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NCLA Amicus Brief Tells D.C. Circuit It Must Avoid Remanding Regulations Without Vacating Them

NCLA Amicus Brief Tells D.C. Circuit It Must Avoid Remanding Regulations Without Vacating Them
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13 Questions: Explaining FDA's Plans to Ban Flavored Cigars, Menthol Cigarettes

13 Questions: Explaining FDA's Plans to Ban Flavored Cigars, Menthol Cigarettes
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FDA Finalizes Rules For Premarket Review—Premium Sector Still Exempt

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In an effort to clarify the sometimes convoluted application process for new tobacco products, the U.S. Food & Drug Administration, which regulates the sale of tobacco, has finalized its foundational rules for its premarket review process, meaning that there should be greater clarity, detail and information regarding the requirements for pathways to market. However, a court ruling from August of 2020 currently exempts the premium cigar industry from the regulation.
The two major pathways to market for new cigars and other tobacco products are either a premarket tobacco product application (PMTA) or substantial equivalence (SE). The FDA believes that the application process for either pathway is now more effective and efficient, providing more details and insight as to the necessary steps required by a manufacturer looking to introduce new tobacco products to the market. ....

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