In March 2008 the vape industry saw its first glimpse of regulation and restrictions. These restrictions started with the ban of all vape products in Turkey after their directory of Ministry Drugs and Pharmacy, Mahmut Tokac, claimed (without evidence) that electronic cigarettes were just as harmful as regular cigarettes, falsely stating that “nicotine is the most dangerous element among the 4,800 poisonous chemicals in cigarettes”. In September 2008 the World Health Organization (WHO) also declared they do not recognize electronic cigarettes as a legitimate cessation aid, demanding that all markets immediately remove any claims of electronic cigarettes as safe or an effective smoking cessation aid.
That same year a study funded by Ruyan Health New Zealand, found quantifiable proof that toxins and carcinogens from vaping present below harmful levels. Their research concluded that vaping is 100 to 1000 times less dangerous than smoking traditional cigarettes, deeming vaping a “safe alternative to smoking”.
2009 was a tough year for the global vaping market. In the first quarter of 2009 alone vaping was banned in several countries including Australia, Jordan, Canada, and Hong Kong. It is worth noting that since 2009 Health Canada classified any e-juice or e-liquid containing nicotine as illegal. While this has been in effect for over a decade, generally speaking vape products are unregulated and widely available in Canada.
In June 2009, President Obama signed into law the Family Smoking Prevention and Tobacco Control Act, enabling the FDA to regulate the tobacco industry. This act also requires that all new tobacco products seeking to enter the market meet FDA premarket standards. During this time the FDA also classifies e-cigarettes as both a drug and device -not a tobacco product.
Later that summer, in July 2009, the FDA issued a press release reinforcing previous claims that vapes are being marketed to people under 18, lacked proper health and safety warnings, and that vapes contain carcinogens and ingredients used in antifreeze (diethylene glycol). What that report failed to mention is that those carcinogens were all at nearly untraceable levels (less than 1%) and only one of the samples they tested contained a trace amount of diethylene glycol. In the 12 years following this FDA report here have been zero cases of diethylene glycol poisoning from vaping and the FDA report from 2009 has since received scrutiny from the scientific community.
“The Food and Drug Administration (FDA) held a press conference...to scare Americans about the so-called “e-cigarette” — claiming it was loaded with harmful “toxins” and “carcinogens.” The agency was implicitly saying: Stay away from these newfangled, untested cigarette substitutes — better to stick with the real ones, the ones that we are more familiar with, the ones that cause over 450,000 deaths annually in the U.S.”
-Dr Elizabeth Whelan, The Washington Times
That same summer, a number of new regulations around the globe and in the US popped up. Brazil and Saudi Arabia both banned e-cigarettes outright, Suffolk County New York banned indoor vaping (the first ban of its kind), Oregon imposes new requirements for vape companies selling products in state, and California passed a bill to ban the sale of all electronic cigarettes and vapor products in state. However, Gov. Arnold Schwarzenegger vetoed that California ban stating that adults should be able to make their own decisions about purchasing and consuming vapor products.
“If adults want to purchase and consume these products with an understanding of the associated health risks, they should be able to do so.”
-Gov. Arnold Schwarzenegger
The month of October 2009 saw the ban of vape products on a retailer level with Amazon.com stating that they are “unable to verify the age of customers purchasing products”. Although years later Amazon did roll out their own system for verifying ages of customers purchasing alcohol, Amazon has not reversed its 2009 decision to ban vapes. That same month Paypal also freezes the accounts of electronic cigarette vendors in the US, banning all US vendors from using the service
All is not lost though! October 2009 did bring some good news to the vape industry as UK ASH (Action on Smoking and Health) released a briefing on electronic cigarettes, reiterating their harm-reduction stance.
“ASH supports a harm reduction approach to tobacco, that is, we recognise that whilst efforts to help people stop smoking should remain a priority, many people either do not wish to stop smoking or find it very hard to do so... We believe that products should be made available that deliver nicotine in a safe way, without the harmful components found in tobacco. Most of the diseases associated with smoking are caused by inhaling smoke which contains thousands of toxic chemicals. By contrast, nicotine is relatively safe. Therefore, e-cigarettes, which deliver nicotine without the harmful toxins found in tobacco smoke, are likely to be a safer alternative to smoking.”
