Avoiding Another Vape Crisis: How ISO Accreditation by Vape Manufacturers Can Grow Business and Keep Consumers Safe

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Medical cannabis is legal for consumption in dozens of states and U.S. territories, which means millions of Americans can access regulated cannabis for a host of qualifying medical conditions, from cancer to chronic pain to anxiety. And while smoking flower is still the most popular mode of consumption, more consumers are turning to vaping as their cannabis delivery method of choice.

The vape crisis a few years ago sparked a national conversation regarding the safety of vaporizer products. Lung injuries and serious complications were ultimately linked to the presence of vitamin E acetate in cannabis products primarily sold in the illicit market, and it’s also likely that some vaporizers themselves—often cheaply made with inexpensive metal components—were a source of heavy metal contamination also contributing to lung injuries.

As the market continues to expand for medical cannabis (which incidentally has a host of ancillary benefits, like fewer prescriptions written for opioids), I believe we must approach the conversation of vaporizer safety with renewed fervor. If cheaply made vapes continue to be made widely available, there could be serious consequences regarding the health and safety of consumers.

One way for manufacturers and consumers to be certain their vaporizer devices are safe is to look for ISO 13485 accreditation held by vaporizer device and cartridge manufacturers. As I’ll explore in detail, this important accreditation for the makers of medical devices helps ensure the vaporizer was made safely, and, if necessary, allows for consumers and manufacturers to trace and report issues with safety or product quality.

Regulatory Oversight—and Lack Thereof

ISO 13485 is an internationally recognized quality management system (QMS) specific to the manufacture of medical devices. It ensures adherence to a system for adverse event reporting and customer complaints, and that proper controls are in place to detect deviations from good manufacturing practices (GMP). These vital process steps help to keep medical-grade vaporizer cartridges and other vape products free from contamination, which can cause injury to consumers and in particular, medically vulnerable patients.

Without current oversight by the U.S. Food and Drug Administration due to federal cannabis prohibition, many organizations rely on ISO accreditations of all kinds to demonstrate their adherence to GMP and systems that ensure accuracy and quality control. In fact, we here at Trichome Analytical are ISO/IEC 17025:2017 accredited. And in our home state of New Jersey, ISO 13485 accreditation is required for all manufacturers of vape products within the adult use program.

Yet in the rapidly expanding cannabis industry, these important details can get lost in the noise, or brushed aside by bad actors that wish to create and vend products as quickly as possible, especially as new markets open up. What I’ve noticed over the past several months are numerous vape companies that purchase cartridges or other components from third-party manufacturers either totally unaware of this ISO accreditation necessity—or willfully in ignorance of it.

If you own or work for a vape company, especially one that sells products for medical consumption, I urge you to work only with cartridge and device vendors that have earned their ISO 13485 accreditation. It’s a good move not just for patient health and safety, but also to ensure your business remains compliant with New Jersey’s new adult-use regulations.

ISO 13485 Accreditation Affects R&D, Acquisitions and More

As the availability of legal cannabis increases, regulated operators are taking note—and making moves.

There have been several acquisitions and sales agreements between cannabis cultivators / processors and vaporizer manufacturers in recent years, like Canopy Growth’s acquisition of Storz & Bickel in 2018. Other organizations, like Grenco Science and Vapium, are entering into joint relationships to create new and improved vaporizer technology to serve medical markets (and beyond). Still others, like inhalation-technology giants Jupiter Research and Qunuba Sciences, are earning ISO 13485 certifications to position themselves more favorably in a growing medical market with increasing regulatory oversight.

These certifications, acquisitions and joint relationships are smart business moves, and they also help these organizations avoid potential litigation stemming from poorly manufactured or dangerous equipment that harms adult-use consumers or patients.

What’s Next for Medical Device Requirements in the Cannabis Industry?

As more state programs come online for medical or recreational cannabis, I anticipate we’ll see a concurrent rise in states that require medical device-grade manufacturing practices for vape products, like New Jersey already does. In the absence of FDA oversight, these ISO accreditations are a key assurance for organizations that their branded vape products are safe for consumers.

Overall, it’s a good idea for cannabis companies to prepare for FDA oversight by ensuring their QMS meets ISO standards that pertain to their specific business niches, whether it’s ISO 9001 general quality management, ISO 22000 for food safety, ISO 13485 for medical devices or ISO 17025 for testing / calibration.

I also can’t stress enough how important it is for cannabis companies that sell vape products to explore this accreditation and engage only with vaporizer cartridge manufacturers that have taken this important step—it will keep consumers safe, and ensure compliance with impending FDA oversight way ahead of the curve.