• May 26, 2024

Red-letter day

 Red-letter day

Michael Siegel

A US public health expert has described Friday, July 28, as ‘truly a great day for public health’.

This was the day that the Food and Drug Administration announced its Comprehensive Plan for Tobacco and Nicotine Regulation.

‘On Friday, the new FDA Commissioner – Dr. Scott Gottlieb – saved the day for the public’s health by officially embracing a harm reduction approach to tobacco control,’ Dr. Michael Siegel, who is a professor in the Department of Community Health Sciences, Boston University School of Public Health, wrote on his tobacco analysis blog.

‘Commissioner Gottlieb announced a new approach to the regulation of tobacco products that, unlike the FDA’s previous strategy, acknowledges the vastly different risks of tobacco cigarettes compared to electronic cigarettes and proposes to regulate each product in alignment with its risk level.’

Siegel said that, previously, the FDA had lumped e-cigarettes into the same category as tobacco cigarettes and, in fact, regulated e-cigarettes much more stringently. The FDA previously required e-cigarettes to complete burdensome and expensive pre-market applications just to remain on the market, a process from which all traditional tobacco cigarettes were exempted.

The old approach, Siegel said, would have destroyed about 99 percent of the existing vaping product market, leading to a major reduction in smoking cessation in the US and with that, an increase in smoking-related morbidity and mortality.

‘Instead, the FDA will now delay the implementation of the pre-market application requirement for e-cigarettes while seeking ways to ease the expense and burden of the process,’ he said.

‘At the same time, the FDA will – for the first time – actually set safety standards for e-cigarettes so that the benefits of these products can be realized while minimizing potential harms.

‘And, to top it all off, the agency will consider – also for the first time – actually setting a safety standard for real cigarettes that would require the reduction of nicotine to non-addictive levels if that is found to be technologically and practically feasible.’

Siegel, in fact, foresaw the possibility of Friday’s announcement by the FDA. Writing on his blog in November, he said that, from a public health perspective, there were many reasons to be concerned about the outcome of the US presidential election. ‘However, there is one reason to potentially be encouraged,’ he said. ‘With a Trump presidency, and with Republican control of the Senate, we ironically have a tremendous opportunity to once and for all craft a sensible regulatory strategy for electronic cigarettes and vaping products.’

Siegel’s blog is at: http://tobaccoanalysis.blogspot.co.uk/.