Order biomarker testing to determine effects of vaping as part of your e-cigarette or e-liquid ENDS PMTA application. Whether you seek biomarker testing services for the effects of vaping or smoking we offer ISO accredited biomarker testing services.
Biomarker Testing – Watch the video
– ISO accredited 17025 lab
– GLP and non-GLP testing
– e-cigarette/cigarette biomarker expertise
Under FDA rules, manufacturers are required to provide biomarker test data as part of their premarket tobacco application – or PMTA for their specific product.
To evaluate the acute and chronic health effects associated with the product, FDA
recommends including studies, other scientific evidence, or both, that identify biomarkers of
exposure, biomarkers of harm, and health outcome measurements or endpoints. For example,
biomarkers of toxicant exposure may include compounds such as cotinine, NNAL, and NNN.
Source: PMTA guidance
What are the biomarkers of exposure and biomarkers of potential harm? Analytes include:
Extract from FDA guidance on biomarker testing
Additional biomarkers of interest:
The following matrix options are available:
LC-MS/MS – All methods are validated.
20 – 25 working days (GLP testing may take longer)
The cost of biomarker testing depends on a number of factors including number of analytes, samples, frequency of testing and quality of the testing e.g. GLP or non-GLP. You can expect to pay in excess of £50,000 for data to support a PMTA application for a range of e-cigarettes or e-liquids.
We are a London-based regulatory affairs consultancy providing services to the biocide, CBD, e-cigarette, cosmetic and pharmaceutical industry. We help e-cigarette companies comply with the Tobacco Products Directive and pharmaceutical companies obtain and maintain medical product licences. We also offer UKAS accredited biocide and CBD analytical testing services.
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