Reasonable "regulations" proposed in the New York Times

On Sunday, an article by Sally Satel, a resident scholar at the American Enterprise Institute, was published in The Opinion Pages of the New York Times. In the article Satel points out that not enough smokers are switching to e-cigs despite their relative safety and that the initial public enthusiasm over e-cigarettes is waning. She mentions a few reasons for this:

Smokers are barraged with news about inaccurate labeling, shoddy counterfeits and poorly made e-cigarettes that emit toxins and cancer-causing chemicals in vapor. And to the frustration of smokers, public health experts and, yes, manufacturers, the Food and Drug Administration, which has not yet set up sensible regulations, is making the situation worse.

The point is that there are some bad apples in the e-cig industry and we currently don't have a good way of knowing which ones are good, and perfectly safe and which ones are not. So it is no wonder smokers are sceptical. But how can we turn this trend around?

You really don't have to be a rocket scientist to see that the proposed FDA regulations would effectively put most of the independent e-cigarette industry out of business, leaving Big Tobacco comfortably in total control of the market. Satal explains why in her article:

Consider the complexity. The proposal has some useful provisions, such as a ban on sale to minors and a requirement to disclose ingredients. But the proposal would also push e-cigarettes into the hugely burdensome regulatory framework that Congress set up for any new tobacco product.

Although the deeming rule does have some traces of reason in it, it will do more harm than good. Satel, however, has some really good suggestions on how the FDA could use their resources to actually help smokers quit instead. You see you don't really need strict, expensive regulations to make vaping safe. The majority of products on the market today are perfectly safe, so all you need to do is point the users in the right direction. 

Instead of waiting years to develop burdensome regulations, the F.D.A. should act now by setting interim safety guidelines. These guidelines would not carry the force of law, but they could go far to bolster smokers’ confidence that a safer way to inhale nicotine exists.

The agency should start by focusing on a few basic steps. It should outline basic good-manufacturing practices for the devices and liquids, including limits on the amount of chemicals, like formaldehyde, and metals, like nickel, that can be present in the aerosols. It should disallow outright some contaminants in the nicotine solution and flavorings.

It should require manufacturers to ensure that all batches of chemicals are traceable and that all sources of hardware are known. The guidelines should also require makers to verify that e-cigarette batteries can be charged safely and that they will operate safely in the course of normal use. Interim guidelines should require manufacturers to use childproof packaging that carries a warning: “This product contains nicotine, which is addictive and is intended for adult smokers only.” Also, a mechanism for reporting adverse effects is needed.

Satel says that these should be only guidelines not laws. In my opinion some of her proposed guidelines could also carry the force of law (limits on chemicals for example), but enforcing them should not be done the way the FDA suggests with a pre-market approval scheme that would put all the innovative forces in the industry out of business. The independent companies are also the ones that are focusing their innovations towards user safety (take Evolv for example). Big Tobacco on the other hand (which would be left in total control under such regulations), has never been, and never will be, very concerned with user safety. Instead of pre-market approval, a system where the authorities can check that the manufacturers are following the rules and their products are safe could be established. If controls show that a manufacturer is not playing by the rules they can be forced to start doing so or eventually be shut down by the authorities. In addition to this the industry organizations could establish a system where manufacturers voluntarily apply for approval, documenting that they follow the organizations guidelines, and then be allowed to use this approval in their marketing. Such systems would let customers choose the safe alternatives, making it hard for the unreliable players to earn money, and eventually vaping will be even safer than it is today.

