FDA monitors adverse events (negative side effects) for dietary
supplements as part of the Special Nutritionals Adverse Event Monitoring
System (SN/AEMS) program. It contains a few thousand reports --
which is a very small number compared with adverse event reports
though this database is small, it is much larger than what it should
be. It is believed to contain many reports unrelated to the effect
of any dietary supplement. The reports within are completely unscreened.
This results in inaccuracies -- such as multiple reports of the
same incident. Such an unregulated system is highly vulnerable to
fraud and error.
the FDA regularly cites AERs in this system as a reason why dietary
supplements present a significant safety problem. FDA spends considerable
resources on public affairs to inform the consuming public of safety
concerns. This often takes the form of press releases that warn
about the dangers of dietary supplements. Such allegations are often
accompanied by claims that the FDA's hands are tied by DSHEA which
prevents them from adequately protecting the public.
DSHEA authorizes the FDA to pull dangerous products from the shelf,
so they in fact have authority to act on any product that presents
a serious threat. They have exercised this authority on only a handful
of occasions. The burden of proof is on the FDA to find a product
unsafe before it can be pulled from the market. This is appropriate
given the extraordinary safety record of dietary supplements.
appears that FDA efforts are aimed primarily at expanding their
control by convincing the public that more regulation is needed.
They lobby for a more sweeping role where they preappove dietary
supplements before they may be sold and thus act as gatekeeper.
This would give the FDA the power to prevent products from entering
the market until the agency gets around to determining that the
product is safe and, in its opinion, effective and worthy of being
the FDA had such power, we can expect dietary supplements to follow
the course that pharmaceuticals have taken under FDA control or
that dietary supplements have taken in Germany where they are regulated
more stringently. Products would be banned from the market and not
returned unless and until approval is granted (which can take years).
In addition, dramatic price inflation would ensue making dietary
supplements unaffordable to people who would otherwise have the
means to purchase them.
than lobby to expand their regulatory power, the FDA would better
serve consumers by acting in accordance with the proven safety record
of dietary supplements and striving for less rather than more regulation.
also our section on industry initiatives
for tracking AERs.