Författare: Jamie Hartmann-Boyce Assistant Professor of Health Promotion

On June 21, 2024, the U.S. Food and Drug Administration authorized the marketing of the first electronic cigarette products in flavors other than tobacco in the U.S. Of the four new authorized products, two are sealed, prefilled pods with menthol flavored nicotine liquid that can be used in certain types of e-cigarettes. The other two are disposable nicotine e-cigarettes – meaning once the prefilled menthol liquid is used, the device cannot be used again.

The Conversation asked Jamie Hartmann-Boyce, a health policy expert who specializes in tobacco control and e-cigarette products, to explain the pros and cons of the FDA’s authorization and what it could mean for vulnerable populations.

What does the new announcement from the FDA mean?

E-cigarettes, also known as vapes, are hand-held, battery-operated devices that heat a liquid to form a vapor that can be inhaled. This vapor can be manufactured to include flavors. Unlike traditional cigarettes, e-cigarettes do not contain tobacco leaf. E-cigarettes can – but don’t always – contain nicotine.

Until June 21, the only nicotine e-cigarettes authorized for sale in the U.S. were tobacco-flavored. Some organizations, including some tobacco industry advocates, described this as a “de facto flavor ban.”

The Centers for Disease Control and Prevention defines menthol as a chemical compound found naturally in peppermint and other similar plants.

This is the first time the FDA has authorized marketing of an e-cigarette flavor other than tobacco. “Tobacco flavor” describes a range of flavors that are designed to taste similar to traditional cigarettes.

What are the potential harms, such as risks to kids?

Tobacco companies have historically added menthol to traditional cigarettes to make them seem less harsh and more appealing. Tobacco companies have aggressively marketed menthol cigarettes to Black people. In 2022, the FDA proposed a ban on menthol cigarettes based on their appeal, including to youth, and the potential of such a ban to improve health and prevent deaths. But the proposal has stalled.

Research shows that nontobacco, e-liquid flavors are more appealing than tobacco flavors, including to young people. The FDA has previously denied applications for menthol e-cigarettes, stating that the applications “did not present sufficient scientific evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use.”

How are e-cigarettes regulated in the US?

In the U.S, e-cigarettes with nicotine fall under the authority of the FDA’s Center for Tobacco Products. For their products to be legally marketed and sold in the U.S., e-cigarette manufacturers must apply for marketing authorization from the FDA.

The FDA evaluates these applications based on the scientific evidence provided by the manufacturers. To be approved, the applications must demonstrate that permitting marketing of the products would be appropriate for protection of public health.

This means the FDA needs to weigh whether the potential benefits of the product – in other words, its ability to help adults quit smoking – outweigh its risks, including its appeal to youth. Though not risk-free, e-cigarettes are considered much less harmful than smoking. This means that adults who switch from smoking to vaping may benefit from improvements in their health.

The FDA’s authorization of menthol-flavored e-cigarettes underscores the growing body of evidence that vaping can reduce the harms of traditional smoking. But many experts are concerned that the new products will entice more young people and nonsmokers to begin vaping and smoking.

Weren’t flavored vapes already available in the US?

Even though only tobacco e-liquids were authorized for sale before this new announcement, many Americans report using flavored e-liquids, with sweet, fruit and mint and menthol flavors being the most popular. This is in part because many vaping products available in the U.S. haven’t been authorized for marketing or sale. These are referred to as illicit products. In addition, some of the products currently available are still being reviewed by the FDA.

Many of the harms the public associates with vaping – such as the serious vaping-related lung injuries that were widely reported in 2019 and 2020 – have been linked to illicit products and the harmful chemicals some contain, which are not present in FDA-authorized products. Earlier in June, the Justice Department and FDA announced a federal multi-agency taskforce to curb distribution and sale of illegal e-cigarettes. Meanwhile, the U.S. is awash in sleek, colorful and highly potent vapes manufactured in China.

What are the potential health effects?

The best available research doesn’t show any clear differences between menthol and tobacco flavored e-liquid in terms of direct health risks to users.

