1930: The first documented reference to an electronic cigarette is a patent granted to Joseph Robinson in 1930 (filed in 1927). It was never commercialized and it is not entirely clear that even a prototype of this primitive device was manufactured.
1960s: Herbert A. Gilbert is generally credited with the creation of the first device that closely resembled the modern e-cigarette. He reports receiving a patent in 1965 (filed in 1963) and created prototypes (possibly never including nicotine), but failed to commercialize it. He attributes this failure the companies who might have commercialized it preferring to wait for the patent to expire rather than license it, though it is not clear whether it had commercial potential at the time.
1979-80s:Starting in 1979, Phil Ray, one of the pioneers of computers, worked with his personal physician Norman Jacobson to create the first commercialized variation on the e-cigarette (which was not actually electronic; it relied on evaporation of the nicotine). They performed the first known formal research in the field on nicotine delivery. The commercialization of the product reached major retailers. But the device was never a promising technology for nicotine delivery; Jacobson attributes its failure to it being inherently faulty. While the device proved to be a dead-end, the inventors did contribute the verb “vape” to the language.
1990s: Numerous patents for nicotine inhaler devices were filed throughout the 20th century and early 2000s by both tobacco companies and individual inventors, with a flurry of activity in the 1990s. Many relied on evaporation or physical propulsion, but a few were fairly similar to modern e-cigarettes. One chemical-reaction based system that was invented in the 1990s is still in the pipeline. Reynolds brought to market the Eclipse “heat-not-burn” device, whose functioning falls somewhere in between that of a pure nicotine inhaler and a combusted cigarette. (See also Philip Morris’s Accord.) Products closely resembling modern e-cigarettes moved toward commercialization in the 1990s (example). A major U.S. tobacco company requested permission from FDA (which did not then regulate tobacco products, but did regulate drug delivery devices) to bring a version of an e-cigarette to market c.1998. FDA denied the request on the basis of it being an unapproved drug delivery device. This may explain the disappearance of the attempts to bring an e-cigarette to market, though the history of what happened is rather murky, and the U.S. ruling does not fully explain the disappearance of the technology elsewhere.
2003 – 2008
2003: What would become the first commercially successful electronic cigarette is created in Beijing, China by Hon Lik, a 52 year old pharmacist, inventor and smoker. He reportedly created the device after his father, also a heavy smoker, dies of lung cancer. (It is not clear the extent to which his was a de novo rederivation of the technology and to what extent he was drawing upon prior art; he failed to cite much prior art 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.”
April 2006: Electronic cigarettes introduced to Europe.
2006-2007: Electronic cigarettes introduced to the U.S. (The first import ruling locatable in the U.S. Customs and Border Protection website database is dated August 22, 2006. NY M85579)
March 2008: Turkey’s Health Ministry suspends the sale of e-cigarettes. Health Ministry Drugs and Pharmacy Director, Mahmut Tokaç, claims electronic cigarettes are just as harmful as regular cigarettes. The vice president of the Foundation Combating Smoking in Turkey, Kiyas Güngör, claims that “nicotine is the most dangerous element among 4,800 poisonous chemicals in cigarettes.” (See discussion here re 2008 decision. Currently, e-cigarettes cannot be sold in stores in Turkey although they can be purchased online. Actual legal status at present is unclear.)
September 2008: The World Health Organization (WHO) proclaims that it does not consider the electronic cigarette to be a legitimate smoking cessation aid and demands that marketers immediately remove from their materials any suggestions that the WHO considers electronic cigarettes safe and effective. (See WHO September 19, 2008 press release here.)
October 2008: In a study funded by Ruyan, Health New Zealand conducts a detailed quantitative analysis and concludes that carcinogens and toxicants are present only below harmful levels. On the basis of the findings, the e-cigarette is rated several orders of magnitude (100 to 1000 times) less dangerous than smoking tobacco cigarettes. The nicotine dose is comparable to that of a medicinal nicotine inhaler. Overall, the product tested was deemed a “safe alternative to smoking.”
Australia bans the possession and sale of electronic cigarettes which contain nicotine, citing that “every form of nicotine except for replacement therapies and cigarettes are classified as a form of poison.” (See NDPSC record of reasons, 54th meeting, 14-15 October 2008 and download provided here.)
Jordan’s Ministry of Health bans the import of the electronic cigarettes, citing World Health Organization’s health concerns. (See discussion here.) In a February 2012 review of the ban, Malek Habashneh, director of the ministry’s awareness and communication directorate, claims that “e-cigarettes contain toxic chemicals that cause more health problems than the nicotine in normal cigarettes.”
FDA adds electronic cigarettes to Import Alert 66-41 and directs the U.S. Customs and Border Protection to reject the entry of electronic cigarettes into the United States on the basis of them being unapproved drug delivery devices. (See pp. 12-13 here.) (At this time FDA had gained authority over tobacco products, but this ruling came not from their nascent Center for Tobacco Products, but from their Center for Drug Evaluation and Research.)
Canada bans the sale, advertising and import of electronic cigarettes. Health Canada advises Canadians not to purchase or use them, claiming they contain a “known irritant” (propylene glycol). (See Health Canada’s advisory here.)
