By Sean Moloughney, Editor05.20.22
FDA has issued a draft guidance on late submissions of New Dietary Ingredient (NDI) Notifications, saying it intends to exercise enforcement discretion “for a limited time and in limited circumstances,” to encourage manufacturers and distributors to correct instances where a premarket NDI notification was required, but never submitted. FDA is accepting comments on its draft guidance by Jul. 19, 2022.
In 1994, the Dietary Supplement Health and Education Act (DSHEA) amended the Federal Food, Drug, and Cosmetics Act (FD&CA) to require premarket notification to FDA of “new dietary ingredients” at least 75 days before introduction into interstate commerce.
Since that time, FDA has received about 1,200 NDI notifications. However, the agency has estimated that more than 4,600 NDI notifications should have been submitted and were not.
“A number of firms have told us informally that they realize they should have previously submitted notifications and have the information ready to be submitted, but they are afraid of drawing attention to themselves with
In 1994, the Dietary Supplement Health and Education Act (DSHEA) amended the Federal Food, Drug, and Cosmetics Act (FD&CA) to require premarket notification to FDA of “new dietary ingredients” at least 75 days before introduction into interstate commerce.
Since that time, FDA has received about 1,200 NDI notifications. However, the agency has estimated that more than 4,600 NDI notifications should have been submitted and were not.
“A number of firms have told us informally that they realize they should have previously submitted notifications and have the information ready to be submitted, but they are afraid of drawing attention to themselves with
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