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What it does is initiate a formal rulemaking process under the Federal Food, Drug, and Cosmetic Act in which the FDA must publish a proposed rule, accept public comment typically for 60 to 90 days and issue a final determination

Purity describes what proportion of the detected material was the target compound in the batch that was tested, by the method stated

Over-the-counter medicines like simethicone (Gas-X) or alpha-galactosidase and invertase (Beano) can help reduce gas and bloating

Postgraduate Medicine, 134 (1), 1419

At 0.5%, you're still delivering concentrations far exceeding the nanomolar levels shown effective in research