July 31, 2014
Lauren Lempert and I just submitted this public comment to FDA on the deeming rule. The tracking number is1jy-8djc-8rr2.
The FDA should not use the results of any Regulatory Impact Analysis (RIA, also known as cost-benefit analysis) when determining the scope and content of the final rule for four reasons:
July 30, 2014
This ad is running in Variety today and Hollywood Reporter next week.
See the ad at and supporting information at http://www.smokefreemovies.ucsf.edu/ourads/ad_sfm98.htm
July 27, 2014
My UCSF colleagues just submitted this comment to FDA:
FDA should prohibit of use of flavors in deemed tobacco products as part of the current rulemaking
Docket No. FDA-2014-N-0189
Elizabeth Couch, RDH, MS, Benjamin Chaffee DDS, MPH, PhD, Gwen Essex, RDH, MS, EdD, Margaret Walsh, RDH, MS, EdD
School of Dentistry
University of California San Francisco
July 28, 2014
Page 23147 of the proposed Rule the FDA states: “The prohibition against characterizing flavors established in the Tobacco Control Act applies to cigarettes only. Consequently, when this regulation is finalized and other tobacco products are deemed subject to FDA’s tobacco product authority, the statutory prohibition against characterizing flavors will not apply automatically to those deemed products (147).”
The FDA specifically states that they may establish a product standard prohibiting flavors in those products only after the rule has been established and requests information and data that would support establishing such a standard (147).
July 23, 2014
This is yet another example of the Obama White House OMB watering down the FDA's proposed deeming rule in a way that seriously harms public health. FDA wanted to end non-face-to-face sales, which would have ended internet sales of tobacco products (including, but not limited to ecigarettes). The OMB deleted this action and replaced it with a limited vending machine restriction. Here is the public comment we submitted on this issue:
FDA Should Prohibit All Non-Face-to-Face (Including Internet) Sales of Tobacco Products as FDA Originally Proposed to the OMB
Docket No. FDA-2014-N-0189
July 23, 2014
The FDA has posted a request for industry research on the effects of pH (acidity) in smokeless tobacco for public comment. This is an important request that could have substantial regulatory implications (if OMB and the White House let FDA do anything).
There are a couple fine points in the request that need tweaking to avoid inadvertently creating loopholes that the industry could use to avoid dislosing important information.
Here is my public comment:
July 23, 2014
Docket No. FDA-2014-N-1009
AGENCY INFORMATION COLLECTION ACTIVITIES; PROPOSED COLLECTION; COMMENT REQUEST; INFORMATION REQUEST REGARDING PH OF SMOKELESS TOBACCO PRODUCTS
There are several places in which the FDA proposes to only request "final" data analyses and reports.