E-cigarettes: Early Regulation

This page details the situation at a specific point in time, in 2014, when there was little regulation in place for e-cigarettes (also known as electronic nicotine delivery systems, or ENDS). At the time, the UK, EU and US were the only significant markets. Regulatory authorities were considering how best to deal with these relatively new products, which were of increasing interest to the transnational tobacco companies.

Links to information on the current regulation of e-cigarettes in the UK, EU and US, and WHO information on e-cigarettes, are given in the boxes on this page.

• The main e-cigarette page contains links to current information on regulation of e-cigarettes around the world.
• It also links to pages for each of the transnational tobacco companies and their products. Their main brands are presented in a diagram on the newer nicotine and tobacco products page and in an associated table.
• See also the timeline of tobacco companies’ early investments in e-cigarettes.

Background

Market analysts such as Merrill Lynch and Wells Fargo argued that the regulation of e-cigarettes would be a crucial factor influencing the growth of its market share. At the time of writing, in late January 2014, there was little regulation governing e-cigarettes, either in the UK or anywhere else in the world.

EU Member States were preparing new laws take different approaches varying between complete prohibition; regulation as tobacco products, medicinal products and consumer products.¹

This was set to change with the EU Tobacco Products Directive Revision (the legislation that regulates the manufacture, presentation and sale of tobacco in Europe) which was agreed in early 2014. The US Food and Drugs Administration (FDA) also presented its proposals for e-cigarette regulation in 2014.

As regulatory authorities around the world examined whether and how to regulate e-cigarettes, many were predicting that there would be strong opposition to any proposed regulations.

Bans in Public Places

Due to a lack of regulations concerning e-cigarettes, local authorities and commercial enterprises started introducing their own rules. In the USA, various cities banned the use of e-cigarettes in public places, such as bars, nightclubs and restaurants, and therefore treating them similarly to conventional cigarettes..

Boston, Chicago, New York and Los Angeles City Council all voted to ban them. In the UK, different companies adopted varying positions. The pub chains Wetherspoons and the Slug & Lettuce banned the use of them insider their establishments, as did the fast food chain McDonald’s. Some train operators, including First Capital Connect, imposed a complete ban on passengers using the devices.²

In early April 2014, the Welsh Health Minister, Professor Mark Drakeford revealed that he was considering a ban amid concerns the products could re-normalise the use of conventional cigarettes. He said there were also concerns that the spread of e-cigarettes could undermine the ban on tobacco smoking in enclosed public spaces, making it more difficult to enforce. The proposal was part of a new set of ideas for public health legislation.³

UK Regulation

In the summer of 2013, the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK decided that e-cigarettes should be regulated as medicines from 2016. This regulation would require manufacturers to present data on the quality of their products, how they deliver nicotine to the body and how they compare with nicotine-replacement products like patches and gums.⁴ However, a final decision would await the outcome of the EU Tobacco Products Directive Revision.

The UK government announced plans to ban sales of e-cigarettes to under-18s. The new regulation could come into force within a year of the announcement in January 2014.⁵

More information on the policy decision process can be found on the Nicotine containing products page on the MHRA’s Q&A on the regulation of e-cigarettes, in the UK national archive.

Information on current UK e-cigarette regulation can be found on the UK Government website.

EU Tobacco Products Directive Revision

On 18 December 2013, after years of delay, a political agreement was reached on the text for a revised Tobacco Products Directive (TPD) between the European Commission, Parliament and the Council.⁶ with member States having two years to implement the new rules at national level.

Although the European Commission⁷ and the Council⁸ proposed to regulate e-cigarettes as a medicine, this approach was rejected by the Parliament in October 2013. In December 2013, a compromise agreement was reached between the three EU institutions to see e-cigarettes regulated for the first time at EU Level. The compromise agreement provided for two ways of placing e-cigarettes on the market:

• as a medicine, if companies choose to make a claim that e-cigarettes help smokers quit smoking
• as a consumer product (if companies did  not make any health claims) subject to certain safeguards, including:
• a limit on nicotine strength of 20mg/ml
• quality and purity standards
• the same advertising bans as for cigarettes
• a size limit and safety mechanisms for e-liquid bottles and refillable cigarettes.

This agreement would also allow the UK Government to introduce extra safeguards for instance on age-limits and flavourings in e-cigarettes.

