The increasingly popular e-cigarettes after strict regulations from the United States Food and Drug Administration (FDA) may stop helping with smoking cessation efforts, according to Jennifer Abbasi. She is a senior staff analyst from the Journal of the American Medical Association (JAMA).
E-cigarettes or electronic nicotine delivery systems are designed to deliver nicotine to their consumers in the form of vapors instead of smoke. The product comes in different flavors and is used in Nicotine replacement therapy (NRT), which entails the use of nicotine without smoking to help people quit smoking.
On May 5, 2016, FDA announced its final rule on all type of tobacco products like cigars, hookahs, e-cigarettes and others. “We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth,” said the US Department of Health and Human Services (HHS) Secretary Sylvia Burwell in the press release.
The rule prohibited the selling of e-cigarettes to individuals under the age of 18 years, both online and in person. Requiring a photo ID before selling such products, selling at vending machines and distribution of tobacco products as free samples was also made illegal. The rule comes into effect on August 8 this year, and will also add additional responsibilities for manufacturers to ensure that e-cigarettes are not making false claims or violating public health standards set forth previously.
‘This raises many questions in the public health community,’ says Abbasi. Will this push out small e–cigarettes manufacturers from the market? Before the new rule, the multibillion dollar industry was flourishing with an estimated worth of 2.5 billion US dollars in 2014. Now all the products would be evaluated by the FDA and new public health protocols would be published. According to Jeff Stier, from the National Center for Public Policy Research, each e-cigarette approval application would cost $1 million or more.
The costly premarket application process that the agency uses for tobacco products could lead to this scenario where only largest players are left standing. The smokers who use e-cigarettes to quit smoking may have fewer choices now. This could result them reverting back to the original source to get their nicotine kick.
This is not lost on the agency’s Center for Tobacco Products (CTP) Director Mitch Zeller, JD, who said in a meeting in May that they were still considering how to implement their new authority over the products while they evaluate the net effect of e-cigarettes on the US population.
The efficacy of e-cigarettes is currently in debate, with people at extreme ends of the prism. The US Preventive Services Task Force (USPSTF) has given their recommendation that the current evidence is not enough to support electronic nicotine delivery systems as a measure to ensure tobacco cessation.
The cousins across the sea disagree. The United Kingdom Tobacco Advisory Group of the Royal College of Physicians recently recommended that the use of e-cigarettes, NRT, and other non tobacco nicotine products should be used as widely as possible to help people quit smoking. Public Health England also supports this recommendation.
Coming to the scientific side of things, Abbasi points out the two randomized clinical trials that were published on the effectiveness of e-cigarettes to help people quit smoking have shown modest results. The research design and method of those trials is however under debate. New research efforts are under way. Currently, CTP is supporting 85 projects that are conducting research on e-cigarettes design, toxicity, addiction, constituents and possible health outcomes.
E-cigarettes have also been under scrutiny due to multiple reports of side effects and dangerous health outcomes they can cause in people using them and their loved ones around them. Just a month ago, a study found that e-cigarette exposure in children can have a 5.2 times higher odds of admission into a medical facility and 2.6 times higher odds of developing severe medical complications.
In June a Morbidity and Mortality Weekly Report (MMWR) found that in US 44.9 percent teenagers have been reported to use the electronic vapor products that include e-cigarettes. Deputy Director for Research Translation from the CDC’s Office on Smoking and Health, Brian King (PHD, MPH) explained that the bottom line is that no teenager should be using any form of tobacco product whether its cigarettes, or e-cigarettes.
A majority of smoking adults prefer to use e-cigarettes to quit compared to a nicotine replacement patch or nicotine replacement gum. According to US household interview survey, nearly 12% of adults have tried e-cigarettes once while less than 4% are current users. The data suggests that the main reason for people to try this product has been to quit smoking or sometimes reduce smoking.