Why e-cigarettes should not (and cannot) be regulated as medications

 

Comment by Dr Farsalinos

 

Sometimes common sense is the missing link in public health authorities’ decisions. There is no other way to understand their reasoning. Several authorities are trying to implement a medicinal regulation for e-cigarettes, the latest being MHRA in UK. First of all, we should remember that whoever tried that in the past has failed; everyone lost in courts (Netherlands, Germany, Estonia, and USA). The same story will be repeated in this case. There are several legal and common-sense reasons for that:

 

1.       1. Definition: nicotine is not a medication. Or, if it is a medication, you cannot discriminate and consider it a medication in some products only and not in others. Since tobacco cigarettes cannot be regulated as medications, all attempts to regulate e-cigarette liquid based on nicotine presence will fail.

 

2.      2. Availability: medicinal regulation will decrease availability, increase cost and limit sales of e-cigarettes. At the same time, tobacco cigarettes will be available everywhere. Thus, the competition is in favour of tobacco cigarettes. One would reasonably think that the exact opposite should happen…

 

3.   3Practicality: medicinal regulation means that you should define specific dosage, determine consistent nicotine delivery and give specific instructions of use. These are impossible to implement in e-cigarettes since every consumer has a different pattern of use (similar to the case of tobacco cigarettes). NRTs have failed for the same reasons (among others). Now, imagine prescribing e-cigarettes with a dosage like “15 puffs lasting 4 seconds, every 4 hours”…. E-cigarettes are effective because they provide pleasure to the user. And every consumer has a different perception of pleasure. This precludes any efforts to regulate it as medication.

 

4.   4. Efficacy: regulation will inevitably limit the variability of devices and e-liquid flavours currently available. Evidence shows that these parameters have a major role in e-cigarettes’ success as a smoking alternative.

 

5.    5. Technology: medicinal regulation is impossible to follow the technologic advance of e-cigarettes. New devices appear every day, batteries will evolve all the time (making them smaller and more efficient) and clever electronic circuits will become integrated and will increase efficacy of the devices. Medicinal regulation will inevitably stop all this progress…

 

6.   6. Philosophy: medicinal regulation based on safety of a consumer product is a very dangerous thinking. With the same reasoning, every consumer product should become a medication in order to ensure quality of production and safety. Even water should be regulated as medication. The regulatory authorities are following a very tricky path…

 

7.    7. Safety myth: regulation proposes medicinal rules because that will improve product safety. This is an absolute myth. No studies on safety will ever be performed for this regulation. In fact, that will significantly reduce real research because all financial resources will be used for the regulation efforts. We already have the example of a UK company which has applied for medicinal approval. They have spent huge amounts of money for this over the past 3 years, and we have not seen a single study providing useful scientific information about the safety of their product. Regulatory tests will provide no significant information about what the vaping and the scientific communities ask: evidence on safety and health improvement. There are already several consumer-product regulations by which quality of production can be reassured and inspected.

 

8.   8. Freedom of choosing a safer alternative: do public health authorities have the right to stop smokers from using a safer alternative? Do they have the right to regulate e-cigarettes so strictly, although we need them as a competitor against the freely-available tobacco cigarettes? Who will bear the ethical and legal consequences of such a decision, which will adversely affect the health of smokers?

 

9.   9. Punishing the name: most authorities simply do not like the name e-cigarettes. And they do not like that they have nicotine, they mimic smoking and they provide pleasure to the user. However, these are the main reasons for their success, and these features are not present in any other medicinal smoking-cessation product. That is why every other product has failed…

 

1   10. Open minded: a major characteristic of science is that you should approach a problem in an open-mined manner. Authorities have displayed the exact opposite: they reject a product because of ideology. The adverse health impacts of this behaviour will be tremendous…

 

 

 

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