5 Things Your PMTA Needs to Make it to Substantive Review
Over the past few months, some of the mystery has lifted surrounding the Premarket Tobacco Application (PMTA) process for vape liquids and devices, as more concrete guidance and application feedback has come from FDA. With the recent issue of the new Final Rule, it is now clear what components are necessary to build a PMTA that will get to the critical substantiative review in FDA’s extensive application process. These are the key pieces of a successful PMTA:
Product Health & Safety
A complete PMTA contains extensive data that demonstrates the health risks of the new product, particularly in relation to similar products and combustible cigarettes. This includes product specific data such as harmful constituent testing that identifies potentially dangerous compounds and toxicology testing that demonstrates how damaging the product is to cells. A complete PMTA will also include pharmacokinetic testing that demonstrates how effectively the product delivers nicotine and identifies potentially problematic biomarkers in a user. While much of the data on the health risk of combustible cigarettes and comparison products can come from the literature, product specific research is necessary to demonstrate the safety of the applicant product.
Actual Use & Abuse Liability
One component of how risky a product is for public health is how people tend to use it. While manufacturers can recommend safe use practices, it is important to understand how people actually use the product and if there’s a high risk of abuse of the product. Performing an actual use study helps identify potential uses that manufacturers did not intend and understand how much users use the product in their day-to-day life.
Understanding how consumers use a product also offers an opportunity to understand how they adopted use of the product. When combined with clinical research and perception data, manufacturers can illustrate how users adopt products and their risk of developing an addiction to the product. In the case of vaping, this should also include how use of the product balances with cessation of combustible tobacco for long term health risks.
Ability to Maintain Quality
Research that demonstrates a particular product is safe is only valid as long as that product stays the same. The complete PMTA must include detailed narrative summaries of all manufacturing practices that ensure ongoing product quality, consistency, and adherence to safety standards. Further, it should explain how a manufacturer plans to maintain records of potential safety and quality concerns for FDA’s annual review.
Protection of Public Health
The PMTA gives vape manufacturers an opportunity to show FDA that their products are appropriate for the protection of public health (APPH). By offering comparisons of health risks to combustible tobacco, showing commitment to responsible marketing and labeling, understanding how people adopt and use a product, and demonstrating a commitment to safe manufacturing and record keeping, a complete PMTA provides proof that a product is up to this challenge.
We Can Help
Not sure where to start on a PMTA or concerned that your current PMTA may not satisfy these requirements? Reach out to BRS for a consultation and to learn how we’ve guided hundreds of SKUs through the PMTA process.
Over the past few months, some of the mystery has lifted surrounding the Premarket Tobacco Application (PMTA) process for vape liquids and devices, as more concrete guidance and application feedback has come from FDA. With the recent issue of the new Final Rule, it is now clear what components are necessary to build a PMTA that will get to the critical substantiative review in FDA’s extensive application process. These are the key pieces of a successful PMTA:
Product Health & Safety
A complete PMTA contains extensive data that demonstrates the health risks of the new product, particularly in relation to similar products and combustible cigarettes. This includes product specific data such as harmful constituent testing that identifies potentially dangerous compounds and toxicology testing that demonstrates how damaging the product is to cells. A complete PMTA will also include pharmacokinetic testing that demonstrates how effectively the product delivers nicotine and identifies potentially problematic biomarkers in a user. While much of the data on the health risk of combustible cigarettes and comparison products can come from the literature, product specific research is necessary to demonstrate the safety of the applicant product.
Actual Use & Abuse Liability
One component of how risky a product is for public health is how people tend to use it. While manufacturers can recommend safe use practices, it is important to understand how people actually use the product and if there’s a high risk of abuse of the product. Performing an actual use study helps identify potential uses that manufacturers did not intend and understand how much users use the product in their day-to-day life.
Understanding how consumers use a product also offers an opportunity to understand how they adopted use of the product. When combined with clinical research and perception data, manufacturers can illustrate how users adopt products and their risk of developing an addiction to the product. In the case of vaping, this should also include how use of the product balances with cessation of combustible tobacco for long term health risks.
Ability to Maintain Quality
Research that demonstrates a particular product is safe is only valid as long as that product stays the same. The complete PMTA must include detailed narrative summaries of all manufacturing practices that ensure ongoing product quality, consistency, and adherence to safety standards. Further, it should explain how a manufacturer plans to maintain records of potential safety and quality concerns for FDA’s annual review.
Protection of Public Health
The PMTA gives vape manufacturers an opportunity to show FDA that their products are appropriate for the protection of public health (APPH). By offering comparisons of health risks to combustible tobacco, showing commitment to responsible marketing and labeling, understanding how people adopt and use a product, and demonstrating a commitment to safe manufacturing and record keeping, a complete PMTA provides proof that a product is up to this challenge.
We Can Help
Not sure where to start on a PMTA or concerned that your current PMTA may not satisfy these requirements? Reach out to BRS for a consultation and to learn how we’ve guided hundreds of SKUs through the PMTA process.
