Tobacco Products Directive

Last updated

The Tobacco Products Directive (TPD) or European Tobacco Products Directive (EUTPD) (2014/40/EU) is a directive of the European Union which places limits on the sale and merchandising of tobacco and tobacco related products in the EU. The TPD aims to improve the functioning of the internal market for tobacco and related products, while ensuring a high level of health protection for European citizens. Based on the proposal of the European Commission the Directive entered into force on 19 May 2014 and became applicable in the EU Member States on 20 May 2016.

Contents

This Directive applies to the manufacture, presentation, and sale of tobacco related products including cigarettes, roll your own tobacco, pipe tobacco, cigars, cigarillos, smokeless tobacco, electronic cigarettes, and herbal products for smoking. To address this situation, the European Union and its Member States have taken various tobacco control measures in the form of legislation, recommendations and information campaigns. Targeting the improvement for function of the internal market for tobacco and related products. The following rules govern the aspects of tobacco sales and requires the tobacco industry to submit detailed reports to the Member States with the ingredients used in tobacco products (includes the health warnings appear on packages of tobacco and related products). The health warnings have to be accurately stated on 65% of the product packaging. This involves the front and back of cigarette and roll-your-own tobacco packages and small containers for certain tobacco products. This directive bans all promotional or misleading sectors on tobacco products, while introducing EU-wide tracking and tracing to prevent illegal trade of tobacco products; allowing Member States to prohibit internet sales of tobacco related products. Setting out the safety and quality requirements for a consumer of electronic cigarettes and compels manufacturers to request literal tobacco products before placing them on the EU market. As an overview, the policies for the Tobacco Products Directive are; the regulation of tobacco products on the EU market (e.g. packaging, labelling, and ingredients), advertising restrictions for tobacco products, the creation of smoke-free environments, tax measures and activities against illegal trade, and acquiring anti-smoking campaigns.

New requirements

The enactment and implementation of the new directive will work to restrict the capacity of e-cigarette refill tanks to no more than 2ml and a maximum volume of e-liquids containing nicotine for sale for one refill container to 10ml. The nicotine strength of e-liquids to no more than 20 mg/ml and require products containing nicotine and their packaging to be tamper proof and resistant to child tampering. The new regulation prohibited the use of certain ingredients that included taurine, colourings, and caffeine, the mandatory use of new labelling and health warning signs on the packaging. The new regulations require that the sale of all e-liquids and e-cigarettes should be done after notifying the Medicines and Healthcare Products Regulatory Agency (MHRA) for the case of the United Kingdom (UK). The TPD was implemented in the UK through the Tobacco and Related Products Regulations 2016 act that also defined producers of e-cigarettes. The definition described e-cigarette producers as any entity that manufactures, imports, or re-brands any tobacco related products for resale. In accordance with the new regulations, producers are required to provide the relevant authorities with all pertinent information regarding their products to the MHRA.

Enforcement and cooperation

The new directive was cognizant of the fact that its success was pegged on the co-operation of all member states that were party to its implementation in their various jurisdictions and pertinent to their internal provisions and laws. All member states were required to ensure that all producers and importers of tobacco and their related products to provide correct information to the pertinent authorities within the provided timelines. The obligation to provide such information was placed primarily on manufacturers and importers of all tobacco and their related products to the relevant authorities. Member states were required to ensure that tobacco and their related products complied with the new directives, failure to which the relevant authorities are empowered to take the appropriate course of action to prevent their entry into the market. The new directive made it the responsibility of member states to formulate and enforce appropriate penalties for the infringement of national and EU provisions and their enforcement. The administration of financial penalties was to be imposed for intentional infringement aimed at accruing financial advantage to the involved entity. The directive required that all member states co-operate with each other to promote the correct application and enforcement of all provisions of the directive in a manner characterised by the sharing of information necessary for its uniform implementation.

Industry response

The initial response to the directive by e-liquid manufacturers was to invest heavily in the testing of their range of products in order to achieve directive compliance. This proved costly due to:

  1. The demand for testing increased significantly in the lead up to the implementation date, leading to cost inflation for basic e-liquid compliance testing as the supply of laboratories was limited and was not pre-emptive to the electronic cigarette market.
  2. The directive required each variation of the relevant nicotine containing e-liquid to also undergo compliance testing. For example, where the relevant e-liquid was to be available in 20 mg and 10 mg, two compliance tests would need to be conducted for each particular nicotine strength. If there were also non-nicotine variations, such as in the vegetable glycerol and propylene glycol ratio, further tests would have to be conducted for each additional ratio at each corresponding nicotine strength.

Alongside the already inflated price of testing due to the sudden increased demand, batch compliance testing proved costly and the industry sought to attain compliance by another less expensive route.