Information on the current regulation of e-cigarettes in the EU, under article 20 of the Tobacco Products Directive, can be found on the European Commission website.

After the final approval of the regulation, the Electronic Cigarette Industry Trade Association (ECITA) and other market players vowed to fight the ‘unworkable’ EU rules.⁹

Also see E-Cigarettes: Lobbying [NB published in 2014 and not updated]

FDA Regulation in the USA

In April 2014, the US Food and Drug Administration (FDA) published the long-awaited blueprint for regulation on e-cigarettes.¹⁰ The new regulations banned the sale of e-cigarettes (and cigars and pipe tobacco) to Americans under 18, and required that people buying them show photo identification to prove their age, measures already mandated in a number of states.

These regulations were to establish oversight of what had been a market free-for-all of products, the New York Times wrote, including vials of liquid nicotine of varying quality and unknown provenance:

• Under the new rules, companies would no longer be able to offer free samples, and e-cigarettes would have to come with warning labels saying that they contain nicotine, which is addictive. Companies would also not be able to assert that e-cigarettes were less harmful than real cigarettes unless they got approval from the F.D.A. to do so by submitting scientific information.
• In the proposed restrictions on sales to minors, vending machines in public places where minors are allowed would no longer be able to carry them. A ban on Internet sales to minors, already in place for cigarettes, would extend to e-cigarettes and cigars.
• Companies would have to apply for F.D.A. approval for their products, but would have two years after the new rules are finalized to do so. Companies could keep their products on the market in the meantime.¹¹

However, the new blueprint did not contain proposals to ban flavours in e-cigarettes, like bubble gum and grape, that public health experts say lure children to use the products, nor any move to restrict the marketing of e-cigarettes, as is done for traditional cigarettes, which are banned from television, for example.

The new regulatory proposal was open to public comment for 75 days, with the agency making final changes, a process taking months, with the risk of affected companies attempting to block them.¹¹

At the time, only e-cigarettes marketed for therapeutic purposes were regulated by the FDA Center for Drug Evaluation and Research (CDER) at the national level. Furthermore, 26 US States had banned sales to minors on the basis that smoking e-cigarettes might tempt them to try smoking.⁵

Until new regulation was in place, the position of the FDA was a cautious one. The agency’s website warned that as long as e-cigarettes had not been fully studied, consumers did not know the following:

• the potential risks of e-cigarettes when used as intended,
• how much nicotine or other potentially harmful chemicals were inhaled during use, or
• if there were any benefits associated with using these products.

Additionally, it was not known at the time if e-cigarettes might lead young people to try other tobacco products, including conventional cigarettes, which cause disease and lead to premature death.¹²

Information on current US e-cigarette regulation can be found on the website of the Food and Drug Administration (FDA)

WHO’s Position on e-Cigarettes

In July 2013, the World Health Organization (WHO) issued a statement on e-cigarettes and advised that consumers should not use e-cigarettes until they were deemed safe. It said the potential risks “remain undetermined” and that the contents of the vapour emissions had not been thoroughly studied.¹³ This statement was updated in March 2015. ¹⁴

The WHO did not consider e-cigarettes to be a legitimate therapy for smokers trying to quit. Furthermore, their efficacy for helping people to quit smoking had not been scientifically demonstrated. According to WHO, they were:

… often touted as tobacco replacements, smoking alternatives or smoking cessation aids. But we know that for smoking cessation products to be most effectively and safely used, they need to be used according to instructions developed for each product through scientific testing.¹³

The WHO concluded it was best to stay away from electronic nicotine delivery systems (ENDS), as they call them:

Until such time as a given ENDS are deemed safe and effective and of acceptable quality by a competent national regulatory body, consumers should be strongly advised not to use any of these products, including electronic cigarettes.¹³

For more information and links to WHO reports on e-cigarettes, see the WHO webpage.

Relevant Links

• UK Government: E-cigarettes and vaping: policy, regulation and guidance
• European Commission: Tobacco: Electronic cigarettes
• US Food and Drug Administration: FDA’s Deeming Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products
• World Health Organization: Electronic cigarettes (e-cigarettes) or electronic nicotine delivery systems
• Institute for Global Tobacco Control E-cigarette Policy Scan

TobaccoTactics Resources

• E-cigarettes
• Harm Reduction
• Product Innovation