Drug Products Containing Quinine for the Treatment and/or Prevention of Malaria for Over-The-Counter Human Use

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The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking that would establish that over-the-counter (OTC) drug products containing quinine for the treatment and/or prevention of malaria are not generally recognized as safe and are misbranded. FDA is issuing this notice of proposed rulemaking after considering data and information on the safety of quinine.