Table of Contents
The e-cigarette has come a long way since its invention in 2003. Initially seen as a safer alternative to traditional cigarettes, the device quickly grew in popularity and sparked debates on its commercial viability, health effects, and global legislation. This article explores the first 9 years of e-cigarette history from 2003 to 2012 – covering topics such as the initial design of the device, flavor bans, and advocacy campaigns. We’ll also look at some of the key figures who have shaped this industry over time. So get some coffee, a favorite beverage, sit back and relax, this is a LONG article.
1. 2003 and Hon Lik
The first commercially successful electronic cigarette is created in Beijing, China by Hon Lik, a 52-year-old pharmacist, inventor, and smoker. He created the device after his father, a heavy smoker, died of lung cancer. (It is not clear the extent to which he derived the technology and to what amount he was using from prior works; he failed to cite previous efforts in his patent applications.) The company Lik worked for, Golden Dragon Holdings, developed the device and changed its name to Ruyan, which means “like smoke.”
2. 2006 Electronic Cigarette Introductions
Electronic cigarettes first appeared in Europe in April 2006 and quickly spread across the UK when the Royal College of Physicians (RCP) concluded that, “low nitrosamine smokeless tobacco products may have a positive role to play in a coordinated and regulated harm reduction strategy which maximizes public health benefit and protects against commercial market exploitation.” (2007) By August 2006, electronic cigarettes made their debut in U.S. markets as well, with the introduction of simple nicotine delivery systems. In 2007, Philip Morris offered their support for an FDA regulation that would potentially reduce the harm of tobacco in the US – but it wasn’t clear if this proposal adhered to the standards set by Britain’s Royal College of Physicians.
3. 2008 Disagreement Starts
The World Health Organization (WHO) declared in September 2008 that it did not consider electronic cigarettes to be legitimate smoking cessation aids and demanded marketers remove any deceptive materials from their promotions.
In March 2008, the Turkish Health Ministry Drugs and Pharmacy Director proclaimed that these devices were just as detrimental to public safety as regular tobacco products – a claim corroborated by Kiyas Güngör of the Foundation Combating Smoking in Turkey who highlighted nicotine’s status amongst 4,800 noxious chemicals found within cigarette smoke. Far from being damaging, nicotine can actually be beneficial as it does not contain any of the dangerous chemicals that are present in cigarettes. A historical discussion of the Turkey pseudo-ban is here.
October 2008 saw the release of a study conducted by Health New Zealand which sought to analyze the presence of carcinogens and toxicants in electronic cigarettes. Their findings indicated that these levels were significantly (100 to 1000 times) lower than those found in conventional tobacco cigarettes, with the nicotine dose approximating that of medicinal inhalers. On the basis of this assessment, the e-cigarette was identified as a “safe alternative to smoking.” Experts recommend utilizing this research to inform decisions involving e-cigarette consumption.
4. 2009 The Bans Begin
In January 2009, Australia took an unprecedented step by banning the possession and sale of electronic cigarettes containing nicotine. This precedent was based on the National Drugs and Poisons Scheduling Committee’s 54th meeting statement that all forms of nicotine, with the exception of replacement therapies and cigarettes, should be classified as poisons. Similarly, Jordan’s Ministry of Health began prohibiting the importation of electronic cigarettes in early 2009 due to health concerns highlighted by the World Health Organization. In 2012, Malek Habashneh, director of the ministry’s awareness and communication directorate conducted a review reiterating that “e-cigarettes contain toxic chemicals that are more dangerous to users than those found in traditional cigarettes.” Government neglect of public health was evident when policies declared cigarettes harmless, yet classified nicotine as a toxic substance.
In March 2009, the FDA added electronic cigarettes to Import Alert 66-41, outlining that US Customs and Border Protection should reject the entry of electronic cigarettes due to being unapproved drug delivery devices. In Canada, a strict ban was also enforced on the sale, advertisement, and import of electronic cigarettes. It was deemed by Health Canada that these products contained “known irritants” such as propylene glycol. Similarly, the Hong Kong Department of Health outlawed these products within its jurisdiction with a hefty punishment for anyone found possessing or selling e-cigarettes – up to a HK$100,000 fine and two years imprisonment. Such measures made a lasting impression on worldwide perceived safety regulations being put in place for or against consumers in 2009. Finally, The Food and Drug Administration put the brakes on “Smoking Everywhere’s” e-cigarette shipments, citing that they appear to be a mix of drug-device products requiring FDA pre-authorization.
