The FDA and e-cigarette regulation
Richmond partner Bryan Haynes was quoted in an April 24 Law360 article – “ FDA’s Timid E-Cig Proposal Plays Into Industry’s Hands”– about the FDA ending a year-long wait on April 24 when it moved to expand its oversight of tobacco and cigarette products to include e-cigarettes. A 240-page proposal issued by the FDA seeks to require e-cigarette makers to register with the agency, disclose the ingredients within their products and to block them from selling to minors. Interestingly, however, is that the agency has given stakeholders 75 days to comment on how flavored e-cigarettes should be regulated. The FDA banned traditional flavored cigarettes in 2009.
“The next 75 days will be very important,” said Bryan. “It’s fair to say that to the extent that the final rules involve a significant impact on getting a product approved or marketing it to adults, the
industry will consider all its options to fight them, including litigation.”
In an April 24 Richmond Times-Dispatch article – “
FDA eases into regulating e-cigarettes” – Bryan also is quoted on concerns that some of the FDA’s proposed regulations, such as obtaining approval on products that were not on the market prior to February
15, 2007, or banning fee samples to adults, could pose problems for the newly-emerging e-cigarette market as well as makers of specialty products such as cigars.