Tag Archives: vaping

The Future of Vape Litigation: Temperature Control

By Michael Preciado
No Comments

The e-cigarette or vaping use-associated lung injury (EVALI) outbreak of 2019 caught the attention of many, and has brought with it the scrutiny of both regulators and plaintiffs’ attorneys eager to act as “civil prosecutors.” As Tolkien would say, the Eye of Sauron has now turned its gaze towards the cannabis vapor industry.

With the misinformation and negative publicity that the EVALI outbreak brought to the industry, vaporizer device manufacturers should expect more lawsuits to be filed against them through 2020 and beyond. The cannabis vapor industry should also expect the theories of defect alleged against their products to become more sophisticated as more plaintiffs’ attorneys enter the arena.

One theory of defect you should expect plaintiff’s attorneys to pursue in 2020 is what I generally refer to as “temperature control litigation.”

These pre-filled cartridges are compatible with just about any battery because of the universal 5/10 thread connectors.

Here is the problem:

Typical additives in cannabis oil, while once thought to be safe, can degrade at higher temperatures into toxic chemicals. For example, the Vape Crisis of 2019 was largely attributed to a cannabis oil additive known as vitamin E acetate. While typically regarded as safe for use in nutritional supplements or hand creams, when used in cannabis oil, investigators believe vitamin E acetate can degrade into a toxic chemical when vaped—and is responsible for causing mass pulmonary illness for thousands of consumers.

Researchers do not fully understand how this process occurs, but chemists from the Royal College of Surgeons in Ireland found in a recent study that the key is understanding how temperatures affect chemicals when vaping. Through a process known as pyrolysis, the study found that vitamin E acetate can possibly degrade into ketene when vaped at higher temperatures—depending on the type of coil resistance, voltage and temperature configuration used in a vaporizer device. (Ketene has a high pulmonary toxicity, and can be lethal at high concentrations, while low concentrations can cause central nervous system impairment.) Similar studies have also shown that additives like Propylene Glycol (PG), Vegetable Glycerin (VG), and Polyethylene Glycol (PEG) can degrade into toxic chemicals at high temperatures—which has led Colorado to ban the use of PEG for inhalable cannabis products altogether.

More shocking, is that such temperature control issues are not limited to additives. It is very common for experienced users to experiment with low to high temperatures when vaping cannabis; it is believed that vaping cannabis at low temperatures (325-350°F) results in a mild high, while vaping cannabis at higher temperatures (400-430°F) results in a more euphoric feeling and intense high. But when cannabis is vaped at even higher temperatures (450°F +), industry experts do not really know if or how cannabinoids and terpenes degrade, which combinations of cannabinoids and terpenes affect degradation and what the health risks could be. It’s anyone’s guess.

Cheap batteries with the universal 5/10 thread can heat the product at inconsistent temperatures, raising safety and quality concerns

These temperature control issues are further complicated due to the universal 5/10 thread. Most consumers purchase cannabis oil through pre-filled “carts” (cartridges)—that are compatible with 90% of vaporizer batteries on the market because of universal 5/10 thread connectors. But vaporizer batteries can operate anywhere from sub-300 degrees to 800 degrees and above. Coupled with varying battery voltages, ceramic coil quality and oil quality, vaporizer batteries can produce a wide range of operating temperatures. Consequently, it is possible users could connect a cart to a vaporizer battery (set at too high a temperature configuration) and risk pyrolysis, change the chemicals inside their cannabis cart, and cause unknown harm to themselves.

Unquestionably, all of the above will result in lawsuits. Companies that manufacture cannabis oil will be sued for failing to conduct emissions testing to properly evaluate safe temperature settings for use of their carts. Vaporizer device manufacturers will be sued for failing to publish warnings, instructions and adequate owner’s manuals regarding the same. And the rallying cry against the cannabis vapor industry will be damaging. Plaintiff’s attorneys will accuse the industry of choosing profits over safety: “The cannabis vapor industry knew cannabis oils could turn into toxic chemicals when heated at high temperatures, but instead of conducting long-term emissions testing to evaluate those concerns, the industry chose profits over safety. As long as the industry made money, no one cared what dangers arose from elevated temperatures—and consumers paid the price.”

With the above as background, it is critical for the cannabis vapor industry to get serious about product testing. The industry needs to know if and why certain cannabinoids, terpenes and additives can turn into toxic chemicals when they are vaporized at high temperatures—and how the industry can guard against such dangers. And to cover their bases, the industry needs to publish proper warnings and owner’s manuals for all products. The time to act is now.

