E-Cigarettes To Be Regulated As Tobacco Products

FDA decides not appeal Federal Courts decisions to regulate e-cigarettes as tobacco, not medical products…

A Federal Court suit has ruled that electronic cigarettes, or e-cigarettes, will not be regulated by the same strict rules that apply to medical products; instead the nicotine dispensing devices will be overseen by the same rules as tobacco products.

The FDA, an agency that wants e-cigarettes to regulated as medical devices, has announce that it will not appeal the decision – a move that spells victory for the manufacturers and distributors of electronic cigarettes.

The court ruling at the U.S. Court of Appeals for the D.C. Circuit, concluded that e-cigarettes “are not drugs or devices” can could be treated as normal tobacco products as long as they are not marketed as a therapeutic device, or a way to quit smoking.

E-Cigarettes To Be Regulated As TObacco Products

Image Credit: TheSmokersAngel, 2011.

E-Cigarettes are powered by a battery and use a heating element to vaporize liquid nicotine that is inhaled by the user. The device is designed to look like a cigarette, with the tip glowing red when in use. This design gimmick, along with the skeptical marketing that claims the e-cigarettes are safer than cigarettes, has lead to activists and health groups such as the FDA to call for stricter regulations on the sales of the device.

In September 2010, the FDA said released a letter to e-cigarette distributors saying that their products were being marketed illegally and should be subject to the same regulations governing drugs and medical devices.

However Sottera Inc., an e-cigarette manufacturer based in Scottsdale, Ariz., quickly responded using the federal court to back up its claim that because the device vaporizes nicotine, it is a tobacco product and not a medical device.

Following the ruling in favor of Sottera Inc, in December 2010, the FDA issued a letter to the public and stakeholders announcing its decision not to appeal. Nevertheless the agency said it would take steps to ensure that appropriate regulations are in place for all “tobacco products”.

Experts worry that the FDA’s acceptance court ruling could lead to the misuse of tobacco in other products. Matthew L. Myers, president of the Washington-based Campaign for Tobacco-Free Kids said:

“[Manufacturers can now] add nicotine to a wide range of products without the stringent regulation traditionally applied to smoking cessation medications and other non-tobacco products to which nicotine has been added.”

Myers did say in a letter posted on the group’s website that the FDA “has taken appropriate action to protect public health by announcing that it intends to assert authority over other tobacco products that meet the statutory definition of ‘tobacco products’” under federal law.