Overview of PMTAA PMTA must provide scientific data that demonstrates a product is appropriate for the protection of public health. To reach such a decision and to authorize marketing, FDA considers, among other things:
- Risks and benefits to the population as a whole, including people who would use the proposed new tobacco product as well as nonusers;
- Whether people who currently use any tobacco product would be more or less likely to stop using such products if the proposed new tobacco product were available;
- Whether people who currently do not use any tobacco products would be more or less likely to begin using tobacco products if the new product were available;
- The methods, facilities, and controls used to manufacture, process, and pack the new tobacco product.
- Whether marketing plans for the product would attract non-users and potentially underage users.
PMTA Review Process
AMV Holdings Actions
AMV has held 3 meetings with the FDA since 2017, including meetings in Washington D.C. and North Carolina.
AMV has filed 105 PMTA applications covering over 5,000 SKU's. The first application was filed on August 24th, 2020. We have received a notification that this application has been accepted for review.
The other 104 were filed subsequent to the accepted application, and follow the same information and file structure as the accepted application.
As part of our application we are submitting HPHC (Harmful and Potentially Harmful Compound) and toxicology data.
We have completed 3 different population studies in 2015, 2018 and 2019. Both the 2018 and 2019 studies include telephone interviews with customers who no longer shop with AMV.
Since 2017 we have been measuring 12 month repeat rates of over 67,000 new customers.
We believe the repeats rates combined with the survey data will lead to a best in class population data.
Our marketing plans include all the rigorous steps we take to prevent sales to underage individuals.
As part of the preparations for the PMTA, we have built a new lab to ISO 7 clean room standards.
AMV has implemented total quality management systems to ensure a quality product is delivered every single time.
We have hired Trinity Environmental Consultants to perform rigorous environmental assessments.
FDA to issue/deny marketing approval.
We have a dedicated customer service team to handle any questions from users.
We have a state of the art ID scanning system to prevent underage sales.
We will continue to conduct customer surveys for an ongoing assessment of our population impact.