A strong public health consensus has formed that not all tobacco products present the same risk. Public health authorities agree that there is a broad continuum of risk among tobacco products, with cigarettes at the highest end of that spectrum. This continuum recognizes that most of the harm caused by tobacco results from the burning of tobacco.
"A centerpiece of this comprehensive regulatory plan is acknowledging that nicotine, while highly addictive, is delivered through products on a continuum of risk. And it’s the delivery mechanism – not the nicotine itself – that is truly the issue at-hand." - Scott Gottlieb, M.D., Former Commissioner of Food and Drugs
In September 2018, then FDA Commissioner Gottlieb reaffirmed the FDA's central principle that the primary cause of death and disease from tobacco use isn't the nicotine in these products, but the act of combustion, which releases harmful constituents into the body. Since then, the FDA has repeatedly affirmed its view that non-combustible, reduced-risk products may offer a promising opportunity to reduce the harm associated with tobacco use for adults who continue to use tobacco products.
According to data from the FDA's PATH study, over half of adult smokers would consider using a tobacco product if it had a reduced harm claim. This equates to about 22 million adult smokers who are interested in less harmful tobacco products, particularly if they receive truthful and accurate risk information.
Seeking Authorization to Communicate Reduced Harm Information
We can only compete in the marketplace with products authorized by the FDA. And we can only communicate reduced harm information if the FDA permits.
That's why we are seeking authorization from the FDA to put truthful, accurate information about reduced-risk products in the hands of consumers so that they can make a choice that's right for them.
To date, we have:
- Submitted a Modified Risk Tobacco Product application (MRTPA) for Copenhagen Snuff.
- Supported Philip Morris International (PMI) on its MRTPA application for IQOS. Philip Morris USA has an exclusive agreement with PMI to commercialize IQOS in the United States.
We believe it is critically important that the FDA take steps to foster the innovation of potentially reduced risk products. For tobacco harm reduction to be successful, a marketplace of FDA-authorized reduced-risk products must be in place, with more information about the relative risks of those products being communicated to adult smokers. The regulatory system should respect the rights of adults to make decisions based on accurate information. To make this a reality, the FDA needs to establish clear foundational rules for bringing these new innovative products to market.