In 2014 Ernst & Young reported that over 73% of the consumer market used e-liquid at 1–11 mg nicotine strength. [1] With this vast consumer trend towards lower strength nicotine e-liquids, and as the directive only concerns itself with nicotine containing e-liquids as opposed to flavourings and other ingredients, it became clear that dilution of a small quantity of highly concentrated nicotine that would only have to be tested once at the maximum nicotine strength was a viable and more cost-effective route to directive compliance.

In essence, dilution involved the creation of a flavourless nicotine-containing e-liquid at a maximum or close to maximum nicotine strength, such as 20 mg, in the maximum capacity bottle size of 10ml to be mixed with a larger bottle of flavoured 0 mg e-liquid in order to create an overall e-liquid concentration that was aligned with the most used nicotine strength. For example, upon mixing 10ml of 18 mg nicotine with a 50ml bottle containing the relevant flavourings, a user can achieve 60ml of e-liquid with an overall nicotine strength of 3 mg. [2]

These small 10ml nicotine bottles containing highly concentrated nicotine have become known as ‘nicotine shots’, and the market has adapted to now recognise this method as the norm.

See also

Related Research Articles

<span class="mw-page-title-main">Diacetyl</span> Chemical compound

Diacetyl ( dy-yuh-SEE-tuhl; IUPAC systematic name: butanedione or butane-2,3-dione) is an organic compound with the chemical formula (CH3CO)2. It is a yellow liquid with an intensely buttery flavor. It is a vicinal diketone (two C=O groups, side-by-side). Diacetyl occurs naturally in alcoholic beverages and is added as a flavoring to some foods to impart its buttery flavor.

<span class="mw-page-title-main">Snus</span> Moist tobacco product placed under the upper lip

Snus is a tobacco product, originating from a variant of dry snuff in early 18th-century Sweden. It is placed between the upper lip and gum for extended periods, as a form of sublabial administration. Snus is not fermented. Although used similarly to American dipping tobacco, snus does not typically result in the need for spitting and, unlike naswar, snus is steam-pasteurized.

<span class="mw-page-title-main">Kretek</span> Type of Indonesian cigarette including cloves

Kretek are unfiltered cigarettes of Indonesian origin, made with a blend of tobacco, cloves, and other flavors. The word "kretek" itself is an onomatopoetic term for the crackling sound of burning cloves.

<span class="mw-page-title-main">Nicotine poisoning</span> Medical condition

Nicotine poisoning describes the symptoms of the toxic effects of nicotine following ingestion, inhalation, or skin contact. Nicotine poisoning can potentially be deadly, though serious or fatal overdoses are rare. Historically, most cases of nicotine poisoning have been the result of use of nicotine as an insecticide. More recent cases of poisoning typically appear to be in the form of Green Tobacco Sickness, or due to unintended ingestion of tobacco or tobacco products or consumption of nicotine-containing plants.


Tobacco harm reduction (THR) is a public health strategy to lower the health risks to individuals and wider society associated with using tobacco products. It is an example of the concept of harm reduction, a strategy for dealing with the use of drugs. Tobacco smoking is widely acknowledged as a leading cause of illness and death, and reducing smoking is vital to public health.

<span class="mw-page-title-main">Electronic cigarette</span> Device that vaporizes a liquid nicotine solution for inhalation

An electronic cigarette (e-cigarette) or vape is a device that simulates tobacco smoking. It consists of an atomizer, a power source such as a battery, and a container such as a cartridge or tank filled with liquid. Instead of smoke, the user inhales vapor. As such, using an e-cigarette is often called "vaping". The atomizer is a heating element that vaporizes a liquid solution called e-liquid, which quickly cools into an aerosol of tiny droplets, vapor and air. E-cigarettes are activated by taking a puff or pressing a button. Some look like traditional cigarettes, and most kinds are reusable. The vapor mainly comprises propylene glycol and/or glycerin, usually with nicotine and flavoring. Its exact composition varies, and depends on several things including user behavior.

<span class="mw-page-title-main">Ventilated cigarette</span> Cigarette that delivers a lower concentration of chemicals than regular cigarettes

Ventilated cigarettes are considered to have a milder flavor than regular cigarettes. These cigarette brands may be listed as having lower levels of tar ("low-tar"), nicotine, or other chemicals as "inhaled" by a "smoking machine". However, the scientific evidence is that switching from regular to light or low-tar cigarettes does not reduce the health risks of smoking or lower the smoker's exposure to the nicotine, tar, and carcinogens present in cigarette smoke.

<span class="mw-page-title-main">Regulation of electronic cigarettes</span> International regulations

Regulation of electronic cigarettes varies across countries and states, ranging from no regulation to banning them entirely. As of 2015, around two thirds of major nations have regulated e-cigarettes in some way.

