When the UK Medicines Regulator (MHRA) consulted in 2010 on whether e cigarettes should be regulated as medicines, it gave three options I summarise the first two and quote the third
Option 1. Regulate as medicines and withdraw unlicensed products in 21 days
Option 2. Regulate as medicines and withdraw unlicensed products in a year (June 2011)
Option 3. “Do nothing and allow these unregulated products containing nicotine that have not been assessed for safety, quality and efficacy to remain on the market.” emphasis mine
See what they did there… ? It’s either medicines regulation or ‘unregulated’. We call this framing bias and they were rightly criticised for it. But the idea persists that e cigs are unregulated, and it is the reason why some people think they should be regulated as medicines. In reality, there is very little in the European Union that is ‘unregulated’. Most products fall under general consumer protection legislation. Here is a selection of the key EU directives and regulations that already apply (or could be applied) to e cigarettes and other non medicinal nicotine containing products
General safety
General Product Safety Directive 2001/95/EC
The RAPEX system notification and alerts of dangerous products
Technical Standardisation under Regulation 1025/2012 and related legislation (an option not so far used, but could be used to set performance or design standards)
Packaging and labelling
Dangerous Substances Directive 67/548/EEC
Dangerous Preparations Directive 99/45/EC
Classification, Labelling and Packaging of Substances and Mixtures the CLP Regulation 1272/2008 applies from 2015.
Chemical safety
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation (EC) 1907/2006
Electrical safety
Low Voltage Directive 2006/95/EC
Electro Magnetic Compatibility Directive 2004/108/EC
Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU (where appropriate)
Waste Electrical and Electronic Equipment (WEEE) Directive 2012/19/EU
Batteries Directive 2006/66/EC
Weights and measures
Making up by weight or by volume of certain prepackaged products Directive 76/211/EEC
Nominal Quantities for Prepacked Products Directive 2007/45/EC
Commercial practice
Sale of consumer goods and associated guarantees 99/44/EC
Distance Selling Directive 97/7/EC
Directive on Electronic Commerce 2000/31/EC
Misleading and Comparative Advertising Directive 2006/114/EC
Unfair Commercial Practices Directive 2005/29/EC
Data protection
Protection of Personal Data Directive 95/46/EC
(with thanks to ECITA)
What the consumer protection framework doesn’t do
- Therapeutic claims. It does not validate a therapeutic (ie. health) claim, such as “relieves nicotine withdrawal symptoms” or “prevents cancer”. Asserting that using an e cigarette is an alternative to smoking cigarettes is not therapeutic see my briefing Are e cigarettes medicines?. It’s a competitive claim about product utility that says nothing about benefits to health, or modification of physiology (the two reasons to class a product as a medicine). In fact surveys show that smokers are often motivated to switch for other reasons (cost, odour nuisance, social etc) as for perceived benefits for long term health. Companies that wish to make therapeutic claims should be able to apply for a marketing authorisation under the Medicines Directive 2001/83/EC but that should be an option, and it certainly has potential benefits for vendors willing to go through the process. Companies that wish to make competitive claims need to be able justify them as a fair marketing practice, as with any other claim for any other product. note this para updated 16 April 2013
- Guarantee a certain nicotine hit. It does not require proof that an e cigarette will deliver a certain quantity of nicotine to the body at a certain speed (ie. validate the so called “pharmacokinetics”). Some commentators believe it should be mandatory to class them as medicines so they can prove they are adequately potent alternative nicotine delivery devices to rival cigarettes. If vendors believe this to be important and wish to communicate that to the customer, they can simply make a factual evidence based claim about the product the consumer is protected by Unfair Commercial Practices Directive (2005/29/EC). If such claims were to be regulated or standardised, it would be better to develop technical standards under consumer protection legislation using Directive 98/34/EC for this.
- Second guess consumer preferences. It does not guarantee that people will like the products and switch over from smoking. We normally allow consumer preferences, trial and error, producer innovation, pricing, fair marketing practices, user feedback and third party commentary (ie market forces) to sort out which products consumers will choose, and so which ultimately succeed in the market. Unless their health is at risk or there are unfair practices, consumers do not need so much protection that they have their choices made for them by a regulator and that is not a good principle for developing the single market.