On April 28, 2009, “Smoking Everywhere” filed a federal complaint against the FDA seeking an injunction against the ban on the import of electronic cigarettes. They argued that the FDA had no authority over such products due to their classification as a “tobacco product,” and viewed any attempts on the FDA’s behalf to regulate them as overstepping Congress’s purpose of withholding authority to do so. According to 21 U.S.C 321(g), they argued that electronic cigarettes were neither drugs, drug delivery systems, nor drug-device combinations. Subsequently, Health New Zealand conducted a study funded by Ruyan. The benchmark results concluded that toxicants and carcinogens levels were at non-harmful levels.
In May 2009, the landscape of e-cigarette regulation changed in the US when Action on Smoking and Health filed a petition to the FDA requesting regulation of electronic cigarettes. NJOY (Sottera) joined forces with Smoking Everywhere in litigation against the FDA. On May 11th, the Electronic Cigarette Association was established as a trade organization to respond to health concerns and help institute industry standards. In reply to NJOY’s legal action, FDA filed a memorandum in opposition. In an FDA trial, two electronic cigarette brands-NJOY and Smoking Everywhere-underwent extensive testing. Of the 18 cartridges tested, trace amounts of tobacco-specific nitrosamines (TSNAs) were discovered in the liquid components at levels comparable to those found in nicotine cessation products approved by the FDA. While non-toxic diethylene glycol was identified within one cartridge’s liquid composition (approximately 1% concentration), no TSNAs nor diethylene glycol residues were observed after vaping; however, it did reveal traces of nicotine in some cartridges labeled 0mg.
In June 2009, President Obama gave the FDA the power to regulate the tobacco industry by passing the Family Smoking Prevention and Tobacco Control Act. In addition, any cigarettes wishing to enter the market must meet FDA pre-market standards, and flavoring such as fruit or mint is now outlawed. Panama bans all importation, distribution, and sale of electronic cigarettes. These are some of the most concerted efforts yet to regulate these increasingly popular devices.
In July 2009, the FDA filed a supplemental brief in the Smoking Everywhere lawsuit, referencing the Family Smoking Prevention and Tobacco Control Act. The FDA argued that they held authority over electronic cigarettes and could make an informed decision to label them as both drugs and devices. After rigorous testing of these cigarettes, the FDA discouraged their use due to their possible appeal to young people and lack of appropriate health warnings, as well as carcinogens and dangerous chemicals like diethylene glycol found contained within them. NJOY commissioned Exponent, Inc. to evaluate the FDA’s May 2009 study, and its subsequent report raised major criticisms regarding standards of documentation and analysis. Exponent also disputed the FDA’s claims of potential adverse health effects due to other FDA-approved nicotine replacement therapy products containing similar or higher TSNA levels as electronic cigarettes. Based upon their findings, this scientific consulting firm effectively debunked the claims made by the FDA in their initial May 2009 study.
August 2009 saw a pivotal moment in the discussion surrounding electronic cigarettes, when Dr. Elizabeth Whelan, president of the American Council on Science and Health, released an op-ed harshly criticizing the FDA statement for its distorted and incomplete information, noting that its intent was to scare people away from these substitutes for traditional cigarettes. The State of Oregon took a stance on the sale of NJOY electronic cigarettes, forcing two national travel store chains – Pilot Travel Centers and TA Operating – to reach settlements that deny their ability to distribute them. As part of these agreements, NJOY is required to provide evidence backing up any claims they make in order for sales within state lines. NJOY voluntarily halted all sales in Oregon. Oregon Attorney General John Kroger announced that Florida-based company Smoking Everywhere has been pushing false health claims and using sweet flavors to attract children—but the company is refusing to back down. This incident resulted in a landmark lawsuit against Smoking Everywhere, as it marks an unprecedented example of holding big tobacco responsible for marketing tactics targeting minors. Oregon commences a lawsuit. Brazil, Suffolk County NY, and Saudi Arabia all take steps to ban the sale, importation, or use of electronic cigarettes. In reaction to statements from the US FDA concerning potentially harmful carcinogenic substances in e-cigarettes such as diethylene glycol – “a toxic chemical used in antifreeze”; Saudi Arabia continues with nationwide bans on sales and usage.