Last, but not least, Satel suggests the FDA lets the industry tell the truth about e-cigarettes. Although I'm not sure about the wording on her label, it would be a big step forward:

Finally, the F.D.A. should allow companies to tell smokers about the benefits of switching to vaping products. Labels could read: “While more research is needed, it is likely that e-cigarettes meeting F.D.A. interim safety guidelines are much safer than smoking.”

photo credit: tbecreview via photopin cc

Big Tobacco's new e-cig warning labels are not what they look like

MarkTen e-cigarette packages now feature a 117-word warning (http://goo.gl/2WHa7z). The full warning can be found on MarkTen's website and goes like this:

This product is not a smoking cessation product and has not been tested as such. This product is intended for use by persons of legal age or older, and not by children, women who are pregnant or breast feeding, or persons with or at risk of heart disease, high blood pressure, diabetes, or taking medicine for depression or asthma. Nicotine is addictive and habit forming, and it is very toxic by inhalation, in contact with the skin, or if swallowed. Nicotine can increase your heart rate and blood pressure and cause dizziness, nausea, and stomach pain. Inhalation of this product may aggravate existing respiratory conditions. Ingestion of the non-vaporized concentrated ingredients in the cartridges can be poisonous.

It's kind of weird that MarkTen and other Big Tobacco companies choose to put warnings on their products that are several decrees more severe than the warnings on their tobacco products, especially when it's not even required by regulation. So what do they hope to achieve with this?

The New York times thinks this is to appear more responsible, open and frank and to insulate themselves against future lawsuits. I think this is an explanation Big Tobacco really likes and can live with, cause wanting to be more responsible and making sure they don't get sued in the future sounds like a reasonable strategy and it doesn't really hurt someone. Sounds like the responsible thing to do.

But I believe that one has to look at what the possible effect of such warnings to see what Big Tobaccos real reasons behind them are. I can think of several rather dangerous effects that would suit Big Tobacco perfectly:

• Even though the warnings are only on Big Tobacco's products, people will draw the conclusion that these warnings apply to all e-cigarette and vaping products. Remember also that Big Tobacco's cig-alikes are entry level products... a lot of vapers start out with them. And according to "Motherboard", Big Tobacco has officially lost its hold on the e-cigarette market: http://goo.gl/1WX9sG. Such warning will serve to keep the customers in a market that Big Tobacco is not loosing, the cigarette market.
• I think Big Tobacco is trying to set a standard on how warnings will look like if they get required by regulations in the future. Such warnings will, as mentioned above, stop some people from buying and using the products. For an independent e-cigarette manufacturer this means loosing customers, but for Big Tobacco it doesn't. They will keep their customers, because the customer is already a smoker. 
• I've written earlier that e-cigarettes work as a firewall, protecting young potential customers of Big Tobacco from the dangers of cigarette smoking. Such warnings would weaken this firewall effect, and make it easier for Big Tobacco to gain new customers in their cigarette market. 

In other words, I don't think Big Tobacco is issuing this warnings just to appear responsible and avoid lawsuits (although it's a nice side-effect), but I think they're doing it to weaken, or ultimately try to get rid of the competition. Big Tobacco has used a lot of money to get into the e-cigarette market, but looking at their morale track record I think it would be pretty naive to think they are doing this because they suddenly realized what they've done and want to make up for it. If you have a closer look at how they are behaving and navigating in the market, you'll see that their actions are not exactly helping the cause. This latest warning labels are a good example and it also gives us a clue to why they've chosen to stay in, and try to get as much control as possible in, the entry level market: Stopping people from switching is the best way of keeping them smoking right? Or even worse: Making teens believe that e-cigarettes are worse than cigarette might lead them to start smoking instead of trying an e-cigarette.

Not everything is what it looks like eyh?

Nicotine poisoning; the anti-e-cig-movements new favourite argument?

Responsible adults is the key to avoid nicotine poisoning.
photo credit: lindsay-fox via photopin cc

The gateway argument has been the anti-e-cigarette-movements favourite argument for a while now, urging us to think of the children that would doubtlessly start using e-cigarettes and then move on to traditional cigarettes, or even worse, according to some of the most delusional anti-e-cig advocates, to harder drugs. However, this argument has been properly ripped apart by people like Clive Bates and Dr. Michael Siegel (read http://www.clivebates.com/?p=2053 and http://goo.gl/tYS7Gb) lately. In my opinion Dr. Glantz himself is kind of responsible for destroying the credibility of this argument totally by publishing his infamous report that, as I've written about earlier (http://goo.gl/AvS6T8), despite failing to provide data to support the argument, claims to prove it by deliberately misusing the data they actually did have.