The use of electronic cigarettes (vaping) carries health risks. The risk depends on the fluid and varies according to design and user behavior. In the United Kingdom, vaping is considered by some to be around 95% less harmful than tobacco after a controversial landmark review by Public Health England.

<span class="mw-page-title-main">Construction of electronic cigarettes</span> Engineering and chemistry of e-cigarettes

An electronic cigarette is a handheld battery-powered vaporizer that simulates smoking, but without tobacco combustion. E-cigarette components include a mouthpiece, a cartridge, a heating element/atomizer, a microprocessor, a battery, and some of them have an LED light on the end. An atomizer consists of a small heating element, or coil, that vaporizes e-liquid and a wicking material that draws liquid onto the coil. When the user inhales a flow sensor activates the heating element that atomizes the liquid solution; most devices are manually activated by a push-button. The e-liquid reaches a temperature of roughly 100–250 °C (212–482 °F) within a chamber to create an aerosolized vapor. The user inhales an aerosol, which is commonly but inaccurately called vapor, rather than cigarette smoke. Vaping is different from smoking, but there are some similarities, including the hand-to-mouth action of smoking and an aerosol that looks like cigarette smoke. The aerosol provides a flavor and feel similar to tobacco smoking. There is a learning curve to use e-cigarettes properly. E-cigarettes are cigarette-shaped, and there are many other variations. E-cigarettes that resemble pens or USB memory sticks are also sold that may be used unobtrusively.

<span class="mw-page-title-main">Composition of electronic cigarette aerosol</span>

The chemical composition of the electronic cigarette aerosol varies across and within manufacturers. Limited data exists regarding their chemistry. However, researchers at Johns Hopkins University analyzed the vape clouds of popular brands such as Juul and Vuse, and found "nearly 2,000 chemicals, the vast majority of which are unidentified."

<span class="mw-page-title-main">Vape shop</span> Shop selling vaping products

A vape shop is a retail outlet specializing in the selling of vaping products, though shops selling derived psychoactive cannabis products have increased since the passage of the 2018 Farm Bill. There are also online vape shops. A vape shop offers a range of vaping products. The majority of vape shops do not sell vaping products that are from "Big Tobacco" companies. In 2013, online search engine searches on vape shops surpassed searches on e-cigarettes. Around a third of all sales of vaping products take place in vape shops. Big Tobacco believes the independent vape market is a threat to their interests.

EC Regulation 1223/2009 on cosmetics sets binding requirements for cosmetic products that have been made available on the market within the European Union. Manufacturers of products that fall under the category or cosmetics are required to abide by this regulation as they prepare their initial release of products and while continuing to sell said products within the Member States of the EU.

A heated tobacco product (HTP) is a tobacco product that heats the tobacco at a lower temperature than conventional cigarettes. These products contain nicotine, which is a highly addictive chemical. The heat generates an aerosol or smoke to be inhaled from the tobacco, which contains nicotine and other chemicals. HTPs may also contain additives not found in tobacco, including flavoring chemicals. HTPs generally heat tobacco to temperatures under 600 °C (1100 °F), a lower temperature than conventional cigarettes.

<span class="mw-page-title-main">Pod mod</span> Type of electronic cigarette

Pod mods are a type of electronic cigarette used to vape nicotine through a mouthpiece connected to the body of the device by magnets. These devices are a newer generation of e-cigarettes that are often marketed to a younger crowd that do not wish to attract attention gained through regular e-cigarettes or traditional tobacco-burning cigarettes. Pod mods contain a disposable cartridge and coils.

Electronic cigarettes are marketed to smoking and non-smoking men, women, and children as being safer than cigarettes. In the 2010s, large tobacco businesses accelerated their marketing spending on vape products, similar to the strategies traditional cigarette comapnies used in the 1950s and 1960s.

Nicotine salts are salts formed from nicotine and an acid. They are found naturally in tobacco leaves. Various acids can be used, leading to different conjugate bases paired with the ammonium form of nicotine.

<span class="mw-page-title-main">Nicotine pouch</span> Nicotine product

Nicotine pouches, also called modern oral nicotine products, are white pouches containing nicotine among other ingredients. They do not include tobacco leaf, dust, or stem. The nicotine may either be derived from tobacco plants or may be synthetic. Nicotine pouches are described as either similar to or a tobacco-free version of snus.

References

  1. "E-cigarettes: An emerging category" (PDF). Ernst & Young. p. 10. Retrieved 1 May 2016.
  2. "Nicotine Shot Calculator". IndeJuice Limited. Retrieved 12 February 2016.
  3. Cigarettes Butts and the Case for an Environmental Policy on Hazardous Cigarette Waste
  4. Cigarette butts are toxic plastic pollution. Should they be banned?

http://ec.europa.eu/health/tobacco/products/revision_en http://ec.europa.eu/health/tobacco/products_en https://eliquidsnow.co.uk/pages/what-is-tpd-e-liquids