Upcoming Bill Strengthens FDA Power To Ban
By Nurse Mark
Machiavelli would be proud of our politicians and
our massive and bloated government bureaucracies.
CAM has come and gone, as we have reported in
previous HealthBeats - it's uproar kept us occupied and diverted for a while...
While we were thus diverted, S.1082, a bill we
talked about a few issues ago has passed the Senate, and it's companion HR 1561
is now working it's way through the House.
Something new, bill HR 2117 would stop the FDA from blocking truthful health
claims from being made on supplements and is being widely talked about and
promoted within the natural health community. This has the potential to be yet
another diversion from the dangers to supplements posed by S.1082 and it's
companion HR 2117.
Make no mistake: passing
bill HR 2117 would be a fine thing - but we must still be vigilant regarding HR
1561 as it could allow the FDA to entirely block our free access to supplements
using their "Critical Path Initiative" (sounds Orwellian, doesn't it?) and the
new and largely unproven sciences of genomics and proteomics which would be used
to challenge the safety of supplements and natural products. This bill must be
amended to prevent the FDA from using drug-based "Risk Analysis" to apply to
foods and supplements the same standards for safety applied to drugs. Using
these standards, the FDA could conceivably ban ordinary water for drinking,
based on the fact that drinking too much water too quickly can be dangerous!
Would the FDA ever do such a thing? Not likely - but they could, and certainly
would using the same sort of "Risk Analysis" reasoning to attack supplements as
they did with the supplement ephedra - an herbal substance used safely for
thousands of years but which, like any substance (including water) can be
dangerous if used improperly or irresponsibly.
HR 2117 would be a good thing for dietary
supplements - but it will mean nothing if HR 1561 passes and we no longer
have access to those supplements!
What can you do?
An amendment has been proposed that would make it
very clear that HR 1561 must not be applied to food or supplements.
It is vitally important to contact your members of
the House and keep hammering at the Senate to let them know you have not
forgotten about this issue. It is also important to send your message to
Senators Hatch and Harkin (the original designers of DHSEA - an act which holds
the FDA at bay and preserves your access to supplements) and Kennedy and Enzi
(who claim that this legislation "is not about regulating dietary supplements")
These Senators will determine the fate of this amendment when it reaches the
conference committee and they need to hear from you loud and often.
You will also want to encourage your
political representatives to support the passage of HR 2117.
To get information on contacting
To contact your House
Please send the following
message (or modify it as you see fit and send it).
HR 1561 (senate bill S.1082) -
Please Amend to Protect Dietary Supplements
June XX, 2007
The Honorable (Representative or
Senator First and Last Name)
Dear Representative (or Senator)
The Senate has recently passed bill
S1082, commonly known as the FDA Revitalization Act. I am concerned that the
legislation, as currently written, opens the door for considerable regulatory
confusion enabling the FDA to use this legislation to undermine my access to
safe and effective dietary supplements.
There must be no confusing the
safety of drugs and the safety of food and food ingredients – which are governed
by different laws. I am sure you and other members of Congress are not intending
to create such concern among the 150 million Americans who rely on dietary
supplements to assist their health, and this matter is easily corrected with the
following amendment, which will not in any way stop the FDA from identifying
truly contaminated food that poses a risk to human health.
Proposed amendment to S 1082 and
The bills are hereby amended to
prohibit the Foundation or Institute from evaluating the health benefit or
efficacy of foods, dietary ingredients, and dietary supplements and to limit
review of foods, dietary ingredients and dietary supplements to a determination
of whether they are safe. In assessing whether dietary ingredients and dietary
supplements are safe, the Foundation or Institute shall not compare product
risks with health benefits or efficacy. Instead, the Foundation or Institute
shall determine whether the product presents a significant risk of illness or
injury under conditions of use recommended or suggested in labeling, or if no
conditions of use are recommended or suggested in labeling, under ordinary
conditions of use.
Please help preserve my rights and
support this amendment.