US to reduce nicotine levels in cigarettes; points to e-cigs as “lower-risk alternative” for smokers

US to reduce nicotine levels in cigarettes; points to e-cigs as “lower-risk alternative” for smokers
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In a surprise move on Friday, the United States’ Food & Drug Administration (FDA) said that it will require tobacco companies to reduce the amount of nicotine in cigarettes to make them less addictive.

The announcement is seen as “a major regulatory shift designed to move smokers toward potentially less harmful e-cigarettes.” It “is likely to upend the $130 billion American tobacco industry and potentially encourage millions of people to quit smoking”, according to Bloomberg.

Cigarette smoking kills some 480,000 people in the US every year, making tobacco the leading cause of preventable deaths in the country.

“The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes — the only legal consumer product that, when used as intended, will kill half of all long-term users,” said FDA Commissioner, Scott Gottleib, when announcing the changes.

“Nicotine itself is not responsible for the cancer, the lung disease and heart disease that kill hundreds of thousands of Americans each year,” Gottlieb said. “It’s the other chemical compounds in tobacco and in the smoke created by setting tobacco on fire that directly cause illness and death.”

Tar and other substances, which are released through tobacco burning, and inhaled through smoking make cigarettes deadly.  

It is, however, the nicotine in tobacco which makes them addictive, which is why the FDA is targeting nicotine levels in cigarettes to help smokers wean themselves off the habit.

The new regulation on nicotine level, which will take some time to implement, is the first time that the US agency has moved beyond traditional measures such as requiring warning labels to be printed on cigarette packs, or imposing higher taxes on tobacco products, to dissuade smoking.

“Unless we change course, 5.6 million young people alive today will die prematurely later in life from tobacco use,” Gottleib said.

Smoking rates in the US has fallen through the years, although it has plateaued in 2015 and 2016 at 15 per cent.

“Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts – and we believe it’s vital that we pursue this common ground,” Gottleib said.

He added that the science of nicotine regulation, and understanding what the addictive level is, “is well established.”

“There is a threshold level below which cigarettes probably wouldn’t be addictive.,” Gottleib said.

According to Eric Donny, director of Pittsburgh’s Center for the Evaluation of Nicotine in Cigarettes, reducing nicotine substantially – by around 90 per cent – leads to smokers being less dependent on cigarettes and smoking fewer of them.

“Most of the harm associated with smoking is related not to the nicotine but everything else in the smoke,” he said. “Reducing nicotine doesn’t make a cigarette safe, it just makes it less addictive.”

The FDA also announced that it is delaying for up to 4 years a key regulation affecting cigars and e-cigarettes, which includes flavored vaping products. The postponement means that such products need not be approved by the FDA for now.

This is seen as a major reprieve for companies producing such products and “opened the door [for the FDA] endorsing e-cigarettes as a means to get smokers to quit”, said The New York Times.

However, e-cigarettes producers may also be affected by the requirement for lower nicotine levels in their products.

Although Gottlieb is concerned about flavoured e-cigarettes being appealing to children or youths, and would consider regulating these, “he also noted the potential benefits to addicted cigarette smokers of products capable of delivering nicotine without having to burn tobacco.”

“We do think there’s a potential opportunity for e-cigarettes to be a lower-risk alternative to smokers who want to quit combustible cigarettes,” Gottleib told The New York Times. “We still have to figure out if they are a way to get people off combustible cigarettes. We don’t fully understand.”

The FDA announcements followed news from the United Kingdom last week where a study found that e-cigarettes indeed have helped existing cigarette smokers quit smoking.

The study, published in the British Medical Journal, conducted by scientists from California, analysed survey data from over 160,000 people spanning almost 15 years, from 2001 to 2015.

The researchers found that those who used e-cigarettes tried more often to quit smoking; and that they succeeded more often than smokers who tried to quit without using e-cigarettes.

The results provided a “strong case” that e-cigarettes have helped to increase rates of smoking cessation, they said.

“These findings need to be weighed carefully in regulatory policy making and in the planning of tobacco control interventions,” the researchers said.

