Updated April 30, 2011The Food and Drug Administration (FDA) has stated it will regulate smokeless electronic cigarettes, or "e-cigarettes," the same way it regulates tobacco products after a federal court ruled the Agency could not regulate them as a drug.
In September 2010, the FDA announced plans to regulate electronic cigarettes under the stricter rules applied to devices used to deliver drugs - specifically nicotine and other chemicals -- found in regular cigarettes. However, on December 7, 2010, the U.S. Court of Appeals for the D.C. Circuit ruled that unless e-cigarettes were advertised as having therapeutic uses, like smoking cessation, the FDA could not regulated them as they do drugs.
FDA Takes it Well
Rather than appeal the court's ruling, the FDA says it will regulate e-cigarettes as it currently regulates traditional cigarettes and other tobacco products under the Food Drug and Cosmetics Act. However, any e-cigarette products advertising claims of helping the user to stop smoking or providing any other health benefit will be more strictly regulated as a drug or medical device.
"FDA is aware that certain products made or derived from tobacco, such as electronic cigarettes, are not currently subject to pre-market review requirements of the Family Smoking Prevention and Tobacco Control Act," stated the agency in a press release. "FDA is developing a strategy to regulate this emerging class of products as tobacco products under the Family Smoking Prevention and Tobacco Control Act."
The Family Smoking Prevention and Tobacco Control Act gives the FDA wide-ranging power to regulate the contents, advertising and sale of tobacco products in the United States.
How E-cigarettes Work
Electronic cigarettes are products designed to deliver nicotine or other substances to the user in the form of a vapor. Typically, they are composed of a rechargeable, battery-operated heating element, a replaceable cartridge that may contain nicotine or other chemicals, and an atomizer that, when heated, converts the contents of the cartridge into a vapor. This vapor can then be inhaled by the user.
Both the makers of electronic cigarettes and anti-tobacco advocates claimed victory in the court ruling and the FDA's response.
In a press release, George Roth, CFO of Smokefree Innotec e-Cigarettes stated, "With this ruling we feel Smokefree, along with many other e-cigarette companies, are victorious in the pursuit of our claims that such products are not drug delivery devices and not subject to FDA regulations as such."
E-cigarette maker Green Nicotine said it welcomed a higher level of government regulation. "We are excited about the opportunity to have the FDA enforce regulations that we [Green Nicotine] have been implementing for years," said CEO Sean Schoepflin. "We know that we have the world's most technologically advanced and safest electronic cigarette. This is our chance to prove it."
While the Campaign for Tobacco-free Kids stated it was "disappointed" in the FDA's decision not to appeal the court ruling, it was happy with the agency's stated intent to regulate e-cigarettes under the Family Smoking Prevention and Tobacco Control Act.
"The FDA's decision to assert jurisdiction over other tobacco products in light of the electronic cigarette decision is important because it will help prevent tobacco companies from creating loopholes and circumventing the law," said Tobacco-free Kids. "Already, some companies have sought to evade a ban on flavored cigarettes by marketing flavored little cigars, and the FDA recently concluded that its current authority does not include certain non-traditional smokeless tobacco products. The FDA's assertion of authority over other tobacco products will make it clear what products are subject to regulation and help prevent future evasions of the law."
What About Those New Warning Labels?
One small question that may become very large is, if the FDA regulates e-cigarettes the same way it regulates tobacco-filled cigarettes, will makers of e-cigarettes be required to apply the shocking new warning labels proposed by the FDA to their product packaging?
According to the Department of Health and Human Services, the grizzly new warning labels would satisfy a requirement of the Family Smoking Prevention and Tobacco Control Act for larger and more noticeable textual warning statements and color graphic images depicting the negative health consequences of smoking.