, appropriate sanitation practices and safe storage and use of ingredients. Audits can also identify deficiencies, putting into motion a corrective action plan to mitigate any further challenges. While a detailed audit scheme is commonplace for established industries such as food, pharmaceuticals and dietary supplements, it is equally important for the cannabis industry to ensure the same quality and safety measures are applied to this budding industry.

If the question then is not whether to audit, perhaps the question is how and when to audit, particularly in the case of a company’s suppliers.This is an opportunity to strengthen the working relationship with each side demonstrating a commitment to the end product.

Supplier audits ensure first and foremost that the company with which you have chosen to work is operating in a manner that meets or exceeds your quality expectations – and you should have expectations because ultimately your product is your responsibility. Any issues that arise, even if they are technically the fault of a supplier, become your issue, meaning any enforcement action taken by your state regulators will directly impact your business. Yes, your supplier may provide you with a batch Certificate of Analysis but you should certify their results as well.

Audits are a snapshot of a moment in time and therefore should be conducted on a regular basis, perhaps biennially or even annually, if they are a critical supplier. In some cases, companies choose to bring in third-party auditors to provide an objective assessment of suppliers. This is especially helpful when the manufacturer or customer does not have the manufacturing, compliance and analytical background to accurately interpret data gathered as part of the audit. With the responsibility for ensuring ingredient identity and product integrity falling on the manufacturer, gaining an unbiased and accurate assessment is imperative to reducing the risk to your business.

Conducting a supplier audit should be well planned in advance to ensure both sides are ready. The audit team must be prepared and able to perform their duties via a combination of education, training and experience. A lead auditor will oversee the team and ultimately will also oversee the results, verifying all nonconformities have been properly identified. They will also work with the supplier to conduct a root cause analysis for those nonconformities and develop a corrective action plan to eliminate them from occurring in the future. The audit lead will also verify follow-up results.

Auditors should discuss with the supplier in advance what areas will be observed, what documentation will need to be ready for review and they should conduct their assessments with professionalism. After all, this is an opportunity to strengthen the working relationship with each side demonstrating a commitment to the end product.This is your chance to ensure your suppliers are performing and will meet your business, quality and product expectations.

Auditors must document that ingredient identity and finished product specifications are verified by test methods appropriate for the intended purpose (such as a whole compound versus a powder). State regulations vary so be certain to understand the number and types of required tests. Once the audit is complete and results are analyzed, you, the manufacturer, have an opportunity to determine if the results are acceptable. Remember, it is your product, so ultimately it is your responsibility to review the available data and release the product to market, you cannot put that responsibility on your supplier.

Quality Agreements as Part of a Business Agreement

There are opportunities to strengthen a partnership at every turn, and one way to set a relationship on the right path is to include a quality agreement as part of a business agreement. A quality agreement lays out your expectations for your suppliers, what you are responsible for and is a living document that, once signed, demonstrates their commitment to upholding the standards you expect. Just as with a business agreement, have any quality agreements reviewed by an outside expert to ensure the wording is sound and that your interests are protected. This is just another step in the development of a well-executed business plan and one that solidifies expectations and provides consequences when those expectations are not met.

Supplier audits must be taken seriously as they are opportunities to protect your brand, your business and your consumers. Enter into an audit as you would with any business endeavor – prepared. This is your chance to ensure your suppliers are performing and will meet your business, quality and product expectations.

Colorado Issues Recall, Pesticides Found In Cannabis

By Aaron G. Biros
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Last week, the Colorado Department of Revenue (DOR), the Colorado Department of Agriculture (CDA) and the Colorado Department of Public Health and Environment (CDPHE) announced a health and safety advisory for a large number of cannabis products grown and produced by Tree of Wellness Inc., doing business as Tree of Wellness. The health and safety advisory, synonymous with a product recall, was issued due to the detection of off-label pesticides in cannabis grown by Tree of Wellness.

Tests found Myclobutanil present in batches going all the way back to May, 2017, with some contaminated batches as recent as late October.

According to the press release, the CDA confirmed the presence of Myclobutanil, a near-ubiquitous fungicide used in a wide range of agricultural practices. The chemical has been a thorn in the side of the cannabis industry for being used off-label, or inappropriately, on cultivating cannabis.

