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North American Quitline Consortium
FDA announces proposed deeming regulation – Conference call at 2:00 EST today!
 
Dear Colleagues,
 
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: (1) 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
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