Only e cigarettes that are marketed for therapeutic purposes are currently regulated by the FDA Center for Drug Evaluation and Research (CDER). Currently, the FDA Center for Tobacco Products (CTP) regulates

• cigarettes,
• cigarette tobacco,
• roll your own tobacco, and
• smokeless tobacco.

FDA has issued a proposed rule that would extend the agency s tobacco authority to cover additional products that meet the legal definition of a tobacco product, such as e cigarettes. FDA s Extending Authorities to Additional Tobacco Products webpage offers more information on the proposed rule, including how to submit comments.

For more information on current regulation

• Tobacco Product Regulation
• Nicotine Containing Products

---

eCigarettes and Adverse Events

What is an Adverse Event?
An adverse event is an undesirable side effect or unexpected health or product quality problem that an individual believes was caused by the use of a tobacco product.

Reporting an Adverse Event
Anyone can report an adverse event to the FDA. In fact, these reports help us identify safety concerns with tobacco products that could cause health or safety problems beyond those normally associated with tobacco product use.

Howstuffworks «how electronic cigarettes work»

You’re at your favorite restaurant, enjoying a meal. A diner at the next table is puffing on a cigarette, letting out a cloud of smoke. Because smoking isn’t allowed in the restaurant, you’re thinking about asking the smoker to put the cigarette out. But before you protest, consider this Your neighbor may not be smoking at all.

Electronic cigarettes, also known as smokeless cigarettes, e cigarettes, or e cigs, are an alternative method of consuming nicotine, the addictive chemical found in tobacco. Manufacturers often design e cigarettes to look like regular cigarettes, but they contain no tobacco and don’t require a match or any flame at all.

An e cigarette is a battery powered device that converts liquid nicotine into a mist, or vapor, that the user inhales. There’s no fire, no ash and no smoky smell. E cigarettes do not contain all of the harmful chemicals associated with smoking tobacco cigarettes, such as carbon dioxide and tar.

Manufacturers and satisfied customers say the e cigarette is a healthier alternative to tobacco cigarettes, which cause millions of deaths every year. Some users say e cigs have helped reduce their «smoker’s cough,» sharpened their senses of taste and smell, and even improved their sleep.

The electronic cigarette was invented by Chinese pharmacist Hon Lik, who patented the device in 2003 and introduced it to the Chinese market the following year. Numerous companies are now selling e cigarettes to customers around the world. But as e cigarette smoking or «vaping» as it’s sometimes called has grown in popularity, some have concerns about its safety, including the possibility that the vapor created by the devices contains dangerous chemicals.

Is the electronic cigarette a cleaner, healthier choice for smokers? Or is it a dangerous device with hidden risks? Both viewpoints have their merits, but on the next page we’ll start with the basics how the product works, and why it’s popular.