HACCP

HACCP for Cannabis: A Guide for Developing a Plan

By Radojka Barycki
1 Comment
HACCP

Hazard Analysis and Critical Control Points (HACCP) is a systematic approach that evaluates hazards that may potentially be present in food products that can harm the consumer. The process used to manufacture the product is evaluated from raw material procurement, receiving and handling, to manufacturing, distribution and consumption of the finished product1. The documented process is what is known as HACCP plan. Although HACCP was designed to evaluate hazards in foods, it can be used to assess or evaluate hazards that may potentially be present in cannabis consumable products (edibles and vaping) that can cause harm to the consumer.

HACCP plan development requires a systematic approach that covers 5 preliminary steps and 7 principles. A systematic approach means that each step must be followed as outlined. Skipping a step will result in a HACCP plan that most likely will be ineffective to control potential hazards in the product.

The 5 preliminary steps are:

  1. Establish a HACCP team
  2. Describe the product
  3. Establish the intended use of the product
  4. Develop a flow diagram
  5. Verify the flow diagram

The 7 Principles are:HACCP

  1. Conduct a hazard analysis
  2. Identify the critical control points (CCPs)
  3. Establish critical limits (CL)
  4. Establish monitoring procedures
  5. Establish corrective actions
  6. Establish verification procedures
  7. Establish records and record keeping procedures1,2

It is important to mention that HACCP plans are supported by programs and procedures that establish the minimum operational and sanitary conditions to manufacture safe products. These programs and procedures are known as pre-requisite programs (PRP) or preventative controls1,2.

Figure 1. Flow Diagram

A multidisciplinary team must be established in order to ensure that all inputs of the product manufacturing process are considered during the hazards analysis discussions. The description of the product and its intended use provides detail information on ingredients, primary packaging material, methods of distribution, chemical characteristics, labeling and if any consumer might be vulnerable to the consumption of the product. A verified flow diagram is an accurate representation of the different steps followed during the product manufacturing process and will be used to conduct a hazard analysis. An inaccurate flow diagram will set the stage for an inadequate HACCP plan. Therefore, it is important that the HACCP team members verify the flow diagram. Figure 1 is a flow diagram for a fictional infused apple juice manufacturing plan that I will be using as an example.

The hazard analysis is the backbone of the HACCP plan. There are two elements that must be considered when conducting the hazard analysis:

  • Identification of the hazard associated with the ingredient(s) and/or the product manufacturing steps. These hazards have been categorized as: Biological, chemical (including radiological) and physical. Biological, chemical and physical hazards should be considered for each ingredient, primary packaging and process step. Also, it is important that the team is specific as to what hazard they are referring to. I often find that biological hazards are identified as “pathogens” for example. The team has to be specific on which pathogen is of concern. For example, if you are processing apple juice, the pathogens of concern are pathogenic coli and Salmonella sp. However, if you are processing carrot juice, you need to add Clostridium botulinum as a biological hazard also. If the choice of method to eliminate the hazards is pasteurization for example, the processing temperature-time combinations will differ greatly when manufacturing the apple juice vs. the carrot juice as C. botulinum is an organism that can sporulate and, therefore, is harder to kill.
  • Characterization of the hazard. This implies determining the significance of the potential hazard based on the severity of the consequence if it is consumed and the likelihood of occurrence in the ingredient or process step. Only steps in the process that has significant hazards should be considered further.
Table 1. Ingredient Hazard Analysis

In my professional experience, the hazard analysis is one of the most difficult steps to achieve because it requires the expertise of the multidisciplinary team and a lot of discussion to get to the conclusion of which hazard is significant. I find that a lot of teams get overwhelmed during this process because they consider that everything in the process may represent a hazard. So, when I am working with clients or providing training, I remind everyone that, in the bigger scheme of things, we can get stricken by a lighting in the middle of a thunderstorm. However, what will increase our chances would be whether we are close or not to a body of water for example. If I am swimming in the middle of a lake, I increase my chances to get stricken by the lighting. In comparison, if I am just sitting in my living room drinking a cup of coffee during the thunderstorm, the likelihood of being stricken by a lighting is a lot less. The same rationale should be applied when conducting the hazard analysis for manufactured products. You may have a hazard that will cause illness or death (high on the severity chart) but you also may have a program that mitigates the likelihood of introducing or having the hazard. The program will reduce the significance of the hazard to a level that may not need a critical control point to minimize or eliminate it.

