FDA Clear On Supplement Ingredient Petitions, But Still Fuzzy On Sec. 912
This article was originally published in The Tan Sheet
Executive SummaryFDA says current dietary supplement regulations make clear that citizen petitions can be filed to request approval of ingredients that were studied in clinical trials and were part of unsuccessful investigational new drug applications
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Supplement industry stakeholders say FDA makes an unjustifiable regulatory move by stating that the widely used dietary supplement ingredient is noncompliant, while the finding compels the agency to reverse its earlier acceptance of NDI notifications for vinpocetine.