Senate Bill 3546-more supplement regulation

I cut and pasted this from an email I got today:


DOCTOR YOURSELF Newsletter **EXTRA**

September 15, 2006



S. 3546 IS GOING to the SENATE FLOOR this WEEK!

The Dietary Supplement and Nonprescription and Drug Consumer Protection Act
(Adverse Event Reporting)


MUST BE OPPOSED

S. 3546 will be voted on Soon!

PLEASE CONTACT YOUR SENATORS TODAY.

ASK YOUR SENATORS TO OPPOSE THIS LEGISLATION AND UNANIMOUS CONSENT



S. 3546 may be placed before the Senators as a Roll call vote (which we
support) or by Unanimous Consent (which we oppose). Unanimous Consent may
be requested by a Senator and, once requested, will expedite the proceedings
so as to rush this bill through to passage.



There is no time to be lost. Today, not tomorrow, tell your Senators to
OPPOSE Unanimous Consent and ask that they NOT support this extremely
harmful legislation.



Reasons to Oppose S. 3546:



It will establish mandatory adverse event reporting for dietary supplements
and over-the-counter drug manufacturers.



Supplements have a proven track record of safety and should not be treated
as drugs.



If passed, it would amend the Federal Food, Drug, and Cosmetic Act (FDCA)
and will mandate needless FDA regulations that will treat supplements like
drugs. DSHEA 's intent was for supplements to be regulated as foods, not
drugs.



It will probably raise the price of supplements to consumers.



If passed, this bill could destroy the availability of effective dietary
supplements in the U.S. by wrongfully associating their usage with serious
health events when in fact it is often the drugs and other interventions
taken by the patients that actually led to the serious event.



It will ensure more federal regulation on supplements and more controls
being imposed on your healthcare choices.



The FDA currently has in place a voluntary reporting system that is working
quite well since its inception in 2003. The FDA itself has already
testified that it does not need AER reporting for supplements.



There are already FDA toll-free numbers and FDA Form 3500 in place for
anyone to submit any drug, device, or dietary supplement that has seriously
harmed anyone.



Senator Durbin has pushed extremely hard for the passage of a mandatory AER
bill and his term does not end until 2008. We must stop Durbin and stop him
now.



As stated by our lobbyist, Lee Bechtel, "The true purpose of the AER system
is to empower the FDA to take supplements off the market upon the least,
little hint (one single report if Durbin has his way) that "harm" has
occurred, even if that report is spurious."



If enacted, AER reporting would establish legislative and regulatory basis
for the FDA to make manufacturers pay "supplement User Fees" to fund AER
functions, costing the consumer.



It would give the FDA more control over market access for new supplement
products.



The AER system would unfairly impact the small natural-products companies.
If an AER is reported, the FDA demands drug-like safety data from the
manufacturer, which will be extremely expensive for the "little guys" versus
the big supplement companies, many owned by pharmaceutical companies. Many
small companies will just have to close their doors and competition will be
reduced.



The end result of this anti-supplement consumer legislation is that more
people will die than would be saved as affordable healthy supplements will
be priced out of the market.

There are at least 60 million or more supplement users and health-freedom
advocates opposed to this legislation. NOW IS THEIR TIME TO BE HEARD.



THIS COULD TRULY BEGIN THE DOWNFALL OF DSHEA LEGISLATION THAT WE ALL WORKED
SO HARD TO HAVE PASSED IN 1994.



Please OPPOSE S. 3546

Go to these links at the NHF website to OPPOSE S.3546 :

Bill information: http://www.thenhf.com/s3546is.pdf

Bill analysis by NHF Lobbyist, Lee Bechtel:
http://www.thenhf.com/government_affairs_93.htm

Sample Petition Letter:
http://www.thenhf.com/S3546_sample_petition_letter.htm

Click on this address to find your U.S. Senators: http://www.senate.gov

Click on the following link for individual mailing addresses for letter
writing and other contact info for Senate Members:
http://www.thenhf.com/U.S.%20Senate%20List%20109th%20Congress.htm


This press release was written by the NATIONAL HEALTH FEDERATION, P.O. Box
688, Monrovia, CA 91017 USA ~ 1 (626) 357-2181 ~ Fax 1 (626) 303-0642



Website: http://www.thenhf.com

E-mail: contact-us@thenhf.com



Best wishes,
A. Saul


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