This morning, FDA released its proposed deeming rule on regulation of tobacco products (including e-cigarettes). FDA will be convening a conference call at 2 pm EST today to present its official statement and answer questions. To participate in the conference call, use the call-in information below:
For participants in the United States or Canada: 866-844-9416
All others should dial 1-203-369-5026.
The passcode for all callers, which will be asked for orally, is “CTP.”
A replay will be available beginning one hour after the briefing until May 8, 2014. To listen to the replay, call 866-415-3310. The passcode for all callers is “CTP.”
Although we have not yet had time to review the full document, highlights include: (1)
companies would have to apply for FDA product approval (but have 2 years after rules are finalized to do so, and can keep their products on the market in the interim and importantly continue to bring new products to market); (2)
no free samples of e-cig products; (3)
ban on the sale of the devices to anyone below age of 18; (4)
no health claims in any advertising; (5)
requiring manufacturers to register with the FDA and list the ingredients in their products (not clear yet if these ingredients will be required to be listed on products); (6)
requiring a warning label stating that nicotine is addictive (which would have to be added no later than 2 years after the rule is finalized). The proposal did NOT include
restrictions of flavors (although it has been suggested this could be re-evaluated at a later time); (2)
a ban on internet sales to adults; (3)
a ban on TV advertising. FDA cannot
enact a federal tax on e-vapor products or ban internet sales as these would fall under the realm of Congress.
Now that the proposed regs are published, there is a 75-day comment period, after which the FDA will review the comments, eventually issuing a final rule which must be reviewed by the OMB before being enacted. The process is likely to take 12-24 months before final regulations are implemented given the rulemaking process though some items will need to be complied with immediately.
The FDA press release: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm394667.htm
The FDA proposed rule (241 pages) https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-09491.pdf
Linda A. Bailey, JD, MHS
President and CEO
North American Quitline Consortium