What now?
- We should ask if medicines regulation is the answer, what was the question? What problem or opportunity do we have and how will regulating as a medicine address it? Does that problem need to be solved by a regulator or by consumer preference? Is there an easier lighter touch way of doing it in consumer regulation?
- The Commission could produce guidance on the application of existing EU consumer protection legislation as it applies to nicotine containing products.
- Where specific standards may be justified ie for contaminants in e liquids a standard can be set.
- The Commission should be asked to conduct a detailed study of the evolving nicotine market and assess whether additional legislative measures are necessary either with specific decisions and standards under consumer protection legislation, or with a purpose built regulatory framework of the type developed for cosmetics (another product that does not fall neatly into any other category).
- Tweet
April 15th, 2013 Category Uncategorized
European parliament rejects medicinal regulation on electronic cigarettes
Posted by Vranks on October 11, 2013 Under E Cigarette Legislation
On October 8, the European Parliament voted against Amendment 71 or the new Tobacco Products Directive, which would have seen electronic cigarettes regulated as medical products and sold only in pharmacies.
It’s not clear whether it was the pleas of reputed physicians, the information campaigns of organizations like the Electronic Cigarette Industry Trade Association (ECITA) or just common sense that made the lawmakers see reason, but in the end they voted against the proposal to regulate e cigarettes as pharmaceuticals, a measure that would virtually annihilate the electronic cigarette market as we know it, allow Big Tobacco to handle its business as usual and put these revolutionary devices in the hands of pharmaceutical companies. Despite heavy lobbying and waves of unsubstantiated claims that e cigarettes are nothing but a gateway to smoking and that they undermine years of anti smoking campaign progress, the Members of the European Parliament decided to reject Amendment 71 and instead treat electronic cigarettes as they do conventional tobacco cigs.
This is a fantastic result for public health and the millions of smokers around Europe who are switching to e cigarettes, said Charles Hamshaw Thomas, corporate affairs director of E Lites, the UK’s largest electronic cigarette brand by sales volume. Common sense has prevailed. Companies like E Lites, supported by thousands of e cigarette users had lobbied hard against the restrictive medical regulation proposed in the new tobacco directive, and welcome the result of Tuesday’s vote as a major victory. However, another disputed proposal, Amendment 170, was passed. It includes measures to restrict the sale of e liquids with a nicotine content over 30 mg, the mandatory inclusion of health warnings and advertising restrictions. “The key aim of today was getting rid of medical legislation,” ECITA spokesperson Katherine Devlin said. However, from our perspective there is still a lot wrong with amendment 170, and over the coming weeks we will be ensuring that it is appropriate.” She claims there are already seventeen directives that apply to electronic cigarettes, including testing processes and safety measures such as child proof caps for e liquid, and electronics and battery testing for hardware.
The European Parliament’s decision to toughen up regulations on tobacco products, but pull back on the issue of regulating electronic cigarettes as medicinal products has put them on a collision course with the European Council, whose members voted in favor of Amendment 71. “The proposition to regulate them as tobacco products won with a majority. That s probably the biggest difference with Council now, said Linda McAvan, the Parliament s rapporteur for the legislation, in a press conference. However, she hopes to negotiate an agreement between Parliament and Council by Christmas. After that, the new Tobacco Products Directive has to be discussed with the national governments of all member states.
Although the fight on the European front is not yet over, experts believe that after Tuesday’s vote, the finish line is finally in sight, after one of the hottest debates in the history of the European Union. Faced with what seemed a very stiff opposition from European lawmakers, electronic cigarettes managed to come out on top. We have yet to see if their decision will have any influence on the upcoming regulations from the Food and Drug Administration, in the United States. The FDA is expected to finally announce its proposed regulations by the end of October, although the federal shutdown could push back that deadline.
Sources New York Times,