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Nicotine Science & Policy | 28 April 2014

The US Food and Drug Administration has published the long awaited proposed ‘deeming’ regulations for e-cigarettes. The major points are that products will need to be registered with the FDA and report product and ingredient listings; that new products can only be marketed after review by the FDA, that companies can only make a claim for reduced risk if the FDA confirms this on the basis of scientific evidence and that the sale of the product will benefit public health. There will be minimum age requirements and restrictions on sales to youth, and a health warning requirement. The FDA has launched a consultation process, with a deadline of July 9th.

For further details from FDA see the links here:

FDA Press release: As part of its implementation of the Family Smoking Prevention and Tobacco Control Act signed by the President in 2009, the U.S. Food and Drug Administration today proposed a new rule that would extend the agency’s tobacco authority to cover additional tobacco products. FDA proposes to extend its tobacco authority to additional tobacco products, including e-cigarettes

The FDA proposed rule in detail: https://www.federalregister. gov/articles/2014/04/25/2014- 09491/sale-and-distribution- of-tobacco-products-and- required-warning-statements- for-tobacco-products

Margaret Hamburg, Commissioner of the U.S. Food and Drug Administration: Proposed Rule Would Expand FDA’s Tobacco Control Authority. http://blogs.fda.gov/fdavoice/ index.php/2014/04/proposed- rule-would-expand-fdas- tobacco-control-authority/# sthash.Z6aLnGo2.dpuf

Initial reactions:

Wells Fargo: ‘E-Cigs’ Proposed Deeming Regulations Finally Released – At First Glance, Not as Bad as Feared’ [link to attached PDF]

Michael Siegel: ‘At the end of the day, while there are some positive aspects to these regulations, it is clear that science is not playing much of a role in the process. That does not bode well for the potential of electronic cigarettes to seriously challenge the combustible tobacco market, and thus to save hundreds of thousands of lives.’ http://tobaccoanalysis. blogspot.co.uk/2014/04/fdas- proposed-electronic-cigarette. html

Lorillard: ‘Company is Encouraged Proposed e-Cigarette Regulations Reflect Potential for Reduced Harm’. http://www.katv.com/story/ 25331029/lorillard-responds- to-proposed-fda-deeming- regulations-for-electronic- cigarettes

American Council on Science and Health: ‘...for us here at ACSH, and for the 44 million smokers in America, a sigh of relief was audible. We had been concerned, mainly, that the hyper-regulatory atmosphere at the FDA and other federal agencies might actually lead to a ban of these products, either overtly or via a stringent, pharmaceutical-type approval process. That thankfully did not come to pass.’ http://acsh.org/2014/04/fda-e- cigs-will-remain-market-thats- good-news/ and https://www.youtube.com/watch? v=InSCNdJKa0I

Statement by SFATA (Smoke Free Alternatives Trade Association) on FDA Deeming Regulations Regarding Electronic Cigarettes and Vaporizing Products -

http://www.marketwatch.com/ story/statement-by-sfata- smoke-free-alternatives-trade- association-on-fda-deeming- regulations-regarding- electronic-cigarettes-and- vaporizing-products-2014-04-24