May 3, 2014
I was at a meeting last week of NIH and FDA scientists on tobacco regulatory science at which FDA officials repeatedly urged people to submit public comments in response to the scientific questions raised in the draft deeming rule.
The absolute best source of data for answering many of these questions is the FDA PATH study, a giant national study of tobacco use, including exposure to tobacco advertising. While the data for Wave 1 is still being collected, the FDA already has a huge amount of information collected that could form the basis for providing scientific guidance to the rule making process.
The problem is that none of this data is scheduled to be released until next year, well after the comment period on the deeming rule is closed (even allowing for the fact that the Obama Administration will almost certainly once again ignore the health community and extend the comment period for the tobacco industry). While under normal circumstances it would be reasonable to wait until the entire sample was collected before releasing the public use data set, we are not experiencing normal situations.
May 2, 2014
Here is Legacy's press release:
FDA Deeming Regulations Released Last Week Fail to Safeguard Young People from Pervasive E-Cigarette Advertising
Washington, D.C. – A new report titled Vaporized: E-Cigarettes, Advertising, and Youth by Legacy, examines the recent rise of e-cigarette use among youth, and the entry of the major tobacco companies into the e-cigarette market. Legacy, the nation’s largest public health foundation devoted to achieving a culture where all youth and young adults reject tobacco, released the report today, amid growing concerns about the rising popularity of e-cigarettes among youth. Legacy’s report provides further evidence for the rapid implementation and expansion of the recently announced deeming regulations by the Food and Drug Administration (FDA). While the proposed regulation would take the very important step of instituting a national minimum age of 18 for the purchase of e-cigarettes, it is essential that the regulation also prohibits marketing of these products to youth, something not included in the proposal.
April 29, 2014
After years of inaction, just last week, the Obama Administration finally let the FDA issue its long-awaited (and disappointing) proposal to "deem' that it had authority to regulate e-cigarettes as well as cigars and other tobacco products.
The FDA’s proposed rule is weak -- and it is only a proposal. It will likely be years, if ever, before it takes effect.
And, aside from restricting in person (but not internet) sales of e-cigarettes to minors, it does not offer any of the common sense protections recently passed by City Councils in New York, Chicago, Los Angeles, San Francisco, and other cities.
New York and Chicago's laws went into effect today.
For example, Chicago requires e-cigarettes to be put behind the counter, out of the reach of children. The FDA did not.
Through licensing, Chicago limited the type of retailers who can sell these products. The FDA did not.
Chicago has prohibited the sale flavored e-cigarettes, which come in dozens of kid-friendly flavors like cotton candy and bubble gum, near schools. The FDA did not.
The FDA did not even attempt to restrict advertising of e-cigarettes to kids. Even if the FDA’s proposed rule takes effect, advertising addictive e-cigarettes to kids will still be completely legal.
April 23, 2014
I could not find the actual rule on the FDA website. This is my first reaction based on what was in the NY Times the evening of April 23, 2014.
While establishing minimum age to purchase e-cigarettes at 18 is sensible, the FDA's proposal does nothing to reign in the wild west marketing of e-cigarettes to kids (that the FDA itself recognizes).
It does not ban flavors that are well-dcoumented to appeal to kids in cigarettes. It does not apply the same restrictions on television and radio advertising of ecigarettes that apply to cigarettes. The FDA's failure to act to reign in youth-rated marketing will allow the ecigarette companies to continue building the youth market for years.
Press reports indicate that there will be a warning that ecigarettes contain the addictive drug nicotine. The specific size and placement of the warning is important. We need to see details. Simply saying "nicotine is addcitive" probably does not inform youth of the risks very well because the idea of "addiction" is so abstract.
April 18, 2014
Just when you thought the Obama Administration's (non) handling of e-cigarettes could not get any more dysfunctional, the FDA posted this announcement on its website on Friday afternoon April 18, 2014:
A Special Statement from CTP [FDA Center for Tobacco Products]
04/18/2014
Updates from the Center for Tobacco Products
The FDA has not issued its proposed rule regarding what additional tobacco products should be regulated by the agency. We are aware that the Tobacco Vapor Electronic Cigarette Association has indicated publicly that they have a copy of our proposal. The proposal is still in draft form and under review. As a matter of policy, the FDA does not share draft rules with outside groups while a rule is still under review.