FDA warns of health risks posed by e-cigarettes

October 17, 8:25 PMHealth ExaminerAngela Spears

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E-cigarettes are battery operated devices designed to look like cigarettes
Courtesy of FDA

Findings from laboratory analysis conducted by the U.S. Food and Drug Administration's (FDA) division of Pharmaceutical Analysis—part of the agency's Center for Drug Evaluation and Research indicates that electronic cigarettes expose users to carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze. The FDA has joined other health experts to warn consumers about potential health risks associated with electronic cigarettes, also known as "e-cigarettes."

Electronic cigarettes are battery-operated devices designed to look like and to be used in the same manner as conventional cigarettes. Sold online and in many shopping malls, the devices generally contain cartridges filled with nicotine, flavor, and other chemicals. They turn nicotine, which is highly addictive, and other chemicals into a vapor that is inhaled by the user. The FDA is concerned about the safety of these products and how they are marketed to the public.

The FDA has cited that:

• e-cigarettes can increase nicotine addiction among young people and may lead kids to try other tobacco products, including conventional cigarettes, which are known to cause disease and lead to premature death
• the products may contain ingredients that are known to be toxic to humans
• because clinical studies about the safety and efficacy of these products for their intended use have not been submitted to FDA, consumers currently have no way of knowing 1) whether e-cigarettes are safe for their intended use, or 2) about what types or concentrations of potentially harmful chemicals or what dose of nicotine they are inhaling when they use these products.

California Governor Schwarzenegger recently vetoed Senate Bill 400, which would have banned e-cigarette sales in the state. In his veto message Governor Schwarzenegger stated that he supports restricting access of electronic cigarettes to children under the age of 18, but items defined as “tobacco products” are legal for anyone over the age of 18.

Matt Salmon, former Arizona congressman and president of the Electronic Cigarette Association (ECA), praised the Governor's decision to veto Senate Bill 400, which would have banned electronic cigarette sales in the state, preventing adult consumers' access to these alternative smoking devices. "This is not just a victory for consumers and common sense but is smart public policy as well," said Salmon. "Rejecting this bill is the right step and should serve as a model for other states to follow."

The potential health risks posed by the use of e-cigarettes is of particular concern for parents. E-cigarettes are sold without any legal age restrictions, and are available in different flavors (such as chocolate, strawberry and mint) which may appeal to young people. In addition, the devices do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes.

There is no research yet available as to whether e-cigarettes might actually encourage children and teens and young adults to take their first step toward smoking cigarettes, drawn in by the products' novelty and variety of flavors. However, the FDA continues to examine and detain shipments of e-cigarettes at the border and has found that the products it has examined thus far meet the definition of a combination drug device product under the Federal Food, Drug, and Cosmetic Act. The agency has been challenged regarding its jurisdiction over certain e-cigarettes in a case currently pending in federal district court. The FDA is planning additional activities to address its concerns about electronic cigarettes.

ECA states that the FDA’s laboratory analysis of e-cigarettes is too narrow to reach any valid and reliable conclusions and ignores the continued efforts by its member companies to ensure that their products include health warnings and to only market its products as an alternative to long-time, adult smokers. They further state that their member companies have taken a responsible approach by ensuring that those who use their products are well-informed about their products and ensure that their products are not marketed or accessible to children.

A summary of the results: Laboratory Analysis of Electronic Cigarettes conducted by the FDA is available on-line.