Broughton Chief Regulatory Officer, Dr. Nveed Chaudhary shares his thoughts on yesterday's announcement from the Food and Drug Administration (FDA).
Nicotine
Broughton Chief Regulatory Officer, Dr. Nveed Chaudhary shares his thoughts on the latest Food and Drug Administration (FDA) updates including Marketing Denial Orders (MDOs) for flavored e-liquids and what these mean for Electronic Nicotine Delivery System (ENDS) companies.
Market Denial Orders (MDOs)
With all the news coming from FDA over the past couple of weeks, two things are very clear:
1. So far, the news has not been good. All we have heard about publicly are Marketing Denial Orders (MDOs)and,
2. The September 9th 2021 deadline on Thursday indicates that a number of marketing orders will hopefully be confirmed this week.Thursday’s pending news will reveal much about the future of the US ENDS market and offer further clarity as to whether flavored e-liquids will be authorized in any ENDS format.
Tobacco and Menthol e-liquid market
Is the US destined to become a Tobacco and Menthol e-liquid market?
The evidence to date and information in press releases from FDA indicate that the e-liquids that received MDOs over the last week lacked two fundamental datapoints; the benefit of these products to adult smokers and evidence to suggest that these products are not attractive to vulnerable populations, especially youth.
The hope resting on Thursday is that a number of companies do receive marketing orders for e-liquid flavors other than tobacco and menthol, creating hope for those receiving MDOs for their flavored e-liquids. If FDA shows that they are willing to authorize the sale of flavored e-liquids with the right data, then the exercise to re-enter the market becomes a relatively easy one.
Light at the end of the tunnel?
At Broughton, we understand the studies needed to demonstrate the evidence required for a Premarket Tobacco Product Application (PMTA) marketing authorization. If you are faced with an MDO, depending on the news later this week, we can help you generate the necessary data to ensure that you can reapply for a PMTA to support your product and be successful.
It is also important to remember that it seems that FDA has not yet reviewed tobacco/menthol e-liquids and open system devices. Given the stance FDA is taking regarding flavored e-liquids, if you are concerned that your application for these other categories does not address the fundamental data FDA require, you may still have the opportunity to significantly reduce the risk of an MDO by acting now to supplement your PMTA application.
To find out more contact us to arrange a meeting.
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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.
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