Regulation of electronic cigarettes


Regulation of electronic cigarettes


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.

Dynamics

Because of the potential relationship with tobacco laws and medical drug policies, e-cigarette legislation is being debated in many countries. The companies that make e-cigarettes have been pushing for laws that support their interests. In 2016 the US Department of Transportation banned the use of e-cigarettes on commercial flights. This regulation applies to all flights to and from the US. In 2018, the Royal College of Physicians asked that a balance is found in regulations over e-cigarettes that ensure product safety while encouraging smokers to use them instead of tobacco, as well as keep an eye on any effects contrary to the control agencies for tobacco.

E-cigarettes were illegal in Japan, which forced the market to use heat-not-burn tobacco products for cigarette alternatives. Others have introduced strict restrictions and some have licensed devices as medicines such as in the UK. as of February 2018, there is no e-cigarette device that has been given a medical license that is commercially sold or available by prescription in the UK.: 46 

The legal status of e-cigarettes is currently pending in many countries. Many countries such as Brazil, Singapore, Uruguay, and India have banned e-cigarettes. Canada-wide in 2014, they were technically illegal to sell, as no nicotine-containing e-cigarettes are not regulated by Health Canada, but this is generally unenforced and they are commonly available for sale Canada-wide. In 2016, Health Canada announced plans to regulate vaping products. In the US and the UK, the use and sale to adults of e-cigarettes are legal.: US : UK 

The revised EU Tobacco Products Directive came into effect May 2016, providing stricter regulations for e-cigarettes. It limits e-cigarette advertising in print, on television and radio, along with reducing the level of nicotine in liquids and reducing the flavors used. It does not ban vaping in public places. It requires the purchaser for e-cigarettes to be at least 18 and does not permit buying them for anyone less than 18 years of age.: 39  The updated Tobacco Products Directive has been disputed by tobacco lobbyists whose businesses could be impacted by these revisions.

As of August 8, 2016, the FDA extended its regulatory power to include e-cigarettes, e-liquid and all related products. Under this ruling the FDA will evaluate certain issues, including ingredients, product features and health risks, as well their appeal to minors and non-users. The FDA rule also bans access to minors. A photo ID is now required to buy e-cigarettes, and their sale in all-ages vending machines is not permitted in the US. As of August 2017, regulatory compliance deadlines relating to premarket review requirements for most e-cigarette and e-liquid products have been extended from November 2017 to August 8, 2022, which attracted a lawsuit filed by the American Heart Association, American Academy of Pediatrics, the Campaign for Tobacco-Free Kids, and other plaintiffs.

In May 2016 the FDA used its authority under the Family Smoking Prevention and Tobacco Control Act to deem e-cigarette devices and e-liquids to be tobacco products, which meant it intended to regulate the marketing, labelling, and manufacture of devices and liquids; vape shops that mix e-liquids or make or modify devices were considered manufacturing sites that needed to register with FDA and comply with good manufacturing practice regulation. E-cigarette and tobacco companies have recruited lobbyists in an effort to prevent the FDA from evaluating e-cigarette products or banning existing products already on the market.

In February 2014 the European Parliament passed regulations requiring standardization and quality control for liquids and vaporizers, disclosure of ingredients in liquids, and child-proofing and tamper-proofing for liquid packaging. In April 2014 the FDA published proposed regulations for e-cigarettes. In the US some states tax e-cigarettes as tobacco products, and some state and regional governments have broadened their indoor smoking bans to include e-cigarettes. As of April 2017, 12 US states and 615 localities had prohibited the use of e-cigarettes in venues in which traditional cigarette smoking was prohibited. In 2015, at least 48 states and 2 territories had banned e-cigarette sales to minors.

E-cigarettes containing nicotine have been listed as drug delivery devices in a number of countries, and the marketing of such products has been restricted or put on hold until safety and efficacy clinical trials are conclusive. Since they do not contain tobacco, television advertising in the US is not restricted. Some countries have regulated e-cigarettes as a medical product even though they have not approved them as a smoking cessation aid. A 2014 review stated the emerging phenomenon of e-cigarettes has raised concerns in the health community, governments, and the general public and recommended that e-cigarettes should be regulated to protect consumers. It added, "heavy regulation by restricting access to e-cigarettes would just encourage continuing use of much unhealthier tobacco smoking." A 2014 review said regulation of the e-cigarette should be considered on the basis of reported adverse health effects.

