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Each time, when challenged, FDA devised a new rationale for the same predetermined conclusion that the changes create a new tobacco product subject to premarket review under the acta results-oriented approach that is antithetical to proper agency decision-making and inconsistent with the plain language of the act. Reynolds Americans operating companies are in compliance with the act, and believe that FDA does not have the authority to impose the restrictions outlined in the guidance, David Howard, a Reynolds spokesperson, told the Journal