Are e-cigarettes approved or regulated by the FDA?

Once the FDA does announce its proposed regulations, ProSmoke is ready and excited to be one of the first e-cigarette products available with FDA approval. Currently, the FDA currently considers e-cigarettes to be  tobacco products. Originally, it claimed that e-cigarettes are being used as smoking cessation devices and therefore they needed to be regulated the same as pharmaceutical nicotine replacement therapy drugs (NRTs). In 2009, the FDA ordered customs officials to start seizing e-cigarette shipments coming into the country.

On April 25, 2011, FDA announced in a letter to stakeholders that it would not appeal the decision by the U.S. Court of Appeals for the D.C. Circuit in Sottera, Inc. v. Food & Drug Administration, stating that e-cigarettes and other products are not drugs/devices unless they are marketed for therapeutic purposes, but that products "made or derived from tobacco??? can be regulated as "tobacco products??? under the FD&C Act.  The FDA stated that it 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.  It is developing a strategy to regulate this "emerging class of products" as tobacco products under the Family Smoking Prevention and Tobacco Control Act.  Products that are marketed for therapeutic purposes will continue to be regulated as drugs and/or devices.

Contrary to some media reports and comments by legislators, regulation as a "tobacco product" under FSPTCA does not mean that e-cigarettes are automatically regulated in the exact same manner as tobacco cigarettes, ie., subject to PACT, flavoring prohibitions and indoor use bans nor subject to the same tax rates. However, it does mean sales of these products to minors are finally prohibited by law.