Our Focus on Responsibility Before and After FDA Authorization

Patricia Miller

Managing Director
Pre-Market Tobacco Applications

Altria Client Services

I lead a team of people who create, plan and coordinate premarket applications for new tobacco products. Those applications go to the FDA, and then the team helps keep FDA-authorized products on the market through compliance with regulations and FDA’s marketing orders.

The Premarket Tobacco Application (PMTA) submission is the culmination of much work that goes into demonstrating to the FDA that a product is, in the Agency’s words, "appropriate for the protection of public health". We believe these products have the potential to reduce harm and we strive to gather the evidence to show that. There's a lot of work that goes in.

Our team manages the project and coordinates the application with many cross-functional partners. For example, Product Development develops a new product. A Regulatory Affairs science lead devises the science plan that serves as the foundation of the PMTA. Product Development and Manufacturing contribute to describing the product, how it’s made and how it’s made consistently through quality principles. Contributors from Regulatory Sciences conduct studies on things like product chemistry and stability, toxicity, clinical effects, and consumer perception and behavior. A brand team develops labeling materials and a marketing plan for submission with the application. And Editorial Services helps these subject matter experts and us write all of this into a PMTA to demonstrate to FDA that marketing of the product is appropriate for the protection of public health.

When I joined Regulatory Affairs, it was to help coordinate between us and PMI for the IQOS regulatory submissions in the United States. The authorizations that eventually came from FDA for IQOS were more marketing focused than we had seen with authorizations for other products previously.

For example, we’re required to submit all marketing materials and marketing plans thirty days before dissemination. FDA also requires quarterly reports of things like sales and distribution data and delivery of advertising executions, and an annual report with a wide array of required information spanning manufacturing, safety, publications and marketing summaries. We built a post-authorization team and compliance processes quickly. We knew there was so much excitement about selling
IQOS in the U.S., but it was essential that it be done in a compliant manner to maintain FDA authorization. The post-authorization work has grown significantly. But it has set us up well for marketing under future FDA authorizations for other products.


Having smoke-free products to which cigarette smokers can transition is key to Altria’s Vision.


But we can't make those products accessible to adult smokers until we get authorization from our regulator. It's necessary to get FDA authorization to be on the market and it's necessary to satisfy post-authorization requirements to stay on the market.

We expect that there will be market authorizations coming from the FDA for many manufacturers’ smoke-free products in the second half of 2021. Every time FDA does that, they not only give the marketing order, but they release a public memorandum on how they analyzed that application. We get so many learnings from our own authorizations and others. I believe the future is bright as we evolve our products and constantly improve our applications for FDA authorization.

Kurt Gottfried Photo

Our Science-based Approach to New Tobacco Products

We follow a rigorous scientific framework for evaluating potentially reduced risk products in our applications that enables us to assess them from design, to individual risk, to overall population impact.
Natasha Knight Photo

Driving a Strategy to Support Adult Consumers in Cessation

We are re-evaluating our foundation for cessation support, making sure that what we're doing makes sense for the time that we're in.