Hong Kong Department of Health bans electronic cigarettes. The maximum penalty for possessing or selling e-cigarettes is a HK$100,000 fine and two years’ imprisonment. Since smoke-free tobacco is prohibited in Hong Kong, the ban on e-cigarettes continues to leave high-risk cigarettes as the only legal tobacco product available. (Information on current legal status of e-cigarettes in Hong Kong can be found here.)
FDA notifies electronic cigarette company “Smoking Everywhere” that its shipments have been refused entry into the U.S. The FDA maintains that electronic cigarettes “appears to be a combination drug-device product” that require preapproval, registration and listing with the FDA. (See pp. 10-11 here.)
Smoking Everywhere files a federal complaint on April 28, 2009 seeking an injunction against the FDA with respect to the FDA’s attempts to ban the import of electronic cigarettes. Smoking Everywhere contends that the FDA has no authority over electronic cigarettes, as they are a “tobacco product,” and the FDA’s attempt to regulate them infringes on Congress’s intent to withhold FDA jurisdiction over tobacco products. Smoking Everywhere contends that electronic cigarettes are not “drugs,” “drug delivery systems,” or “drug device combinations” under 21 U.S.C 321(g).
In a study funded by Ruyan, Health New Zealand conducts a detailed quantitative analysis and concludes that carcinogens and toxicants are present only below harmful levels. Bench-top test results presented as a poster at SRNT poster at SRNT in Dublin April 30, 2009. (Click here to download the poster.)
Action on Smoking and Health in the United States (ASH-US) files a petition to the FDA calling for FDA regulation of electronic cigarettes.
NJOY (Sottera) joins Smoking Everywhere’s lawsuit against FDA.
The Electronic Cigarette Association (ECA) is formed. The ECA (now defunct) is a trade association made up of electronic cigarette producers, distributors and retailers; whose aim is to speak on behalf of the electronic cigarette industry, especially in response to health concerns, and to help institute industry standards. The group is headquartered in Washington, D.C. Its president and spokesman is former United States congressman Matt Salmon. (See video statement from ECA here and ECA’s brochure on e-cigarettes here. Tobacco Vapor Electronic Cigarette Association (TVECA) claims to be ECA’s successor.
FDA tests 2 brands of electronic cigarettes, NJOY & Smoking Everywhere. 18 cartridges are tested. Tests reveal trace amounts of tobacco-specific nitrosamines (TSNAs) in the liquid in levels comparable to those found in FDA-approved nicotine cessation products. The liquid of one cartridge is found to contain a non-toxic amount (approximately 1%) diethylene glycol. TSNAs nor diethylene glycol is detected in the vapor. Some cartridges labeled as 0mg nicotine are shown to contain trace amounts of nicotine.
President Obama signs into law the Family Smoking Prevention and Tobacco Control Act, giving the FDA the power to regulate the tobacco industry. Although nicotine and cigarettes as a whole cannot be banned outright, flavoring such as fruit or mint can. Additionally, new tobacco products seeking to enter the market will be required to meet FDA pre-market standards, which could affect electronic cigarette regulation.
Panama bans the importation, distribution and sale of electronic cigarettes.
FDA files a supplemental brief in the Smoking Everywhere lawsuit referencing the Family Smoking Prevention and Tobacco Control Act. The FDA contends that it still has authority over electronic cigarettes and FDA stands behind the decision to label it a drug-device combination. “FDA found, after examining the product, the claims made in the product labeling, and information SE submitted to FDA, that SE’s product met the definition of both a drug and device under the FDCA.”
Two months after testing, the FDA issues a press release discouraging the use of electronic cigarettes and repeating previously stated concerns that electronic cigarettes may be marketed to young people, lack appropriate health warnings and that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze. The FDA did not reveal that the carcinogens found were similar to those found at the same levels in FDA-approved nicotine cessation products, nor that the amount of diethylene glycol found would not be toxic. The FDA also did not disclose that neither substance was found in the actual vapor to which the user is exposed.
FDA’s May 2009 study is reviewed by scientific consulting firm Exponent, Inc., in a report commissioned by NJOY. Some of the criticisms of the FDA study, as set forth in Exponent’s report, are poor standards of documentation and analysis and failure to perform relevant comparisons to FDA-approved nicotine replacement therapy products, which Exponent claims contain TSNA levels comparable to those of electronic cigarettes. The study concludes that the FDA’s claims of potential adverse health effects were not supported by the study.
Israeli Health Ministry considers banning e-cigarette sales and importation. (The ban discussed here in 2009 was never implemented, although in 2013, it was reported that Israel was considering either a ban or tobacco classification.)
In a Washington Times op-ed, Dr. Elizabeth Whelan, president of the American Council on Science and Health, calls the FDA press statement about electronic cigarettes “distorted, incomplete and misleading” and meant to “scare Americans” to stay “away from these newfangled, untested cigarette substitutes — better to stick with the real ones.”
The State of Oregon announces two settlements have been reached that prevent two national travel store chains, Pilot Travel Centers and TA Operating, from selling NJOY electronic cigarettes. In addition, the company must give the Attorney General advance notice that they intend to sell electronic cigarettes in Oregon, provide copies of all electronic cigarette advertising, and provide copies of the scientific studies they maintain substantiates their claims. NJOY voluntarily stops all sales in Oregon.
Oregon Attorney General John Kroger announces a lawsuit against Smoking Everywhere, alleging that the Florida-based company made false health claims about its nicotine delivery device and targeted children with sweet flavors. Smoking Everywhere refuses to settle. (Smoking Everywhere eventually settled in August 2010.)
