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The Future of Device Regulation

Historically, state governments have pioneered the regulation of public health and safety. In fact, over a century ago, they were the key experiment stations across a broad spectrum of regulatory policy domains, including public health, child labor, and workplace and consumer safety. Fast-forward to today and this state-centric, regulatory-building process is replaying before our eyes in the cannabis industry.

But what will the future of cannabis regulation be? The latest FDA guidance on e-Nicotine devices (ENDs) offers one clue (1). According to the guidance, manufacturers of ENDs will be required to i) produce rigorous materials and chemistry characterization of their product, and ii) conduct stability testing across the product’s lifecycle – before gaining commercial approval. 

So, what are the implications for the cannabis industry? 

But if the devices themselves are not properly tested for potentially harmful leachables, how can we be certain of their safety?

For one, we will soon live in a world in which a delivery device in one market sector – tobacco – is subject to the gold standard of safety requirements, while the same device used in another market sector – cannabis – is not. As the saying goes, “only in America.” Today, states require testing of cannabis products for many potentially harmful contaminants. And Colorado recently announced it will also require testing of cannabis vape device aerosols for heavy metals contamination beginning 2022 – an industry first (2).  But if the devices themselves and their components are not properly characterized and, if necessary, tested for potentially harmful leachables, how can we be certain of their safety?

There can be little doubt that the FDA will eventually extend the same requirements to cannabis delivery devices that are to be imposed on ENDs (of all delivery devices, aerosolizers are ranked as having the highest risk by US regulators (3)). In fact, the FDA is already making moves with its recently drafted guidance on quality assurance for cannabis-derived drug candidates, which explicitly references compendial literature mandating toxicological risk assessments (including extractables/leachables profiling) of delivery devices and their primary and secondary packaging (4). 

The drafts signal that expanded and costly analytical testing requirements are coming to the cannabis delivery device industry – and they are coming fast. But why wait for the shoe to drop? States, in collaboration with industry stakeholders, could initiate materials and chemistry characterization requirements for cannabis vape devices right now. Such requirements – when implemented stepwise with stakeholder input, over a reasonable time frame (years, not months) – could produce lasting benefits for the industry.    

I know a woman who used to swear by her vape pen – not anymore. The vape crisis scared her. Now, her trepidation extends to cannabis products generally, not just vapes. If you’re reading this, chances are you too know someone who has expressed similar concerns. The crisis tarnished the nascent industry, especially among consumers still uncertain about legal cannabis. Shoring up consumer confidence in cannabis vape products is in the industry’s long-term best interest.

Beyond any commercial calculus, state public health officials have a basic responsibility to protect consumer health and safety. That same obligation falls heavily on the cannabis industry. Cannabis industry stakeholders should welcome the same safety and testing requirements of their devices that are soon to be expected for ENDs.  

As our nation’s history has shown all too painfully, separate has never meant equal.

Currently, the cannabis industry enjoys a window of policy making opportunity. Regulatory capacity expands by accretion, with each new layer built upon, and shaped by, pre-existing institutional and political relationships. Act now, and cannabis stakeholders lay practical and moral claim to the regulatory frameworks that they themselves help to build. Wait to act, and the FDA’s eventual involvement surely will be more disruptive to the industry.

There is also a powerful cultural reason to embrace characterization requirements for CBD/THC vape devices. So long as cannabis vape devices are treated differently than other like-products, the cannabis stigma endures. As our nation’s history has shown all too painfully, separate has never meant equal.

Over a century ago, the weakness of federal administrative capacity prompted the states to build new and durable regulatory frameworks for many industries. Today, the cannabis industry stands in a similar position vis-á-vis federal authority. Achieving scientifically valid and reproducible methods for characterizing cannabis vape devices will take time and resources. But there is no reason why the industry and its leading scientists – in collaboration with state administrative agencies – cannot begin now to map the regulatory future. Arguably, waiting to do so will only increase the costs to the industry. 

Is that a price we’re willing to pay? 

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  1. FDA, “Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems: Guidance for Industry” (2019). Available at: www.fda.gov/media/127853/download.
  2.  Marijuana Business Daily, “Colorado Marijuana Rules Will Require Testing of Vapor, Not Just Oil,” (2020). Available at: bit.ly/319QX8T
  3. USP,  “Assessment Of Drug Product Leachables Associated With Pharmaceutical Packaging/Delivery Systems,” (2015). Available at: https://bit.ly/3EDorLd [Author note: It is worth noting that Germany requires extractables/leachables profiling and stability testing of Cannabis vape devices before commercial licensing. See Marc Stegeman, “Market Access to Europe,” Presentation Delivered at Canna Pharma Conference, November 2019, San Diego, USA, for more information.]
  4. FDA, “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research: Guidance for Industry (Draft Guidance)” (2020). Available at: bit.ly/3nK0f3f
About the Author
Mark Hubbard

Chief Scientific Officer at Pharma Ed Resources and Canna Pharma 2022

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