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FDA approval requires a number of things, which include but are not limited to: proving the drug is safe, proving it works for the intended purpose, and showing it can be manufactured at scale

In contrast, exogenous leptin, at the dose (10 g/kg ip) that raised plasma leptin to the level occurring postprandially, reduced markedly plasma levels of ghrelin and attenuated food intake and these effects can be reversed by the administration of specific IgG anti-leptin antibodies (28)

The unique dietary fibers in the prebiotics are inactive ingredients in food that are beneficial to host health and participate in regulating body immunity and maintaining gastrointestinal function, including inulin, dextrose and lactulose (82)

FEMS Yeast Res 14:977987