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Inside Health Group Policy reports that the suit brought against the FDA by health entities such as the American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids and Truth Initiative, has come under the scrutiny of Marc Scheineson, head of the food and drug practice at Alston & Bird and former associate commissioner for legislative affairs at FDA. To recap: the groups’ complaint alleges, among other things, that, “FDA has no power to act unless and until Congress confers that power.” Further:

“Agencies may not modify unambiguous requirements imposed by a federal statute. The Guidance does not simply fail to enforce statutory requirements; it purports to alter those requirements and to establish, with the force of law, that otherwise prohibited conduct does not violate the Tobacco Control Act.”

Interestingly, of course, the “deeming rule” also modifies the scope of the Tobacco Control Act without input from Congress, by declaring devices and substances which do not contain tobacco to be “tobacco products.” This modification of Federal statute, however, seems to trouble these groups not in the slightest.

Marc Sheineson contends however that, for the most part, these groups have no genuine standing from which to see this case succeed on Administrative Procedure Act grounds, and are in fact simply grandstanding. He elaborates:

“In order to have a case accepted procedurally, you have to be in a class that was intended to be protected or regulated by the rule … the [deeming] rule is designed to regulate industry so a company that would be required to be compliant with the provisions is really the category that would have the most obvious standing. Public health groups like this really are not impacted one way or another by the rule because they don’t make the products … it would be a step removed.”

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