News Feature | January 10, 2014

The FDA Takes Control Of E-Cigarettes

Source: Pharmaceutical Online

By Cyndi Root

The Food and Drug Administration (FDA) is expected to issue rules on electronic cigarettes, also called e-cigarettes or e-cigs. “The FDA intends to propose a regulation,” said Jenny Haliski, press officer for the FDA, “that would extend the agency’s ‘tobacco-product’ authorities.” Currently, the FDA controls tobacco but not tobacco products like e-cigarettes.

E-cigarettes dispense nicotine in vapor form. They look like a cigarette but have a rechargeable heating element and a replaceable nicotine cartridge. An atomizer, when heated, converts the nicotine and other chemicals in the cartridge into a vapor. Proponents of the device say that the vapor is less harmful to the lungs than smoke from a real cigarette.

FDA Actions

In 2010, the FDA evaluated some types of e-cigarettes and found quality issues. Some brands misrepresented the amount of nicotine in each vapor puff. The agency issued letters to five distributors, warning them about substandard manufacturing and unsubstantiated claims. Since then, most states have urged the FDA to do more by regulating e-cigs like they do tobacco. The FDA has enlisted the support of the White House’s Office of Information and Regulatory Affairs and the Office of Management and Budget in reviewing the draft FDA rules.

Widespread Support for Rules

The U.S. Congress is working on creating laws for the booming industry. Congress seeks to regulate sales, impose taxes, and control advertising, especially to minors. State legislatures are also examining their options. Some states have already passed bills controlling sales and advertising to minors. U.S. agencies and legislatures join global efforts in regulating e-cigarettes. The European Union (EU) is also addressing the situation, with 28 governments of the EU considering banning them altogether. The tobacco industry is opposed to bans and restrictions.

Approved Smoking Cessation Aids

People who want to quit smoking have FDA-approved products to choose from. Oral products are nicotine gum and lozenges. People can use nicotine skin patches or nicotine nasal spray. Oral medications indicated for smoking cessation and approved by the FDA include Chantix (varenicline tartrate) and Zyban (buproprion). Neither drug contains nicotine and are available by prescription only. Both drugs carry warning labels citing possible side effects of mood fluctuations, hostility, and suicidal thoughts and actions.