This article explores a few of the evolving industry standards, customs, and practices percolating throughout the cannabis vapor industry.
Industry standards are generally accepted requirements or business customs followed by members in an industry. From a marketing perspective, adhering to industry standards is critical to demonstrate that your products are mechanically and electronically safe as well as properly-designed (e.g., “xyz certified”). And from a litigation perspective, complying with industry standards or customs is vital to show the jury that your company was not negligent in designing or manufacturing your products. The jury wants to know that your company followed the “rules”—because people like companies that follow rules.
Focusing on the cannabis vapor industry here, while industry standards and customs have not been cemented just yet, as the space is dynamic, best practices and industry standards are slowly developing. With that in mind, here are a few recommendations every Vaporizer Device Manufacturer (“VDM”) should consider when designing and manufacturing their products. (For purposes of this article, VDMs are defined as manufacturers of vaporizer pens, pods, mods, pod-mods, batteries, and vaporizer cartridges, including any component parts.)
Emissions testing is now standard in the nicotine, e-cigarette market and will become standard in the cannabis space. For vaporizer devices, emissions testing checks for pesticides, heavy metals, or toxic chemicals that may materialize from the atomizer, ceramic coil, or cannabis oil through the vapor process. While there are various ways to conduct the testing, the goal is simple: connect the vaporizer device to a machine that mimics inhalation (sometimes called a “puffing box”), and analyze what is inhaled using standard laboratories procedures.
Why this is important: 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, investigators at the FDA believe the use of vitamin E acetate in cannabis oil caused mass pulmonary illness to thousands of consumers. Through a process known as pyrolysis, one 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.
VDMs need to know how their vaporizer devices will interact with certain cannabis oil formulations and additives. To that end, VDMs should conduct emissions testing to properly evaluate what temperature settings their vaporizer devices can be used with when paired with specific types of cannabis oil formulations and additives. Proper warnings and instructions should be detailed in the owner’s manual.
(Side Note: VDMs should always test vaporizer devices for the presence of heavy metals such as arsenic, cadmium, lead, and mercury. (The California Bureau of Cannabis Control mandates heavy metals testing for vaporizer devices.)
Plagued by “exploding” vape cases in the early 2010s, allegedly caused by defective lithium-ion battery designs, the industry reacted with simple design changes that VDMs should consider implementing. The vaporizer device should require a sequence of multiple button presses to activate (or better yet, activate by auto-draw) so it does not activate in a user’s pocket. VDMs should also consider a time-out function on their vaporizer devices that stops discharge after 10 seconds if the activation button is held continuously or if the auto-draw last too long. These simple features can prevent overheating and possible battery fires.
(Side Note: While not mandatory, VDMs should strive to comply with UL 8139, a standard for e-cigarette battery safety. UL 8139 applies to all vaporizer devices, and VDMs in the cannabis space should voluntarily comply.)
The manufacturing and assembly of vaporizer devices should be performed in a clean room environment in accordance with current Good Manufacturing Practices (cGMP). This should include, among many others, establishing robust operating procedures, investigating product quality deviations, and maintaining reliable testing laboratories. Compliance helps prevent hardware contamination, deviations, and product failures. VDMs should consider getting cGMP certified by a major accreditation body (e.g., the American Association for Laboratory Accreditation).
Why this is important: Under the federal Food, Drug & Cosmetic Act, the FDA regulates the manufacture and sale of dietary supplements, food and beverage, cosmetics, and pharmaceutical products by requiring compliance with cGMPs. With authority under the federal Agriculture Improvement Act of 2018 to regulate CBD, expect the FDA to similarly require CBD companies to comply with cGMPs in the near future. And while THC is not legalized at the federal level, most state regulations (like Florida) will or do require cannabis producers, including VDMs, to conform with cGMPs.
Unfortunately, counterfeit products run rampant in the cannabis space—especially in the vaporizer device market. There is a good chance, for example, that the CCell cartridge you are using is fake. And because that cartridge is counterfeit, it most likely contains lead, heavy metals, or other contaminants. Because of this well-known problem, VDMs should use anti-counterfeiting ink technology on their products.
Sometimes referred to as “invisible ink,” anti-counterfeiting ink uses ink that is undetectable unless illuminated by a specific wavelength of light. From a liability and quality control perspective, it is important to know whether it was the VDM’s vaporizer device that allegedly failed, or if the product at issue is counterfeit. Anti-counterfeiting ink allows VDMs to trace their products through the supply chain, and can allow VDMs to accurately identify faulty products—especially if the product is the subject of litigation.
Michael Preciado is a senior litigator in the Orange County office of Buchalter. He is a member of the firm’s Cannabis & Hemp Industry Law Group, and helps clients navigate the legalities in the vapor, e-cigarette, cannabis, and CBD industries. (Contact Mike at [email protected])