Electronic cigarettes not drugs according to court
There has been a court ruling that saying that the FDA cannot consider electronic cigarettes as drugs, not even as devices. This is applicable as long as the makers of e-cigs aren’t made available to the market to help resolve smoking problems.
An affirmation was released on Tuesday by the U.S. Court of Appeals for the DC circuit that the FDA was certainly wrong when it blocked stopped the shopping of these battery-powered cigarette look-alikes from being imported to the U.S. in 2009.
The famous e-cigarettes are made by Njoy and are not commercialized to stop smoking or for any other therapeutic uses. The court justified that if the e-cigs were marketed as a means to help patients quit smoking, then they would have the reason to qualify it as a drug or device. If so, the electronic cigarette can be subjected to FDA approval required for all new drugs and devices. In addition, the court added that the FDA cannot provide evidences that the e-cig is harmful.
The electronic cigarettes are powered by batteries and are made of metallic tubes that look like the traditional cigarettes. These are filled with liquid nicotine mixture that came from tobacco. Flavors and other chemicals are also included. The liquid nicotine mixture is converted into vapor and then inhaled by the user. These e-cigs have no health warnings unlike the traditional cigarettes and other nicotine replacements that are approved by the FDA. Because of this, just little is known about the product.
Currently, the FDA does have any regulatory measurement and authority over tobacco, as granted by a law that was passed in 2009. However, the said law does not give the FDA the rights to ban the sales of tobacco products.
The decision announced last Tuesday by the court of appeals highlighted that the said 2009 law confirms that the legislation does not, in any way, expand, affect or limit the jurisdiction of FDA to control the products that are categorized under the drug and device provisions in the Food, Drug, and Cosmetics Act or FDCA.
In addition, the said law illegalizes a company to claim that its product can provide treatments or alleviate a certain disease. This includes the addiction to nicotine. The law is neutralized once the FDA gives affirmation that the drug is safe and proven effective. However, Njoy claims that its e-cig is only for “smoking pleasure” and not for smoking cessation.
An agency spokesman said that the FDA is currently going over the decision of the court. There were many public health groups that expressed their dismay with the ruling. According to Matthew L. Myers, the president of Campaign for Tobacco-Free Kids, said that the court ruling is “wrong on the law, wrong on the facts, and fails to take into account the harmful implications of this decision for public health.”
He further said that the decision would allow the manufacturer to put a level of nicotine based on without anyone restricting them. They can even sell the e-cig anyone, including children since there isn’t any government regulation at the present time.