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Examining the legal frameworks for new analogues.
No matter what your nicotine product category is, we offer a comprehensive testing strategy to establish scientific evidence for regulatory approval and to build consumer trust. Our experts specialize in all forms of testing for next-generation consumer nicotine products, including heated tobacco products, modern oral nicotine pouches and e-cigarettes. Click on the information below to learn more about Broughton’s product expertise, experience, and our partnership approach.
Heated tobacco products (HTP) heat a tobacco substrate to temperatures that are high enough to produce a nicotine-containing aerosol but not to burn the tobacco. The tobacco substrate is heated by an external heat source, most commonly electrical.
Broughton has invested in a dedicated facility for testing heated tobacco products. This test facility includes devoted vaping machines, conditioning cabinets, and analytical equipment to allow testing of HTPs to support all stages of product development and regulatory submission, including FDA (USA) Premarket Tobacco Application (PMTA) Testing and Tobacco Product Directive (TPD) in the EU.
E-cigarettes consist of a nicotine-containing flavored e-liquid, which is heated to aerosolize the nicotine and flavors, which can then be inhaled.
We have extensive experience in achieving several successful regulatory submissions for e-cigarettes and e-liquid products. This includes submissions for the PMTA, MRTP, TPD and TRPR.
Modern Oral Nicotine Pouches (MONPs) have gained significant popularity over the past few years, and consumer demand is rising for such products.
As they do not contain tobacco, MONPs are exempt from the ban imposed on similar products that do.
However, manufacturers still need to ensure that MONPs are regulatory compliant, and this requires an ongoing programme of data collection, testing, and validation.
Maintaining such expertise in-house can be challenging, and this is where we can help.
Our scientists have worked on a wide variety of oral pouch projects across a range of active ingredients to support regulatory projects and for R&D purposes. We bring the benefit of an integrated service across data generation, analysis, insight, and consultancy.
Nicotine replacement therapy (NRT) is a method to quit smoking by gradually reducing the nicotine concentration of the NRT product until the smoker is no longer dependent on nicotine. This approach has been used for many years to help smokers quit. A similar approach can be used with e-cigarettes.
Our highly skilled laboratory services team provides product analysis, scientific support, and reliable, high-quality data using accredited test methods from an in-house testing facility.
We provide a comprehensive suite of testing services for all next-generation nicotine products.
Click on the information below to discover more about the testing services we offer.
Bespoke analytical method development and validation using cutting-edge technology and equipment.
QC release testing and investigatory analysis to guarantee the quality and safety of products.
Stability studies in support of nicotine-related R&D projects, in conjunction with in-house analytical expertise, providing data for regulatory submissions, and post-market compliance.
Testing to identify and measure Harmful and Potentially Harmful Constituents (HPHCs) that may be produced or consumed when using a nicotine-based consumer or medicinal product.
Toxicology risk assessments of the materials and ingredients for next-generation nicotine delivery development projects.
Testing to ensure a full understanding of the potential leachable compounds and their toxicity that may leach into a nicotine product from its container closure system, manufacturing process, or packaging.
Learn more about how we can help bring your nicotine delivery product to market through our high-quality analytical testing services.
At Broughton, our consultants have deep industry knowledge across all the elements required for a PMTA. We guide you through and generate the required data, to ensure that FDA finds your applications strong and compelling.
Learn more about our activities and gain insight from our scientific and regulatory experts
4 minute read
Examining the legal frameworks for new analogues.
5 minute read
On January 16, 2025, the FDA granted marketing authorisation for Swedish Match’s Zyn nicotine pouches, marking a significant regulatory milestone for ....