DSHEA Alert

[Guest guest]

Hello -

 

I received an urgent e-mail yesterday afternoon from the Allergy Research

Group supplement manufacturers regarding a bill put forth by Senator Kennedy (S.

1082) yesterday that will allegedly " gut " DSHEA and give the FDA much broader

power than it has now. In light of the recent threads regarding the FDA Draft

Guidance on CAM products - and the fact that that entire current issue turned

out to be a tempest in a teapot - I was hesitant to share this initially.

 

Statements within the e-mail - which the authors had requested be forwarded to

all intersted parties - claim that " Bill S1082 pretends to address drug safety

while in fact proposing a set of laws that helps hide existing risks while

ushering in the next generation of extreme drug risk (the Critical Path

Initiative). At the same time the bill dramatically broadens FDA regulatory

power to attack dietary supplements and health freedom. " This quote is from an

article by a nutritionist named Byron Richards embedded within the e-mail. Here

is a link to his analysis of the bill:

 

http://www.newswithvi ews.com/Richards/byron23.htm

 

Here is another quote from this analysis:

 

" Furthermore, the new bill seeks to allow a massive expanse of FDA regulatory

power through this new foundation. For example, on pages 106-107 the bill

states: “The purpose of the Foundation is to advance the mission of the Food

and Drug Administration to modernize medical, veterinary, food, food ingredient,

and cosmetic product development, accelerate innovation, and enhance product

safety….The Foundation shall [take] into consideration the Critical Path reports

and priorities published by the Food and Drug Administration, identify unmet

needs in the development, manufacture, and evaluation of the safety and

effectiveness, including post approval, of devices, including diagnostics,

biologics, and drugs, and the safety of food, food ingredients, and cosmetics.”

Through this foundation the FDA is seeking broad new regulatory power that it

currently does not possess. This will include the authority to attack any

dietary supplement (which are food ingredients) as unsafe based on its use of

“Critical Path” technology. "

 

 

The shrill tone of much of the information in the e-mail, similar to that

circulating in regard to the FDA Draft Guidance document, caused me to be

skeptical at first. But I did a little research and found that Sen. Kennedy had

in fact introduced the bill yesterday and that the wording of parts of the bill

seem to fall in line with what is stated in the e-mail.

 

I'm certainly not qualified to interpret legalese or read between the lines of

government legislation but I felt that this was worthy of perusal by those on

this group who are more in tune with these issues. And the strength of the

reaction by an established supplement manufacturer and the possible negative

ramifications for those of us using Chinese herbs got my attention.

 

Kim Blankenship, L.Ac.

 

 

 

 

 

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[Guest guest]

S1082 is called The Food and Drug Administration Revitalization Act.

It has been sponsored by Sen. Kennedy. It is a massive Bill, over 140

pages, and it is being hurried through the Senate at such a pace that

no one can properly digest its contents. First introduced 4/10/07,

then sent to Committee on Health, Education, Labor and Pensions on

4/24/07. There, the entire Bill was substituted with a new draft, and

released to the Senate floor without written report on 4/30/07...where

action on the Bill now takes place.

 

At the level of process, we observe the subversion of what should be a

public process of discussion. The Party that controls the chamber, in

concert with the Bill's supporters (FDA among them) make such changes

as they see fit, and then ram it through. Not a pretty sight, but an

all too common one.

 

At the level of content, I am still reading through the Bill, and will

report what I learn ASAP, probably tomorrow.

 

Best Regards,

 

David Kailin, Ph.D.,M.P.H.,L.Ac.

Author, Quality In Complementary & Alternative Medicine

http://www.convergentmedical.com

[Guest guest]

Shrill??

 

Come on Kim, You know me better than that Thanks for the alert.

 

I think this does demonstrate the general trend of the FDA.

 

David, thanks very much for your efforts!! Look forward to your analysis.

I had heard of this bill, but had not been able to check it out.

 

dr.w