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What’s the current FDA status of e-Cigs in the US?

The FDA does not currently have answers as to:

  • whether e-cigarettes are safe for their intended use,
  • how much nicotine or other potentially harmful chemicals are being inhaled during use, or
  • if there are any benefits associated with using these products.

Additionally, it is not known if e-cigarettes may lead young people to try other tobacco products, including conventional cigarettes, which are known to cause disease and lead to premature death.

Report Adverse Events

Please report adverse events with e-cigarettes by:

  • filling out the online form or
  • calling 1-800-FDA-1088.
FDA Regulation of e-Cigarettes

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

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

FDA has stated its intent to issue a proposed rule that would extend FDA’s tobacco product authorities to products that meet the statutory definition of “tobacco product.” For further details, please see the Unified Agenda entry describing this rulemaking:  http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201210&RIN=0910-AG38.

Warning Letters Sent to Electronic Cigarette Distributors

In September 2010, FDA issued a number of warning letters to electronic cigarette distributors for various violations of the Federal Food, Drug, and Cosmetic Act including “violations of good manufacturing practices, making unsubstantiated drug claims, and using the devices as delivery mechanisms for active pharmaceutical ingredients.”

More Information FDA’s Authority to Regulate e-Cigarettes
More Information on Safely Quitting Tobacco

Take a look at these recent articles that document the FDA’s stance on e-Cigs and Vapes:

 

E-cig sellers jockey for market position before FDA issues regulations by CNBC

Makers of electronic cigarettes are enjoying a booming marketplace even as they keep wary eye on the Food and Drug Administration, which is expected to release proposed regulations of the nicotine-vapor-peddling category this fall.

The lack of federal regulations on e-cigarettes—in contrast to tight rules on traditional smokes—has given companies a long leash. Sales of the products are projected to double to $1 billion, with about 250 different brands, all without nationwide restrictions on advertising, Internet sales, flavorings or even the age of buyers.

But those days are numbered.

Vivien Azer, a Citigroup tobacco analyst, said the lack of federal regulations has given e-cig companies “some breathing room” to grow. ”You think about the competition landscape,” she said. “Part of that is trying to get as much done as possible before regulation.”…

Read the full article here on CNBC.com

FDA faces dilemmas in regulating e-cigarettes by Clinical Advisor

The FDA faces a dilemma as electronic cigarettes, or e-cigarettes, grow in popularity, according to researchers.

The agency initially tried to block the sale of e-cigarettes, claiming that they were unapproved “drug/device combinations.” Manufacturers successfully challenged the FDA’s position, but in a 2010 ruling, a federal appeals court held that e-cigarettes could be regulated by the agency as tobacco products.

In 2010, 11.4% of U.S. smokers report ever using an e-cigarette, and 4.1% report using one within the last 30 days, the most recent data from two surveys that involved more than 6,000 people indicate. In the city of Boston, 28 permits to sell e-cigarettes were given out in June 2013, compared with only three in June 2012…

Read the full article here on ClinicalAdvisor.com

FDA: Second-hand smoke from e-cigarettes may be harmful to your health by GMA Network

E-cigarettes, the seemingly innocent alternative to the real thing, may not be that harmless after all, the Food and Drug Administration said as it issued an advisory identifying the “volatile” substances in the device and its emitted smoke.
“Electronic cigarettes are not emission-free.  E-cigarettes contain volatile organic substances, including propylene glycol, flavors and nicotine, and are emitted as mist or aerosol into indoor air,” it said in FDA Advisory No. 2013-015 dated June 26, which was posted on the FDA website Thursday night.
“If several people are using e-cigarettes in a room at the same time, considerable indoor air pollution will accumulate and may result to harmful second-hand exposure,” it added…

Read full article here on GMA Network.com

FDA warns on dangers of e-cigarettes by Inquirer News

MANILA, Philippines—The Food and Drug Administration on Thursday warned the public against using electronic cigarettes (e-cigarettes), saying their smoke contained substances that might be harmful to one’s health.

In a statement, the FDA said that e-cigarettes were not emission-free and that they contained “volatile organic substances,” like propylene glycol, and “carcinogenic” metals like nickel and chromium.

“The public, especially the youth sector, is advised not to start smoking at all and to stop using cigarettes, cigars, or e-cigarettes,” the FDA said.

“These ultra-fine liquid particles of less than 2.5 micrometer in diameter may penetrate deeply into the lungs … second-hand exposure to e-cigarette emission, which may lead to adverse health effects, cannot be excluded,” it added.

Read full article here on Inquirer News.com

Americans Strongly Back FDA Authority over Tobacco, Want FDA to Regulate E-Cigarettes by Tobacco Free Kids

WASHINGTON, DC – Four years after passage of a landmark law giving the U.S. Food and Drug Administration (FDA) the power to regulate tobacco products, American voters strongly support the law and want the FDA to extend its authority to all tobacco products, including cigars and electronic cigarettes, according to an online poll conducted by the Mellman Group for the Campaign for Tobacco-Free Kids.  They strongly oppose efforts in Congress to prevent FDA from regulating cigars.

Key findings of the poll include:

  • By a 76 to 14 percent margin, voters back the 2009 law giving the FDA authority over tobacco products, which included restrictions on sales and marketing to children.
  • By a twenty percentage point margin (54-34) voters think the FDA should extend its authority to regulate all tobacco products, including cigars, pipe tobacco, and electronic cigarettes.  After being shown pictures of a number of tobacco products that are currently not subject to FDA regulation, support for regulation of all tobacco products increased to 61 percent, with just 31 percent opposed…

Read full article here on Tobacco Free Kids.org

e-Cig Creations Keeps Active Watch on FDA Regulations of e-Cigs

San Diego e-Cig and Vape Shop, e-Cig Creations has been actively reviewing the latest information regarding the FDA regulation of e-Cigs and Vapes. Being a leading e-Cig and vaporizer store in San Diego, California, it’s in e-Cig Creations’ best interested to stay on top of the subject. Since they have such a large inventory of e-Cigs, Vapes and Flavors, any sudden regulation or ruling on e-Cigarette smoking would cause a substantial impact on their ability to assist their loyal customer base with their smoking needs.

Read full article here on e-CigCreations.com