Broughton, a leading testing and regulatory consultancy, is emphasising the importance of expert assistance in navigating the US Food and Drug Administration’s (FDA) Pre-Market Tobacco Applications (PMTA) process, particularly in relation to the stringent requirements of PMTA Module 3. This approach aims to improve the likelihood of securing a marketing grant for new tobacco products.
PMTA serves as the FDA’s gateway for bringing new tobacco products to market, with Module 3 focusing on detailed product descriptions and manufacturing processes. However, many applicants encounter significant challenges, leading to a high failure rate. In response, Broughton is offering comprehensive support to manufacturers seeking to overcome these obstacles.
PMTA Module 3 requires manufacturers to submit extensive documentation, covering every aspect of a product’s design and specifications, including ingredients, additives, performance, manufacturing processes, and comparisons to other tobacco products. This documentation must fully characterise the product, from raw materials and ingredients to its overall performance and how it compares with alternative products used by the same consumer base.
One of the most common issues manufacturers face with Module 3 is misinterpreting its requirements, often assuming it pertains solely to testing. Another challenge arises from changes in product stability over its shelf life, which can lead to failure in mandatory stability studies.
“Applications are frequently rejected because they fail to provide the FDA with sufficient validated data on test methods,” explained Paul Hardman, managing consultant for product chemistry at Broughton. “The FDA demands that manufacturers demonstrate full control throughout the supply chain to ensure the product’s consistency and safety. Manufacturing processes must be standardised and validated to reassure the FDA that the data submitted during the PMTA process accurately reflects the product, regardless of when or where it was produced.”
Any variability in product batches can undermine the FDA’s confidence, potentially leading to deficiency letters. If such issues are not resolved, manufacturers may face a marketing denial order (MDO), which can prolong the process, increase costs, and delay market entry by several years.
“In recent years, we have successfully supported PMTA submissions by developing and validating test methods that are housed within our tobacco product master file,” Hardman continued. “These methods have been reviewed by the FDA and deemed appropriate, resulting in marketing-granted orders for products. This means we are confident that our methods meet PMTA requirements and can help bring products to market.”
Broughton offers manufacturers the opportunity to outsource their PMTA Module 3 submissions, ensuring that all necessary data and documentation are prepared efficiently and effectively. “By working with us, manufacturers can minimise disruption as we handle testing and paperwork, while also designing studies that save time and resources,” said Hardman. “For instance, we’ve successfully justified a reduction of over 50% in analytical tests for multiple product variants, which has led to significant cost savings for clients and marketing-granted orders.”
For manufacturers looking to increase their chances of success during the PMTA process, Broughton’s Module 3 specialists offer invaluable expertise in navigating the complexities of FDA regulations. Visit their website to learn more about how they can help bring your tobacco product to market.
