Troutman Sanders tobacco team partner Bryan Haynes was quoted in a February 20th article titled “E-cig industry on tenterhooks ahead of U.S. regulation.”
The article discusses the heavy cloud of speculation hanging over the rapidly expanding e-cigarette industry as it awaits the release of deeming regulations by the FDA. In addition to concerns over potential advertising restrictions, flavoring bans, and the regulation of internet sales, the article also discusses how regulations could affect this relatively new segment of the tobacco industry when it comes to its rapidly changing product dynamic.
In the article, Haynes is quoted as saying “The concern is that a product that is constantly changing could be tied up in a very time-consuming process before the products could be legally marketed”. Currently, the FDA is still slogging through a backlog of over 4,000 new or modified product applications for the tobacco products it currently regulates. Some of these applications have been pending for over two years.
Although logic would dictate that new product requirements will not apply to e-cigarettes in the same way they currently apply to cigarettes, ominous signs from FDA regarding the content of the deeming regulations suggest that the Tobacco Control Act’s generally-applicable requirements, which include new product approval requirements, will apply to newly-deemed products, which would include e-cigarettes. Such requirements could entail substantial compliance burdens and barriers to new product entry.
Please contact us if you would like to discuss how the Tobacco Control Act’s new product requirements may apply to your products.
To read the full article, click here.