On October 21-23, the Food and Drug Law Institute (FDLI) gathered experts from the federal government, industry, non-profits, consumer advocates, and academia to address the complex legal, regulatory, compliance, and policy issues currently impacting all facets of the FDA-regulated industry. One of the main topics during the sessions was dedicated to the discussion of modified risk tobacco products.
To deal with cigarette-related diseases, tobacco companies are working to create modified risk tobacco products which aim to reduce the health risks associated with tobacco smoke. A modified risk tobacco product (MRTP) application can be submitted by any person for a proposed MRTP seeking an FDA modified risk order, under section 911 of the Federal Food, Drug, and Cosmetic (FD&C) Act. Consequently, only modified risk tobacco products (MRTPs) reviewed by the FDA get the marketing authorization.
“For the product to get the authorization, it is expected to benefit the public health, have significantly reduced harmful substances, it must be used for reducing the risks and smoke-related diseases for individual users, or benefit the public health as a whole,” said Benjamin Apelberg, Supervisory Health Scientist at FDA.
In 2019, the US Food and Drug Administration authorized the marketing of products through the modified risk tobacco product (MRTP) pathway for the first time. The company which got the authorization was Swedish Match USA. They got authorized to market SNUS smokeless tobacco products sold under the “General” brand name. The most recent authorization was for the IQOS system issued on July 7, 2020. Philip Morris International got the MTRP authorization for a tobacco heating system and heat sticks.
“Scientific studies showed that switching completely from conventional cigarettes to the IQOS systems significantly reduces body exposure to harmful or potentially harmful chemicals,” stated Apelberg.
For consumers to switch to a better alternative, they need to have access to the information and have the trust of manufacturers. But David Sweanor, Professor at the University of Ottawa, pointed out that consumers are often misinformed, and due to this, they cannot make informed and rational decisions about their health.
As Sweanor stated, consumers have a desire to move towards the alternatives. Having more information means having more ability to make better decisions, and that is what consumers lack.
Sweden has the lowest rates of tobacco death in the European Union, Norway reduced cigarette sales by half in just 10 years, Japan reduced cigarette sales by 34% only in 4 years. It is the most rapid decline we have ever seen in a major market, said Sweanor.
As the professor explained, the reason for the change was not the government’s efforts to force smokers to stop using cigarettes, but the basic opportunity.
“Norway is using SNUS, Japan is using a tobacco heating product, Iceland is using the combination of SNUS and vaping products. And they do not force consumers to change. Consumers want to change,” explained Sweanor.
As speakers stated, it is the obligation of governments and health organizations to protect public health; the obligation to give more information. And the responsibility also falls on manufacturers.
“Nobody has a better hold on this than the tobacco companies themselves. They see what is happening with the sales of cigarettes in various markets, and I understand it is scary if your business is based on selling cigarettes, and seeing people switching to alternatives is a risk. But if we are going to have an informed public, we need that sort of information,” Sweanor said.
By combining truthful information with a wider range of products, change will be possible. As the speakers pointed out, for smokers to switch to better alternatives, they need better education and understanding about nicotine and the relative role of combustion in the exposure to harmful chemicals, as well as the health consequences associated with smoking.
