USA…Regulation of E-Cigarettes by the FDA.
April 25, 2011
The American Food and Drug Administration(FDA) between 2008 and 2010 determined certain electronic cigarettes were unappproved drug/device combination products. However, recent events have changed the fuzzy landscape somewhat with the U.S. Court of Appeals for the D.C. Circuit, in Sottera amending the previous act. It now determines that electronic cigarettes and other products made or derived from tobacco can be regulated as “tobacco products” and are not drugs/devices unless they are marketed for therapeutic purposes.
On Monday, April 25, 2011, FDA announced in a letter to stakeholders that it will not appeal the recent decison. FDA 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.