February 21, 2014
One of the huge potential loopholes in the Family Smoking Prevention and Tobacco Control Act is that it allowed tobacco companies to market products that are "substantially equivalent" (SE) to existing products without going through a full FDA new product application. Products that were placed on the market before March 11, 2011 could be marketed while the FDA considered the SE application.
Yesterday, February 21, 2014, the FDA announced that it had taken its first action to require that a tobacco product be removed from the market on the grounds that it is not "substantially equivalent" to a pre-existing product.
As the FDA stated in its press release,
February 16, 2014
There has been a lot of coverage of the federal indictment of former Virginia governor Robert McDonnell and his wife Maureen for accepting bribes from Star Scientific, which makes two anatabine-based dietary supplements: CigRx®, a tobacco alternative; and Anatabloc®, for anti-inflammatory support. The media attention has been focused on "gifts" of use of a house, Ferrari, paying for a wedding dress, and a Rolex watch.
What has got less attention is that the thing that Star Scientific wanted was for scientists at two state universities, University of Virginia and Virginia Commonwealth University, to do studies designed to prove that Anatabloc was beneficial. Moreover, to hide Star's role as a sponsor and to save the company from paying for the research, Star (and Gov McDonnell) wanted the state's Tobacco Indemnification and Community Revitalization Commission (which provides grants for the promotion of economic growth and development in tobacco dependent communities using proceeds of the Master Settlement Agreement) to pay for the studies.
Star also wanted state employees to serve as research subjects.
February 16, 2014
On February 15, the New York Times reported the election year politics were making it all but impossible for President Obama to get "fast track" authority he needs to get the TransPacific Partnership (and likely a similar TransAtlantic deal) through Congress. Fast track is an agreement in which Congress cedes is authority to amend a trade deal and only allows an up-or-down vote. It effectively freezes the public out of the process.
According to the Times, "Last month, the Senate majority leader, Harry Reid of Nevada, said he had no plans to schedule a vote on trade promotion authority. On Wednesday, Ms. Pelosi told reporters that giving Mr. Obama that authority was “out of the question.”
February 15, 2014
We just submitted this public comment through regulations.gov (tracking number 1jy-8ags-t5ln)
COMMENT SUBMITTED IN RESPONSE TO FDA ON PROPOSED COLLECTION OF INFORMATION REGARDING EXEMPTIONS FROM SUBSTANTIAL EQUIVALENCE REQUIREMENTS FOR TOBACCO PRODUCTS
Docket No. FDA-2013-N-1588
Stanton Glantz, PhD
Lauren Lempert, JD, MPH
Center for Tobacco Control Research and Education
University of California San Francisco
February 17, 2014
We submit these comments in response to FDA’s notice concerning the proposed collection of information regarding exemptions from substantial equivalence requirements for tobacco products. We previously submitted public comments on substantial equivalence in reference to docket 2010-D-0635 which are incorporated by reference in this comment.[1]