Public Health England, an agency in the Department of Health UK, and the Royal College of Physicians (RCP), had also conducted their own study in 2016.

They found that the risks posed by e-cigarettes “are unlikely to exceed 5 per cent of those associated with smoked tobacco products, and may well be substantially lower than this figure.”

The RCP recommended that “in the interests of public health it is important to promote the use of e-cigarettes, NRT [nicotine replacement therapy] and other non-tobacco nicotine products as widely as possible as a substitute for smoking in the UK.”

There are, however, concerns from other parties, such as the World Health Organisation (WHO) which said in a 2016 report that electronic nicotine delivery systems (ENDS) do not help smokers quit smoking.

The US Surgeon General also cautioned that “although e-cigarettes generally emit fewer toxicants than combustible tobacco products, we know that aerosol from e-cigarettes is not harmless.”

In Singapore, as in several other countries, a blanket ban is imposed on all alternative tobacco products and nicotine delivery systems.

The Singapore Health Sciences Authority said that these new inventions “should demonstrate their safety and effectiveness with the same level of scientific rigour required for approved Nicotine-Replacement Therapies under the Medicines Act.”

It is doubtful that the authorities here, which has adopted a two-phase approach to eliminating smoking altogether, will reverse its complete ban and allow ENDS, despite the study results from the UK and the FDA’s announcement.

Philip Morris International, the biggest tobacco company in the world, said that the company “believes the FDA’s commitment to encourage science based innovations that have the potential to make a notable public health difference will be an important development in helping achieving a smoke-free future.”

“The FDA’s stated aim to develop science-based policies to reduce the harm caused by tobacco is also a welcome development,” it said.

At a recent company shareholders’ annual meeting, its CEO Andre Calantzopoulos said:

“Key to achieving a smoke-free future are regulatory frameworks that are as innovative as the smoke-free products that are now available. Adoption of sound regulations can significantly accelerate switching from cigarettes to reduced risk products”

The FDA is currently reviewing IQOS, a product from Altria Group Inc and Philip Morris International that heats tobacco instead of burning it, according to a Reuters report.

The company said IQOS “reduces the formation of the harmful or potentially harmful compounds by on average 90 percent compared to smoke from a reference cigarette designed for scientific research purposes.”

What do all these mean for the smoker or the vaper in Singapore, which has a  cigarette smoking rate of about 14 per cent?

For Mr Ng (not his real name), who had been smoking cigarettes for 20 years, the ban here has not stopped him from vaping – only that he does not do it in public. He now vapes at home.

He had picked up vaping before the most recent changes to the ban in Singapore, which now prohibits the use, possession and distribution of all nicotine delivery systems.

Mr Ng says vaping “is a very effective way to quit smoking, and a healthier replacement for smoking.” He is not, however, in favour of making these products available to everyone. His concern is that children or youths may be attracted to trying them.

42-year old Sam (not his real name) had been smoking regular cigarettes for 25 years. He turned to vaping the last two years, before the ban. He is disappointed that he can no longer use vaporisers.

“When I was vaping, I did not touch a single regular cigarette,” he tells Publichouse.sg. “That’s how effective vaping was for me.”

He explains that vaping can help smokers stop smoking regular cigarettes.

“It’s nicotine on demand,” Sam says. “With a cigarette, you light one and you finish it. Sometimes it is more than you wanted, sometimes it is less and you’ve got to light another. With vaping, you do it only when you need it, and only as much as you need.”

He says that the ban in Singapore has deprived him of an opportunity for a much safer substitute, and has reduced his chances of quitting smoking altogether.

38-year old Tang is another vaper who has been at it for 1.5 years. Formerly a regular smoker of cigarettes, he says he vapes as frequently as he used to smoke, but vaping is not as addictive as he experienced with regular cigarettes.

“I can do without [vaping] for 6 hours without feeling discomfort, unlike smoking,” he says. With cigarettes, he needed to have one every 1-2 hours.

Vaping has helped improve his overall health, he says.

“I don’t wake up with smokers’ cough,” he explains, “and my gums are back to pink colour, I’m able to smell, and my breath and sense of taste are better now.”



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