November 24, 2013
Once of the concerns that I had about the FDA getting into the tobacco business was that it would divert limited resources available to the public health community into useless bureaucratic processes.
This concern was realized in spades as people worked to get public comments into the FDA in response to its request for public comments on its Advanced Notice of Proposed Rule Making (ANPRM) on menthol.
The FDA is required to consider information submitted by the public (including the tobacco companies as well as public health and other interested parties) to its "docket," which is the office record of submitted materials. Only comments submitted to the docket can be considered.
The way that the FDA has chosen to interpret this requirement, however, has generated a lot of extra work that adds nothing of substance to the discussion, as the following tale from the Tobacco Control Legal Consortium illustrates:
November 21, 2013
Lauren Lempert and I just submitted a public comment on the FDA's Advanced Notice of Potential Rulemaking for menthol.
Our key points:
- The FDA should simply ban menthol rather than menthol as a characterizing flavor.
- There would be large and rapid health benefits because of people quitting smoking and fewer kids starting
- It would be easier to enforce
- Smuggling, to the extent that it exists, would be less of a problem
- While the effects on smoking initiation and cessation are more important, the industry's own research, properly interpreted, shows increased toxicity of cigarette smoke when menthol is added
- The FDA cannot take industry scientific submissions at face value
You can read the whole submission here.
November 20, 2013
BELLE (Fox, May 2014) has been rated “PG for thematic elements, some language and brief smoking images.” Watch the smokefree trailer.
BELLE is the dramatized biography of Dido Elizabeth Belle, daughter of an enslaved, biracial mother and a British admiral, raised as a ward in the household of the admiral’s uncle, William Murray, Earl of Mansfield and Lord Chief Justice of England. Ruling in a 1772 legal case, Mansfield put England on the path to outlawing slavery.
November 15, 2013
The FDA has approved eight "substantial equivalence" applications for loose moist snuff products sold in plastic cans. These products and all the predicate tobacco products are manufactured by Altria's Swedish Match North America in several flavors including wintergreen, peach, and apple.
As with the substantial equivalence applications the FDA approved for new Lorillard cigarettes, the FDA's public notice announcing the decision is so heavily redacted that it is impossible to make any independent scientific judgment about whether the FDA's decision was reasonable or even the scientific standards it used to make its decision.
Even worse, the FDA seems to have abandoned any consistent requirement that puts the burden on the tobacco companies to present affirmative evidence that the product is, indeed, "equivalent" to existing products. Despite well-developed evidence that color affects perceived risk and flavor or cigarettes, the FDA said:
November 12, 2013
This is very important.
This leaked copy of an important chapter in teh Trans Pacific Partnership confirms our worst fears on how the TPP could be used by Big Tobacco to fight sensible public health policies. The irony is that many of these changes will increase health costs, both by increasing tobacco-induced disease and by making it harder to control drug and other medical costs, at the same time that the Affordable Care Act continues to come under attack.
Reposted from CPATH:
The leaked text of the Intellectual Property chapter of the TPP reveals a cascade of U.S. proposals that would backtrack on public health and drive up the costs of health care. The U.S. would perpetuate the rights of tobacco and other corporations to challenge public health measures, criminalize reimportation of prescription drugs, patent surgical procedures (explicitly opposed by the World Medical Association in 1999 and 2009), and skew access to information.
---------- Forwarded message ----------
From: Peter Maybarduk [email protected]>
Push for Internet Freedom Limits, Terms That Raise Drug Prices in Closed-Door Trade Talks