E-cigarettes to be regulated by the U.S. Food and Drug Administration

The U.S. Food and Drug Administration (FDA) has issued a proposed rule to begin regulating electronic cigarettes. E-cigarettes are battery-operated products designed to deliver nicotine, flavor and other chemicals. There are currently more than 250 brands on the market and the industry is valued at $2.5 billion. They turn chemicals, including highly addictive nicotine, into an aerosol that is inhaled by the user. The FDA has stated that e-cigarettes have not been thoroughly studied and we currently do not know their potential risks, including how much nicotine and harmful chemicals are being inhaled during use. However, the FDA did discover that e-cigarette samples contained carcinogens and toxic chemicals such as diethylene glycol, which is an ingredient used in antifreeze.

There have been a limited number of studies that have begun to explore the potential hazards of e-cigarettes. One study reported that nicotine-laced vapor generated by these devices promoted the development of cancer in certain types of human cells much in the same way that tobacco smoke does. There has been evidence that the use of e-cigarettes can lead to heavy use of conventional cigarettes as well as a decreased likelihood of quitting.

Additionally, the Centers for Disease Control and Prevention (CDC) found that the use of e-cigarettes has more than doubled for middle and high school students. According to the Surgeon General, adolescents are particularly vulnerable to the adverse effects of nicotine and adolescent exposure may have lasting adverse consequences for brain development. A new study, which appeared in the medical journal JAMA Pediatrics, notes that the “use of e-cigarettes does not discourage, and may encourage, conventional cigarette use among U.S. adolescents.”

The FDA is using its authority under the Family Smoking Prevention and Tobacco Control Act of 2009, which allows regulation over cigarettes, smokeless tobacco and roll-your-own tobacco, as well as the ability to extend its jurisdiction to all other tobacco products.

Under this proposed rule, makers of newly deemed tobacco products would, among other requirements:

• Register with the FDA and report product and ingredient listings;
• Only market new tobacco products after FDA review;
• Only make direct and implied claims of reduced risk if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit the public health as a whole; and
• Not distribute free samples.

In addition the following provisions would apply to newly “deemed” tobacco products:

• Minimum age and identification restrictions to prevent sales to underage youth;
• Requirements to include health warnings; and
• Prohibition of vending machine sales, unless in a facility that never admits youth.

The Prevent Cancer Foundation strongly urges the FDA to move forward in strictly regulating e-cigarettes. We are concerned about the health hazards and safety of these products, the potential to increase nicotine addiction in users, and the danger presented to minors who take up this habit. We also question claims that these e-cigarettes can help current traditional cigarette smokers quit.