Find Information About:

Drugs & Supplements

Get information and reviews on prescription drugs, over-the-counter medications, vitamins, and supplements. Search by name or medical condition.

Pill Identifier

Pill Identifier

Having trouble identifying your pills?

Enter the shape, color, or imprint of your prescription or OTC drug. Our pill identification tool will display pictures that you can compare to your pill.

Get Started
My Medicine

My Medicine

Save your medicine, check interactions, sign up for FDA alerts, create family profiles and more.

Get Started

WebMD Health Experts and Community

Talk to health experts and other people like you in WebMD's Communities. It's a safe forum where you can create or participate in support groups and discussions about health topics that interest you.

  • Second Opinion

    Second Opinion

    Read expert perspectives on popular health topics.

  • Community


    Connect with people like you, and get expert guidance on living a healthy life.

Got a health question? Get answers provided by leading organizations, doctors, and experts.

Get Answers

Sign up to receive WebMD's award-winning content delivered to your inbox.

Sign Up

Smoking Cessation Health Center

Font Size

FDA to Regulate E-Cigarettes Just Like Tobacco

Agency Will Not Regulate E-Cigarettes Under the Stricter Rules That Apply to Medical Products
WebMD Health News
Reviewed by Laura J. Martin, MD

April 27, 2011 -- The FDA has decided to oversee electronic cigarettes the same way it does tobacco products. The agency will not regulate the vapor-producing devices under the stricter federal rules that apply to medical products.

The FDA says it decided not to appeal a federal appeals court ruling asserting that e-cigarettes could be regulated as tobacco products and “are not drugs or devices” unless specifically marketed for therapeutic purposes, such as purporting to help people quit smoking.

The decision not to appeal was announced in a letter to the public and stakeholders from Lawrence R. Deyton, MD, MSPH, director of the FDA's Center for Tobacco Products, and Janet Woodcock, MD, director of the agency’s Drug Evaluation and Research.

E-cigarettes are marketed as cigarette substitutes but with claims to be safer than tobacco cigarettes.

The electronic devices are powered by a battery, and a liquid nicotine mixture derived from tobacco is converted into a vapor that can be inhaled by a user.

Courts Step Into E-Cigarette Controversy

The FDA had previously wanted to regulate e-cigarettes as drug-delivery devices such as nicotine gum and patches.

But the U.S. Court of Appeals for the D.C. Circuit decided in December 2010 that e-cigarettes are not medical devices and therefore must be regulated as tobacco, since the devices vaporize liquid nicotine.

Deyton and Woodcock, in a letter posted to the FDA’s web site, said the agency will take steps to ensure that appropriate regulatory mechanisms govern all “tobacco products” and all other products made or derived from tobacco.

“We look forward to working with all stakeholders to ensure that the existing authorities granted the agency are harnessed to best protect and promote the public health,” their letter said.

The federal court suit was brought by Sottera Inc., based in Scottsdale, Ariz., which does business as Njoy. It claimed its device, because it generates a nicotine vapor and not smoke, is a tobacco product, and not a drug.

The FDA’s acceptance of the appeals court ruling means the manufacturers of e-cigarettes will not be required to conduct animal or human studies, which the government requires for drugs and medical devices.

Today on WebMD

hands breaking a cigarette
Is quitting cold turkey an effective method?
14 tips to get you through the first hard days.
smoking man
Surprising impacts of tobacco on the body.
cigarette smoke
What happens when you kick the habit?

Filtered cigarettes
an array of e cigarettes
human heart
Woman experiencing withdrawal symptoms

man smoking cigarette
no smoking sign
Woman ashing cigarette in ashtray
chain watch