Electronic cigarette manufacturers summarize the unique toxic characteristics of electronic cigarettes, regulations on electronic cigarettes

E-cigarette manufacturers and officials are still inconclusive as to whether e-cigarettes are as effective as nicotine replacement therapy or more effective in helping smoking cessation. To date, the U.S. Food and Drug Administration (FDA) has not approved e-cigarettes as a smoking cessation aid.

Although e-cigarettes may not expose users to all the toxicants from tobacco combustion, the health risks associated with e-cigarette aerosol exposure have not been well characterized. This means that the harms reduced by smokers switching to e-cigarettes should be weighed against the potential risks faced by non-smokers who find e-cigarettes more appealing than cigarettes and that they are safer than cigarettes.

Some countries, including Brazil, India and Uruguay, have banned the sale of all e-cigarettes or products that contain nicotine. 102,103,104 The European Union has set a regulatory limit of 20mg/mL for nicotine in e-liquids to prevent e-cigarettes from releasing more nicotine than standard cigarette doses. 105

In the United States, e-cigarettes and others known as electronic nicotine delivery systems (ENDS) fall under the Tobacco Control Act. The FDA made this decision in the "Determination Rule" that took effect on August 8, 2016 (meaning that ENDS are deemed to be bound by the Act). 106 All brands of e-cigarettes on the market at the time had to be approved by the FDA prior to being marketed; however, no manufacturer complied with this requirement. In other words, all ENDS products sold at the time should be considered illegal sales. 107 (As of this writing, there are still no ENDS products on the market that have actually been approved by the FDA.)

Initially, the FDA issued a warning letter to the manufacturer, but no further action was taken. That changed as youth vaping rates began to soar. In January 2020, the FDA announced the start of enforcement of the Act. 107 Since none of the e-liquids on the market were compliant, the company was given a month to take the product off the shelves. If manufacturers wish to resume sales, they must submit a premarket tobacco product application to the FDA by May 12, 2020. 106 These applications must provide "scientific data that can demonstrate the suitability of the product to protect public health."

E-cigarette manufacturers responded that regulatory action on e-cigarettes is complex and requires a balance between protecting non-smokers from harm and reducing harm to existing smokers. "Smokers who completely [switch to e-cigarettes] are exposed to lower levels of [certain] carcinogens and other toxicants," 90,109 Gideon St. Helen, assistant professor of medicine at UCSF. "This reduces the risk of some tobacco-related diseases and may have public health benefits."

Other experts agree with this consideration, although the net impact of e-cigarettes on public health depends on demographics and future population growth in the long term. 4 For example, risk reduction in adolescents may be prioritized when birth rates are growing, which may be different than when the proportion of older adults who smoke lifetimes is growing.

The picture shows an e-cigarette store with a "Healthier Life" logo written on it

E-cigarettes have long been touted as a healthy alternative to smoking. E-cigarette users do avoid many of the toxic exposures associated with smoking. However, e-cigarettes themselves also have potentially harmful exposures. Image: ©PhilipBrookes/AlamyStockPhoto.

Other possible policies, such as allowing only smokers who wish to quit smoking to buy e-cigarettes by prescription, have also been criticized. "Some people believe that the prescription-based market is unfair to smokers because it creates barriers to access to safer products," said Joanna Cohen, a professor of disease prevention at Johns Hopkins University, whose academic field is Tobacco control from a global perspective. "The best example of a comprehensive smoking cessation system is the UK, where public health experts have long argued that smoking is bad for health and that anything better than smoking should be readily available."

For St. Helen, this is a sound argument. "We already know that in the U.S., minorities and disadvantaged groups have more difficulty accessing nicotine replacement therapy," he said. "We don't want the same problem with e-cigarettes. But it would be a good thing to somehow make e-cigarettes only available to adults who smoke."

Talhout and Jaspers called for policy guidance to test the inhalation toxicity of flavouring chemicals and solvents. Eissenberg suggested combining the EU's nicotine cap with a mathematical model of nicotine flux he co-developed. 110,111 "As it is very difficult to address the multiple design components in e-cigarettes, regulation should focus on the end result," he said. Eissenberg's team showed that the model's predicted nicotine flux (the rate at which nicotine is released from e-cigarettes) is highly correlated with actual measurements, mainly depending on e-cigarette power and e-liquid nicotine content.

The nicotine flux policy will ensure that users cannot circumvent the nicotine cap in the e-liquid of high-powered e-cigarettes. It will be suitable for formulations containing nicotine salts or free-base nicotine (also known as free-radical nicotine). But it only works with "closed system" vapes, whose components cannot be replaced or refilled, Eissenberg said. Regulation of open-system e-cigarettes in the U.S. market is more challenging at the moment, he added.

Some other emergency action items are not limited to regulations. "We need to help kids who have been addicted to nicotine since vaping," said Jaspers of the vaping company. "This will require scientists, parents and medical professionals to come together to develop new tools to free them from this dangerous habit. Teachers will help educate about the potential harms of vaping."