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Products like Zyn don't need to be proven safe and effective for a specific population the manufacturer just needs to comply with "requirements under the law to bring its product to market," the FDA website says

[58] Ibid

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Instruct patients to discontinue ZYBAN and contact a healthcare professional if they experience such symptoms [see Warnings and Precautions (5.2), Adverse Reactions (6.2)]

Beyond the numbers, the 2025 edition reflects a qualitative shift: an increasing convergence between countries of very different income levels