The industry of new nicotine products has sent a direct message to the Ministry of Health, and that is, that the “disguised ban” policy will not work. During the official presentation in Madrid of the Spanish Association of Nicotine Bags (ABN), its president, Mónica Andrade, has called for a stable legal framework that allows the development of alternatives to the traditional cigarette. “Spain needs coherent regulation and information, based on data and not ideology,” Andrade stated, in clear reference to the draft of the Royal Decree with which Mónica García’s department intends to restrict this market.
The point of conflict is in the modification of Royal Decree 579/2017, where Health proposes limiting the nicotine content to 0.99 milligrams per bag, a figure that the industry considers arbitrary and lethal for the sector. According to the ABN, which brings together more than 40 European manufacturers and distributors, this threshold represents a technical prohibition, since the vast majority of products marketed in Europe to be effective in smoking cessation exceed that amount.
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The association contrasts this measure with the reports of the German toxicology institute itself, which endorses doses of up to 16 mg, or with the regulations of neighboring countries such as Italy, Greece or, more recently, Portugal, which has approved limits of up to 12 mg.
The Swedish mirror against Spanish immobility
Andrade’s speech is based on the comparison of public health statistics. While Spain maintains a smoking rate stagnant at 25.8% despite successive restrictive laws, Sweden is about to declare itself a “smoke-free” country (less than 5% prevalence). The key to Scandinavian success, according to experts cited by the ABN, has been the adoption of “harm reduction” policies, which facilitate access to non-combusted oral nicotine products.
“Our message is clear: regulate instead of prohibit,” said the president of the association. The sector’s argument is that legally equating nicotine pouches (which do not contain tobacco or generate smoke) with conventional cigarettes closes the door to a tool that, according to various studies, is up to 200% more effective than pharmaceutical patches or gum to quit smoking. This pragmatic vision is what the United Kingdom has also adopted, where the NHS (National Health Service) integrates these alternatives into its anti-smoking plans.
Black market risk
The ABN warns and informs that the lack of specific and “proportionate” regulation will not end consumption, but will push it underground. “We want to be an active part of the solution,” said Andrade, offering a “total willingness to dialogue with the Administration.”
To demonstrate its commitment, the association presented a self-regulation code that includes strict measures to prevent access by minors, guarantee product quality and ensure responsible labeling. The sector thus seeks to distance itself from the image of lack of control and position itself as a regulated actor capable of contributing to the reduction of mortality from smoking, which in countries with harm reduction strategies has fallen by 40% compared to the European average.