-UK ASH statement
On January 14th, 2010, District of Columbia Judge Richard J. Leon granted an injunction blocking the FDA from seizing e-cigarettes as a drug or drug delivery system. A 32-page memorandum opinion is released regarding the ruling. This ruling is supported with a petition from American Association of Public Health Physicians asking for the FDA to reclassify e-cigarettes as a tobacco product. Even though the FDA filed appeals, it won’t be until April 2011 when the FDA reclassifies electronic cigarettes as “tobacco products”.
Only two countries banned electronic cigarettes in 2010, both due to unsubstantiated claims. Thailand bans the use of electronic cigarettes due to higher nicotine levels than traditional cigarettes and Singapore labels them as a non-recognized cessation product and prohibits the importation and sale of electronic cigarettes. While Thailand has since reversed their ban on vapor products, as of 2021, possession or use of electronic cigarettes and vapor products are still banned in Singapore, punishable with fines and even jail time.
In February 2011, the American Journal of Preventive Medicine reported that electronic cigarettes show promise in helping smokers quit traditional cigarettes. This study tracked smokers who abstained from traditional cigarettes using e-cigs over a course of 6 months. The data revealed that 66% of participants reduced their cigarette intake with 48.8% of participants refraining from smoking the entire six months. The same study found that participants who abstained from smoking for six months without the aid of e-cigarettes were at less than 35%.
A similar study took place also in 2011 with similar findings. This research results in the British Cabinet Office Behavioral Insights Team endorsing e-cigarettes as an effective substitute for smoking and recognizes them as harm reduction. This is compounded with results from a clinical trial by PMC Public Health, suggesting e-cigarettes may be more effective than traditional smoking cessation/ nicotine replacement therapies (NRTs).
Even with compiled data and research bolstered by the scientific community, the FDA still pushed forward with vaping regulation attempts. Countries and territories that banned the importation, sale, and distribution of electronic cigarettes in 2011 include Argentina, Holland, and the German State of North Rhine-Westphalia.
2012 and 2013 were relatively peaceful years for the industry with no major bans, regulations, or restrictions happening in most of the world (with the exception of Venezuela which sets out new fines and penalties for distributing electronic cigarettes in the country). Several new organizations are created around the world to unite vapers as well as provide public clarification and insight on the health benefits of using electronic cigarettes as a means of harm reduction. These groups include American E-liquid Manufacturing Standards Association (AEMSA), Vape-A-Vet, and Smoke-Free Alternatives Trade Associate (SFATA).
PMTAs
In April, 2014, the FDA released a proposal of regulations in an attempt to impose regulatory authority on e-cigarettes as tobacco products. Regulations required disclosure of ingredients used in e-liquids, proof of safety with said ingredients, ban all sales to minors under the age of 18, as well as regulation of the devices used for vaping. Over the next year the FDA will hold several public forums on electronic-cigarettes, ultimately leading up to the May 2016 FDA final deeming regulations which would take effect on August, 8th 2016.
As of August 8th, 2016, vendors and manufacturers with products currently on the market would have two years to prepare Pre market Tobacco Applications (PMTAs) with the FDA in order for their product to remain on the market. This would mean that after 8/8/2016, no new vapor products would be allowed on the market (including new devices, flavors, nic strength variations, etc). Under the new deeming rule the following regulatory provisions were applied immediately:
-Minimum age ID requirement (18 and older)
-Required warning labels on products
-Prohibited vending machine sales in non-18 and up establishments.
All new tobacco products released after the August 8th, 2016 deadline are now required to obtain authorization from the FDA before they can legally be on the market.
FLAVOR BANS AND EVALI
Even with the plethora of new rules and regulations imposed by the FDA, lawmakers and politicians in individual states and territories still actively pursued their own set of rules and regulations. This is in spite of numerous scientific studies and reviews published noting the major health benefits of vaping as means of harm reduction. The majority of these new attacks are specifically in response to the growth of Juul Labs and its youth aimed marketing tactics.