Brazil bans the sale, importation and advertisement of electronic cigarettes. (See discussion here.)
Suffolk County, NY passes first legislation banning indoor use of electronic cigarette in areas where smoking is also prohibited and bans sales to persons under age 19.
Saudi Arabia bans sales of electronic cigarettes based on the statement made by the US Food and Drug Administration which had said [e-cigarettes] “contain harmful carcinogenic and toxic substances, notably diethylene glycol, a toxic chemical used in antifreeze.” (This ban continues today, as discussed here.)
California passes a bill to ban the sales of electronic cigarettes in the state. Governor Schwarzenegger vetoes the bill stating, “If adults want to purchase and consume these products with an understanding of the associated health risks, they should be able to do so unless and until federal law changes the legal status of these tobacco products.”
September/October 2009: Amazon.com prohibits sale of electronic tobacco products on its website. (See discussion here.)
Consumer Advocates for Smoke-free Alternatives Association (CASAA) forms and board members elected. The organization is made up of both consumers and retailers, with the mission to ensure the availability of effective, affordable and reduced harm alternatives to smoking by increasing public awareness and education; to encourage the testing and development of products to achieve acceptable safety standards and reasonable regulation; and to promote the benefits of reduced harm alternatives. In order to ensure CASAA is first and foremost a consumer-based organization, the number of vendors elected to the board is limited so that consumer board members control a super majority.
UK ASH recognizes that products should be made available that deliver nicotine in a safe way, without the harmful components found in tobacco, but those attempting to quit should use conventional NRTs. (For a copy of UK ASH’s October 2009 briefing, click here. The current flyer, updated February 2016, can be found here.)
PayPal freezes accounts of electronic cigarette vendors in the U.S. and prohibits them from using the service; however, vendors outside of the U.S. are allowed to continue using PayPal for electronic cigarette sales. (See discussion here and here.)
November 2009: New Jersey State legislators pass a bill including electronic cigarettes in the state’s public smoking ban.
December 2009:NJOY announces it is discontinuing, in the U.S., the availability of all flavors except its traditional tobacco flavor and menthol. The move aligns the flavors offered by NJOY with those allowed for combustible tobacco cigarettes under the Family Smoking Prevention and Tobacco Control Act. (NJOY’s corporate policy on flavors changed in 2014 with, among other things, its release of a premium line of e-liquid, as discussed here.)
January 2010: On January 14, 2010, Judge Leon grants the injunction sought by Smoking Everywhere/Sottera prohibiting the FDA from seizing e-cigarettes as drug or drug/device combinations. Judge Leon issues a 32-page memorandum opinionexplaining the ruling.
Appellate Court grants the FDA’s request for a stay of Judge Leon’s injunction pending appeal. (See discussion here.)
The American Association of Public Health Physicians submits two Citizen Petitions to the FDA, one asking for reclassification of e-cigarettes to “tobacco product” and the other asking for a follow up statement to the July 2009 press conference. (See here and here for Citizen Petitions.)
First Vapefest™ is held in Richmond, VA
Ministry of Public Health bans the import and sale of electronic cigarettes in Thailand. It warns “the cigarettes contained more nicotine than normal ones.” (See discussion here on the issue and also see 2014 ban on import by Ministry of Commerce.)
April 2010: CASAA and others help persuade Illinois legislators not to pass SB 3174, a law which would ban the sale of e-cigarettes in the state.
FDA files appellant brief in Smoking Everywhere v. FDA case (U.S. Court of Appeals for District of Columbia).
Coalition files amicus brief in the Smoking Everywhere v. FDA case supporting FDA’s position. Coalition members include 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.
American Medical Association (AMA) House of Delegates (HOD) passes a policyurging the FDA to regulate e-cigarettes as drug delivery devices.
Sottera (NJOY) files Appellee brief in Smoking Everywhere v. FDA (U.S. Court of Appeals).
Singapore bans e-cigarette importation, distribution and sales. Fine is of up to $5,000 upon conviction. (See here for current policy, which remains the same.)
Marine Corps Base in Quantico bans e-cigarette use in its facilities. (See discussion here.)
FDA files appellant reply brief in Smoking Everywhere v. FDA case (U.S. Court of Appeals for the District of Columbia Circuit).
CASAA joins other e-cigarette and reduced-harm smokeless alternative proponents in filing an amicus brief in the Smoking Everywhere v. FDA case. Other amicus curiae named on the brief include Smokefree Pennsylvania, The American Council on Science and Health, National Vapers Club, Midwest Vapers Group, Michael Siegel, MD, MPH, and Joel Nitzkin, MD, MPH, DPA.
Washington Legal Foundation (WLF) files amicus brief in the Smoking Everywhere v. FDA case.
Oregon’s Attorney General John Kroger announces a settlement preventing the two national travel store chains from selling e-cigarettes. (The settlement with Smoking Everywhere can be viewed here.)
Air Force surgeon general’s office categorizes e-cigarettes as “tobacco products” and prohibits their use in most Air Force facilities. (See discussion here.)
September 2010: Oral arguments before the U.S Court of Appeals in SE vs. FDA. (Transcript available here.)
October 2010: First VapeFest is held in UK.
