We have all seen the chilling ads that many companies have put out into the world that focus on the dangers of smoking cigarettes. Whether it is the multitude of medical issues that can arise from the smoke itself or the astronomical amount of chemicals that are being put into those cigarettes, everyone knows that it is a habit that can kill.

For those who have tried to quit, or at least cut back drastically, e-cigarettes have become a saving grace. Finally, a way to receive your nicotine in a much safer way than smoking traditional cigarettes. However, it has led many to question whether e-cigarettes are even FDA approved, and the short answer is yes.

fda approved Cigarettes

Supreme Court Case

Back in 2009, serial entrepreneur and founder of the first e-cigarette companies in the US Eli Taieb had filed a suit against the FDA, along with a company known as Sottera, as the FDA had attempted to ban imports of both companies’ e-cigarette products. They had justified the ban saying that they were unapproved drug-device combination products that had been designed to deal with nicotine withdrawal. However, this was not what Sottera or Eli Taieb’s company were trying to promote their product as, but rather, they were intended for the enjoyment of smoking.

Luckily the courts sided with Eli Taieb in 2010, stating that if e-cigarettes were being classified as a drug-device for carrying nicotine, then cigarettes would need to be listed as a drug-device as well. While the FDA appealed the decision, Eli Taieb continued the case and again had the courts siding with him, which led to the ruling that the FDA was only allowed to regulate e-cigarettes as tobacco products, not drug-device combination products.

Further Rulings

In 2016, the FDA finalized a rule that would extend regulatory authority to cover all tobacco products, including electronic nicotine delivery system (ENDS), providing they meet the definition of a tobacco product.

However, there are some items that each distributor of ENDS must keep in mind in order to be FDA compliant with their products. The FDA regulates the manufacturing, import, packaging, labeling, advertising, promotion, sale, and distribution of ENDS, including the components and parts of ENDS, but excluding any accessories. This means that even from the design and testing period, companies need to have the FDA guidelines in mind in order to create an ENDS that will be approved with little feedback.

All companies who are looking into creating and distributing ENDS are required by the FDA to follow the standard tobacco regulations, which means they need to register their establishment and submit a list of products, submit data and pay user fees, submit an ingredient listing, submit a warning plan, and submit tobacco health documents, among other items.

Eli Taieb has been a part of the ENDS game since the beginning and has made a pretty big name for himself. He found a way to revitalize an industry that hasn’t changed in years and continues to thrive doing what he loves to do.