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"I don't think the spirit of the law ever envisioned this type of cumbersome scrutiny." For example, Kessler said that under the FDA's guidelines, if the nation's third-biggest tobacco company wanted to take a Kent brand cigarette and rename it "Newport," it would be subject to review even though "it's not substantially equivalent it's exactly equivalent." Lorillard petitioned the agency in June seeking to speed the reviews

We had all this data and no one was analyzing it, said Agaku, an epidemiologist who previously worked as a senior scientist at the Office of Smoking and Health (OSH) and left the agency in 2019

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