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E-cigarettes will no longer be considered pharmaceutical products in Chile following the passage of bill 12626-11 – with outlining regulations expected to be issued by May 2024. The bill, incorporating bills 12908-11 and 12632-11, was approved by the Senate on 5th October 2023. It will regulate vaping products in a similar way to tobacco products, though it will also introduce some additional regulations. Approved unanimously in both the lower and upper houses, bill 12626-11 sets the rules for the packaging of electronic smoking devices (ESDs), such as the display of nicotine concentration, and establishes criteria for direct and indirect advertising of these products. It also prohibits ESDs in vending machines, health facilities (both public and private), and the sale and delivery of e-cigarettes to under-18s. Previously, neither nicotine-containing nor nicotine-free e-cigarettes were subject to any age restrictions. The former are considered pharmaceutical products and can be sold to anyone with a doctor’s prescription, and the latter are considered consumer products and can be sold freely. An important step forward “The bill has been developed with support from all sectors of society and the federal government,” Andrés Celis, a parliamentarian who helped develop the bill in the Chamber of Deputies, added. “Today, illegal ESDs are easily available in the market, and we have no control over what substances consumers are being exposed to. The bill is an important step forward.” While bill 12626-11 passed less than two months ago, the debate on e-cigarettes has been going on in Chile since 2019, when parliamentarians identified the need to prohibit these products for minors. “Chile’s government has been standing for strict, evidence-based regulation since before the pandemic,” Andrea Martínez, a public health professor at the University of Chile and member of the Ministry of Health’s citizen panel on tobacco said. “The government has been supportive of regulation for heated tobacco and vaping products, particularly since [former] president Piñera’s second term.” The professor said a 2016 Ministry of Health report found that “in Chile, 10% of youngsters between 9 to 18 years old were either regular consumers or had tried [some form of alternative tobacco product].” Industry pressure While both sources celebrate that the bill prohibits the use of ESDs in public spaces and limits minors’ access to these devices, the public health professor confirmed the bill does not reflect the recommendations from public health organizations. “It allows nicotine concentrations that are higher than those that pose health risks, and doesn’t limit use in indoor spaces,” said Martínez, alleging this was due to the weight of industry stakeholders in the making of this bill. The maximum nicotine content the bill proposes is 45 mg/ml. According to Martínez, “there has been lots of pressure from vaping associations, such as Asovape,” some of which include industry members. What’s more, Martínez alleges that the bill determines looser restrictions for nicotine-free devices – which are treated more leniently in terms of their packaging – due to the connections of some parliamentarians with the national cannabis industry: “As these devices are also used to smoke cannabis products, there has been pressure from this sector for a more permissive law,” she said. Expectations for May 2024 Martínez says Ministry of Health representatives have already started to work on the regulation for bill 12626-11. “We are hoping that the regulation developing the bill will be issued in May 2024, it is then when it will enter into force.” With the regulation being responsible for establishing the norms – such as restrictions, health warnings and TV advertising times – parliamentarians are holding the Ministry of Health accountable for the next steps. “The regulation is urgent, so that the law doesn’t turn into a dead document,” Celis said. “For every day we don’t have a regulation, more Chilean youngsters are exposed to illegal electronic smoking devices.” The bill is now under review by the Constitutional Court and pending the president’s signature.

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