Africa

Currently, the majority of countries in Africa have implemented laws that govern the sale, distribution, importation, and usage of electronic cigarettes. However, the existing laws on tobacco control do not extend to e-cigarettes or other electronic smoking devices since they specifically define tobacco products as those made from the tobacco plant. As a result, regulations such as minimum age requirements for sales, smoking bans, advertisement bans, and other sales restrictions (such as online trading or vending machine sales) are not legally regulated and therefore permitted.

Notable exceptions to this trend are Ethiopia, Gambia, Mauritius, Seychelles, and Uganda, which have outright banned the manufacturing, sale, supply, and importation of electronic cigarettes. In the case of Ghana, although a ban on recreational e-cigarette sales is in place, there is a provision for exceptions in a medical context, effectively resulting in a de facto ban. Similarly, South Africa has taken a similar approach by restricting e-cigarettes with nicotine to patients with a medical prescription. However, unlike Ghana, e-cigarettes without nicotine are legally available to anyone in South Africa.

Asia

Several countries and jurisdictions in Asia, including Bhutan, Brunei, Cambodia, Hong Kong, Macau, Iran, Iraq, Lebanon, North Korea, Oman, Palestine, Qatar, Singapore, Sri Lanka, Syria, Taiwan, Thailand, and Turkmenistan, have implemented bans on the importation, sale, and distribution of electronic cigarettes.

In Malaysia, e-cigarettes containing nicotine are classified as medicinal products requiring a medical prescription, while nicotine-free products can be legally sold without limitations. However, certain Muslim-majority states such as Penang, Kedah, Johor, and Kelantan have enacted laws that completely prohibit the sale of e-cigarettes, regardless of nicotine content. Similarly, in Japan, e-cigarettes without nicotine can be freely sold, while those with nicotine are considered medicinal products requiring registration. As of now, no medicinal e-cigarettes have been approved. Nevertheless, the Ministry of Health, Labor and Welfare has issued a statement permitting the private importation of medicinal e-cigarettes for personal use, provided the imported quantity is less than a one-month supply.

On the other hand, countries like mainland China, Israel, Jordan, Kazakhstan, Kyrgyzstan, Saudi Arabia, and the United Arab Emirates have implemented laws that set maximum limits on the nicotine content allowed in e-cigarette liquids.

Oceania

Laws and regulations concerning the production, import, sale, and usage of electronic cigarettes can vary significantly from country to country.

In the case of certain countries like Micronesia, Samoa, Solomon Islands, Tonga, American Samoa, and Vanuatu, there is currently a lack of specific regulations addressing e-cigarettes, or the existing tobacco control laws do not encompass e-cigarettes as tobacco products. Consequently, the existing regulatory framework does not apply to e-cigarettes in these jurisdictions.

In contrast, Australia has implemented the most stringent laws on e-cigarettes. As of October 1, 2021, obtaining a medical prescription has become a requirement for purchasing nicotine cartridges. This restriction also extends to the importation of e-cigarette products from overseas, which previously did not necessitate a prescription. Moreover, state and territory laws within Australia prohibit the sale and possession of e-cigarettes containing nicotine without a prescription. The process of acquiring a medical prescription for e-cigarettes in Australia generally requires smokers to have made unsuccessful attempts to quit smoking using Therapeutic Goods Administration (TGA) approved medications. These measures reflect the aim of ensuring strict control over the availability and use of e-cigarettes, particularly those containing nicotine, as part of a comprehensive tobacco control strategy.

Europe

European Union

On 19 December 2012 the European Commission adopted its proposal to revise the European Union Tobacco Products Directive 2001/37/EC which included proposals to introduce restrictions on the use and sales of e-cigarettes. On 8 October 2013 the European Parliament in Strasbourg voted down the commission's proposal to introduce medical regulation for e-cigarettes, but proposed that cross-border marketing of e-cigarettes be regulated similarly to tobacco products, meaning that sales of e-cigarettes to under-18s would be prohibited in the European Union, along with most cross-border advertising. Warning labels also would be required. The Parliament and Member States are involved in trilogue discussions to reach a common conclusion.

In February 2014, the European Parliament approved new regulations for tobacco products, including e-cigarettes. The new regulations forbid advertising of e-cigarettes, set limits on maximum concentrations of nicotine in liquids, limit maximum volumes of liquid that can be sold, require child-proof and tamper-proof packaging of liquid, set requirements on purity of ingredients, require that the devices deliver consistent doses of vapor, require disclosure of ingredients and nicotine content, and empower regulators to act if the regulations are violated. In October 2014 e-cigarette manufacturer Totally Wicked won the right to challenge the directive at the Court of Justice of the EU. The hearing took place on 1 October 2015 and the results will not be announced until early 2016.

