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NDI Draft Guidance (supplements).


possible threat to OTC supplements

Not sure I understand this whole proposal, but sounds like a potential danger to supplements. Might be something to check out and take action on.


If the ingredient was already used in a supplement legally marketed before the IND (drug) application was filed, then the supplement company can continue to market it even after the drug filing. But what does legally marketed mean to the FDA? It can mean that the supplement was sold in quantity before 1994. Or it can mean that the supplements NDI (new supplement) filing has been accepted by the FDA. The problem is that the FDA rejects most NDI (new supplement) filings. And it takes a long time to review even the few it accepts, giving drug companies plenty of time to get a competing drug application in. In complete disregard of the clear intent of the law governing supplements, the FDA has stacked the deck against any new supplement and in favor of any new drug.