A “new dietary ingredient,” defined in the Dietary Supplement Health & Education Act (DSHEA), means a dietary ingredient that was not marketed in the United States before October 15, 1994, when DHSEA was enacted. We’ve been waiting so long for FDA to fully implement this provision that perhaps, for the sake of accuracy, we should just be calling them “post-DSHEA dietary ingredients” rather than “new.” Twenty-six years is a long time.
The NDI requirements established by DSHEA were intended to give consequence to the dividing line between grandfathered ingredients and ones introduced after the passage of the law. Dietary ingredients already on the market received a presumption of safety, but ingredients introduced after the law’s enactment would have to demonstrate they are reasonably expected to be safe.
DSHEA commands that a supplement containing a new dietary ingredient is adulterated unless it was already in the food supply in a form that has not been chemically altered or there is a history of use or other evidence that the ingredient, if used as recommended or suggested in the labeling, will reasonably be expected to be safe. The law further provides that the manufacturer or distributor provide FDA with the basis for concluding that the dietary ingredient will reasonably be expected to be safe in the form of an NDI notification. (21 USC 350b)
Moreover, DSHEA declared that a supplement is adulterated if it contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. (21 USC 342(f)(1)(B)) It commands that introducing a dietary supplement into interstate commerce that is unsafe under the NDI provisions of the law is an expressly prohibited act. Public safety seems intrinsically intertwined with the new dietary ingredient requirements.
"ingredients" - Google News
August 05, 2020 at 09:24PM
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New Dietary Ingredients: Will FDA protect consumers from pirates and piggybackers? - NutraIngredients-usa.com
"ingredients" - Google News
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