Anti-smoking groups sue FDA for delaying e-cigarette review

Anti-smoking groups sue FDA for delaying e-cigarette review

Even as the Food and Drug Administration (FDA) made a “historic move” recently to reduce nicotine content in cigarettes, it seems not doing enough to regulate and curb the electronic cigarette use. Upset over the deferment of review of e-cigarettes, various anti-smoking groups filed a lawsuit against the agency in the last week of March 2018.

The lawsuit filed in a Maryland federal court alleges that the FDA did not follow the process last year when it decided to delay the deadline for manufacturers of e-cigarettes to submit their products for evaluation. The activists contended that the delay poses a risk to the health of children. The FDA decision effectively means that e-cigarettes will continue in the market without undergoing the necessary regulatory review.

E-cigarettes are vapor emitting devices that were introduced as a means to help smokers quit smoking. In the present times, it has burgeoned into a multibillion-dollar industry in the United States. However, despite its huge popularity, there is no concrete evidence to suggest that these devices actually aid people in kicking the habit of smoking. In fact, they are known to contain nicotine, which is an addictive substance and its exposure to children could lead them to smoking.

E-cigarettes no solution to cigarettes

Tobacco use has been a leading preventable cause of deaths in the U.S. and has proved to be a huge burden on the nation’s economy costing more than $300 billion in health care every year. E-cigarette was introduced to help reduce cigarette addiction without any definitive research on its long-standing effects. Despite the lack of scientific backing, it has managed to grow into a $4-billion industry.

While smoking has been going down over years, the increasing popularity of vaping products has now become a cause of concern. Some manufacturers have specifically tried to target kids by introducing e-cigarettes in various flavors. A report found that there is an alarming jump in the use of e-cigarettes – from 1.5 percent to 11.3 percent within five years – among the high school students. Currently, almost 10 percent of students reportedly use vaping products. Unfortunately, this is not very reassuring because, according to a government-commissioned report, there is “substantial evidence” that youngsters who use e-cigarettes are likelier to try cigarettes eventually.

Review in 2022

A review of the e-cigarettes that hit the market after February 2007 was to be submitted by the manufacturers by August 2018. However, as per FDA Commissioner Scott Gottlieb, the deadline will be delayed until 2022 as more time is needed to prepare the review.

The anti-smoking groups have contended in their lawsuit that the delay on part of FDA is an overreach of their authority under Family Smoking Prevention and Tobacco Control Act. They also emphasized that this delay permits the unimpeded presence of flavored tobacco products in the market, exposing impressionable youngsters “to thousands of tobacco products containing lethal and addictive components that have not met the statutory requirements” for years.

The suit – filed by the American Heart Association, American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Lung Association, Campaign for Tobacco-Free Kids, Truth Initiative and several individual  paediatricians – says the FDA’s decision was in contravention to the rules that required the input of the public and “offered no meaningful justification for ripping a hole in the statutory framework by exempting, for more than half a decade, newly deemed products from premarket review–review FDA previously described as ‘central’ to the regulatory scheme Congress enacted for tobacco products.”

Long-term implications of addiction

According to the Centers for Disease Control and Prevention (CDC), while is still no evidence whether e-cigarette can help one quit smoking, the presence of addictive components like nicotine and other harmful chemicals in are considered unsafe for adolescents, young adults, and pregnant women. As per a study, people smoking e-cigarettes are more likely to try cigarettes, which could develop into an addiction to smoking.

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