On July 1, the US Food and Drug Administration issued draft guidance for complying with the New Dietary Ingredient (NDI) notification protocols required by the Dietary Supplement Health and Education Act (DSHEA)—seventeen years late.
The biggest problem is that this guidance will turn a notification system into an approval system—a terrible precedent that will utterly cut off the supply of nutritional supplements. It will also create such huge barriers for supplement manufacturers that it will be much more difficult and expensive to produce them. But of course, that means consumers would either have to pay much more for nutritional supplements, or else risk not being able to buy them at all if the manufacturer deems them too expensive to produce.
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