In a letter to stakeholders, Dr. Lawrence Deyton, director of the CTP, said his organization would not be appealing the recent decision by the U.S. Court of Appeals for the D.C. Circuit in Sottera Inc. v. Food & Drug Administration.
Deyton wrote: "The court held that e-cigarettes and other products made or derived from tobacco can be regulated as [image-nocss] 'tobacco products' under the [Family Smoking Prevention & Tobacco Control Act of 2009] and are not drugs/devices unless they are marketed for therapeutic purposes."
In December of last year, three judges of the U.S. Court of Appeals for the D.C. Circuit ruled that the FDA can only regulate electronic cigarettes as tobacco products and not as drugs--and therefore cannot block their import.
Sottera could not immediately be reached for comment on this story. In January, Matt Salmon, then Scottsdale, Ariz.-based Sottera Inc.'s CEO, told CSP Daily News that Sottera had spent about $2.5 million and a year and a half to get to that point--not to mention the "tens of millions of dollars" lost in FDA-confiscated product. (Click here for previous coverage.)
At the time, he said the company was ready to move forward with expanded efforts in China, where its NJOY e-cigarettes are manufactured.
Up next for the CTP is a plan to propose a regulation extending its "tobacco product authorities" to additional categories.
According to Deyton, "The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products and the adulteration and misbranding provisions--as well as to the premarket review requirements for 'new tobacco products' and 'modified-risk tobacco products'."
Since the Sottera decision states that products made or derived from tobacco can be regulated as drugs and/or devices, Deyton also said, "The agency is considering whether to issue a guidance and/or a regulation on 'therapeutic' claims."
He added, "We look forward to working with all stakeholders to ensure that the existing authorities granted the agency are harnessed to best protect and promote the public health."
(Click here for previous CSP Daily News coverage of e-cigarettes.)
Meanwhile, click here to watch exclusive CSPTV video featuring Deyton addressing the future of menthol products and other industry issues.
For more on tobacco,click here to subscribe to Tobacco E-News.
Members help make our journalism possible. Become a CSP member today and unlock exclusive benefits, including unlimited access to all of our content. Sign up here.