December 2010: Smoking Everywhere v. FDA, U.S. Court of Appeals in Washington rules the FDA can only regulate e-cigarettes as a tobacco product, unless therapeutic claims are made. (The order is here and the 25-page decision is here.)
February 2011: Study is published in the American Journal of Preventive Medicine reporting that electronic cigarettes are a promising tool to help smokers quit, producing six-month abstinence rates that are better than those for traditional nicotine replacement products.
April 2011: FDA announces it will regulate e-cigarettes as it currently regulates traditional cigarettes and other tobacco products under the Food Drug and Cosmetics Act. However, any e-cigarette products advertising claims of helping the user to stop smoking or providing any other health benefit will be more strictly regulated as a drug or medical device.
May 2011: Argentina passes resolution 3226/2011 banning the importation, distribution, commercialization and advertising of e-cigarettes and paraphernalia related to them. (See here for an unofficial translation followed by a copy of the original untranslated document.)
June 2011: First Vapestock held in Clearwater Beach, FL.
August 2011: Study published in the journal “Addiction” provides strong evidence that electronic cigarettes are being used with success by many smokers to quit smoking or cut down substantially on the number of cigarettes they consume, and that e-cigarettes are being used with success by many ex-smokers to remain off cigarettes.
The Obama administration proposes banning the use of electronic cigarettes on airline flights, saying the “new rule would enhance passenger comfort and reduce any confusion.” The Department of Transportation says that although it considers electronic cigarettes to be covered under the existing law banning smoking on airplanes, it intends to adopt a rule specifically banning them in the summer of 2012. (See Joint Comment filed by CASAA and Competitive Enterprise Institute, filed November 2011.)
The British Cabinet Office’s Behavioural Insights Team (BIT) strongly endorses tobacco harm reduction in its first annual report. E-cigarettes are cited as potentially effective substitutes because of their behavioral attributes. (See news article here and actual report here.)
First VaperCon is held in Richmond, VA
The results of the first clinical trial of electronic cigarettes, reported in the journal BMC Public Health, suggests e-cigarettes may be more effective than traditional NRT products for smoking cessation and may be particularly effective in smokers who are not motivated to quit.
CASAA and Competitive Enterprise Institute file a comment regarding the Department of Transportation proposal to amend its existing airline smoking rule to explicitly ban the use of electronic cigarettes on all aircraft in scheduled passenger interstate, intrastate and foreign air transportation. This regulation would impose fines of up to $3,300 for “smoking” an e-cigarette on an airplane. Those who use an e-cigarette would be treated exactly as if they were smoking a combusted tobacco product. See also comment from Smoke-free Pennsylvania.
Holland’s Minister of Health, announces that the sale and import of electronic cigarettes is banned. E-cigarette sales will require a pharmaceutical license. (See discussion here.)
The health minister of the State of North Rhine-Westphalia announces that the state government has determined that e-cigarettes and their cartridges fall under regulations concerning medicines and medical products. She states that the state government is planning to adopt regulations to ban their sale unless approved for sale in pharmacies.
First VapeBash is held in Chicago, IL.
United Tobacco Vapor Group Inc., a branch of TVECA, wins a lawsuit challenging the Dutch Ministry of Health’s ban on e-cigarette sales.
Consumer groups including CASAA, ECCA UK, Stelda NL (Netherlands), IGED (Germany) and ATACA (Australia) organize the first World Vaping Day.
Smoke-Free Alternatives Trade Association (SFATA), a trade association representing a wide cross section of the vapor products industry, is formed.
Nearly 200 of Germany’s estimated 1.2 million electronic cigarette users march peacefully in Düsseldorf in protest of “lies, missinformation [sic], raids at [e-cigarette] liquid stores by the police and a witch hunt against German vapers.”
Venezuela’s government threatens to punish with fines up to $8,400 for those who distribute or promote electronic cigarettes banned in the country for not having permits or corresponding health records.
June 2012: U.S. Inspector General’s office issued an “Early Alert” letter to Thomas Frieden, director of the Centers for Disease Control and Prevention (CDC) regarding whether the CDC was illegally using federal funds tied to wellness programs to encourage local communities to adopt a bevy of tobacco restrictions. (Original letter extracted from a file found on the CauseOfAction.org site, the full file which can be downloaded here.)
September 2012: R.J. Reynolds, through its pharmaceutical subsidiary Niconovum, launches Zonnic gum (a nicotine-replacement therapy) in test markets in Des Moines, IA.
American E-Liquid Manufacturing Standards Association (AEMSA), a trade association specifically dedicated to creating/maintaining self-regulating standards for the manufacturing of its members’ e-liquids used in e-cigarettes, announces its launch.
Smoke-free Alternatives Trade Association (SFATA) debuts at 2012 NACS Trade Show.
December 2012: FDA holds a public hearing, and several members of industry as well as consumers and consumer representatives made presentations. CASAA issues a Call to Awareness as well as a Call to Action in connection with this hearing. FDA delayed publishing many of the comments for more than a year, which comments can be viewed here.
January 2013: A petition to the White House is created to “prevent the FDA from regulating or banning the sale and use of electronic cigarettes, accessories and associated liquids.” While not created by CASAA, CASAA urged its members to signthe petition. The petition gained the required number of signatures (25,000), and a response from FDA was published in April 2014, which advocates characterized as largely nonresponsive. (FDA’s response can be seen here.) This is the second community-supported White House petition effort, the first being in 2011 when the threshold for signatures was 5,000.
