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Tobacco Regulations Proposed Rules

Troutman Pepper

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

Troutman Pepper

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

Troutman Pepper

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

Foley & Lardner LLP

Will FDA’s Proposed Ban on Flavored Tobacco Products Ever be Implemented?

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On April 28, 2022, the U.S. Food and Drug Administration (FDA) released two proposed rules that would ban menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors such as strawberry and menthol...more

Roetzel & Andress

FDA Issues Proposed Tobacco Product Standard for N-Nitrosonornicotine (NNN) in Finished Smokeless Tobacco Products

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On January 23, 2017, the Food and Drug Administration (FDA) issued a proposed tobacco product standard that would establish a limit of N-nitrosonornicotine (NNN) in finished smokeless tobacco products not to exceed 1.0...more

McDermott Will & Emery

FDA Proposes to Modify Good Laboratory Practice Regulations, Broaden Application and Authority

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On August 24, 2016, the US Food and Drug Administration (FDA) issued a Proposed Rule on Good Laboratory Practice for Nonclinical Laboratory Studies (Proposed Rule), which broadens the application and authority of Good...more

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