The Food and Drug Law Institute organized on July 30 a webinar on the perilous process for innovative tobacco manufacturers to obtain an authorization to communicate to the public. This conference followed the July 7 decision of the US FDA (US Food and Drug Administration) to authorize the marketing of IQOS as a Modified Risk Tobacco Product. The US regulator directed to indicate specific information to the consumers as: “The IQOS system heats tobacco but does not burn it. This significantly reduces the production of harmful and potentially harmful chemicals. Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.” To this day, IQOS is the only electronic nicotine product to receive such authorization from the FDA.
Modified Risk Tobacco Products are tobacco products that are sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products. An MRTP application includes a description of the proposed tobacco product and any proposed advertising and labeling, conditions for using the tobacco product, and data and information about how consumers actually use the tobacco product.
The webinar hosted three experts to discuss the MRTP process in detail and whether it is an effective tool for risk communication and for facilitating smoking cessation and promoting public health: Joe Ackerman, Vice President for Marketing smokeless, at Swedish Match US, Clive Bates, Public health expert, former Director of Action on Smoking and Health in the United Kingdom and Mohamadi Sarkar, tobacco Harm Reduction expert.
While all speakers recognized this decision by the FDA as a milestone in Public Health, some questioned the process and made some suggestions about what they thought could be improved.
Food and Drugs Administration’s Center for Tobacco Products (CTP) recently issued its second round of MRTP marketing orders. CTP is currently reviewing applications for several additional types of products, and manufacturers have announced that more applications are on the way.
However, many challenges are faced by those manufacturers when they decide to apply for those risk modification orders. For Clive Bates, the MRTP could merit with some improvements: “In my view, if you look at the way the MRTP is designed, it is designed for modified-risk combustible products. It doesn’t start from the consumer perspective. It doesn’t say: what is it that the consumer needs to know in order to quit smoking or to switch to non-combustible products and what do we (the agencies, the FDA, Centers for Disease Control and Prevention) need to tell them. It is not designed to do that, and it doesn’t.
Moreover, Clive Bates pointed out the amount of paperwork involved in the MRTP application. When interrogating PMI about their application, they said to him that they initially submitted 2.9 million pages of information to the FDA which declined to accept some of that and it was cut down to 1.1 million pages which the FDA assessed. He added that this is equivalent to 100 meters of studies and data collected.
For him, the process is way too long. For example, PMI applied in December 2016 and received the authorization in July 2020. Along with all these challenges, Clive Bates regrets the misconceptions of the public about electronic tobacco alternatives: “Only 3.6 million of Americans think that vaping is much less risky than smoking. We have a job to do in correcting gigantic misconception of the public. There are misconceptions about risks that lead to poorly informed choices resulting in riskier behaviors and more smokers.”
In his view: “MRTP will have to be radically slimmed down. These products being non-combustible are beyond any reasonable doubt far less risky than smoking. That is the baseline we need. From that baseline, you can now build up the process for specific products that have specific risk characteristics.”
Mohamadi Sarkar added: “If we are going to make progress in harm reduction, we should get smokers to move from combustible to non-combustible. If the product meets the needs, then people will use it. The MRTP authorization allows us to accelerate this process but I think it’s time for the FDA to do a reset.”
How about Africa and low-income countries?
Africa has some of the highest rate of smoking related deaths. Yet, experts affirm that the African consumer has little exposure to knowledge of safer nicotine and tobacco products.
Public Health expert, Mark Tyndall, who spoke to AllAfrica, shared his view on the situation in Africa regarding tobacco harm reduction products and communication: “Smoking is so far down on the list of health concerns on the continent that it is hard to know where to start. It is also complicated by the tobacco exports that some governments rely on for international income. However the toll of smoking on the health of people in Africa is still massive and should be a priority as elsewhere. The whole concept of harm reduction is not well established and the introduction of vaping may require a completely different approach – maybe not use the term harm reduction at all. We want to get the point out to the public that there is a far safer way to use nicotine than burning tobacco.
“My understanding is that there is not much vaping going on in African countries although I did read an article from Kenya from November 2019 that there is growing concerns because young people think that it is cool. Obviously, the target audience needs to be people who want to stop smoking, so I think that there is great potential. Whether it can start in Africa is a big question.”
To date, South Africa is the only African country where the electronic tobacco system IQOS is sold.