The Food and Drug Law Institute (FDLI), which gathered experts from federal government, industry and non-profits to discuss the complex legal, policy, compliance and regulatory issues that are currently affecting all aspects of the FDA-regulated industries, gathered on October 21-23. The main topic of discussion during the sessions was modified risk tobacco products.
To combat cigarette-related illnesses, tobacco companies are creating modified risk tobacco products that aim to reduce health risks associated with smoking tobacco. Anyone can submit a modified risk tobacco product application (MRTP) for a proposed MRTP that seeks an FDA modified-risk order, under section 911 of the Federal Food, Drug, and Cosmetic Act. Only modified risk tobacco products (MRTPs), which have been approved by the FDA, are allowed to be marketed.
“For a product to be approved, it has to benefit public health and have significantly reduced harmful chemicals. It must also be used to reduce the risks of smoking-related diseases or to benefit public health in general,” said Benjamin Apelberg.
The US Food and Drug Administration approved the first time in 2019 the marketing of products via the modified risk tobacco products (MRTP) path. Swedish Match USA was the company that received the authorization. The company was authorized to sell SNUS smokeless products under the “General” label. The most recent authorization for the IQOS System was issued on July 7, 2019. Philip Morris International received the MTRP approval for a tobacco heating device and heat sticks.
Apelberg stated that “scientific studies showed that switching from conventional cigarettes to IQOS systems reduces the body’s exposure to harmful or potential harmful chemicals.”
To switch to a healthier alternative, consumers need to be able to access the information they need and trust the manufacturers. David Sweanor is a professor at the University of Ottawa. He believes that consumers are often misinformed and therefore cannot make rational and informed decisions about their health.
Sweanor said that consumers are looking for alternatives. More information is needed to make better choices, and this is what consumers lack.
Norway has reduced cigarette consumption by half in only 10 years. Japan has reduced cigarette consumption by 34% in just 4 years. Sweanor said that this is the fastest decline in a large market he has ever seen.
The professor explained that the main reason for the change is not the government’s efforts in forcing smokers to quit using cigarettes but the opportunity.
“Norway uses SNUS. Japan uses a tobacco heating product. Iceland uses a combination of SNUS products and vaping products. They don‘t force the consumers to change. Sweanor explained that consumers want to change.
As the speakers said, it is the responsibility of governments and health organizations that they protect the public health. It is also their obligation to provide more information. Manufacturers also have a responsibility.
“Nobody knows this better than the tobacco companies.” It is frightening to see people switch from cigarettes to alternatives if you are in the business of selling cigarettes. We need this information if we want to have a well-informed public,” Sweanor said.
Change is possible by combining truthful information and a wider variety of products. The speakers emphasized that for smokers who want to switch to healthier alternatives, they must be better educated and understand the role of nicotine and combustion in the exposure to harmful chemical as well as health consequences.
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