The FDA has approved menthol vapes despite serious risks. Here’s why. : ScienceAlert

On June 21, 2024, the U.S. Food and Drug Administration approved the first non-tobacco flavored electronic cigarettes to be marketed in the U.S.

Of the four new authorised products, two are sealed, pre-filled pods of menthol-flavoured nicotine liquid that can be used in some types of e-cigarettes. The other two are disposable nicotine e-cigarettes – meaning that once the pre-filled menthol liquid has been used, the device cannot be reused.

During the conversation, Jamie Hartmann-Boyce, a health policy expert specializing in tobacco control and e-cigarette products, asked for clarification on the pros and cons of FDA approval and what it could mean for vulnerable populations.

What does the new FDA announcement mean?

E-cigarettes, also known as vaporizers, are handheld, battery-powered devices that heat a liquid to create a vapor that can be inhaled. This vapor can be made to contain flavorings. Unlike traditional cigarettes, e-cigarettes do not contain tobacco leaves. E-cigarettes may, but do not always, contain nicotine.

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

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

This is the first time the FDA has allowed the sale of e-cigarettes with flavors other than tobacco. “Tobacco flavor” describes a range of flavors that taste similar to traditional cigarettes.

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What are the potential harms, e.g. risk to children?

In the past, tobacco companies added menthol to traditional cigarettes to make them appear less pungent and more attractive. Tobacco companies aggressively market menthol cigarettes to black people.

In 2022, the FDA proposed a ban on menthol cigarettes because of their appeal, including to young people, and the potential for improving health and preventing deaths. But the proposal stalled.

Research shows that tobacco-free e-liquid flavours are more attractive than tobacco flavours, even for young people.

The FDA has previously rejected applications for menthol e-cigarettes, stating that the applications “do not present sufficient scientific evidence to demonstrate that the potential benefits to adult smokers outweigh the risks associated with youth initiation and use of cigarettes.”

What are the regulations regarding e-cigarettes in the US?

In the U.S., e-cigarettes containing nicotine are regulated by the FDA’s Center for Tobacco Products. In order 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 uses based on scientific evidence provided by manufacturers. To be approved, applications must demonstrate that allowing the products to be marketed would be appropriate to protect public health.

That means the FDA must consider whether the product’s potential benefits—in other words, its ability to help adults quit smoking—outweigh its risks, including its appeal to young people. While e-cigarettes aren’t risk-free, they’re considered significantly less harmful than smoking. That means adults who switch from smoking to vaping could benefit from improved health.

Weren’t flavored vaporizers already available in the US?

Although only tobacco-flavored e-liquids were allowed for sale before this change, many Americans admit to using flavored e-liquids, the most popular of which are sweet, fruity mint, and menthol.

This is partly because many vaping products available in the U.S. have not been approved for marketing or sale. These are referred to as illegal products. Additionally, some of the products currently available are still under review by the FDA.

Many of the harms that society associates with vaping—such as the serious vaping-related lung injuries that were widely reported in 2019 and 2020—have been linked to illegal products and the harmful chemicals they contain that are not found in FDA-approved products.

Earlier in June, the Justice Department and the FDA announced a federal multi-agency task force to crack down on the distribution and sale of illegal e-cigarettes. Meanwhile, the U.S. is full of sleek, colorful, and very powerful vaporizers made in China.

What are the potential health risks?

The best available research shows no clear difference in the immediate health risks for users of menthol and tobacco-flavored e-liquids.

As mentioned above, research suggests that tobacco-free e-liquid flavors are more appealing than tobacco-flavored ones, at least in some groups. This could mean an increased risk of nonsmoking youth starting to vape.

However, it may also encourage smokers to switch to vaping, which may pose fewer risks than smoking. Quitting smoking can also improve the health of others by reducing exposure to secondhand smoke.

Smoking kills half of people who smoke regularly and is the leading cause of preventable death in the US and worldwide. Therefore, alternatives that increase the chances of successfully quitting smoking may have significant health benefits.

To authorize the four new approved products, the FDA had to analyze a huge amount of documents and studies that showed that the benefits of the new products outweighed their risks.

Jamie Hartmann-Boyce, assistant professor of health promotion and policy, UMass Amherst, UMass Amherst

This article is reprinted from The Conversation under a Creative Commons license. Read the original article.