As mentioned above, research suggests that nontobacco e-liquid flavors are more appealing than tobacco-flavored ones, at least in some groups. This might mean an increase in the risk of nonsmoking youth taking up vaping. But it might also encourage people who smoke to switch to vaping, which can pose fewer risks than smoking. Quitting smoking can also improve the health of other people, by reducing secondhand smoke exposure.

Smoking kills half of its regular users and is the leading cause of preventable death in the U.S. and worldwide. So alternatives that increase chances of successfully quitting smoking can bring substantial health benefits.

To grant authorization for the four new approved products, the FDA had to review an extensive amount of documents and research showing that the benefits of the new products outweighed their risks. Läs mer…

Oral nicotine pouches – like Zyn and Velo in the U.S. – appear to be less toxic than cigarettes and deliver comparable levels of nicotine. This makes them an alternative for people who smoke. However, people who’ve never smoked are using them, too, and youth are open to trying them. These are key findings of our recent systematic review, published in the journal Nicotine and Tobacco Research.

Oral nicotine pouches are preportioned pouches sold in various flavors and nicotine strengths. They are similar in appearance and use to traditional ‘snus’, a form of smokeless tobacco placed between the gum and lip, which is popular in Scandinavia. However, unlike snus, nicotine pouches do not contain tobacco leaf. As a result, they are often marketed as “tobacco-free.”

One of the studies in our review found that the “tobacco-free” label is confusing to some and may lead people to think nicotine pouches do not contain nicotine.

On average, studies in our review showed that nicotine pouches had fewer harmful chemicals, present at lower levels, than in cigarettes and smokeless tobacco, like snus.

This varied by product, though. It could be that different flavorings have different levels of harmful chemicals. The most common reasons given for using pouches were curiosity, flavors and the perception that they were discreet and could be used where other tobacco products could not.

Why it matters

More people are using nicotine pouches than ever before.

While manufacturers claim to target people who smoke, we found that 35% to 42% of U.S. youth were aware of oral nicotine pouches. Of those who didn’t use any form of nicotine, we found 9% to 21% open to trying pouches.

As public awareness of these products is growing – due to increased use and increased marketing – people want to know more about their effects. This includes people who smoke, who might switch to them, people who don’t smoke, who might use them recreationally, and policymakers.

Central to all of this is nicotine. Nicotine is not the component in cigarettes that causes disease and death, but it is the addictive one. Too much nicotine can make you sick, and people who don’t smoke shouldn’t use nicotine products.

At the same time, though, safer forms of nicotine have been helping people quit smoking for decades.

Cigarettes remain the leading cause of preventable disease and death worldwide and in the U.S. If they completely replace smoking, alternative nicotine products have the potential to bring substantial health benefits, both to people who smoke and the people around them.

Health officials are concerned about the growing popularity of nicotine pouches among adolescents.

What still isn’t known

There’s a lot we researchers still don’t know about nicotine pouches.

Hundreds of randomized trials show nicotine replacement therapies – like gum and patches – are safe and that they help people quit smoking.

There is also an ever-growing number of trials – currently 49 – showing that e-cigarettes with nicotine help people stop smoking and are substantially less harmful than smoking.

With oral nicotine pouches, however, only a handful of studies exist. Though most studies show that pouches expose users to lower levels of toxic substances than smoking, these studies were often small, and most were conducted by the tobacco industry, which has a long history of distorting science.

What’s next

We know that smoking is remarkably lethal – cigarettes kill approximately half of regular users. It’s probably reasonable to assume and not surprising to see data indicating that pouches are less harmful than smoking. That doesn’t mean they are safe, though.

We need large, long-term independent studies to say anything for sure about the health effects of nicotine pouches. People’s use patterns and the marketing need to be carefully monitored to ensure that products aren’t being targeted at groups who don’t smoke, and particularly aren’t targeted at historically disadvantaged or marginalized groups, as they have been in the past.

The Research Brief is a short take on interesting academic work. Läs mer…