April 2013: Senators Dick Durbin (D-IL), Frank Lautenberg (D-NJ), Richard Blumenthal (D-CT), Sherrod Brown (D-OH) and Jack Reed (D-RI) send a letter to FDA urging FDA to issue deeming regulations to exert regulatory authority over cigars, pipe tobacco, electronic cigarettes, and dissolvable tobacco products.
May 2013: CASAA launches its Testimonials Project to collect success stories from smokers who used smoke-free alternatives to quit or reduce their smoking. This public collection of success stories was created as a powerful response to those who want to restrict access to e-cigarettes and other smoke-free products. CASAA’s goal is to present a large collection of compelling individual reports that will make it impossible for anyone to claim that substitution of low-risk alternatives (e-cigarettes, snus, and other smoke-free tobacco/nicotine products) is not a proven method for quitting smoking.
R.J. Reynolds announces new vapor product, VUSE, will be launched in July in Colorado as the first state in an eventual nationwide rollout.
The U.K. Medicines and Healthcare Products Regulatory Agency announces it will regulate e-cigarettes as medicines when new European tobacco laws come into force. (Note that this position has since changed.) See Clive Bates’ analysis here and here and also CASAA’s analysis.
Vape A Vet, a nonprofit 501(c)(3) organization, forms to provide active and former military service members with the equipment and knowledge necessary to switch to a healthier alternative at no cost to them.
Dragonite International Limited (formerly Ruyan Group (Holdings) Limited), and its wholly-own subsidiaries, sold its vapor business for $75 million to Fontem Ventures B.V., a wholly-owned subsidiary of Imperial Tobacco Group plc.
E-cigarette opponents sent a coalition letter to President Obama urging him to impose FDA deeming and other regulations on electronic cigarettes, cigars and other tobacco products.
National Association of Attorneys General sent a letter to FDA urging the issuance of proposed regulations.
Germany, Higher Administrative Court of North Rhine-Westphalia upheld three previous decisions that electronic cigarette products containing nicotine were not medicines, unless presented as such. See news report here.
Government Accountability Office Report finds FDA needs to set time frames for its review process of Substantial Equivalence (SE) applications for tobacco products, noting FDA that on June 25, 2013—about 3 years after FDA’s receipt of the first SE submission—the Center for Tobacco Products (CTP) made a final decision on only 6 of the 3,788 SE submissions.
CASAA calls out various legislators, state attorneys general, as well as the Centers for Disease Control (CDC), for launching a bad-faith campaign against electronic cigarettes, a low-risk alternative to smoking.
A press release is issued by a dozen legislators regarding letters they sent to various companies demanding information about marketing to children.
European Union issues a press release rejecting a wholesale ban on the sale of e-cigarettes: “E-cigarettes should be regulated, but not be subject to the same rules as medicinal products unless they are presented as having curative or preventive properties. Those for which no such claims are made should contain no more than 30mg/ml of nicotine, should carry health warnings and should not be sold to anyone under 18 years old. Manufacturers and importers would also have to supply the competent authorities with a list of all the ingredients that they contain. Finally, e-cigarettes would be subject to the same advertising restrictions as tobacco products.”
Association of State and Territorial Health Officials (ASTHO) sends letter to FDAurging FDA to issue proposed regulations addressing advertising, ingredients and sales to minors before October 31, 2013.
First E-Cigarette Summit was held at the Royal Society in London to provide a platform to present and scrutinize the available science and evidence on electronic cigarettes with the aim to help inform public health and policy debates that were being held in the run up to the vote on the European Tobacco Products Directive.
First three electronic cigarette commercials banned in the U.K. “In their efforts to comply with the ad codes, the marketers were guilty of lack of clarity. All three spots are pretty obscure because they try so hard not to promote smoking that they neglect to mention what the product does. While they were condemned for being misleading, the ads were cleared by the ASA of being ‘irresponsible and harmful.'” (See here for full article.)
New York City C.L.A.S.H. (CLASH) filed a lawsuit against the City of New York and the New York City Council seeking to overturn a ban on e-cigarette use wherever smoking is prohibited. See here and here for more information on the lawsuit. CASAA donates $1,000 to support the effort.
Western Australia – The Magistrate’s Court ruled in Hawkins v. Van Heerden (October 2013) that Van Heerden did not violate S106(a) of the Tobacco Products Control Act 2006 (WA) (the “Act”). The matter was appealed by Hawkins, a compliance officer with the Department of Health, to the Supreme Court of Western Australia, which court ruled in April 2014 that Vince Van Heerden violated the Act by selling products (electronic cigarettes) designed to resemble a tobacco product. Van Heerden appealed that decision to the Court of Appeal, but the appeal was dismissed in March 2016, meaning that it remains illegal in Western Australia to sell vapor product devices, regardless of whether they contain nicotine. (We note that the vapor products in question were described as “510-T” and “eGo-T,” which one would not describe as looking like traditional combustible cigarettes or cigars.) (In November 2014, CASAA made a donation of $500 to help fund the legal battle in an effort to help preserve consumer access to vapor products in Western Australia.)
American Vaping Association (AVA), a nonprofit vapor industry advocacy organization, formed in December 2014 announces that Gregory Conley as its president. AVA champions the use of of vapor products and e-cigarettes to help smokers quit.