In autumn 2013, the e-cigarette industry ran "a determined lobbying campaign" to defeat proposed European legislation to regulate e-cigarettes like medical devices. Pharmaceutical manufacturers GlaxoSmithKline and Johnson & Johnson have lobbied the US government, the Food and Drug Administration (FDA), and the EU parliament for stricter regulation of e-cigarettes which compete with their products Nicorette gum and nicotine patches.

By country

The Americas

United States

Federal regulation

Prior to 8 August 2016, regulations concerning the use of e-cigarettes varied considerably across the United States, although there is more variation regarding laws limiting their use by youth than regarding multi-level regulations, such as banning their use in public places. The FDA classified e-cigarettes as drug delivery devices and subject to regulation under the Food, Drug, and Cosmetic Act (FDCA) before importation and sale in the US. The classification was challenged in court, and overruled in January 2010 by Federal District Court Judge Richard J. Leon, explaining that "the devices should be regulated as tobacco products rather than drug or medical products."

In March 2010, the U.S. Court of Appeals for the District of Columbia stayed the injunction pending an appeal, during which the FDA argued the right to regulate e-cigarettes based on their previous ability to regulate nicotine replacement therapies such as nicotine gum or patches. Further, the agency argued that tobacco legislation enacted the previous year "expressly excludes from the definition of 'tobacco product' any article that is a drug, device or combination product under the FDCA, and provides that such articles shall be subject to regulation under the pre-existing FDCA provisions." On 7 December 2010, the appeals court ruled against the FDA in a 3–0 unanimous decision, ruling the FDA can only regulate e-cigarettes as tobacco products, and thus cannot block their import. The judges ruled that such devices would only be subject to drug legislation if they are marketed for therapeutic use – E-cigarette manufacturers had successfully proven that their products were targeted at smokers and not at those seeking to quit. The District Columbia Circuit appeals court, on 24 January 2011, declined to review the decision en banc, blocking the products from FDA regulation as medical devices.

In April 2014, the FDA proposed new regulations for tobacco products, including e-cigarettes. The regulations require disclosure of ingredients used in e-cigarette liquids, proof of safety of those ingredients, and regulation of the devices used to vaporize and deliver the liquid. The FDA proposed regulation would ban the sale of e-cigarettes with nicotine to any individual under 18 years of age. In August 2014, attorneys general from over two dozen states advised the FDA to enact restrictions on e-cigarettes, including banning flavors.

On 10 May 2016, the FDA published their deeming regulations in the Federal Register, which were to take effect on 8 August 2016. Vendors and companies had until two years afterward to prepare paperwork with the FDA to have their product remain on the market. Currently, there are lawsuits and amendments made in the works in Congress to change that provision. The lack of research on the risks and possible benefits has resulted in precautionary policymaking in the US "which often lacks grounding in empirical evidence and results in spatially uneven diffusion of policy". The time by which applications to market regulated non-combustible tobacco product devices must be submitted for review has been extended to August 8, 2022.

As of 8 August 2016, the FDA extended its regulatory power to include e-cigarettes. Under this ruling the FDA will evaluate certain issues, including ingredients, product features and health risks, as well their appeal to minors and non-users. The FDA rule also bans access to minors. A photo ID is required to buy e-cigarettes, and their sale in all-ages vending machines is not permitted. The FDA in September 2016 has sent warning letters for unlawful underage sales to online retailers and retailers of e-cigarettes. FDA regulations have also applied to the advertising of e-cigarettes since 2016. Per FDA regulations, e-cigarettes, e-liquid, and associated products cannot be advertised as safer than other tobacco products unless they have received modified risk tobacco product (MRTP) status. As of August 2018, this status has not been granted to any e-cigarette or e-liquid product. Though no companies have applied for an MRTP permit for their vaping products, similar heat-not-burn tobacco products have been denied MRTP status on the grounds that they are not safer than traditional cigarettes.

On December 5, 2016 HUD passed a rule banning the use of tobacco products in common areas and within each home unit. HUD did not include e-cigarettes in their list of prohibited tobacco products, and they will allow each public housing agency to make that decision. The ban includes cigarettes, cigars, pipes and waterpipes (hookahs). E-cigarettes were not included because they believe there would be no maintenance cost savings or a lowered risk of destructive fires. HUD commented that there is a lack of evidence that the vapor causes any damage to the units.

