What Did the EU Parliament’s TPD Do About E-cigs? Will the FDA Follow Suit?

Many observers are suggesting that the FDA’s deeming regulations with resepct to e-icgarettes will be similar to what the European Union’s Parliament directed earlier this year.  So, what did they direct?  Surprsingly they did not ban refillables!


Will electronic cigarettes still be available to buy/smoke?

 Yes. However new rules will be put in place so that the product’s safety and quality can be assured. The new rules are designed to ensure equal treatment across the EU for nicotine containing e-cigarettes (products that do not contain nicotine are not covered by the Directive).

E-cigarettes can be disposable (i.e. single use), rechargeable (with a single use cartridge) or refillable (by means of a refill container).

Why are new rules needed for e-cigarettes?

E-cigarettes are a relatively new product category and their market share is growing. While they may have a role to play in smoking cessation or reduction, their long-term effects on public health are not yet known. As nicotine is an addictive and toxic substance, safety and quality requirements for nicotine-containing e-cigarettes are necessary. Reporting obligations are also needed so that public authorities can monitor and learn more about these products. A number of decisions on e-cigarettes will be left to the Member States, e.g. the regulation of flavours, advertising without cross border effects, and age limits.

The new rules will not apply to medicinal e-cigarettes (as set out in Directive 2001/83/EC) or medical devices (Directive 93/42/EEC), but will cover all consumer electronic cigarettes placed on the EU market.

What will change for e-cigarette consumers and manufacturers?

Consumers of eCigarettes:

  • will benefit from improved safety and quality requirements for products: taking into account nicotine’s classification as a toxic substance, there will be a maximum nicotine concentration level for e-cigarettes and maximum volumes for cartridges, tanks and containers of nicotine liquids. These will have to be child and tamper-proof and protected against leakage to limit the risk of exposing consumers – in particular children – to the risks of handling or ingestion. Only ingredients of high purity may be used in the nicotine-containing liquid, and e-cigarettes will be required to deliver the nicotine doses at consistent levels under normal conditions of use. This means that a similar level of nicotine should be delivered each time an e-cigarette is puffed for the same amount of time and with the same strength.
  • will be better informed through new packaging and labelling requirements: health warnings on e-cigarette packs will be mandatory, as will instructions for their use, information on addictiveness and toxicity, a list of all substances contained in the product and information on the product’s nicotine content. No promotional elements will be allowed on packs.
  • will be better protected: Member State authorities and the Commission will be able to act in cases of justified safety concerns relating to these products. Authorities will monitor the market for any evidence that e-cigarettes lead to nicotine addiction or to traditional tobacco consumption, especially in young people and non-smokers, and the Commission will report on safety concerns and market developments.

E-cigarette manufacturers (in addition to manufacturing their products in line with the above rules on safety, quality and packaging) will be required to:

  • notify Member States before placing new products on the market: notification will include information on the manufacturer, the ingredients used and emissions, nicotine dose and uptake, product and production process and a declaration that the manufacturer takes full responsibility for the quality and safety of the product under normal use.
  • report annually to Member States: on the sales volumes of the products, types of users and their preferences and trends.
  • comply with specific rules on advertising: existing rules for cross-border advertising and promotion of tobacco products will also apply to e-cigarettes.

Can the rules on e-cigarettes be revisited at a later date?

Monitoring and reporting on all developments relating to e-cigarettes – including market and health related developments – has been built into the new Directive. The information collected will provide a good overview of what additional legislative action, if any, is required, and the Commission will revisit the issue if necessary.


#1 Candy Girl on 04.23.14 at 7:39 AM

If the FDA follows suit in the US, the deeming regs will likely have the same effect as most regulations do- manage to anger both sides of the debate and please neither those trying to ban or severely restrict the product nor those hoping to keep the vast array of products, flavors and styles relatively free of regulations and restrictions.

#2 play@playacarmen on 04.23.14 at 11:13 AM

This is goofy analysis. The EU ministers WANTED to ban refillables. Political pressure from Euro Parliamant relaxed the TPD. FDA is not writing the deeming regs in concert with Congress, one, and two, the deeming regs have not been re-drafted in recent months to reflect where the TPD wound up.

Expect the FDA to land much closer to the EU Ministers than the ultimate TPD.

#3 Anonymous on 04.23.14 at 8:19 PM

Folks – Tomorrow is the day we can put away our questions. We will then have multiple conversations on what it all mean!! Cheers!

#4 Anonymous on 04.24.14 at 7:38 AM

yep they came in

#5 Lou Maiellano on 04.25.14 at 11:45 PM

want to thank folks for making an effort to be ahead of the curve – posts where right on and on target – from what I see the anonymous post on 4-23 @ 8:19 was correct and actually before it happened – thank you

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