In September 2009, the Alliance of Electronic Smokers filed an amicus curiae brief in order to support the plaintiff in a Smoking Everywhere v. FDA lawsuit. On the other side, ASH (US) offered a similar amicus curiae brief in order to defend the FDA’s stand. Additionally, California passed a bill that proposed a ban on the sale of electronic cigarettes in the state. Governor Schwarzenegger refused to sign off on the bill and vetoed it, citing that adults should be able to purchase and consume these products with a full understanding of any associated health risks. Amazon followed up by prohibiting any sale of electronic tobacco products on its website as well.
In October 2009, the Consumer Advocates for Smoke-free Alternatives Association (CASAA) was formed, with board members elected to oversee the organization’s mission. The association is composed of both consumers and select retailers, all aiming to ensure the availability of smoke-free alternatives that are effective, affordable, and safe. To remain a consumer-centric organization, CASAA limits the number of vendors on their board to a minority so that consumers have control over the majority. In order to help people quit smoking, the UK’s Action on Smoking and Health (ASH) organization advocated for products delivering nicotine without any of tobacco’s harmful components. However, PayPal blocked electronic cigarette vendors in the U.S., while allowing overseas merchants to use their services unhindered. (Historical discussions: If you sell E-Liquid with Paypal make sure they don’t say in the Notes and Paypal Shutting Down ALL E-Cig Accounts!)
In November 2009, New Jersey legislators took action by including electronic cigarettes in its public smoking ban. Manufacturers like NJOY understood that regulations around flavored vaping would eventually take place. In December 2009, NJOY announced that they would discontinue all flavor options available in the U.S., except traditional tobacco and menthol.
5. 2010 – Legislation and Legal/Political Maneuvering
January 2010 was an important month in the history of e-cigarettes. On January 14th, Judge Leon granted an injunction sought by Smoking Everywhere/Sottera that prohibited the FDA from seizing e-cigarettes as drug or drug/device combinations. A 32-page memorandum opinion was issued to explain the ruling and its implications, opening doors to further study and development within this industry.
In March 2010 the FDA successfully appealed Judge Leon’s injunction. They were granted a stay pending appeal. Meanwhile, the American Association of Public Health Physicians submitted two Citizen Petitions to the FDA, demanding greater regulation and oversight regarding these smoking alternatives. This month also saw the first Vapefest™ take place in Richmond, VA–an event that celebrated the vaping community and increased e-cigarette visibility. Thailand’s Ministry of Public Health went on to ban the import and sale of electronic cigarettes concerned they contained higher levels of nicotine than traditional cigarettes. (Obvious Mistake – Discussion)
In April 2010, the Consumer Advocates for Smoke-free Alternatives Association (CASAA) led the fight against Senate Bill 3174 in Illinois, which sought to ban the sale of e-cigarettes in the state. In May 2010, the FDA filed its brief appealing Smoking Everywhere v. FDA. A coalition formed including organizations American Academy of Pediatrics, American Cancer Society, American Cancer Society Cancer Action Network, American Heart Association, American Legacy Foundation, American Lung Association, American Medical Association, and Campaign for Tobacco-Free Kids. This coalition filed an amicus brief supporting FDA’s position on the case. In June 2010, the AMA House of Delegates passes a policy to tackle e-cigarettes. They urged the FDA to begin regulating the same as drug delivery devices so they would be subject to public safety measures. Smoking Everywhere Sottera (NJOY) filed an Appellee Brief contesting the FDA (the fight goes on and on). The Washington Legal Foundation submitted an amicus brief in the Smoking Everywhere v. FDA lawsuit, increasing the number of challenges.
In August 2010, Oregon’s Attorney General John Kroger announced a settlement with Smoking Everywhere preventing two national travel store chains from selling e-cigarettes. Following this, the Air Force surgeon general’s office classified e-cigarettes as “tobacco products” and prohibited their use in most Air Force facilities. In September 2010, Smoking Express vs FDA have oral arguments before the U.S. Court of Appeals. In October, VapeFest (an event geared toward education on vaping and advocacy for harm reduction strategies) was held in Britain. Finally, in December 2010, the U.S. Court of Appeals ruled in Smoking Everywhere v. FDA that the FDA has the right to regulate e-cigarettes as tobacco products unless therapeutic claims are made regarding the product’s usage.
