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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

Tobacco became a global commodity in the 20th century, with transnational corporations such as Philip Morris, British American Tobacco, and Japan Tobacco dominating the industry

[11] [12] [13] Total losses from the failure are estimated at $800 million to $1 billion