the July 4 holiday weekend, hoping to limit media attention, the FDA
dropped a bomb on dietary supplements. Don’t let them get away with it! A new Action Alert.
On July 1, the US Food and Drug Administration issued draft guidance for complying with the New Dietary Ingredient (NDI) notification protocols
contained in the Dietary Supplement Health and Education Act (DSHEA).
Ever since DSHEA was enacted in 1994, supplement manufacturers have had
very little guidance on what counts as an NDI and when or how to send an
NDI notification. The government has arbitrarily ignored or enforced
this section of DSHEA, doing as it liked, without spelling out the
Why does this
matter? Because when you hear New Dietary Ingredient (NDI), substitute
“New Supplement” in your mind. What we are dealing with here is whether
the supplement industry is allowed to innovate and create new
supplements—and if so, under what rules.