Proposed FDA regulations for e-cigarettes just a start

April 25th, 2014
World Lung Foundation today welcomed the U.S. Food and Drug Administration's (FDA) proposed regulations to the e-cigarette industry, which include sales restrictions and labeling requirements of products that deliver vaporized nicotine, although the regulations fall short of what World Lung Foundation had hoped to see. The multibillion dollar e-cigarette industry has been expanding rapidly without oversight and amidst growing concerns about the health and safety of the products. The regulations, which require products to be registered with the FDA, ban sales to minors, restrict vending machine sales, eliminate provision of free samples, and introduce warning labels and content disclosures, are important but represent only a first step in protecting the public's health.

Dr. Neil Schluger, Chief Scientific Officer, World Lung Foundation, commented: "The FDA has finally taken a few steps to reign in an industry that is creating a generation of nicotine addicts. It has been alarming to see the massive uptake of e-cigarettes, particularly among non-smokers and youth.

"We particularly welcome restrictions on sales to minors and clear labeling of product contents. At minimum, kids should not be inhaling addictive chemicals and adults should know which and how much addictive chemicals they are inhaling. Guidelines must be developed to ensure this information is delivered clearly and effectively.

"It is a mistake for the FDA to stop here, though. It should introduce restrictions on e-cigarette advertising, especially to minors, ban Internet sales and also restrict the use of flavorings that are attractive to children. In addition, child-safe packaging and guidelines for safe use should also be implemented in light of alarming reports of ingested liquid poisoning and product malfunctions.

"We don't know whether long term e-cigarette use will harm consumers, but a recent study indicated that e-cigarette vapor causes changes at the cellular level in a similar way as traditional cigarettes. That there may be hidden harms in e-cigarette vapor combined with what we do know about nicotine are reasons enough to regulate a market of highly addictive products.

"Until now, e-cigarette companies have happily lived in a gray area where they can market and sell their products as safe alternatives to tobacco without proving they are actually safe. Bringing the industry out of the shadows is not, however the same as bringing it into the light. The FDA should assert its authority to ensure public health is protected before business interests."

Risks associated with nicotine and e-cigarettes
Researchers find that many e-cigarettes contain toxins, contaminants and carcinogens that conflict with the industry's portrayal of its products as purer, healthier alternatives. They also find considerable variations in the amount of nicotine delivered by different brands. None of this information is made available to consumers so they really don't know what they are ingesting, or how much.

Nicotine – a highly addictive drug - can have powerful negative effects on the cardiovascular system, including causing high blood pressure and abnormal heart rhythms. In women, nicotine reduces estrogen levels and has been linked to early menopause. Prenatal exposure has been linked in epidemiological studies to obesity, diabetes, high cholesterol and high blood pressure in children. To date, there has been little research on the emission of fine and ultrafine inhalable liquid particles, nicotine and cancer-causing substances into indoor air, so we cannot exclude the risk of adverse health effects generated by second-hand exposure to e-cigarettes.

A CDC study showed that e-cigarette experimentation and recent use doubled among US middle and high school students during 2011–2012, resulting in an estimated 1.78 million students having ever used e-cigarettes as of 2012. Public health experts are concerned that slick product design and fruity flavors is driving the uptake of e-cigarettes and related devices among young people and non-smokers. The increase in young vapers is particularly concerning; in addition to the above health risks, there is higher potential for negative impact of nicotine on adolescent brain development, as well as the risk for life-long nicotine addiction.

Evidence of e-cigarettes as a smoking cessation aid is contradictory at best. A study in the American Journal of Public Health showed that those who incorporated e-cigarettes into a quit-smoking attempt were less likely to succeed after six months. In fact, unrestricted e-cigarettes on the market may end up preventing persons from seeking proven methods of quitting – including cold turkey. Public health experts also are concerned that e-cigarettes will undo decades of progress in public health by re-normalizing smoking in public and act as a gateway to cigarette use among youth.

About World Lung Foundation

World Lung Foundation (WLF) was established in response to the global epidemic of lung disease, which kills 10 million people each year. The organization also works on maternal and infant mortality reduction initiatives. WLF improves global health by improving local health capacity, by supporting operational research, by developing public policy and by delivering public education. The organization's areas of emphasis are tobacco control, maternal and infant mortality prevention, tuberculosis, asthma and child lung health. For more information, please visit worldlungfoundation.org.

For more information, please contact Jorge Alday, World Lung Foundation, at +1.212. 639.0070 or jalday@worldlungfoundation.org.


More information:
Jorge Alday
World Lung Foundation
61 Broadway, Suite 2800
New York, New York 10006
USA
Tel: 212-542-8870
worldlungfoundation.org
jalday@worldlungfoundation.org


Provided by World Lung Foundation

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