Guess who’s back? The
Office (GAO) has
emerged to meddle with
our health freedom once
again. In a new report, the GAO has
suggested there may be more adverse
event reports (AERs) associated with
supplements than previously believed.
The GAO also weighed in on the New
Dietary Ingredient (NDI) Draft
Guidance for supplements, recommending
that the FDA establish a time
frame for NDI implementation.
AER Shows Supplement Safety
According to the GAO’s latest analysis,
6,300 adverse events linked to nutritional
supplements were reported to
the FDA between 2008 and 2011. The
GAO also found that an additional
1,000 AERs were reported to poison
control centers and not counted by
the FDA. In its report, the GAO recommends
that the FDA access poison
control AER reports and include them
in the overall AER numbers.
Let’s do that. If we include the extra
1,000, we have 7,300 adverse events
associated with supplements over four
years. That amounts to 1,825 supplement
AERs per year. Conservatively,
183 million Americans take supplements.
Therefore, using the GAO’s
analysis figures, it appears that every
year, about 1 out of every 100,000
people taking a supplement reports an
adverse event. If the adverse events
reported were not actually caused by
supplements in some cases, this
miniscule percentage would diminish
Meanwhile, according to the federal
government’s Agency for Healthcare
Research and Quality (AHRQ), adverse
drug events (ADEs) cause 770,000-
plus injuries and deaths each year.
This amounts to 1 out of every 400
people experiencing a drug-related
adverse event—versus 1 out of every
100,000 supplement users.
GAO Encourages NDI
With this dramatic discrepancy, it
seems absurd that the GAO should be
spending any of its resources “watching”
the nutritional supplement industry!
Exacerbating matters, the GAO
takes it upon itself to “remind” the
FDA to implement NDI regulations,
which may triple resources wasted—
draining the GAO, the FDA and the
entire supplement industry.
Even more puzzling is the fact that
the GAO is not a government agency,
but an independent group. For its
2013 budget, the GAO requested
$526.2 million from Congress.
This huge taxpayer expense may be
warranted when the GAO investigates
critical national issues, such as homeland
security, toxic waste, climate
change and the economy. And
—given the huge numbers that occur
—perhaps synthetic drug adverse
event reports should be added to the
list as well.
But the GAO watchdog is barking
up the wrong tree with dietary supplements.
By the GAO’s own analysis,
nutritional supplements are overwhelmingly
safe. Plus, the nutritional
supplement industry is enjoying a
renaissance of innovation that could
forever change our nation’s health.
The GAO, in urging the FDA to implement
NDI for supplements, may
unwittingly bring this innovation to a
screeching halt—and pull thousands
of health-enhancing nutritional supplements
from store shelves, never to
be seen again.
How do you feel about the GAO’s
apparent attack on nutritional supplements?
Where would you prefer
this “government watchdog” agency
spend its tremendous resources and
$526 million budget?
As a taxpayer, you have a voice in
government spending! Write to your
elected officials today and let them
know you do not want the GAO meddling
with your health freedom. Send
a strong message to the GAO: Hands
off the dietary supplement industry!
Let your elected officials know where
you want the GAO to focus their
Fight for your health freedom, and
direct your tax dollars where they are