May 2014: CASAA releases an overview of its Action Plan regarding proposed FDA regulations
CASAA submits a comment to OMB Office of Information and Regulatory Affairs regarding Paperwork Reduction Act and FDA deeming regulation.
European Union adopts Tobacco Products Directive (TPD), Directive 2014/40/EU, to be implemented by member states by May 20, 2016.
CASAA issues Third Call to Action as part of its Action Plan, encouraging consumers to demand a congressional hearing involving CDC’s and FDA’s actions.
Smoke-Free Alternatives Trade Association (SFATA) announces its Age to Vape™ program, which will distribute free age-restriction signs to brick-and-mortar vapor product retailers across the nation.
First Global Forum on Nicotine (GFN) took place in Warsaw, Poland, in June 2014. The event attracted around 200 people from 26 countries and featured presentations from many of the world’s leading nicotine researchers and policy analysts. (See here for for Conference Report.)
CASAA issues Fourth Call to Action as part of its Action Plan, encouraging consumers to submit a comment in response to FDA’s proposed regulations. (See also streamlined version of Fourth Call to Action here.)
Organizations submit comments involving FDA proposed regulations.
FDA opens a docket for public comment on modified risk tobacco product applications (MRTPAs) submitted by Swedish Match North America Inc. for 10 tobacco products. (Swedish Match’s actual application downloadable here.)
Launch of E-Research Foundation, a nonprofit 501(c)(3)organization established to further advance the scientific study of e-vapor products (aka electronic cigarettes), related products and their use.
Pillbox 38 (UK) Limited (Totally Wicked) wins the right to formally challenge the validity of the EU Tobacco Products Directive (TPD) at the Court of Justice of the EU (CJEU) in Luxembourg.
Third community-based effort to petition the White House regarding regulation of e-cigarettes. The minimum threshold of 100,000 signatures was obtained, and the response was again largely nonresponsive. (Response can be viewed at petition link.)
Letter from Speaker of the House John Boehner, Majority Leader Kevin McCarthy, and Chair of Energy & Commerce Committee Fred Upton to Sylvia Burwell (Secretary Department of Health and Human Services) asking that the grandfather date for newly deemed tobacco products be moved from February 15, 2007 to April 25, 2014 (date the proposed deeming regulation was published) or the date the regulation is finally published. (See also CASAA Call to Action issued December 2014 requesting legislators consider a different regulatory scheme for e-cigarettes and support a change in the grandfather date.)
December 2014: First of three FDA workshops held, this one being on the physical characteristics of e-cigarettes. (You can find the transcript of that workshop here.) CASAA issues Call to Action March 2015.
January 2015: CASAA relaunches its testimonials project and creates new website for its tobacco harm reduction success stories collection.
February 2015: Center for Environmental Health announces it is initiating legal action against 19 companies for alleged California Proposition 65 violations. (See here for analysis of the lawsuit.)
Second of three FDA workshops held, this one being about issues related to individual health. (You can find the transcript of that workshop here.) CASAA issues Call to Action April 2015.
California Department of Public Health (CDPH) announces its premiere of “a series of television, digital, and outdoor ads in a new campaign called ‘Wake Up,’ as part of its educational effort to inform the public about the dangers of e-cigarettes.” CDPH promotes the website stillblowingsmoke.org as part of that effort, which effort was promptly derailed by a campaign developed by Stefan Didak entitled “Not Blowing Smoke” (NBS) at a cost of less than $100. Within days, NBS dominated Twitter, almost completely eclipsing the CDPH’s multi-million dollar effort. (NBS was later incorporated in August 2015 as a California nonprofit.)
April 2015: Tobacco Products Scientific Advisory Committee (TPSAC) holds a public hearing on Swedish Match’s modified risk tobacco product application (MRTP filed August 2014). TPSAC could not reach a consensus. Among other things, Swedish Match proposed replacing the warning that “This product is not a safe alternative to cigarettes” with the statement, “No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.” Four of the eight TPSAC members felt that the evidence presented did not support the alternate warning label.
May 2015: Indiana passes HB 1432, which, among other things, prohibits e-liquid manufacturers (whether in-state or out-of-state) from selling products to retailers and distributors in Indiana without a permit. (See CASAA Indiana Call to Action issued in March 2015 for more details.) The permit would require compliance with burdensome and expensive manufacturing and security protocols that may be impossible to meet. Of particular concern, these requirements only apply to e-cigarette refill liquid used in open-system products and specifically do not apply to closed-system products (i.e., cigalikes). In response, a federal lawsuit was filed in May of 2015 by two out-of-state manufacturers and an in-state vendor. In September of 2015, The Right to be Smoke-Free Coalition filed a motion to intervene and its complaint. December 2015, Hoosier Vapers, Inc. and five other plaintiffs filed a lawsuit at the state level.
June 2015: Third of three FDA workshops held, this one being about issues related to population health. (You can find a transcript of that workshop here.) CASAA issues Call to Action June 2015.
August 2015: Public Health England announces its expert independent reviewconcludes that e-cigarettes are significantly less harmful to health than smoking and have the potential to help smokers quit smoking.
Final deeming regulations delivered by FDA to OMB Office of Information and Regulatory Affairs (OIRA) for review.
