Explained: Why the US is under pressure to choke its vaping industry

What are e-cigarettes, the epidemic they have caused?

E-cigarettes, also called ‘vapes’ or ‘electronic nicotine delivery systems (ENDS)’, are battery-run devices that were originally marketed as a safer alternative to smoking traditional cigarettes. In recent years, there has been a deadly rise in nicotine addiction in the US, allegedly due to aggressive marketing by manufacturers.

Minors have been particularly affected, with a 2018 survey showing that as many one in five and one in 20 students going to high school and middle school respectively using e-cigarettes.

The disease caused by vaping — suspected to be behind at least six deaths — is unknown to doctors, and a link between vaping and the lung illness is yet to be concretely established. Symptoms, according to the Centers for Disease Control and Prevention (CDC), are those in common with other respiratory illnesses, including coughing, chest tightness, shortness of breath, extreme fever or fatigue.

Deemed as tobacco products in 2016

The FDA in 2016 categorised e-cigarettes as a ‘tobacco product’, expanding its authority to regulate the product’s sale. Following this decision, a ban was placed on distributing free samples of e-cigarettes and their sale through vending machines. Importantly, it was provided that new vaping products could enter the market only after obtaining a premarket review clearance from the FDA. However, the products having ‘grandfather status’, meaning those introduced before February 15, 2017, were excluded from the clearance requirement.

While the FDA widened its mandate to control e-cigarette sales, the agency stopped short of taking a tougher stance, such as banning some of the varieties of the product.

2017 compliance policy

In a policy decision announced in July 2017, the FDA tried to give some relief from regulations to manufacturers. It was believed that this would spur innovation for new products that could help reduce the nicotine addiction rate in the US, which at the time was already levelling off. The FDA thus kept extending the enforcement deadline of the 2016 deeming rule.

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2019 draft guidance

In the period since the 2017 policy, a marked increase in vaping-related illnesses was reported, and studies revealed the phenomenal rise in addiction among youth. The availability of vapes in flavours such as fruit, candy, and chocolate was purported to be among the reasons for the product’s popularity.

Thus, in March 2019, the FDA issued a draft guidance, the precursor to a new policy, seeking to adopt a tougher stance on e-cigarettes, especially the flavoured variants. Except for tobacco, menthol, and mint flavours, the draft guidance sought to enforce the premarket review deadline for all e-cigarettes immediately.

What could happen now?

With political pressure increasing, the Trump administration could roll out even tougher rules. Juul, the market leader in the US e-cigarette industry, is already under the FDA’s scanner for its allegedly youth-targeted aggressive marketing campaign.

This month, the state of Michigan banned flavoured e-cigarettes entirely, and more US states could follow the example. The federal government too could take such a decision, thus going beyond the March 2019 draft guidance’s recommendations.