My
last post on Vital Votes about a recent FDA initiative not warranting alarm
caused quite a stir -- and received well more than 100 comments.
Despite what I feel was a "false alarm" with the FDA initiative noted
previously, Senate bill S1082 -- The FDA Revitalization Act -- does present some
threat. This upcoming bill (which could be voted on as early as tomorrow) could
be yet another one of the FDA's sneaky tricks. Again, I paid my attorney who
defends against FDA actions to review this bill and provide a quick summation:
My Attorney's Review of S1082
There are several different versions of this bill floating around. One is simply
a reauthorization of the user fees legislation. Another creates a not-for-profit
foundation who is to advise FDA on scientific matters. Many are concerned that
this foundation is a backdoor way of attacking DSHEA. The foundation, however,
has no regulatory authority but it could evaluate safety issues related to all
products regulated by FDA and provide recommendations.
So, in a sense, it could have an impact. The threat to supplements at this
point would be minimal because the funding is no more than 1.5 million a year
-- but could, in years to come, be more significant if the foundation is actually
provided with funding through private sources. I do believe some are using the
bill to hype up business.
Quite frankly, I oppose it because it creates a useless Foundation that will
be subject to the whims of politicians and does not add anything to the National
discourse on health care. And it could have a negative impact on complementary
and alternative health care in the future (but not the foreseeable future).
Summary -- Plus Action Steps You Can Take
Whether the threat is short-term or long-term, you can take action by calling
or faxing your Senators and telling them you are opposed to bill S1082 -- the
Food and Drug Administration Revitalization Act (there is probably not enough
time to write them about it at this point). You can locate your Senators at
http://www.senate.gov.
Many comments
from my 4/27/07 FDA article also had helpful suggestions.
For more information, you may also want to view an article by Byron Richards,
CCN about this issue: Dietary
Supplements Threatened, Freedom in Danger.