The FDA have included particle size measurement testing in their proposed rulemaking for e-cigarettes due in November 2020. This post is written to help you to understand what particle size measurements are in relation to ENDS, why the FDA may propose testing as part of the regulations for safe ENDS products and what you need to do to prepare.

When a person uses an e-cigarette, they exhale vapour into the air (hence the use of the word vape). This cloud of vapour is comprised of small droplets of formulation and some formulation in a gas state. 

The particles in combustible cigarette smoke are extremely concentrated, carry substances which are extremely toxic and carcinogenic and are easily absorbed by the body. On the other hand, the e-liquid vapour released by e-cigarettes is much less toxic and has fewer, if any, harmful compounds. However, this does not mean that vapour is completely harmless.

While the droplets from e-cigarette vapour tend to evaporate, it’s also possible for them to condense on a surface or coagulate, both of which increase the particle size. Ultimately, any potential health risks depend on the “physical properties of the emitted particles and vapors”.

As e-cigarettes have risen in popularity, manufacturers have been able to develop higher-powered devices which are able to produce more vapour and therefore a more satisfying experience for users.

However, this also means that the particles produced in the vapour could potentially be harmful to users and anyone else in the presence of the vapour who may be breathing it in. The FDA’s role is to ensure that ENDS products are safe for consumers and don’t pose a risk to public health, and so testing the particle size measurements of e-cigarettes will allow them to understand whether vapour poses any health risks.

Particle sizes are measured using different methods including laser diffraction which is able to measure the size of both particles and droplets across a wide size range and recording any changes across spray plumes to provide accurate results without risking contamination. This measurement principle uses the diffraction of light to measure the angle of the droplet surface enabling calculation of the size of droplets in aerosol down to sub-micron levels. 

Inter Compliance offers particle size determination for our clients to ensure that our clients’ PMTA applications contain the information required by FDA to determine the appropriateness for the product for the protection of public health (APPH). We also offer this service to companies looking to develop new products and those looking to characterise the performance of their devices.  

We are offering a service to help you measure the particle sizes created by your products so that you can understand your products performance and safety. Contact us by email: info@inter-scientific.com or online to learn more about this service and how our experts can help you.

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