FDA update - disappointing news or an opportunity?

Broughton Chief Regulatory Officer, Dr. Nveed Chaudhary shares his thoughts on yesterday's announcement from the Food and Drug Administration (FDA).

What does it really mean?

What seems like disappointing news from Food and Drug Administration (FDA) isn’t when you consider the detail and what it means. Although our hopes of seeing marketing orders being granted, one year after the Premarket Tobacco Product Application (PMTA) submission deadline, were not realized, there are positives that can be gleaned from this announcement.

FDA seems to be granting Marketing Denial Orders (MDO) to products that have not proven that a benefit to current adult smokers outweighs the potential youth use of the products. Interestingly, for those products that have PMTA’s filed, it is a status quo situation. Under the law in the US, all deemed tobacco products are illegal and are subject to enforcement at any time. What we have seen over the last year is FDA exercising its authority to provide enforcement discretion to those products that have PMTAs filed. Nothing in the announcement changes that. This means that if you have not received a marketing order, the likelihood is that enforcement discretion will continue until a decision is made on your product.

Advice to companies

The key to avoiding an early MDO seems to be based on the submission of empirical data specific to your product. My strong advice to all the companies that are still waiting for an outcome to their submission is; if your PMTA has not yet entered substantive review, use this time to supplement your applications with the data that FDA wants to see, and inform them that you are submitting more data with a defined timeframe. We all want Electronic Nicotine Delivery Systems (ENDS) products in the market, we know that they are the best option for smokers who cannot quit smoking, but none of us want youth to get hooked on nicotine because of them. FDA wants comfort that this is not going to happen with the products they authorize, and as a society, this is what we should expect them to do – provide solutions for the needy and protect the vulnerable.

I understand that tempers are running high at this time, but if we are serious about tobacco harm reduction, let’s do what it takes to make this happen.

To find out more contact us to arrange a meeting.

Can we help you?

Broughton have deep CRO capabilities and an experienced team of scientific and regulatory professionals to manage full service global regulatory projects. Our knowledge of global regulatory pathways offers significant insights that can be incorporated into your project plans. Our mission is to accelerate safer nicotine-delivery products to market; advancing a smoke-free future.

Book a meeting with us today to discuss your requirements.