Here are the batch numbers included in the recall

Myclobutanil is the active ingredient in Eagle 20, a pesticide used frequently in other agricultural fields like grapes, apples and spinach. According to UC Davis professor and Steep Hill scientist Dr. Don Land, Myclobutanil becomes significantly more dangerous when heated, or smoked. That chemical reaction produces hydrogen cyanide, an extraordinarily toxic chemical. Because of this, and the lack of research on what happens when these chemicals are burned or heated, there is a growing public concern that cannabis laced with a chemical like Myclobutanil can cause adverse health reactions.

The public health and safety advisory says they detected Myclobutanil in cannabis flower, trim, concentrates, and infused-products from Tree of Wellness. The CDPHE and DOR recommend consumers that have the affected products return them to where they were purchased for proper disposal.

Consumers in Colorado should check their labels to see if their products fall under the recall. Look for the Medical Optional Premises Cultivation License 403-00664 and/or Medical Marijuana Center License 402-00443. The recall includes batches of 23 different strains grown by Tree of Wellness.

Canadian Company Recalls Contaminated Cannabis

By Aaron G. Biros
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Broken Coast Cannabis Ltd., a cannabis business located on Vancouver Island, issued a voluntary recall of three cannabis lots due to the detection of pesticides. According to the safety alert published on Health Canada’s website, the voluntary Type III recall follows an inspection of the facility back in March of this year.

A Type III recall means those products are not likely to cause negative health effects. Sampling of those three cannabis lots found a cannabis oil product in July to contain low levels of Myclobutanil and Spinosad.

Upon further testing, a cannabis leaf sample was found to contain 0.017 parts-per-million of Myclobutanil. A third party laboratory confirmed the presence of that fungicide, leading them to recall three lots of dried cannabis sold between July and December of 2016, according to that safety alert.

Spinosad, an insecticide, and Myclobutanil, a fungicide, are not authorized for use with cannabis plants per the Pest Control Products Act, however they are approved for use in food production. The health risks of ingesting either of those two chemicals are well documented. “Health Canada has not received adverse reaction reports related to Broken Coast Cannabis Ltd.’s products sold affected by the recall,” reads the safety alert. “Health Canada recommends that any individual affected by the recall immediately stop using the recalled product and to contact Broken Coast Cannabis Ltd., at the following number 1-888-486-7579.”

OHA Addresses Oregon Growing Pains, Changes Testing Rules

By Aaron G. Biros
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Last week, the Oregon Health Authority (OHA) published a bulletin, outlining new temporary testing requirements effective immediately until May 30th of next year. The changes to the rules come in the wake of product shortages, higher prices and even some claims of cultivators reverting back to the black market to stay afloat.img_6245

According to the bulletin, these temporary regulations are meant to still protect public health and safety, but are “aimed at lowering the testing burden for producers and processors based on concerns and input from the marijuana industry.” The temporary rules, applying to both medical and retail products, are a Band-Aid fix while the OHA works on a permanent solution to the testing backlog.

Here are some key takeaways from the rule changes:

Labeling

  • THC and CBD amounts on the label must be the value calculated by a laboratory, plus or minus 5%.

Batch testing

  • A harvest lot can include more than one strain.
  • Cannabis harvested within a 48-hour period, using the same growing and curing processes can be included in one harvest lot.
  • Edibles processors can include up to 1000 units of product in a batch for testing.
  • The size of a process lot submitted for testing for concentrates, extracts or other non-edible products will be the maximum size for future sampling and testing.

    Oregon Marijuana Universal Symbol for Printing
    Oregon Marijuana Universal Symbol for Printing

Sampling

  • Different batches of the same strain can be combined for testing potency.
  • Samples can be combined from a number of batches in a harvest lot for pesticide testing if the weight of all the batches doesn’t exceed ten pounds. This also means that if that combined sample fails a pesticide test, all of the batches fail the test and need to be disposed.

Solvent testing

  • Butanol, Propanol and Ethanol are no longer on the solvent list.

Potency testing

  • The maximum concentration limit for THC and CBD testing can have up to a 5% variance.

Control Study

  • Process validation is replaced by one control study.
  • After OHA has certified a control study, it is valid for a year unless there is an SOP or ingredient change.
  • During the control study, sample increments are tested separately for homogeneity across batches, but when the control study is certified, sample increments can be combined.

