May 7, 2014
There are several examples in the deeming rule of the FDA laying out a good scientific case to do something, then ignoring the evidence they present and saying that they are going to do the opposite thing that the evidence suggests. (More evidence of White House meddling?) A great example of this is the FDA's decision not to have a warning on cigars about reproductive toxicity.
I just submitted the following public comment on this point:
May 7, 2014
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA–2014–N–0189
RE: FDA proposal not to include reproductive warning on cigars
On page 23168 of the Proposed Rule the FDA states: “FDA is not proposing the fifth FTC warning (Tobacco Use Increases The Risk Of Infertility, Stillbirth And Low Birth Weight), because although cigarette smoking has been shown to cause these health effects and cigar smoke is similar,
the Agency is not aware of studies specifically linking cigars to these reproductive effects.”
FDA specifically requested comment on its proposal to require the use of only four of the five current FTC warnings for cigars.
May 4, 2014
I just submitted this public comment on the FDA deeming rule on Regulations.gov:
May 4, 2014
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. Docket No. FDA–2014–N–0189
RE: 2014 Surgeon General Report and Deeming Rule
In reviewing the proposed rule I could not find a single citation to the 2014 Surgeon General's Report, The Health Consequences of Smoking: 50 Years of Progress (available at http://www.surgeongeneral.gov/library/reports/50-years-of-progress/index...). This report contains important information that is directly relevant to the proposed deeming rule, including:
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.