Users and companies ask for total transparency to Health to give certainty about vaping | Innovation

The controversies raised around the electronic cigarette in the US have put the focus in recent months on the safety, regulation and effects of these devices also in Spain, with the first effects on the sector.

The Union of Promoters and Entrepreneurs of Vapeo (UPEV), the association of independent sellers of electronic cigarettes and their refills, estimates that during the second half of 2019 they closed about 40 stores linked to this activity, which caused more than 400 Workers lost their jobs.

Year-round sales were 75 million, 15% below the 88 million billed in the previous year, due to a 30% drop in revenues in the second half. The reason, according to the association, was in the advertising campaign of the Ministry of Health under the slogan "Tobacco binds and kills you," which agglutinated both traditional combustion cigarettes and new alternative devices.

According to the data of the 600 stores associated with the UPEV, since the beginning of the campaign the sale of starter kits in vaping was reduced by 70%, recommended for traditional tobacco smokers who want to start quitting.

This joins the confusion generated in the United States as a result of the distribution, by illegal channels, of charges of vapers whose liquids contained vitamin E acetate linked to tetrahydrocannabinol (THC), the psychoactive component of the cannabis plant. Irregularities that would be behind the death of more than 30 people in that country, according to research that in recent months has undertaken the US FDA.

All these ingredients have provoked a growing debate, also in Spain, about how far the regulation of these devices should go, and also about the health effects they can have compared to traditional tobacco. About it the breakfast organized by CincoDías and El País Retina, which brought together representatives of consumers, distributors and scientific experts in the field who, in the first place, agreed on the need for representatives of the Ministry of Health to be present in this type of debate.

The first point to discuss was the one related to regulation, which is relatively recent. This is based on a directive developed by the European Union in 2014, but whose transposition in Spain did not come until 2017. In fact, it was one of the countries in the European environment to do so with greater delay. It was at the end of that year when the Congress of Deputies approved the decree that completed that transposition and that incorporated own measures for Spain. For example, it prohibited the distance selling of devices capable of releasing nicotine, such as vapers, and also their refills, in addition to assimilating their advertising to that of traditional tobacco. Control measures for manufacturing, composition, distribution or labeling were also established by law. That is, what is sold must receive the approval of Health, which limits the maximum that cases such as those in the United States may occur.

“The European Union has a fairly strict regulation regarding electronic cigarettes, and the Spanish is, if possible, a more demanding point,” explains Rodrigo Fernández Navarro, a member of the board of directors of the UPEV. “This regulation requires all agents in the sector to carry out informative work on devices and loads. Spain is the country with a more rigorous standard and with the highest level of compliance, ”he asserts, concluding that“ this is a sector of every safe point of view ”.

European regulation requires, for example, that liquids containing nicotine go through toxicity and traceability analyzes, as well as reflecting all the elements of their composition. A control that, on the other hand, is not similar in the case of liquids that do not contain nicotine, although the UPEV has approved a code of good practices to also incorporate them into these analyzes. "The only thing that changes in these liquids is nicotine, but we have incorporated those that do not include it so that they have the same standards and quality controls."

On the other hand, those present in the debate raise a pending issue to be resolved by the Health Department regarding liquids. And, although these are analyzed, controlled and registered, the Administration does not make them public. "In Spain all the devices and liquids that carry a load of nicotine must be approved by Health, but does not publish the list of them, giving the feeling that it is not a regulated product", analyzes Ángeles Muntadas-Prim, president of the Spanish Association of Users of Personal Vaporizers (Anesvap) “We are working on the issue of the list,” says the representative of UPEV.

"From the commercial point of view, for establishments and consumers there is a regulation to inform us of the products that we put on the market, but the absence of that list causes some legal uncertainty on the part of the stores," adds Fernández. He remembers that since 2016 there is a project to create a public portal that is still standing.

At this point Ángel González Ureña, Professor of Chemistry at the Autonomous University of Madrid, believes it is important, "to eliminate all confusion", to analyze the emissions of substances that generate all the ingredients of the liquids, not just nicotine. “Technically you can quantify how much it reaches the lung of each thing. We already know that liquids have propylene glycol, glycerin and nicotine, but aromas are not analyzed, for example. It is regulated, but if the list were required, many problems would be eliminated, ”he says. “We are contemplating the analysis of all the ingredients, qualitative and quantitative including aromas,” says Rodrigo Fernández, from UPEV.

Closed or open?

Another point of debate regarding the devices is the suitability of their charges being open or closed. The defenders of the latter argue that they prevent any manipulation of the liquid. "Closed charges can be handled," says, however, the president of Anesvap. “I don't think it's something that can be decisive at all. What has happened in the US has been given with closed cartridges, ”adds Rodrigo Fernández. He remembers that “all the products that are bought in the stores are regulated and controlled”, and that a distributor “cannot take ingredients, make his liquid and sell it. We recommend that customers open the product seals. ”

Elena Ordozgoiti, head of the agri-food service of the Spanish Association for Standardization UNE, describes how at European level there are draft regulations regarding preventing the manipulation of devices by children, to strengthen the safety of designs, or to fix a series of reference substances on which to carry out the analyzes, also liquids without nicotine. “The hope is that a scientific debate will open and that the regulations are linked to that debate. What dictates common sense is a scientific table, ”estimates Rodrigo Fernández.

In this sense, Elena Ordozgoiti recalls that standardization can play that role: “It allows the development of analytical methods, good practices, but with the participation of all the agents in the sector, because they are consensus documents. In this case it would allow to balance what the user demands, what the technology allows, what the manufacturer wants and what Health wants to put on the table ”. The standardization documents, which would emerge from a hypothetical consensus between the parties, are voluntary technical documents that allow all of them to establish clear rules of the game. "Then it is the decision of the legislator to take these documents as a reference," says Ordozgoiti.

But even before that step, Ángel González believes it is necessary “to eliminate the stigma of the electronic cigarette, and this not only has to be done by scientists but also by other components of the organization chart”.

In this regard, he considers that “it is very important to spread the message that these devices are not harmless, but are not so dangerous. It is undeniable that these alternative products represent a positive step in harm reduction, ”he says. "The Administration must accept that scientific evidence and promote a national research plan to deepen this field," he adds.

Rodrigo Fernández, from the UPEV, summarizes by way of conclusion that "vaping in Spain is a very small and controlled sector, professionals know each other very well and that is why we have those levels of professionalism." "We say no to misinformation," says Ángeles Muntadas-Prim, and concludes: "We want to be informed of what vaping really is and that people who want to quit tobacco to access this type of tobacco are given the opportunity alternatives".


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