Failing a test

  • Test reports must clearly show if a test fails or passes.
  • Producers can request a reanalysis after a failed test no later than a week after receiving failed test results and that reanalysis must happen within 30 days.
Gov. Kate Brown Photo: Oregon Dept. of Transportation
Gov. Kate Brown
Photo: Oregon Dept. of Transportation

The office of Gov. Kate Brown along with the OHA, Oregon Department of Agriculture (ODA) and Oregon Liquor Control Commission (OLCC) issued a letter in late November, serving as a reminder of the regulations regarding pesticide use and testing. It says in bold that it is illegal to use any pesticide not on the ODA’s cannabis and pesticide guide list. The letter states that failed pesticide tests are referred to ODA for investigation, which means producers that fail those tests could face punitive measures such as fines.

Photo: Michelle Tribe, Flickr
Photo: Michelle Tribe, Flickr

The letter also clarifies a major part of the pesticide rules involving the action level, or the measured amount of pesticides in a product that the OHA deems potentially dangerous. “Despite cannabis producers receiving test results below OHA pesticide action levels for cannabis (set in OHA rule), producers may still be in violation of the Oregon Pesticide Control Act if any levels of illegal pesticides are detected.” This is crucial information for producers who might have phased out use of pesticides in the past or might have began operations in a facility where pesticides were used previously. A laboratory detecting even a trace amount in the parts-per-billion range of banned pesticides, like Myclobutanil, would mean the producer is in violation of the Pesticide Control Act and could face thousands of dollars in fines. The approved pesticides on the list are generally intended for food products, exempt from a tolerance and are considered low risk.

As regulators work to accredit more laboratories and flesh out issues with the industry, Oregon’s cannabis market enters a period of marked uncertainty.

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Labeling Cannabis Products is a Booming Market

By Marsha Frydrychowski
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Legal marijuana sales are expected to hit $6.7 billion in 2016, with the market expected to climb to $21.8 billion in sales by 2020. As legal cannabis sales rise, cannabis labels are quickly becoming one of the fastest growing markets for label manufacturers.

An Industry Gaining Legitimacy

Since California first legalized medical cannabis in 1996, the cannabis industry has grown considerably. Voters in four states legalized recreational cannabis last week on Election Day, including California, which is currently the world’s 6th largest economy. Voters in another four states legalized medical cannabis as well, bringing the total to 28 states with some form of legalization measure.

The market is moving ahead and will not be limited to small businesses and dispensaries either. Already, more than 50 publicly traded companies have blitzed the market, including pharmaceuticals, medical growers and even major tech companies.

An example of a cannabis flower label in Oregon with all of the required information.
An example of a cannabis flower label in Oregon with all of the required information.

What’s more, public support for full cannabis legalization is at an all-time high 61 percent, according to a recent survey from the AP-NORC Center for Public Affairs Research. The market is here to stay.

Cannabis flower labels

Legal cannabis has primarily consisted of dispensaries selling cannabis flower or leaves (ready-to-smoke marijuana) in pouches or childproof containers. Regulations have essentially required two cannabis labels for the pouches: a branded label on the front and a regulatory label on the back. Many dispensaries also use pre-printed pouches.

Similar to the way alcohol labels must contain information for alcohol content, the informational labels that sit on the backs of pouches are legally required to provide certain accurate information, including:

The universal symbol required on all cannabis products in Colorado
The universal symbol required on all cannabis products in Colorado
  • THC %
  • CBD %
  • Net weight in grams
  • Lab name and test number confirmation
  • Batch number
  • Date tested
  • Strain name
  • Warning Label

And cannabis flower labels are just the beginning. Many smoke-free product categories are emerging with similar labeling requirements. These often allow for increased branding opportunities that will afford better profit margins for label suppliers. Some of the many products in this young category include:

  • Edibles — such as dark chocolates, baked goods, snack crackers and teas infused with cannabis.
  • Topicals — such as pain-relieving lotions and creams.
  • Tinctures — cannabis-infused oils that are applied in drops to the tongue.

Bottom line: For label and packaging suppliers, cannabis represents one of the fastest growing market opportunities today and the opportunities extend way beyond labeling for the flower itself.

Managing Compliance

As more and more states move toward legalization and regulation, uneven laws in different states are increasingly governing the market. Businesses must respond to ever-changing requirements, including labeling standards. While many dispensaries have gotten away with minimalist labels, states are increasingly demanding dispensaries meet more stringent legal requirements. For example, Oregon passed new labeling requirements this year and products that failed to meet them by October 1, 2016 were not allowed on store shelves.

Label suppliers entering the market must keep abreast of the changing regulations and be able to help brands navigate them. They need to work to understand the intricacies of this new market, rather than simply looking to redirect the capabilities they already possess. See the original post here.