Is The U.S. FDA Finally Turning to Science?

The U.S. Food and Drug Administration is finally turning to scientists specializing in tobacco control and commissioning studies that will enable it to take informed decisions in regulating vape flavours.

This month, the FDA’s Center for Tobacco Products awarded Tracy Smith, Ph.D., from MUSC Hollings Cancer Center two grants to study the likely effects of allowing vape flavours and banning menthols. Naturally, this move is highly welcomed by tobacco harm reduction (THR) experts worldwide who have been urging the FDA to look at the science about the products for years.

“There’s a lot that the FDA has the authority to do that could go a long way toward improving public health and toward reducing preventable illness from cigarette smoking,” said Smith. Together with Theodore Wagener, Ph.D., director of the Center for Tobacco Research at The Ohio State University Comprehensive Cancer Center, she will be using the first grant, at $3.9 million,  to conduct a study looking into vape flavours.

Wagener explained that up until now the any regulatory decisions the FDA has taken were based on incomplete scientific data. He added that this will be the first study providing the agency with “definitive information” as whether the products are of benefit to adult smokers.

Vape flavour bans
In fact, driven by the FDA’s guidance on vape flavours, many US states have either banned or been considering vape flavour bans. Oregon’s recent House Bill 3090 proposes a ban on the sales of flavoured vaping and tobacco products with the aim of reducing teen vaping.

THR experts have pointed out that such restrictions would only serve to destroy small vaping businesses and drive consumers to the black market. However Senator Elizabeth Steiner (D), a physician and one of the bill’s four main sponsors, believes that this bill would act as a preventative measure.

Meanwhile, Smith and Wagener will be recruiting 1,500 smokers from across the US and give them vapes with different flavours to different participants while a control group will be given regular NRTs instead of vapes. Then they will look into whether particular flavours seemed to drive a complete switch from cigarettes to vapes.

While with the funds from the second grant, amounting to $3.6 million, will be going towards a study looking into whether a ban on menthol flavours in both cigarettes and vapes would lead to increased smoking cessation rates and/or rates of switching to vapes.

The data about menthol bans
Many experts argue that banning menthols, whilst leaving regular cigarettes on the market would not make make much difference. While others insist that if menthols were banned consumers would just switch to safer products such as vapes.

A recent paper discussing the 2020 menthol cigarettes ban set in Massachusetts, found that actually this just led to increased smoking amongst women. The letter titled, “Association of Comprehensive Menthol Flavor Ban With Current Cigarette Smoking in Massachusetts From 2017 to 2021,” found that contrary to what it aimed to achieve, the menthol cigarette ban set in in Massachusetts just led to an increase in smoking among black female adults.

In line with arguments by countless THR experts, the paper acknowledged that the increase in cigarette sales had mainly affected the population it aimed to target. “As the FDA plans to eliminate menthol as a characterizing flavor in cigarettes, interventions should address possible increases in cigarette smoking among Black females.”

In other news, a study by researchers from the University of Pittsburgh concluded that menthol-containing e-liquids generate a greater number of toxic microparticles than their menthol free counterparts.

The study titled, “Electronic cigarette menthol flavoring is associated with increased inhaled micro and sub-micron particles and worse lung function in combustion cigarette smokers,” was published in Respiratory Research. The research team conducted preclinical studies on robotic platform Human Vaping Mimetic Real-Time Particle Analyzer (HUMITIPAA) which generates fresh aerosols for any desired vape.

The team found that the addition of menthol flavouring e-liquid base propylene glycol leads to increased toxicity similar to the infamous effect of adding vitamin E acetate to e-liquid. The researchers also found that menthol vs. non-menthol-flavoured pods found in e-cigarettes available on the market, leads to the generation of significantly higher quantities of 1–10 µm particles upon inhalation.

On analysing data from the COPDGene study, the research team also found a relationship between the use of menthol flavored ECs and reduced lung function. While based on entirely different data, a 2022 study published in BMJ’s Tobacco Control, concluded that a menthol ban would avoid 16,250 tobacco-related deaths per year by 2060.

The findings were based on the data analysis and computational modeling infrastructure compiled as part of the Center for the Assessment of Tobacco Regulations. The research team used the Smoking and Vaping Model, a simulation model they had previously developed to study smoking and vaping behaviour with regards to menthol and non-menthol cigarettes.

They found that in the presence of a menthol ban, combined menthol and non-menthol cigarette smoking would decline by 15% by 2026. Deaths attributable to smoking and vaping were estimated to drop by about 5% and life-years lost by 8.8%. This would translate to 16,250 deaths less per year and 11 million life-years gained (almost 300,000 per year) over a 40-year period.

Canada’s menthol cigarettes ban yielded results
Supporting these figures, data from Canada has shown that the local menthol cigarettes ban has had a positive effect on local smoking cessation rates. The study suggests that a similar ban in the United States would have even greater benefits, given that menthol cigarettes are even more popular across the States.