On July 1, the US Food and Drug Administration issued draft
guidance for complying with the New Dietary Ingredient (NDI)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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