The FDA’s current approach to e-cigs is comparable to what would happen if you showed a Luddite a 3D printer or an internet-equipped, app-laden smart phone. It’s a mixture of fear, sensationalist rhetoric, misleading studies and an apparent inability to accept the technology for what it is: a revolutionary product with substantial potential for harm reduction.
In the UK, however, the Medicines and Healthcare Products Regulatory Authority (MHRA) has recently announced that it will regulate e-cigarettes (as well as other nicotine-containing products) as medicines from 2016 onwards.
The MHRA is the UK equivalent of the FDA, and the new legislation casts the spotlight back on the US regulator, which is still pointlessly posturing and concealing its inevitable plans for regulation. This move is a huge step forwards for the e-cig industry – despite some concerns – but what will the legislation mean for UK vapers? And is the FDA likely to pursue their regulation in the same vein?
Summary
- UK regulations will see e-cigs treated as medicines from 2016.
- Legislation requires e-cigs to meet product standards.
- Existing e-cigs which don’t meet the standards won’t be recalled.
- Will be available through prescription, effectively legitimizing e-cigs as a method of stopping smoking.
- MHRA claims most e-cigs don’t currently meet safety and efficacy standards.
- MHRA argues nicotine levels can vary, and e-cig use could renormalize smoking, but pushes ahead thanks to their harm reduction potential.
- Sweet and fruity flavors might have a harder time getting licensed, due to the unproven notion that they could make e-cigs “appeal to children.”
- The FDA must take cues from this (relatively) rational approach in its upcoming legislation, for the sake of smokers struggling to quit across America.
The UK Legislation
According to the BBC, e-cigarettes are already the most widely-used quit smoking aid in the UK, with around 25 percent of all quit attempts being made using them. This places the regulation in context, since it’s clear that with or without it, smokers will be switching to e-cigarettes to help them stop.
The basic premise of the legislation can be summarized pretty simply: smokers should have a choice of how they want to quit, e-cigarettes are undoubtedly safer than smoking, and regulation will help to ensure that the products smokers are using are safe and effective for their intended purpose. According to the regulator, e-cigs have the potential to save 57,000 lives in the UK alone.
In essence, this means that a quit smoking attempt from 2016 onwards in the UK will probably involve the smoker phoning a quitting helpline or visiting their doctor and being literally recommended an e-cig. Generally speaking, harm reduction approaches are well-received in the UK, which can be seen very clearly in the approach to drug abuse in the country.
There are several positive points to the legislation, despite some expected down-sides. The legislation will push e-cig manufacturers to meet product standards in order to obtain a license, but it will not recall products that are already on the market which don’t meet those criteria. The reasoning behind this is the sort of thing e-cig users have been hoping to hear from law-makers since the technology’s inception: it’s much safer to use an unlicensed e-cig than to smoke cigarettes, so recalling existing products could potentially do more harm than good. Even if you’re of the opinion that increased regulation might drive small companies out of the industry, the fact that the potential for harm reduction takes precedence over the new legislation (at least in this sense) is undoubtedly a step in the right direction.
The fact that doctors will be prescribing e-cigs to smokers looking to quit is also a great thing for a couple of reasons. Doctors are trusted, and could well encourage smokers who are unsure about the technology to give it a try. More importantly, however, the move will legitimize e-cigarettes in the eyes of many people in the public. Currently, sensationalistic reports of it being a backwoods, murky, untrustworthy and unregulated industry obviously pervade the minds of people who don’t conduct independent research into e-cigs, but the official stamp of approval will undoubtedly allay these fears.
Not All Good News, However
One of the big driving points behind the MHRA’s move was the notion that e-cigs don’t currently meet the required standards of safety and efficiency. This was pretty consistently mentioned in news reporting of the story, but reading through the MHRA document on the subject reveals that the primary concerns are either virtually irrelevant when compared to cigarettes or are basically related to the fact that e-cigs haven’t been extensively studied yet. However, the studies quoted in the paper show that side effects from e-cigs are less likely than with currently-regulated nicotine inhalers. In other words, there is very little evidence to suggest that they are actually unsafe or ineffective, but there isn’t a big enough body of support for that conclusion to be officially vindicated.
Other main concerns are the variation in the nicotine levels from that reported by the manufacturer, and the old line (repeated by e-cig haters ASH in the news stories) that the sweet and fruity flavors could appeal to children. The first point may be justified in some cases (and the regulation will obviously help to improve that issue), but the second one is such nonsense that it can’t be addressed with sufficient vitriol within this article.
The key point is that to buy e-cigs you either need identification or a freaking credit card, which they don’t tend to give to children. The BBC ran a great quote from a tobacco researcher at University College London with reference to the “worst case scenario,” in which (despite existing evidence to the contrary) children start taking up e-cigs in significant numbers:
“If those young people are people who would have smoked but instead they're using e-cigarettes, then that's a huge public health gain. If they're people who would never have smoked but they've taken up e-cigarettes, frankly in public health terms it's not really an issue – it's like drinking coffee or something, there's no real risk associated with it.”
However, despite these obviously well-founded criticisms, Jeremy Mean (who is spear-heading the MHRA’s move) has stated that flavors like chocolate and bubblegum are unlikely to be licensed under the new rules, according to the Independent. Of course, this is completely stupid, but it’s hopefully something some well-conducted campaigning on the part of ECITA and UK vapers will be able to correct.
Similarly, some have raised concerns that this move will “re-normalize” smoking, but this is another case of baseless criticism which doesn’t really stand up to genuine scrutiny. Unless you think that people can’t tell an e-cig from a tobacco cig or you don’t understand why smokers are using e-cigarettes, you will know that there is no such risk, because it isn’t smoking and people know that. Of course, whilst these concerns were mentioned, it’s clear that the MHRA has sided with common sense and pushed ahead with the plans anyway.
Pressure on the FDA
The most immediately relevant aspect of the decision for vapers in the US is the fact that the move is realistically something the FDA should have done already. Instead, the US regulator has a less than favorable reputation thanks to its past efforts to ban imported e-cigs, and the absurd study which its advice is still riding on the coat-tails of. The efforts already made essentially rendered e-cigs “tobacco products” in the eyes of the law. Essentially, as long as a product doesn’t make therapeutic claims, the FDA has the same power as they do over cigarettes.
The FDA has long been promising drafted regulations regarding e-cigs (but has missed the previously stated deadline of April), and these are expected to attempt to reclassify e-cigs and bring them under regulation. Although the regulator has a dismal record on e-cigs so far (having said very little, if anything, positive about the technology), the move by the MHRA should hopefully push the FDA in a more reasonable direction. It’s becoming painfully clear – even to other regulatory bodies – that coming down too hard on e-cigs is a move that will ultimately damage the health of the nation.
Regulation isn't a Death Sentence, if it’s Done Right
This move could lead to a boom in the e-cig industry in the UK, and is unlikely to cripple the technology unless the standards imposed are entirely unreasonable. Regulation to protect the consumer is a good thing, but over-regulating is condemning smokers to inadequate methods of quitting smoking, making it more likely that they will return to the habit which is slowly killing them. Even if e-cigs aren’t perfect, the alternative is around a 50 percent chance of dying as a result of smoking. That choice cannot be an option, and any regulator who decides to take steps to effectively ban e-cigs clearly misunderstands the concept of harm reduction. This is the lesson the FDA must learn, otherwise the vaping community will kick up a storm like never before.