FDA Vaping Rules vs. Europe Vaping Laws
One of the many ongoing discussions around e-cigarettes is how vaping devices and liquids should be regulated. This varies a lot around the world, from outright bans in some countries through to partial bans (like in Australia, where only nicotine-free e-cigs can be legally sold) and more permissive attitudes. The US and countries throughout Europe are great examples of places where lawmakers trying to exercise some control without outright banning vaping or nicotine-containing e-liquid. So what do the FDA vaping regulations mean for the industry in the US? What will be the impact of Europe vaping laws?
Here’s a run-down of the basics.
FDA E-Cig Regulation: The Basics
The FDA’s vaping regs essentially “deem” e-cigarettes, liquids and most other vaping products as “tobacco products” in the eyes of US law. This means that they fall under the provisions of the 2009 Family Smoking Prevention and Tobacco Control Act. This legislation was written before e-cigarettes had really took off, so it didn’t have the current situation in mind.
It’s main goal was to stop the tobacco industry from implying that some cigarettes are safer than others by using words like “mild” and to stop new cigarettes from being brought to the market. Cigarettes that were on the market anyway – anytime before February 15th 2007 – could stay on the market. This means that most cigarettes were basically unaffected by the change.
To bring out a new tobacco product after February 15th 2007, companies either have to show that their product is “substantially equivalent” to something already on the market before that date, or submit a new application to market it. The main one is a pre-market tobacco application, but in theory it’s also possible to put something forward as a modified risk tobacco product (which really means reduced risk).
How it Affects Vaping
So the FDA vaping regulations mean that e-cigs have to contend with these requirements. First, the 2007 date means that they can’t get a “free pass” like cigarettes did. It also rules out any substantial equivalence claims – there were hardly any e-cigs around in 2007 and only ineffective, early models.
You might think that modified risk is the right approach for vaping, but that’s unlikely to work either. Swedish Match – who manufacture snus, a type of smokeless tobacco – have attempted this and have been met with a lot of opposition, despite submitting over 100,000 pages of evidence supporting their case. No vaping products could come close to doing that yet.
So the only option left is the pre-market tobacco application, but this isn’t as reasonable as it might sound. Since they didn’t want more cigarettes on the market, the application is costly to complete and the hurdles companies have to surmount are extremely high. Collecting the evidence required is a huge challenge on its own (including the probable need for lab-conducted studies on your products), and on top of that there are administrative costs.
Overall, it’s estimated that each application under the FDA vaping regulations will cost over 1 million dollars per product. Even worse, there will need to be an application submitted for every variation of the product – for example, e-liquid manufacturers will need to submit one for each flavor, but also for each nicotine strength for the same flavor. This process is expected to decimate the industry, unless the February 2007 date can be changed to something more appropriate.
While some e-cigarette companies will be able to bear this cost, the requirements give a huge advantage to the tobacco companies involved in the industry, who have deeper pockets and more experience with regulators.
Europe Vaping Laws
The Europe Vaping Laws come in the form of the Tobacco Products Directive (TPD) of the European Union. The EU vaping rules may not impose huge barriers to entry to the vaping market in the way the FDA vape regulations do, but there are still many similarities, as well as some highly questionable restrictions.
The most relevant parts of the legislation are collected in a post on Clive Bates’ blog, and this mainly covers article 20 of the TPD. This states (among other things) that:
- Manufacturers and importers of vaping products have to notify the authorities of their intention to place products on the market, as well as a full ingredients listing, emissions data and toxicological data.
- The size of tanks is limited to 2 ml, and no individual bottle of e-liquid can be sold in containers over 10 ml in size.
- The maximum nicotine strength allowed in e-liquids or cartridges is 20 mg/ml.
- Additives (such as caffeine or vitamins) are not allowed to be used in e-liquids.
- High-purity ingredients must be used for e-liquids.
- The devices have to provide a consistent dose of nicotine to the user.
- All e-liquids must be sold with child-proof caps, and there must be a mechanism for leak-free filling.
- E-cigarette products have to come with an information card covering instructions for use, addictives, toxicity and more.
- Packages for e-cigarettes must carry one of two warnings, both of which focus on the presence of nicotine, a “highly addictive substance.”
- Most forms of marketing are prohibited in print, radio and television, as are sponsorships with the aim of promoting vaping.
This just gives a basic overview of the regulations, but immediately shows how the new Europe vaping laws will needlessly impact both businesses and consumers.
For instance, the registration and ingredient listing entails gathering a lot of information which will only have questionable usefulness and may be beyond the scope of some small businesses. This isn’t as severe a problem as it is in the FDA vaping rules, though, since there is nothing close to as onerous as a pre-market tobacco application.
For consumers, the limitations on the nicotine strength of e-liquids and the size of tanks and bottles are the most problematic. Despite a general shift to lower-nicotine e-juice, some smokers could still benefit from stronger e-liquids (24 mg/ml used to be common). Removing this option for no good reason is really indefensible.
The bizarre limits on the size of e-juice bottles and especially tanks are especially hard to justify. These will undoubtedly lead to a lot of unnecessary packaging, and most ironically, the need to fill your tank more frequently and therefore a bigger chance of spilling some e-liquid.
UK Vaping Laws – What Happens After Brexit?
The UK vaping laws – imposed by the Medicines and Healthcare Regulatory Authority (the MHRA) – are ultimately the same as the Europe vaping laws, unless a bid to repeal the TPD is successful. If it isn’t, the TPD will have been written into UK law, along with all other EU legislation, pending potential removal in future.
This means that the MHRA vaping laws will be essentially those from the EU, but there is some flexibility in how many restrictions can be applied. Generally, the UK is quite pro-vaping as a country, and the MHRA is opting for a bare-minimum approach to implementing the TPD. With an upcoming general election and quite an uncertain future, it’s hard to make firm predictions but this appears to be the way things are progressing.
However, EU member states and the UK could go further than the minimum requirements of the Europe vaping laws, possibly including bans on flavors with the intention of reducing the appeal of vaping to teens. We’ve covered this whole argument in detail elsewhere, but the short version is that it’s unlikely to have a positive impact. But that doesn’t mean no countries will attempt it when implementing the TPD in their own territory.
Conclusion: Europe Vaping Laws are Bad; the FDA Vaping Regulations are a Disaster
While there are big problems with both approaches to regulating e-cigarettes, it’s hard to deny that the FDA’s approach is much worse than the EU’s. The approach taken by the FDA vape regulation has been called a “slow motion ban” as a result of the insurmountable barriers to the market for small and medium-sized businesses. In comparison, the Europe vaping laws are over-reaching, often-illogical and needlessly restrictive, but still fall short of banning or putting up hurdles too significant for companies hoping to sell vaping products.
Perhaps Brexit will produce a change in UK vaping laws that comes closer to how the products should be regulated, but at present, the situation still looks bleak.