Table 2. Process Hazard Analysis (1)

Clear as mud, right? So, how would this look like on the infused apple juice example? Table 1 shows the hazard analysis for the ingredients. Tables 2 and 3 show the hazard analysis for the part of the process. In addition, I have identified the CCPs: Patulin testing and pasteurization. There is a tool called the CCP decision tree that is often used to determine the CCPs in the process.

Once we have the CCPs, we need to establish the critical limits to ensure that the hazard is controlled. These limits must be validated. In the case of Patulin, the FDA has done several studies and has established 50 ppm as the maximum limit. In the case of pasteurization, a validation study can be conducted in the juice by a 3rd party laboratory. These studies typically are called thermal death studies (TDS) and provide the temperature and time combination to achieve the reduction of the pathogen(s) of concern to an acceptable level that they do not cause harm. In juice, the regulatory requirement is a 5-log reduction. So, let’s say that the TDS conducted in the infused apple juice determined that 165°F for 5 seconds is the critical limit for pasteurization. Note that the 5 seconds will be provided by the flow of the product through the holding tube of the pasteurizer. This is measured based on flow in gallons per minute.

Table 3. Process Hazard Analysis (2)

Monitoring is essential to ensure that the critical limits are met. A monitoring plan that outlines what, how, when and who is responsible for the monitoring is required.

Ideally, the system should not fail. However, in a manufacturing environment, failures can happen. Therefore, it is important to pre-establish steps that will be taken to ensure that the product is not out of the control of the facility in the event of a deviation from the HACCP plan. These steps are called corrective actions and must be verified once they are completed. Corrective actions procedures must address the control of the product, investigation of the event, corrective actions taken so the deviation doesn’t reoccur and product disposition.

Table 4. HACCP Plan Summary

Verification activities ensure that the HACCP plan is being followed as written. Typically, verification is done by reviewing the records associated with the plan. These records include but are not limited to monitoring records, calibration records, corrective action records, and preventive maintenance records for equipment associated with the CCPs. Record review must be done within 7 working days of the record being produced.

Finally, establishing records and record keeping procedures is the last step on developing HACCP plans. Records must be kept in a dry and secure location.

Table 4 show the summary of the HACCP plan for the infused apple juice example.

For more information on how to develop a HACCP plan for your facility, read the resources below:

  1. HACCP Principles and Application Guidelines – The National Advisory Committee on Microbiological Criteria for Foods (NACMCF)
  2. ASTM D8250-19: Standard Practice for Applying a Hazard Analysis Critical Control Points (HACCP) Systems for Cannabis Consumable Products

How to Protect Your Business from the Emerging Vaping Crisis

By Tom BeLusko, Kelly McCann
No Comments

The year 2020 may become a pivotal year for cannabis operators and service providers, including increased access to financial services, and increased exposure to product liability lawsuits. On a positive note, if enacted, the Secure and Fair Enforcement Banking Act of 2019 (SAFE Banking Act) promises to enable cannabis businesses to gain access to financial services previously unavailable to them, including banking and insurance services. The House of Representatives passed the SAFE Banking Act of 2019 on September 25th, 2019. Skopos Labs, an automated predictive intelligence service, predicts there is a 52% chance of the SAFE Banking Act of 2019 becoming law. A recent discovery that vitamin E acetate is likely the culprit in the vaping-related illness epidemic may increase the exposure to costly litigation that cannabis businesses face.

An uptick in litigation like that currently affecting the vaping industry may soon affect cannabis businesses. More litigation affecting the vaping industry is due in large part to the growing number of lung injuries and deaths linked to vaping. As of November 13th, 2019, the CDC reported 2,172 cases of lung injury, and 42 deaths linked to vaping. The cases of lung injury and death have predictably resulted in an increase in litigation facing the vaping industry. Most of the plaintiffs in these cases allege they became addicted to vaping but at least two lawsuits go further. In one, a Connecticut man alleges that he suffered a massive, debilitating stroke as a result of vaping, while in another the parents of a teenage girl allege in a proposed class action suit that their daughter has suffered seizures linked to vaping. On November 14th, 2019, the CDC identified vitamin E acetate as a chemical of concern among people with vaping use associated lung injury. Vitamin E acetate is an additive commonly used as a cutting agent in vape cartridges. About 86% of individuals who have either vaping-related lung injuries, or died due to vaping had used a product containing THC.

The increase in perceived exposure cannabis businesses face has increased their interest in obtaining insurance, but unfortunately insurers are not always interested in insuring them. There are at least two reasons that getting insurance can be difficult for cannabis businesses: (1) insurance industry appetite for cannabis risk is very low due to its status under federal law and (2) express coverage exclusions or limitations of cannabis exposures from standard-form coverage are becoming more common. However, even if cannabis businesses are able to obtain insurance, their insurance may cover them for far less than they believe.