Now, however, I'm a bit worried by a new kind of propaganda emerging in the media. Yesterday this headline was screaming against us from the New York Times: Selling a Poison by the Barrel: Liquid Nicotine for E-Cigarettes. To be fair, however, the article itself is not as bad as the headline would suggest. It does recognize that most of these poisonings are due to the lack of proper regulations and careless adults, and it has some statements that supports reasonable regulations. However I am afraid such headlines, and the scaremongering cited in there, will be picked up by the anti-ecig-movement and used to support their crusade against vaping. It might very well become the anti-e-cig-movements new favourite argument.

I did some google searches on the topic and I noticed several newspapers and websites have published stories on the topic last week. A press release from Minnesota seems to be a favourite source of information. Read about it here (among other places): http://www.wdaz.com/event/article/id/23361/. The case in Minnesota is that the number of reported incidents of nicotine poisoning by e-liquid among teens and children has jumped from 5 to 50 from 2012 to 2013. Sounds bad huh? Well, first of all we see e-cigarette use booming around the world so an increase in poisoning cases are not unexpected, and e-cigarettes are not even close the the number of poisoning cases from other household products. But does that mean we shouldn't worry about this? Not at all... we need to take this seriously of course. We should start out by trying to figure out the reasons why kids get poisoned, and what we can do about it.

On thing I notice is that 50% of the cases are children younger than 3 years. These kids are not capable of opening a child proof bottle, so all these cases are caused irresponsible adults, either leaving childproof bottles opened in reach of children, or leaving bottles that are not childproof in their reach. 9 of the cases were teenagers meaning that 16 we're kids older between 3 and 13 years old. The reasons for these poisoning could very well be the same as for the ones under 3 years, but it could also be that these children actually had bought the e-liquid, as there is no age limit. Other reasons for poisonings could be unsafe bottles (leaking), unsafe equipment, and that people are really not aware what is in the bottles and how to treat them. The solution to all of this is reasonable regulation, with emphasis on reasonable. That means labelling and information requirements, reasonable nicotine concentration limits and age limits on sales.

Over-regulation or banning will on the other hand lead to more cases of poisoning. I've earlier written about the consequences of over-regulation, and in addition to forcing a lot of ex-smokers back to cigarettes and denying heavy smokers the option of e-cigarettes, over-regulation or banning will have negative impacts on the safety of e-cigarettes. Some examples:

• One of the worst consequences is a thriving black market. A black market is by it's nature not at all regulated and will supply a lot of unsafe equipment, unlabelled e-liquid bottles with nicotine concentrations off the chart and no information to the customers whatsoever. 
• Regulating the sizes of bottles and cartridges, like the TPD does, will also have negative consequences on safety. It will lead to more bottles and cartridges around the house (easier to loose, misplace), or carried around. Filling will also need to happen more often, leading to even more risk.
• Limiting the nicotine content too low (like 20ml/mg in the TPD) will have a couple of negative effects as well: It will force a lot of people to get their products from a black market, which is as I said above not good, but it will also lead to more filling, more frequent use and more e-liquid around children.

Nicotine poisoning from e-liquid is a matter we really do need to take into consideration. And the e-cigarette industry (well most of it anyway) and vapers do take this seriously and most important, they do know what measures need to be taken to ensure safety in this matter. This brings further support to the claim that vapers should write the laws on vaping, because the regulators have shown that they do not understand this. The EU rules on nicotine concentration and bottle and cartridge sizes are perfect examples of over-regulation that will work against its intention. The rules were put there to enhance safety (at least that is what the EU claim), but will in fact lead to less safety. Another example is that the EU (and the American Cancer Association) is against age limiting, while the the e-cigarette industry is currently self regulating and the great majority of vendors enforce an age limit on e-liquid and vaping equipment. Almost all the e-liquid I buy also has good labelling with ingredients and health warnings. In conclusion, the e-cigarette industry, and the vapers do need to worry about the children... and they do that today. And, unlike the regulators, they do understand the safety aspects of vaping and e-cigarettes.