FDA rules six Vuse Alto e-cigarettes can no longer be sold in the US

Risks associated with the products outweigh the benefits, per the FDA

The US Food and Drug Administration (FDA) has determined that six Vuse Alto e-cigarettes do not “meet the public health standard”, and, thus, must stop being marketed in the US. Three mixed-berry and three menthol flavours were among those that have been banned.

A statement from the agency issued 12 October says that marketing denial orders (MDOs) have been issued to the makers of the Vuse Alto e-cigarettes, R.J. Reynolds Vapor Company. The move indicates the FDA may be cracking down on e-cigarette regulation in the US.

The statement said the FDA had found that the risks associated with Vuse Alto e-cigarettes—which can become addictive for children—outweigh the potential benefits, such as helping cigarette smokers quit.

Matthew Farrelly, PhD, the FDA’s director of the Center for Tobacco Products Office of Science, said in the statement that there’s simply not enough evidence to claim the public are better off with access to the six Vuse Alto e-cigarettes. “We review each application on its own merits, and it’s the responsibility of the applicant to provide sufficient science to support the product they’re seeking to market,” Dr Farrelly said. “If an application contained sufficient scientific evidence to meet the necessary public health standard, including a non-tobacco-flavored product, we’d authorize the product. But such evidence was lacking in this case.”

The statement said that Vuse is the “most commonly sold” e-cigarette brand in the US and that Vuse Alto is the most popular sub-brand owned by the company.

Though e-cigarettes—which work by heating a liquid into an aerosol which users then inhale—are often marketed as healthy alternatives to cigarettes, they’ve been associated with many major health issues in children and adults.

They produce dangerous chemicals like acrolein, acetaldehyde, and formaldehyde, some of which can cause cardiovascular disease and lung disease, per the American Lung Association (ALA). Acrolein, in particular, which is used to kill weeds, can cause acute lung injury, and it may lead to asthma or lung cancer.

Research has also shown that two “primary ingredients” in e-cigarettes—vegetable glycerin and propylene glycol—are toxic to cells.

E-cigarette use among young people has skyrocketed in recent years, according to a statement from the office of the Surgeon General.

Even though they’re marketed as tools to help people quit smoking, it’s important to acknowledge how addictive e-cigarettes are themselves, experts say. Importantly, many e-cigarette products have more nicotine—in “extra-strength” cartridges—than traditional tobacco products. The Vuse Alto products which were targeted by the FDA this week are offered in three different nicotine strengths.

R.J. Reynolds immediately challenged the FDA’s decision to issue MDOs to six Vuse Alto products this week. The parent company of R.J. Reynolds, British American Tobacco, said in a statement that the agency’s ruling “flies in the face of proven science,” and said it would challenge the ruling in court, per The New York Times.

But for now, the products must be taken off store shelves; moving forward, it will be illegal to introduce any more of the six Vuse Alto products targeted by the FDA into interstate commerce.

The FDA statement clarified that the agency has only authorised 23 tobacco-flavoured e-cigarettes (which can be found here); these are the only devices that can be “lawfully sold and distributed” in the US.

Brian King, PhD, director of the FDA’s Center for Tobacco Products, said the agency’s process is intended to keep the public safe from harmful devices. “The Center for Tobacco Products continues to make meaningful progress in reviewing the unprecedented amount of premarket tobacco product applications that have been received,” he explained. “We’re committed to completing review of these applications as soon as possible while ensuring that they undergo a rigorous scientific review in accordance with the law.”