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[h=1]FDA approves smokeless substantial equivalence claims despite the fact that Altria failed to provide key information[/h]
Submitted by sglantz on Sat, 2013-11-16 07:52
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:
[h=1]FDA approves smokeless substantial equivalence claims despite the fact that Altria failed to provide key information[/h]
Submitted by sglantz on Sat, 2013-11-16 07:52
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:
By setting this precedent, the FDA is putting the burden on public health researchers to demonstrate that color changes are a problem, rather than the tobacco companies to demonstrate that they are not a problem.
