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The Nutritional
Health Alliance
(NHA) has received
inquiries on the
status of the Food
and Drug Administration’s Draft
Guidance for New Dietary Ingredient
(NDI) notifications. The comment
phase is now closed, and the FDA is
reviewing the feedback it has received
(reportedly over 150,000 comments!).
While the FDA is reviewing these comments,
our health freedom hangs in
the balance.
In other words, right now is the perfect
time for health freedom fighters to
ramp up the pressure and urge elected
officials to squash this ill-conceived
draft guidance before it is cemented in
place. A concerted effort to save health
freedom is needed to tip the scales
back in our favor—and ensure that we,
along with future generations of
Americans, will always have access to
safe, natural nutritional supplements.
A Promising Development
We must keep voicing our opposition
to the NDI draft guidance, especially
because it appears that our voices are
spurring elected officials into action.
On March 29, 14 members of Congress
sent a letter to the FDA commissioner
pointing out the many flaws of the
NDI draft guidance and requesting a
“significant” revision of the document.
The members of Congress accurately
point out that the FDA’s proposed
draft guidance seems to undermine the
Dietary Supplement Health and
Education Act (DSHEA) by imposing a
pre-market review process that is usually
reserved for drugs. DSHEA has
already established that nutritional
supplements are foods—not drugs.
The 14 Congressional members also
point out that the NDI guidance will
require multiple, redundant filings for
a single new dietary ingredient—which
needlessly complicates a long-standing
practice in a way that places unreasonable
burden on nutritional supplement
manufacturers.
In addition, the Congressional members
seem to take a strong stand in
defending and praising the innovation,
outstanding track record for safety and
economy-stimulating practices of the
nutritional supplement industry. In
fact, their letter goes so far as to tell
the FDA that at this time, “We should
be encouraging, rather than hindering
[nutritional supplement manufacturers’]
efforts.”
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Keep It Consistent—And
Maintain the Pressure
In closing their letter, the representatives
urge the FDA to rework the draft
legislation in a way that is consistent
with DSHEA. And really, that is all we
are asking for. This groundbreaking
legislation was designed to help
Americans achieve good health and
greater well-being by making supplements
abundant and affordable. We
must not allow DSHEA to be rewritten,
retooled or reinterpreted. By
upholding DSHEA we will not only
protect our health freedom, but protect
an industry that is creating jobs
and promoting good health throughout
the United States.
The 14 members of Congress who
have taken a stand to preserve health
freedom by opposing the FDA draft
guidance are listed below, along with
their home state and Washington, DC,
office fax number (area code 202
except where indicated). Take a
moment to send them a fax to express
your gratitude, and ask them to continue
fighting for health freedom:
Brett Guthrie, Kentucky, 226-2019;
Joe Barton, Texas, 225-3052;
John
Shimkus, Illinois, 225-5880;
Ed
Whitfield, Kentucky, 225-3547;
Mary
Bono Mack, California, 225-2961;
Lee
Terry, Nebraska, 226-5452;
Mike
Rogers, Michigan, 225-5820;
Marsha
Blackburn, Tennessee, 225-3004;
Sue
Myrick, North Carolina, 225-3389;
Brian Bilbray, California, 225-2558;
Charles Bass, New Hampshire, 225-
2946;
Bob Latta, Ohio, 800-278-8203;
Gregg Harper, Mississippi, 225-5797;
Adam Kinzinger, Illinois, 225-3521.
Stay tuned: The supplement industry
is joining forces for a major call-toarms
against NDI guidance. Visit
this website for up-to-the-minute
news!
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