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Tobacco Proposed Rules

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FDA Proposes Submission Tracking Number Requirement for ENDS Imports

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In August, the U.S. Food and Drug Administration (FDA) issued a new proposed rule that would require importers of electronic nicotine delivery system (ENDS) products to provide an FDA-issued submission tracking number (STN)...more

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Advocacy Organizations Sue FDA Over Delay in Menthol Cigarette Ban

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On April 2, three advocacy organizations filed a complaint in the U.S. District Court for the Northern District of California seeking an order directing the U.S. Food and Drug Administration (“FDA”) to promulgate its...more

Latham & Watkins LLP

FDA Publishes Proposed Rule for Tobacco Product Manufacturing Practice Requirements

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The proposed rule, if finalized, would impose new manufacturing practice requirements on foreign and domestic manufacturers of finished and bulk tobacco products. On March 10, 2023, the Food and Drug Administration (FDA...more

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FDA Announces New Proposed Rule on “Tobacco Product Manufacturing Practices”

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On March 8, the Food and Drug Administration announced that it is proposing a long-awaited rule on so-called “tobacco product manufacturing practices.”  Here are some preliminary thoughts on the proposed rule...more

Saul Ewing LLP

FDA Publishes Court-Ordered Cigarette Graphic Warning Proposed Rule, Industry Challenge Expected

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On August 15, 2019, the U.S. Food and Drug Administration (FDA or the Agency) published a court-ordered proposed rule that, if finalized, would mandate graphic health warnings for cigarette packaging and advertisements to...more

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