Rethinking the approval process for improving risky tobacco products

This seems to be an excellent test case for the new system. After playing the role of a member of the Scientific Advisory Committee on Tobacco Products (TPSAC) of the US Food and Drug Administration, I listened to the host of Altria rehearse their speeches, which is my impression. I believe that Copenhagen Snuff is likely to successfully pass the MRTP application process.

This product has been sold in some form since the 19th century and is widely known. From a regulatory perspective, this is boring. Altria's statement of harm reduction that it tried to put on the Copenhagen label seems to be indisputably correct: "If you smoke, please consider: switching from cigarettes to this product can reduce the risk of lung cancer."

In February 2019, the TPSAC review team concluded with an 8-0 vote that the statement was scientifically accurate. Group Chairman Robin Mermelstein said, "The consensus I heard is that this is an understandable statement. It's clear," and "I think this is a reasonable starting point for starting message transmission


Forty nine months later, the FDA finally approved Copenhagen Classic Snuff as MRTP.


No tobacco product is safe or 'FDA approved', so people who do not use tobacco products should not start using them, "Brian King, director of the FDA Tobacco Products Center (CTP), said in a March 2023 press release. But tobacco products do have a range of risks, with smoking the most risky. In this case, the FDA's scientific review found that if adult smokers completely switch from cigarettes to smokeless products, it will reduce their risk of lung cancer


Why does it take so long to approve the obvious fact that a complete shift from cigarettes to (familiar) smokeless products can reduce the risk of lung cancer? This has sparked a new critical examination of the MRTP process: its origin, utility, and potential future.