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
November 11, 2013
Public health advocates have, for a long time, felt that the Obama White House intervened to slow down FDA action on menthol. Heavily redacted documents recently released under the Freedom of Information Act shows that the White House, operating through it Office of Management and Budget (OMB), did delay release of the FDA’s scientific report on menthol for over a year, until well after the 2012 election.
The report was complete by late 2011 and the documents indicate that FDA was ready to release it in the first half of 2012.
Emails show two active rounds of correspondence between FDA and OMB. The first round in May and June 2012 strongly suggests that FDA was ready to release the report in May 2012 and was not sure if the report required OMB approval. (Timeline)
OMB indicated it would need to review the report. FDA attempted to push back, but OMB did not budge. There are records of calls between OMB and FDA on this topic, but it does not appear that the report was submitted to OMB in 2012.
November 5, 2013
Congressman Henry Waxman and two other Democrats on the House Committee on Energy and Commerce have written to FDA Commissioner Margaret Hamberg calling the FDA's attention to the aggressive youth-oriented advertising by e-cig companies. Even better than their letter is a gallery of e-cig ads side-by-side with old cigarette ads.
Some things never change. Check out the ad flashback gallery here.
November 5, 2013
Under the 2009 Family Smoking and Prevention Tobacco Control Act (FSPTCA) there are two ways in which the FDA can approve a new tobacco product to be marketed: (1) a tobacco company can submit a “new product” application, or (2) it can submit a “substantial equivalence” application to the FDA making the case that the new product is “substantially equivalent” to a product already on the market as of February 15, 2007.
To date there have been over 4,300 substantial equivalence applications (and no new product applications), so the scientific standards that the FDA uses to determine that a new product is “substantially equivalent” are very important in terms of determining the public health impact of approving the new product. It is, therefore, particularly important that the public know precisely on what grounds such decisions are being made.