New Wrinkle In NDI Debate: Supplement Ingredients Used As Drugs Outside US
This article was originally published in The Tan Sheet
Senator McCaskill asks FDA to halt sales of supplements containing vinpocetine and picamilion after research, led by an advocate for tighter regulation of supplement manufacturing, shows the ingredients are not derived from natural sources but are synthetic and used as drugs in other countries.
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The Council for Responsible Nutrition and the Natural Products Association argue in comments that FDA would establish a process for removing ingredients from the marketplace outside its regulatory authority if it follows on its proposal to remove vinpocetine, currently widely used in supplements.
Hatch, primary author of the legislation Congress passed in 1994 as FDA's framework for regulating the supplement industry, notes in a letter that FDA did not question vinpocetine's safety in evaluations of five NDI notifications.
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.