In May, 2019, North Carolina sued Juul for marketing its products to minors. Juul at the time was advertising heavily on instagram and other social media, hiring young influencers to emphasis themes of freedom, relaxation, and sex appeal. In June, 2019, San Francisco -the home of Juul headquarters, banned vaping, becoming the first city in the U.S. to ban the sale of all vaping products.
In the Summer of 2019 the vaping industry would see the biggest draw of negative attention and hysteria to date. A mysterious illness began popping up around the United States with flu / pneumonia-like symptoms. This acute respiratory illness was referred to as E-cigarette or Vaping Associated Lung Injury. Thankfully, research shows the cause of this mysterious illness was due to an ingredient, Vitamin E Acetate, being used in black-market, illegal THC concentrates and not nicotine e-cigs.
Vitamin E Acetate is a flavorless oil used as a thickening agent to “stretch” THC and CBD extracts. While not harmful when swallowed, Vitamin E Acetate is very dangerous when vaped. Unfortunately, due to the rather large target on our industry’s back, politicians, lawmakers, and news stations played up this vaping hysteria, falsely claiming it was impacting ALL vaping products and not just counterfeit THC vape oils.
The mass hysteria created by these false equivalencies was further compounded by criticism of Juuls approach towards marketing to youth. Governors in Michigan, New York, Washington, Utah, California, Massachusetts, Rhode Island, Montana, and Oregon capitalized off this hysteria in order to push through draconian “emergency bans” and new taxes on vape products.
During this time, Washington State rolled out its own version of a floor tax that impacted both manufactures and retailers. Both businesses would need to report and pay a $0.09 tax per ml of e-liquid of their current inventory. Because of this tax in Washington, Baton Headquarters relocated to Las Vegas, late 2019.
On September 11th, 2019, the Trump administration announced the intention to ban flavors of vaping products on a national level. This proposal is met with an abundance of objection and is delayed and postponed for months. Eventually in early 2020 the Trump administration finally released a modified version of its original ban which only focuses on banning pre-filled flavored pods and cartridges.
While the ban on pre-filled pods and cartridges is still in effect today, the majority of the “emergency bans” states enacted were eventually overthrown or expired. As of March 2021, the only three states with bans on vape products are: New York, New Jersey, and Massachusetts.
MASTER SETTLEMENT AGREEMENT
In order to understand why electronic cigarettes and vaporizers are under such strict scrutiny and regulations it is important to first understand the symbiotic relationship between individual States and Big Tobacco Companies.
In November 1998, the “Master Settlement Agreement” was made between 46 state Attorneys Generals and the 4 largest US Based tobacco companies (RJ Reynolds, Brown & WIlliamson, Philip Morison, and Lorillard). In this agreement the 46 AGs leverage Medicaid lawsuits against the tobacco industry in exchange for big tobacco companies to cease certain tobacco marketing practices, fund new anti-smoking advocacy groups (the Truth Initiative), as well as pay states directly, in perpetuity, annual payments to compensate for potential medical costs of caring for person with smoking-related illnesses. In other words, the more people who smoke traditional cigarettes in a state the more money that state will receive from big tobacco companies.
Over 25 years states received over $206 billion due to the Master Settlement Agreement. A noted controversy regarding the MSA came in 2018 when it was uncovered that states were only utilizing less than 3% of MSA money for preventing youth smoking and helping people quit. While the money states receive is designated for anti-smoking campaigns, there are no provisions that require states to allocate settlement revenues into tobacco prevention and cessation. As a result, states have allocated MSA funds for budget remedies, golf courses, and even direct payments to tobacco farmers.
Due to the amount of money each state receives directly from the MSA, it is no coincidence that the states that received the most in MSA money are also the most strict against vaping. For example, New York State saw a dramatic decline in MSA money from 2016 ($1.5 billion) to 2017 ($618 million). That following year, in 2018, NY State Gov Andrew Cuomo actively pursued a full-state ban on flavored vape products which was rolled out in 2019 and is still in effect today.
As you can see, the electronic cigarette industry has fought many battles and will continue to face battles as we further establish ourselves as an industry. Big Tobacco and Government agencies are actively working together to limit our industry’s growth as a means to increase the number of cigarette smokers and thus increase the amount of Master Settlement Agreement funds received annually.