6. 2011-2012 Growth of Electronic Cigarettes vs the Government
E-cigarettes continue as a debated topic. In February 2011, a study published in the American Journal of Preventive Medicine reported that e-cigarettes are a promising tool in helping smokers quit, yielding better six-month abstinence rates than traditional nicotine replacement products. However, In April 2011, the FDA responded by announcing that it would be regulating e-cigarettes similarly to traditional cigarettes and tobacco products under the Food Drug and Cosmetics Act. This included regulating any e-cigarette product claims about quitting smoking or providing general health benefits. In May 2011, Argentina passed resolution 3226/2011 which banned the importation, distribution, commercialization, and advertising of e-cigarettes and related paraphernalia. In June 2011, the community descended on Clearwater Beach for its first Vapestock event.
Electronic cigarettes are gaining more attention for the benefits they bring to adults trying to quit or cut down on smoking. A study published in the journal “Addiction”, in August 2011, provided evidence of the positive impact e-cigarettes had on those trying to quit smoking. On the other side, the Obama administration proposed a ban on e-cigarette use on airline flights (September 2011). The Department of Transportation announced it intended to adopt a rule prohibiting them by the summer of 2012. The Obama administration’s proposed ban on electronic cigarettes on flights faced criticism from advocacy groups like The Consumer Advocates for Smoke-free Alternatives Association (CASAA). After filing a petition to the White House concerning the DOT’s proposed ban, with a complaint that “contrary to DOT’s Claims, E-Cigarettes Pose No Safety Issue”, CASAA was met with a “non-responsive” response.
October 2011 was a good month for e-cigarettes, with the British Cabinet Office’s Behavioural Insights Team expressing support for tobacco harm reduction and citing the potential of e-cigarettes as effective substitutes for traditional NRTs due to smoking addiction and behavior.. The crowd went wild (quip) when Virginia held its first VaperCon, signaling changes in public perception. The results of a clinical trial published in BMC Public Health support electronic cigarettes as a potential solution to smoking cessation. The study found that e-cigarettes could be more beneficial than traditional nicotine replacement products when used for quitting smoking. In December 2011, the health minister for Holland in North Rhine-Westphalia announced that the state government determined e-cigarettes and cartridges should be subject to regulations associated with medicines and medical products. Regulations were proposed to prohibit the sale of these items outside of pharmacies. (Discussion)
March 2012 proved to be an interesting month for e-cigarette users. The first VapeBash was held in Chicago, IL. United Tobacco Vapor Group Inc., a branch of TVECA, won a lawsuit challenging the Dutch Ministry of Health’s ban on e-cigarette sales. In addition, Consumer groups including CASAA, ECCA UK, Stelda NL (Netherlands), IGED (Germany), and ATACA (Australia) organized the first World Vaping Day. This month also saw the formation of the Smoke-Free Alternatives Trade Association (SFATA), aimed at representing a vast cross-section of the vapor industry. Germany held an electronic cigarette user march in Düsseldorf demonstrating against misinformation surrounding e-cigarettes and “lies, misinformation [sic], raids at [e-cigarette] liquid stores by the police, and a witch hunt against German vapers.”
In April 2012, Venezuela’s government stands against electronic cigarettes by threatening to impose fines of up to $8,400 on anyone distributing or promoting without permits or proper health records. Lorillard Inc. purchased blu eCigs for $135 million. In June, the U.S. Inspector General’s office issued an “Early Alert” letter to Thomas Frieden of the Centers for Disease Control and Prevention (CDC) regarding the CDC’s use of federal funds tied to wellness programs encouraging cities and towns to adopt tobacco restrictions.
In October 2012, American E-Liquid Manufacturing Standards Association (AEMSA) launched. AEMSA was committed to creating and maintaining self-regulating standards and ensuring product quality for e-liquids. The FDA held a public hearing on December 2012, allowing members of the industry, consumers, and consumer representatives to share their views. The advocacy group, CASAA, issued two calls to action in connection with this public hearing. FDA delayed the publication of comments for more than a year (here).
It’s clear that e-cigarette history has been a roller coaster ride of commercial viability, global legislation and bans, advocacy, and more. Over those early 9 years, we’ve seen it all: from Virginia holding its first VaperCon to Venezuela threatening fines for those distributing or promoting without permits; from Lorillard Inc purchasing blu eCigs for $135 million to the FDA holding public hearings on regulation; from Consumer groups organizing World Vaping Day to AEMSA launching their self-regulating standards. The modern era of e-cigarettes is far from over – stay tuned for Part 2 as we continue our journey through this industry!
7. Modern E-Cigarettes History Part 2
This article will be out soon and covers the period from 2013 to 2021.
8. Additional References
The FDA had gained authority over tobacco products, but this ruling came not from the Center for Tobacco Products, but from the Center for Drug Evaluation and Research.