TVECA announces it has a copy of the final deeming regulations and industry guidance and promises to release them to the public. TVECA only publishes what they claim to be a draft industry guidance document and the table of contents for the final deeming regulations. Center for Tobacco Products (CTP) releases a special statement, noting that FDA’s policy is not to release draft documents or negotiate with outside groups while documents are under review and refuse to confirm or deny that TVECA has authentic or current documents. “It is our understanding based on recent conversations between the FDA and TVECA, that the group will not be releasing the document in question.”
Eleven U.S. Senators deliver a letter to OIRA, stating, among other things, “We urge OMB to work quickly to finalize review of the final deeming rule, ensuring that the rule gives FDA authority over all tobacco products including e-cigarettes and cigars, explicitly bans the use of flavorings and marketing that appeals to children, and mandates child-proof packaging of e-liquids (liquid nicotine). We also implore that the final rule not move the ‘grandfather date’ for new products (set at February 15, 2007). Altering this grandfather date would exempt a wide range of e-cigarettes and related products from any premarket review to determine whether they constitute threats to public health.”
FDA grants PMTA approval to eight Swedish Match smokeless tobacco products. According to the FDA press release, “This action permits the tobacco products to be sold in the U.S., but does not mean that they are safe or ‘FDA approved.’” (See analysis by Carl Phillips here.)
Several lawsuits filed, including (1) a class action lawsuit against Five Pawns, Inc. involving the presence of diacetyl and acetyl propionyl in their e-liquids and alleged failure to disclose or properly warn consumers, and (2) two lawsuits (here and here) filed by Center for Environmental Health (CEH) against various e-cigarette companies alleging California Proposition 65 violations. CEH reports that it has filed lawsuits against a total of 60 e-cigarette companies, only one of which was settled. (See analysis by Carl Phillips here.)
Paper published in Tobacco Control wherein the authors alleged “brandalism” of CDC materials and claim that e-cigarette advocates with close ties to industry are misleading and deceiving the public and infringing on the government’s copyright. See commentary by Dr. Michael Siegel here, Not Blowing Smoke’s press release here, and Dr. Carl Phillips’ discussion here of the base inappropriateness of CDC’s campaign.
Smokefree Pennsylvania submits 158-page report to OMB/OIRA calling for FDA’s proposed deeming regulation to be withdrawn.
American E-Liquid Manufacturing Stands Association (AEMSA) meets with, andsubmits report to, OMB/OIRA.
Nine Senators send a letter to the Federal Trade Commission (FTC) asking it to investigate unfair or deceptive acts of e-liquid retailers. In addition, these senators sent letters to various e-liquid retailers regarding possible marketing of nicotine-containing products using recognizable brand names of various foods and drinks. Letters were also sent to companies informing them that their brand names/images were being used in connection with e-liquid marketing and asking them what steps they were taking to prevent this kind of use.
Iowa Attorney General Tom Miller issues a press release noting, “The harm of the combustible cigarette is dramatically greater than the harm of the e-cigarette.” Mr. Miller also corrects some of the misinformation regarding youth use of e-cigarettes and says, “adults misleading kids to get them to do what we want has always been a failed strategy.”
SEVIA USA, an association of Chinese e-cigarette manufacturers, forms in order to commit resources to fight against “unfair and burdensome FDA regulations.” SEVIA USA’s founding members include Aspire, Kangertech, Innokin, and SMOK.
The country of Turkmenistan is reported to have banned the sale of all tobacco products.
Appeal filed in New York City C.L.A.S.H. (CLASH) lawsuit against City of New York challenging City’s ban of e-cigarette use wherever smoking is prohibited. (This appeals the grant of summary judgment in favor of the City May 2015.)
National Centre for Smoking Cessation and Training (UK) issues a briefing making recommendations for stop smoking practitioners and services, providing common questions and suggested answers about e-cigarettes, and summarizes the evidence upon which these recommendations are drawn.
Van Heerden had been previously convicted in April of 2014 by the Supreme Court (Western Australia) for violating S106(a) of the Tobacco Products Control Act 2006 (WA) (the “Act”). He sold electronic cigarettes (without nicotine), which the Supreme Court determined were products designed to resemble a tobacco product. Van Heerden appealed the conviction to the Court of Appeal (Western Australia), which appeal was dismissed in March 2016. It remains illegal in Western Australia to sell vapor product devices, regardless of whether they contain nicotine. (We note that the vapor products in question were described as “510-T” and “eGo-T,” which one would not describe as looking like traditional combustible cigarettes or cigars.)
The Royal College of Physicians (UK) issued a 200-page report entitled “Nicotine without smoke: tobacco harm reduction, examining the science, public policy, regulation and ethics surrounding e-cigarettes and other non-tobacco sources of nicotine, and addressing these controversies and misunderstandings with conclusions based on the latest available evidence. Significantly, the report notes that “[s]mokers can . . . be reassured and encouraged to use them, and the public can be reassured that e-cigarettes are much safer than smoking.” (To download the full report, click here.)
Competitive Enterprise Institute (CEI) and CASAA filed a lawsuit challenging the Department of Transportation’s (USDOT) recent regulation extending the existing statute prohibiting smoking aboard aircraft to cover electronic cigarettes, maintaining that USDOT was exceeding the scope of its congressional grant of authority. (See also the comment filed by CEI and CASAA in November 21, 2011 in response to USDOT’s proposed rule and also this for further analysis of the legal underpinnings of the case. See also statement of issues filed May 2016 and brieffiled August 2016.)
