February 24, 2014
We just submitted this comment to the FDA:
COMMENT SUBMITTED IN RESPONSE TO FDA ON PROPOSED COLLECTION OF INFORMATION REGARDING SECTION 905(j) REPORTS: DEMONSTRATING SUBSTANTIAL EQUIVALENCE FOR TOBACCO PRODUCTS
Docket No. FDA-2013-N-1558
1jy-8an3-hgzl
Stanton Glantz, PhD
Lauren Lempert, JD, MPH
Center for Tobacco Control Research and Education
University of California San Francisco
February 25, 2014
We submit these comments in response to FDA’s notice concerning the proposed collection of information regarding Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products. We previously submitted public comments on substantial equivalence in reference to dockets 2010-D-0635 and 2013-N-1588, which are incorporated by reference in this comment.[1]
1. The proposed collection of information is necessary for the proper performance of FDA’s functions.
February 23, 2014
Today (Feb 23, 2014), the New York Times ran a front page story on the debate going on inside the health community about e-cigarettes. Earlier this week The Guardian in the UK ran a similar story.
Leaving aside paid shills for the e-cigarette companies like former Surgeon General Rich Carmona, a careful reading of these news stories reveals that the thing that defines the difference between the optimists and pessimists in whether they focus on what might happen or what is happening with e-cigarettes.
The optimists are careful to condition their statements with a lot of caveats that, taken together, envision an environment in which the FDA is heavily regulating cigarettes to make them less addictive (by, say, ratcheting down nicotine) or by making them harder to smoke (by, say, manning menthol, added sugars, or ammonia).
February 22, 2014
This is an informative email I received from Ellen Shaffer at CPATH:
Negotiators of the Trans-Pacific Partnership (TPP) Agreement are currently meeting in Singapore in the hopes of ironing out a set of thorny political issues remaining after years of talks. Among the most important of those issues is the treatment of tobacco in what would become the largest regional trading bloc in the world.
After years of study and debate, several TPP countries have endorsed the unanimous call by public health, medical, and legal organizations to support the only effective policy: excluding tobacco entirely from TPP provisions. Malaysia has proposed such a carve out.
However, the U.S. has leaked that it may propose a half-measure that will leave intact avenues for the tobacco industry to block or overturn tobacco control regulations and laws like plain packaging.
February 21, 2014
Last Sunday, February 26, 2014, San Francisco radio station KCBS broadcast a 30 minute interview with me that covered the state of tobacco control, including:
- the fact that we could reach C. Everett Koop's goal of a smokefree society in 3-5 years here in California and 10 years if people live Governor Jerry Brown and President Barack Obama were willing to stand up to Big Tobacco and do what we know works
- Smokefree movies
- the FDA
- e-cigarettes
- the fact that Jerry Brown is the first governor to take tobacco money in 20 years and that Assembly Speaker Perez, also who takes tobacco money, has aggressively protected tobacco interests in the Legislature. (Sacramento Bee editorial page editor Dan Morain had a great column on this on February 9 on this point.)
The full interview is here: http://sanfrancisco.cbslocal.com/2014/02/17/kcbs-in-depth-ucsf-dr-stanton-glantz-on-smoking-and-the-tobacco-industry/
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,