Beginning in May 2018, the FDA began to crack down on e-liquid brands whose packaging resembles food or beverage products. FDA is particularly concerned about e-liquids whose packaging resembles that of candy, juice boxes, and other products intended to appeal to children, because of concern that children will mistakenly drink the e-liquid and die of nicotine poisoning. Nicotine is especially toxic to young children, and a 60 ml bottle of e-liquid with 11 mg/ml nicotine concentration, the average e-liquid bottle in the U.S., is likely to kill a child of age 4 or younger. As such, the FDA has charged e-liquid products with branding that resembles food, candy, or beverage items as being misbranded and using false advertising, which is illegal under the Tobacco Control Act of 2009 (specifically sections 903(a)(1) and 903(a)(7)(A) of the Food, Drug, and Cosmetic Act, 21 U.S.C. § 387c).

In September 2018, the FDA has further strengthened its Youth Tobacco Prevention Plan by targeting the e-cigarette industry with fines for retailers and manufactures that are illegally selling to youth. FDA commissioner Scott Gottlieb, M.D., has indicated that this is a first step in a new and significant enforcement strategy against the e-cigarette industry. In November 2018, the FDA announced new steps to curb youth vaping while still ensuring the adults who would benefit from e-cigarettes still had access to a healthier nicotine delivery system. Sales of flavored tobacco products will be limited to adult only stores and online vendors with the exception of tobacco, mint or menthol e-cigarettes that will remain for sales wherever combustible cigarettes are sold (convenience stores). If the FDA does not see a change in the illegal youth access of menthol or minty vapes currently 20% of their use, they will move to adjust their regulations. The decision to allow menthol vapes was to ensure that an alternative was present should an adult go to purchase menthol cigarettes. The age verification of online vendors for vape products will see an increased level of security.

In the midst of an outbreak of lung illness in the US linked to vaping products, Donald Trump said in September 2019 that his administration planned to propose a ban on e-cigarette liquid flavors. In December 2019, congress enacted a law raising the age for sale of all tobacco products, including electronic cigarettes, from 18 to 21 years old. In 2020, the FDA ordered a halt on sales of vaping products with sweet and fruity flavors. In 2021, the FDA has denied marketing approval for a large number of e-cigarette products. In 2022, the FDA targeted the company Juul, denying it a marketing application and ordering Juul's products off of the US the market. However, some regulatory loopholes (specifically around disposable, pre-filled products) still allow flavored products from other companies.

State regulation

In the United States, different measures have been taken to regulate e-cigarettes. In March 2010, New Jersey became the first state to implement e-cigarette Minimum Legal Sale Age Law (MLSA) and comprehensive indoor use ban in workplaces, restaurants, and bars. That same year, Minnesota imposed the first e-cigarette tax in the country. Six years later, the Food and Drug Administration's Center for Tobacco Products (FDA-CTP) deemed e-cigarettes to be tobacco products. In May 2016, the FDA-CTP made the following requirements: e-cigarettes are required to carry a warning label, a national e-cigarette MLSA of 18 was put in place, and the FDA-CTP must eventually approve all e-cigarette products through a pre-market application process.

Effective 8 August 2016, all US states will follow the same, uniform federal guidelines. With an absence of federal regulations, many states and cities had adopted their own e-cigarette regulations, most commonly to prohibit sales to minors, including Maryland, Kentucky, Minnesota, New Jersey, New Hampshire, Tennessee, Utah, Wisconsin, and Colorado. Other states are considering similar legislation. Several US cities and states have enacted laws that increased the legal age to purchase e-cigarettes to age 21. As of 2014, some states in the US permit e-cigarettes to be taxed as tobacco products, and some state and regional governments in the US had extended their indoor smoking bans to include e-cigarettes.

Governor Arnold Schwarzenegger vetoed a bill that would regulate the sale of e-cigarettes within the state on grounds that "if adults want to purchase and consume these products with an understanding of the associated health risks, they should be able to do so."

A review of regulations in 40 U.S. states found that how a law defines e-cigarettes is critical, with some definitions allowing e-cigarettes to avoid smoke-free laws, taxation, and restrictions on sales and marketing. Fewer policies have been created to restrict vaping indoors than with cigarette smoking.

