FDA approves smokeless substantial equivalence claims despite the fact that Swedish Match failed to provide key information

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:

The review considered whether the darker color of the new tobacco products compared to the corresponding predicate tobacco products increases the appeal  of the new tobacco products. The SE Reports included information about consumer perception testing that was performed, but the submitted information did not address the specific color differences between the new and corresponding predicate products. At this time, the available scientific evidence is not sufficient to establish that the product color differences in this case are significant enough to cause the new tobacco products to raise different questions of public health.

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.
 
What the FDA should have done was return the application and tell Swedish Match to provide affirmative evidence that the color change did not affect the perceived risk (and any other important factor that could affect health) before acting on the application.
 
This opens up yet another loophole in the substantial equivalence process while at the same time making Congress' intent to ensure that the public clearly understood the grounds for such decisions.