The psychiatrist and smoking expert Karl Fagerström He has defended the introduction of nicotine bags in the market as a less detrimental alternative to smokers, ensuring that “with Regulation and information to the appropriate smokers, Pure nicotine is much less harmful than combustion“
In depth
Fagerström has commented in an interview with Europa Press some of the details about the Royal Decree project for which certain aspects of tobacco products and derivatives are regulatedsent by the Spanish Ministry of Health to the European Commission last Friday and whose text was known yesterday.
Thus, consider that nicotine envelopes could be a good way to cause change to smokers to a product that is “much less harmful than combustion”, always accompanied by “The appropriate regulation and the corresponding information to the smokers“
The expert, author of the famous tobacco dependence test that bears his name, considers that the Spanish decision to limit nicotine envelopes to 0.99 mg is far from what would be considered effective to achieve that change, something for which he believes “No more nicotine is needed than about 10 mg“, below the average of the products currently in the market but well above Spanish limitation.
More details
“In Sweden The notice of the product, for example, governs the taxation of the same. Good products [desde el punto de vista de que logren provocar el cambio a los ya fumadores] They do not need more nicotine than about 10 mg“He explained.
In fact, the Spanish Ministry of Health has published on its website a single report on nicotine envelopes, translated from the Federal Institute for Risk Assessment (BFR) of Germany, which taking into account the acute toxicity of the nicotine defines the 16.6 mg/bag as the acceptable upper limit, which it considers “comparable with that achieved in the blood after the consumption of cigarettes.”
Fagerström considers that the initial use of these bags certainly It can attract some young people, similar to what happened with electronic cigarettes, but has predicted that “after the initial outbreak of fashion, use will be reduced,” In the case of vapers and other systems.
The posture of the US FDA
The expert stressed that the United States Food and Medicines Administration (FDA) has determined that “The existence of nicotine bags in the market was positive for public health“, compared to The rest of the products and that is why the marketing of 20 products has recently authorized the Zyn company.
The psychiatrist has criticized possible prohibitions, arguing that “Prohibit is not an option“And that restrictions on cultural drugs such as Alcohol and tobacco would allow them to break and be market “in the hands of organized crime and low quality products“, without the corresponding regulation.
Regarding the tobacco industry, he said that “Of course it loses with the decrease in the cigarette market and benefits from the increase in the damage reduction market“, but considers that none of these certainties is so relevant” that it is not interesting to save lives changing the consumption patterns of the most harmful products by others less harmful“
In addition, he has shown his concern about the position of the European Commission, stating that “It is not good when snus is prohibited [el tabaco masticado, muy extendido en Suecia] and not the cigarettes that should be progressively eliminated“
Fagerström has compared the consumption of nicotine with other substances, noting that “The damage is much lower with pure nicotine than with cigarettes“, which would no longer place it as a”health problem“Public of the current magnitude, but rather in the league of other products” such as coffee and energy drinks. “
The expert has also stressed that prohibiting these alternatives could have unwanted consequences, since “modern electronic commerce would facilitate purchase and the State would lose with taxes.”
To take into account
In addition to the regulation of nicotine bags and changes in electronic cigarettesthe Ministry of Health has eliminated the regulation of generic packaging within this Royal Decree project, sent to the European Commission last Friday, specifically to the notification system Tris which analyzes the transparency and compatibility of technical standards within the European Union.
Asked the Ministry of Health in this regard by Europa Press, they point out that “it has retired from that RD for a matter of regulatory range”, but “They do not give up“As they hope to recover later. The text presented last November, before the public hearing, promoted the generic packaging – with three new sections 4, 5 and 6 to article 19, of RD 579/2017- in addition to limit the nicotine bags and regulate the ‘Vapers‘With and without nicotine, including restrictions on aromas.
Thus, the same project presented The TRIS is eliminated from its main novelties, among which it lists that “restricts the presence of flavorings or flavorings in electronic cigarettes, with or without nicotine”, and that “two new categories of products are introduced in Our legal system, nicotine bags and heated herbal products“
The Royal Decree project includes a unique article with 16 sections for the approval of the different changes raised, some of them in an innovative character when regulating several several regular categories of products. In addition, the norm incorporates an additional provision, a transitory provision and a final disposition.
Thus, section one modifies the object of the standard to include electronic cigarettes without nicotine; Section two modifies and introduces definitions of the terms expressed throughout the norm; section three modifies the regime of ingredients and additives for include to the products by heating: sections four to fifteen regulate electronic cigarettes without nicotine, and regulate Communication obligations in relation to these products, tests and control and verification requirements.
Section seven modifies certain quality and safety requirements of electronic cigarettes; And the sixteen section adds a new title to regulate different related products of electronic cigarettes, electronic cigarettes without nicotine and smoking herbs. In addition, two new categories of products are introduced in our legal system, nicotine bags and heated herbal products. And finally, The unique final disposition provides for the entry into force on the day after its publication in the BOE.
The Ministry has also sent Impact evaluationwhere it is pointed out that it has no effect on the economy in general. However, a transitory period is recognized through the extension of manufacturing and marketing that responds to the need to allow manufacturers and marketers Adapt the products affected to the new established requirements, as well as the exhaustion of the available stake.
Depending on the different changes produced in the project, a period of 10 and 12 months is recognizedwhich is considered wide enough to allow the adaptation of the sector without putting public health at risk.
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