Broughton has launched a new extractables and leachables (E&L) testing service for the reduced-risk nicotine industry. The new service will offer tailored E&L studies for products aimed at the premarket tobacco product application (PMTA) and the marketing authorization application (MAA) pathways.
According to Broughton, regulatory bodies increasingly focus on the interactions between manufacturing components, nicotine delivery devices and container-closure systems, and the final product formulation. Producers must identify and assess any toxicological risks that could arise via such interactions via E&L studies.
Aimed at supporting reduced-risk nicotine product categories such as electronic nicotine delivery systems, Modern Oral nicotine pouches and nicotine replacement therapy, the service is available across all stages of the product development lifecycle.
The new testing service includes study design, extractables studies, extractables toxicology assessments, leachables method development and validation, leachables shelf-life studies and leachable toxicology evaluation.
“Extractable and leachable studies are essential to the PMTA and MAA regulatory pathways for reduced-risk nicotine products to ensure their safety and demonstrate evidence of mitigating risk. Even in emerging categories, where regulations may not exist, such as nicotine pouches, they should be adopted as a best practice approach to product understanding and stewardship,” said Chris Allen, CEO of Broughton.
“Our scientific experts and toxicologists have years of combined experience conducting E&L studies across a range of reduced-risk nicotine product and device categories. By offering a one-stop solution for E&L studies, we can ensure a fully integrated approach across study design, extractables study delivery, leachables method development and toxicology assessment with our specialized consultants available to troubleshoot, problem-solve and develop analytical solutions to issues that may arise.”