Communication Resources for Final Rule Extending Authorities to All Tobacco ProductsSmall Entity Compliance Guide: FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements.
Lawsuits filed challenging the deeming regulations:
Nicopure Labs files complaint in federal court (DC District) challenging the deeming regulations.
Lost Art Liquids files complaint in federal court (Central District CA) challenging the deeming regulations.
John Middleton Company LLC files complaint in federal court (DC District) challenging FDA’s authority to ban the use of the word “mild” to describe/brand their Black and Mild cigars.
17 U.S. Senators (Democrats) send letter to FDA demanding additional regulations on flavoring and marketing.
Coalition (R Street Institute, Americans for Tax Reform, Campaign for Liberty, Competitive Enterprise Institute, Council for Citizens Against Government Waste, FreedomWorks, Heartland Institute, Jeffersonian Project, Less Government, Log Cabin Republicans, National Taxpayers Union, and Taxpayers Protection Alliance) sends letter to Committee on Energy and Commerce requesting that Congress pass HR 2058 to change the predicate date for newly deemed tobacco products (which would include e-cigarettes).
Sen. Ron Johnson (R-WI), chairman of the Senate Homeland Security and Governmental Affairs Committee, sent a letter to FDA raising concerns about the agency’s recent e-cigarette regulation, which could create undue burdens on small businesses and possibly lead to negative unintended health consequences.
European Court of Justice upholds Article 20 of the Tobacco Products Directive (TPD), dismissing several lawsuits, including one by Totally Wicked (Pillbox 38) which claimed Article 20 was a disproportionate impediment to the free movement of goods and the free provision of services, placed electronic cigarettes at an unjustified competitive disadvantage to tobacco products, failed to comply with the general EU principle of equality, and breached the fundamental rights of electronic cigarette manufacturers.
Sen. Ron Johnson (R-WI), chairman of the Senate Homeland Security and Governmental Affairs Committee, sent a second letter to FDA raising concerns about new e-cigarette regulations, a follow-up to his previous letter to FDA Commissioner Robert M. Califf on May 17, 2016.
Global Premium Cigars files complaint in federal court (Southern District of FL, Miami Division) challenging the deeming regulations.
Right to be Smoke-Free Coalition (RSF) files lawsuit in federal court (DC District) challenging the deeming regulations, and court orders it consolidated with the Nicopure Labs lawsuit.
Pennsylvania enacts a 40% wholesale tax on “other tobacco products” (smokeless tobacco, roll-your-own tobacco, pipe tobacco, and e-cigarettes). The tax, effective October 1, 2016, is on not on e-liquid, but also devices, batteries, and most accessories. It also includes a crippling 40% floor tax on all inventory assessed October 1, 2016 and payable 90 days later. (You can see the Pennsylvania Department of Revenue’s guidance here.) Pennsylvania is also assessing the tax on consumers who purchase products out of state. More information about the devastating impact of the tax can be found here.
CEI and CASAA file a brief in lawsuit challenging DOT’s authority to redefine “smoking” to ban e-cigarette use on planes.
FDA issues first warning letters for sales to minors of newly deemed tobacco products (e-cigarettes/e-liquids and cigars).
NJOY files for Chapter 11 bankruptcy. In his declaration to the court, interim President Jeffrey Weiss blames the company’s troubles in part on (1) failure of King 2.0 brand , (2) increased relaunch expense and research and development costs, (3) governmental regulation and increased legal expense associated with FDA regulation and state restrictions, (4) expenses related to intellectual property litigation and prosecution (primarily involving lawsuit with Fontem Ventures BV), (5) limited liquidity and capital resources.
Anti-vaping groups send letter to Senators Thad Cochran, Jerry Moran, Barbara Mikulski, and Jeff Merkley asking that they deny attempts to allow policy riders that would modernize the predicate date for newly deemed products or exempt cigars.
Right to Vape Tour launched as a joint effort by CASAA, SFATA, and AVA. The Right to Vape coalition is urging Congress to change the “predicate date” of the Tobacco Control Act from February 15th of 2007 to August 8th of 2016, a recognition that a new industry selling products that are at least 95% less harmful than combustible cigarettes should not be treated more harshly than cigarettes ever were. Without a change in the predicate date, an estimated 99% of the vapor products currently on the market will be eliminated, thousands of businesses will close, and millions of consumers will lose access to these low-risk products.
UK Centre for Tobacco & Alcohol Studies issues response to WHO’s report on electronic nicotine delivery systems and electronic non-nicotine delivery systems. (Response can be downloaded here.)
Tom Miller, Iowa Attorney General and Chairman of the Board of Directors of Truth Initiative, spoke about the promise vapor products hold for millions of smokers and of the importance of regulating based on comparative risk. Text of his powerful remarks at the FDLI tobacco conference can be found here.
Tobacco Harm Reduction Expert Group (Konstantinos E. Farsalinos M.D.; Professor Riccardo Polosa; Christopher Russell Ph.D.; Amir Ullah Khan Ph.D.; Julian Morris; and Prof. Rajesh N. Sharan) issues its mission statement. Among other things, the group notes its support of government policies that seek to remove barriers to the availability of better, safer, non-combustible nicotine delivery products, with appropriate quality standards and regulations, and the group urges the World Health Organization (WHO) to apply harm reduction strategies in connection with its tobacco control efforts.