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GTNF 2021 - Industry reflections


October 8, 2021

Published by Dr. Nveed Chaudhary

ENDS, PMTA, FDA

Broughton's Chief Regulatory Officer, Dr Nveed Chaudhary shares his post-event reflections on Global Tobacco Nicotine Forum (GTNF) 2021.

 

GTNF 2021 has come and gone, and after a hiatus for two years, it was really fantastic to be back together in person with friends and colleagues from all over the world. 

Whilst meeting everyone again after two years was fantastic, however, the issues discussed were all too familiar.

The keynote from Stefan Bomhard, CEO of Imperial Brands on day one, highlighted the need for developing next generation products (NGP) which had the consumer at the center. Imperial seems to be resetting their NGP program, focussing on their combustible business whilst taking their time to redevelop their NGP offering. Great news for their shareholders, but not necessarily the news that smokers and public health want to hear. It seems Imperial Brands are a few years away from having credible and viable propositions that smokers will want to use. The discussion of investor analysts on the second day seemed to validate this approach, it seems that for the stock market, this is what they would want to see.

But the question is, whilst Imperial lags behind, what are the real prospects of getting large numbers of smokers to switch to non-combustible products.? As you would expect, there was a lot of talk and discussions about the pending Premarket Tobacco Product Application (PMTA) decisions coming from Food and Drug Administration (FDA).

FDA Center for Tobacco Products (CTP)

This culminated in a fireside chat between Joe Murillo, CRO Juul labs, and deputy director of the CTP, Todd Cecil. It’s clear, FDA is taking a robust line in assessing PMTAs. Whilst there has been a lot of noise over the number of Marketing Denial Orders (MDOs) that FDA is issuing, the position from FDA is clear - the burden of proof is with the manufacturer and is on a product-specific basis. As in the guidance documents and in the withdrawn PMTA final rule, FDA expects data to show that each product they authorize demonstrates that the benefit to smokers greatly outweighs the risks of youth using the product as an entry into nicotine use. Todd was very clear, if you don’t have the data and it can’t be collected within the period of a 3-month deficiency response, you will receive an MDO. However, it is expected that there are likely to be some marketing orders granted by FDA soon. 

The WHO

The inability to have open discussions with many governments due to the World Health Organisation (WHO) Framework Convention on Tobacco Control (FCTC) was a hot topic for the morning for day 2. The COP9, scheduled for later this year, will, as always, talk about the future of tobacco control, without any media or industry representatives present - the only industry and public health issue where this is the case. It’s time for the WHO to realize that despite having been the cause of significant morbidity and mortality for decades, the nicotine industry is very much where the solutions for this will be found. Coupled with this, are a number of anti-tobacco researchers, conducting shoddy science to refute the credibility of industry-generated data. This license to publish shoddy science is only enjoyed by these anti-tobacco lobbyists and is detrimental to public health and tobacco harm reduction. However, the industry does have a short memory, 20 years earlier, it was the tobacco industry that spun misinformation about nicotine not being addictive and cigarettes not causing lung cancer. The industry has to learn, these people are not friends, the industry has a lot of baggage to carry, and they absolutely have no choice but to continue to operate in this environment. Over time, the data will talk for itself. In the meantime, fake news is something they simply have to live with.

Innovation

Innovation was the theme of the second day, which was encouraging to see. However, innovation seems to be defined as making the next blockbuster product. But are these the areas companies should be focussing on? Looking at the conversations, regulators and society have many concerns, which we in the industry have to address. Take potential for youth use - innovation needs to address that; Environmental impact of the waste products of ENDS - that area is rife for innovation; finally, with around 100 million users of NGPs in the world, there are still over 1 billion smokers, why are they not off-ramping from smoking cigarettes? Doesn’t improving the satisfaction of these products so more smokers switch, make sense as an area in which innovation should be focussing? Instead of chasing the iPhone equivalent of the ENDS product, let’s focus on innovating in the areas that are at the top of regulator’s and society’s concerns - that surely is a way to accelerate the options available to smokers and realize widespread tobacco harm reduction.

The Foundation for a smoke-free world

The Foundation for a smoke-free world, published their patent report. Over 74,000 patents have been filed in the NGP space over the last ten years. However, very few are filed and protected in low-income countries; what does this tell us? Companies will generally protect patents in the countries they want to sell products. The fact that many patents are not filed in these countries, maybe a strong indicator that there is little appetite to market NGPs in these countries. Sadly, these are the countries where cigarette smoking is most prevalent. These low-income countries need, perhaps, even more, products that their populations can afford and use. This must be a focus for industry innovation. How to develop, low cost, effective solutions for these countries. Tobacco harm reduction must not only be for the rich, we need to advocate for alternative products to be a human right.

Final thoughts

I hope, that next year, as a community, we’ll stop thinking about what is stopping us, and share ideas for how we can push this forward, innovate in the right areas and create societal movements to want and demand alternative NGP products which are less risky for smokers.

Did you attend #GTNF2021? - we would love to hear your thoughts.

To find out more contact us to arrange a meeting.

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