The product liability coverage (which is increasingly crucial for both growers and manufacturers given the mounting litigation facing the vaping industry) may cover far less than it at first appears. The interplay of exclusions and limited coverages in many cannabis-specific policies may leave a cannabis business uninsured.

It is vital now more than ever to ensure you are properly protected against loss.Crucial for cannabis businesses to appreciate is the distinction between “occurrence” and “claims-made” coverage triggers as it relates to both the premises on which cannabis businesses operate their business, and the products they sell.

Many cannabis businesses have an occurrence-based general liability insurance that might actually exclude: (1) product-liability risks; (2) any tobacco-related risks; and (3) any risk associated with governmental investigation or enforcement. These exclusions oftentimes concern cannabis businesses because there is a high likelihood one of these risks could manifest itself as an uninsured loss. Still, the costs of eliminating these exclusions in an occurrence-based general liability insurance policy is often large, assuming an insurer is willing to eliminate the exclusions on an occurrence basis at all. Therefore, cannabis businesses often pair their general liability insurance policy with a “claims-made” coverage trigger for products liability. Navigating the waters of managing the differences between “occurrence” and “claims-made” forms are best left to a qualified and experienced insurance professional.

Consult a local insurance professional that understands how to help your business become properly protected in what would be considered a tumultuous market for this burgeoning industry.

It is vital now more than ever to ensure you are properly protected against loss. As a first step, you must determine what your current insurance policy does and does not cover. After a loss, it is too late to change policies. Rely upon someone that knows the market of insuring this industry and has deep experience in managing both occurrence and claims-made policies.

Choosing Filling Machinery for CBD and THC Products

By Michelle Pudlo
4 Comments

As the legalization of cannabis continues to spread across the U.S., both THC and CBD products are rapidly growing in popularity, and we can expect that popularity to increase in the coming years. The cannabis industry alone is expected to account for nearly $16.9 billion in revenue this year.

Subsequently, there is a rising need among infused product manufacturers for sufficient filling machinery for CBD and THC products. These products, including CBD oil cartridges, require filling equipment that can provide quick turnaround, detailed parts and simple changeover and cleanup, among other factors. Let’s go over the different types of filling machinery used for these products.

Vial Filling Machines

For small vial packages made of glass, metal or plastic, vial filling machines are available. Often used for a variety of pharmaceutical products, they’re now suitable for filling liquid THC and CBD oil. Vial fillers are also often suitable for filling liquid products of varying viscosity levels, with either the installation of peristaltic pumps or volumetric filling stations.

Rotary Fillers

Rotary fillers can also fill containers at high speeds and with quick turnaround, and are ideal for filling various types and sizes of containers made of materials such as plastic, metal or glass. A good rotary filler will be able to meet the demands of high-speed environments consistently and with accuracy.

Fixed or Variable Volume Cartridge Filling ToolsAs the industry develops more demand for high-quality filling and other types of equipment, more machines are likely to be manufactured or configured specifically with these types of products in mind.

Fixed and variable volume cartridge filling tools often feature a single-handed operation and are used to rapidly fill cartridges for THC and CBD oils used for vaping. With fixed volume fillers, you’ll be able to designate a specific and consistent volume, while variable volume models allow for different fill volumes for applications requiring versatility.

Automatic Fillers

Automatic filling machines will be able to fill a large number of products at varying speed settings, without the need for manual operation. These machines can fill many different types of products with consistency that helps maintain optimal productivity. As with other fillers, automatic fillers are often customizable in a wide variety of configurations.

Filling Syringes

For concentrates, filling syringes are ideal in many cases. Many patients are in need of a specific dosage of oil, and a syringe can allow for accuracy through the inclusion of measurement indicators. Many dispensaries sell syringe units, so this type of packaging method is likely to continue to rise in popularity.

Other Types of Equipment for Liquid Cannabis Packaging

In addition to reliable filling systems, manufacturers should make sure every other aspect of their packaging lines is covered with high-quality equipment. Facilities will require a variety of conveyors to transport products from one end of the line to the other, cleaners to ensure that bottles or other containers are clean prior to filling, and labelers to apply custom labels to packaging, among other machinery.

With one or more of these types of liquid fillers in a facility, companies can maintain accuracy and efficiency throughout their operations when filling CBD or THC products. As the industry develops more demand for high-quality filling and other types of equipment, more machines are likely to be manufactured or configured specifically with these types of products in mind.