ingredient prior to October 1994. New ingredients or formulations introduced after
1994 would be reclassified as an NDI and
subject to review.
How ‘Old’ Becomes ‘New’
This sounds reasonable, but there’s a
catch: Since there was no official definition of“dietary supplement” or“dietary ingredient” prior to DSHEA in 1994, it could
be hard to prove something was in fact a
dietary ingredient in the pre-DSHEA era.
Under the new guidelines, many old ingredients could be reclassified as NDIs—
and subject to costly review—if any aspect
of the formulation has changed.
Several industry thought leaders have
pointed out that any change in a supplement’s formulation, manufacturing
process, dosage or delivery form could
reclassify an ingredient as an NDI, and
require it to undergo a quasi-pharma
level of safety review.
One could argue, for example, that turmeric is a naturally occurring substance
that’s been part of the food supply for centuries prior to passage of DSHEA.
But a highly purified isolate of curcumin extracted from turmeric? That might
not fly under the FDA’s new proposed
rules, meaning that any or all curcumin
supplements could be pulled from the
market until FDA completes exhaustive
Some medical people might consider
the increased safety scrutiny to be a good
thing. There’s no question there are holes
in existing supplement regulation. But
given how widely supplements are used—
a recent estimate published in JAMA indicated that 52% of all U.S. adults use these
products regularly—the incidence of sup-plement-related adverse events remains
The United Natural Products Alliance
estimated that compliance with the new
rules as written could cost manufacturers
somewhere between $2 billion and $6 billion annually, and will strongly discourage
companies from developing new formulations or introducing new ingredients.
There will be heavy costs on the federal
side as well. Unless Congress markedly
augments the FDA’s budget, the agency
won’t likely have the resources to handle
the surge of NDI notifications the new
guidelines would generate.
Arrivaderci, Cousin Vinnie
For a foretaste of life under the new NDI
rules, consider vinpocetine.
Just a few weeks after releasing the
NDI guidance, the FDA announced an
intention to deem this vasodilator com-
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