Many local and state jurisdictions have recently begun enacting laws that prohibit e-cigarette usage everywhere that smoking is banned, although some state laws with comprehensive smoke-free laws will still allow for vaping to be permitted in bars and restaurants while prohibiting e-cigarettes in other indoor places. As of August 2016, the United States Navy is considering banning e-cigarettes. A 2017 report stated "As of 2 October 2015, five US states and over 400 counties have implemented some form of restriction of ECIG use indoors. International policies are more varied with certain restrictions for ECIG use in UK airports and trains and reports of complete ECIG bans in indoor public places for Malta, Belgium and Spain". San Francisco banned the sale of flavored e-liquids in 2018. They are the first city in the US to enact such a ban.

In November 2018, the FDA required e-cigarette manufacturers not to sell e-cigarette products online without strict age verification. It was also requested e-cigarette suppliers to end bulk purchasing of e-cigarettes and to remove flavored e-cigarettes from stores. In January 2020, the city of San Francisco banned e-cigarette (but not traditional cigarettes). By January 2020, twenty states had implemented e-cigarettes taxes, sixteen had comprehensively banned indoor use of the product, and eight had imposed temporary restrictions on the sale of all e-cigarettes or flavored e-cigarettes.

Policy evaluation studies

Studies that examine the impact of e-cigarette taxes on use of e-cigarettes and traditional cigarettes have found that e-cigarette taxes increase cigarette use across different populations (adults, children, pregnant), thus providing evidence that the two products are economic substitutes. Along the same line, another study found that e-cigarette minimum legal purchase age laws increase cigarette use among 12 to 17 years old, suggesting that e-cigarettes are displacing youth smoking rather than acting as a gateway to youth smoking. Regarding indoor vaping regulations, one study found that it increased prenatal smoking by about 0.8 percentage points had no significant impact on birth outcomes.

By country

The regulations surrounding the production, importation, sale, and use of electronic cigarettes can vary greatly from one country to another.

Several countries like Antigua and Barbuda, Argentina, Nicaragua, and Uruguay have completely banned the importation, sale, and distribution of electronic cigarettes. In Mexico, there is a national ban in place, although some individual vendors have obtained the right to sell e-cigarettes through court decisions. On the other hand, Brazil and Venezuela have prohibited the importation, sale, and distribution of e-cigarettes, but their legal frameworks potentially offer a pathway for future legalization and sales.

Moreover, several Caribbean countries currently allow the sale of e-cigarettes. However, their existing tobacco control laws do not classify e-cigarettes as tobacco products, which means that regulations such as minimum age requirements for sale or restrictions on advertisements do not apply to e-cigarettes.

Canada stands out as the only country thus far that imposes restrictions on the sale of e-liquid with a maximum nicotine content of 20mg per ml. This approach is similar to that taken by many European countries.

Criticism of vaping bans

Critics of vaping bans state that vaping is a much safer alternative to smoking tobacco products and that vaping bans incentivize people to return to smoking cigarettes. For example, critics cite the British Journal of Family Medicine in August 2015 which stated, "E-cigarettes are 95% safer than traditional smoking." In 2019, San Francisco's chief economist, Ted Egan, when discussing the San Francisco vaping ban stated the city's ban on e-cigarette sales will increase smoking as vapers switch to combustible cigarettes. Critics of smoking bans stress the absurdity of criminalizing the sale of a safer alternative to tobacco while tobacco continues to be legal. Prominent proponents of smoking bans are not in favor of criminalizing tobacco either, but rather allowing consumers to have the choice to choose whatever products they desire.

In 2022, after two years of review, the Food and Drug Administration (FDA) denied Juul's application to keep its tobacco and menthol flavored vaping products on the market. Critics of this denial note that research published in Nicotine and Tobacco Research found that smokers who transitioned to Juuls in North America were significantly more likely to switch to vaping than those in the United Kingdom who only had access to lower-strength nicotine products. This happens as the Biden Administration seeks to mandate low-nicotine cigarettes which, critics note, is not what makes cigarettes dangerous. They also note that vaping does not contain many of the components that make smoking dangerous such as the combustion process and certain chemicals that are present in cigarettes that are not present in vape products.

Notes

References

External links

  • Database of laws regulating e-cigarettes by country — from the Johns Hopkins Bloomberg School of Public Health

Text submitted to CC-BY-SA license. Source: Regulation of electronic cigarettes by Wikipedia (Historical)



 








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