FDA to cut the amount in nicotine in cigarettes

The FDA has proposed a new rule to limit the amount of nicotine in cigarettes sold in the US as a first prong of its attack on the addictive nature of the products.

Nicotine is the active part of tobacco which most scientists think is to blame for both the stimulating and addictive effects of cigarette smoking.

Despite widespread efforts by US regulators and the World Health Organization to stem the sale of cigarettes and their devastating public health consequences, smoking kills 480,000 Americans every year.

The FDA first announced its intent to regulate nicotine levels in 2009, but the formal notice, published on Thursday, marks the first real action the agency has been able to take after spending years hamstrung by Big Tobacco’s legal challenges.

The FDA announced its proposed limit on nicotine levels in cigarettes on Thursday, but no specific cap has been determined and the process of implementing a standard may take years

Of all the preventable ways that Americans die, cigarettes claim more lives than any other every year, directly leading to nearly one in every five deaths.

Yet, 15 percent of adult Americans smoke, and tobacco remains a $700 billion industry in the US.

Groups like the World Health Organization (WHO) and the Food and Drug Administration (FDA) have been trying to change that for decades, but – particularly in the US – the wealthy tobacco industry has maintained a firm hold on political purse strings, delaying or altogether blocking public health efforts.

Last summer, the FDA’s announcement that it would be pivoting to anti-smoking strategies called nicotine-delivery products a ‘continuum of risk,’ with combustible cigarettes posing the greatest danger.

It also promised to ‘begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels.’ Today’s announcement is official opening of that dialogue.

Until recently, the option to regulate nicotine was not even on the table for the FDA.

In 2009, the agency won the right to limit – but not eliminate – nicotine in cigarettes with the passage of the Tobacco Control Act.

While experts say that cutting the nicotine in cigarettes would undoubtedly help to diminish their habit-forming power, the goal of ‘non-addictive’ levels may be unattainable simply because we do not know how much – or how little – nicotine is required for addiction to form.

A cigarette contains an average of between 10 and 12 mg of nicotine, but the human body can only absorb 10 percent of that – one to two mg per cigarette.

In 1994 – before the FDA had the legal bandwidth to do anything about it, Dr Neal Benowitz and Dr Jack Henningfield (of the University of California San Francisco and Johns Hopkins University, respectively) recommended that lowering the amount of nicotine in a cigarette to 0.5 mg ‘would minimize the addictiveness of cigarettes.’

Their subsequent analysis, published in 2013 in Tobacco Control, said that even tobacco companies’ own research laid bare the industries dependence on its consumers’ dependence on nicotine.

But the later report also cited new evidence that subtracting the addictiveness from the cigarette equation would require reducing nicotine even further than the previously-suggested 95 percent cut.

However, the study stops short of recommending a new maximum.

Perhaps for that reason, the FDA’s notice claims to round up the most recent relevant research, and also calls for public and expert comment on that information to help inform whatever rule it will ultimately implement.

The notice is ‘an historic move and will deal a necessary blow to Big Tobacco’s immense power… but the announcement triggers a long rule-making process,’ says Lincoln Mondy, creator of the documentary Black Lives/Black Lungs.

The FDA is one of many federal agencies notorious for its slowness. For example, it took a 12-year comment period for the FDA to decide the minimum percentage of peanuts required for peanut butter to be called ‘peanut butter.’

And it seems safe to say that the tobacco industry probably wields substantially more influence over political bodies than does the peanut industry.

As Mondy and his film point out, the 2009 Family Smoke Prevention and Control Act was intended to ban the kinds of flavors that entice children from cigarettes. 

This is an historic move and will deal a necessary blow to Big Tobacco’s immense power… but the announcement triggers a long rule-making process

Lincoln Mondy, creator of the film Black Lives/Black Lungs 

It effectively outlawed sweet flavors like strawberry, grape and vanilla, but, Mondy says, hard lobbying from the tobacco industry kept menthol cigarettes around. 

Mondy says that this win for tobacco is an echo of a the disparity he documents in his film: while only about 20 percent of white smokers prefer menthols, around nine out of 10 black smokers do. 

‘If menthol was disproportionately smoked by white smokers, we wouldn’t be having this conversation,’ he says. 

As the FDA opens the comment period on nicotine reduction, his concerns remain the same: ‘We’ve seen this play out time and time again, and most of the time [these comment periods] are not inclusive to the actual impacted communities,’ he says.  

According to the Centers for Disease Control and Prevention, black Americans smoke fewer cigarettes, but are more pervasively targeted by industry advertisements and more likely to die of smoking-related disease than are whites.   

But the hope is that the new proposed rule – whenever it actually comes into effect – will play into a larger picture that helps reduce addiction risks broadly and close disparity gaps. 

We need an ‘all-of-the-above’ approach, Mondy says. ‘A ban on menthol, nicotine reduction; these can have an immense impact because menthol cigarettes are easier to pick up but harder to put down because they mask the harshness.

‘If there is less nicotine, they will be easier to put down because they don’t have as much of the chemical compounds to addict you,’ he says. 

For its part, the FDA is optimistic that nicotine reductions could a key public health initiative. 

‘We believe the public health benefits and the potential to save millions of lives, both in the near and long term, support this effort,’ wrote commissioner Dr Scott Gottlieb, citing his agency’s estimate that as many as five million Americans might be able to quite within a year of a nicotine standard’s introduction- whatever it might be. 

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