WHY SENATE BILL 1082 IS A DANGER TO SUPPLEMENTS

[Guest guest]

May 2, 2007

 

 

 

Senate Bill 1082 began as a reauthorization bill for the drug-fee

requirements for pharmaceutical companies that were seeking FDA

approval of their drug products. It has now been revised so many

times it is becoming what is known as a legislative sausage with

perhaps some 5-6 other amendments in the works.

 

And even as we write this, S.1082 is being held in abeyance while

a " Manager's Amendment " (technical amendments only) is being made to

the bill. Senator Dick Durbin has also jumped into the act but not

with his so-called " Safe Food Act " ; instead, his proposed amendment

will make corrections to existing Food, Drug, and Cosmetic Act law.

In short, more FDA authority for food inspections, more money for

food inspections, and user fees for food producers. That is, big-

food companies and not supplement makers would pay these fees. And

his amendment would not move food functions out of the FDA, leaving

supplements to be regulated as drugs.

 

At the same time, Senator Dorgan is attaching as an amendment to

S.1082 his bill to allow the importation of prescription drugs from

Canada and other countries. These imported drugs, while usually

manufactured in exactly the same facility as American drugs, are

significantly cheaper than American-sold drugs and of usually the

same quality. Senator Dorgan has enough votes behind him to make his

amendment stick. The proponents of S.1082 detest this amendment and

are making efforts to eliminate it. This means that the bill is not

as yet close to being voted on; but, as always, events in the Senate

on this matter are changing rapidly so it is best to act as if the

bill could pass at any time.

 

Regardless, the current version of S.1082 warrants strong opposition

from all of us for the following reasons:

 

It would create a so-called " Foundation " seemingly independent of the

FDA but in reality nothing more than a side-kick of the FDA and its

pharmaceutical-industry partners. Seven of its twelve board members

would be from the drug industry and the government. This " fatal

embrace " partnership - antithetical to supplements - would dominate

this new organization.

 

 

This Foundation would purportedly be scientific, with an aura of

scientific responsibility; but in reality, the Foundation would be a

political animal subject to the whims of politics and not rational

science. No good could ever come from such an organization, which

would simply provide political cover for anti-supplement actions.

 

 

Ostensibly intended to accelerate the drug-approval process, the

Foundation will - we predict - simply increase drug-approval costs

and the time involved in obtaining approval.

 

 

On the " research " front, the real risk here is one that parallels the

ephedra legal case that Washington attorney Jonathan Emord and his

clients have been fighting and that we all hope will result in a

favorable decision from the U.S. Supreme Court. That is, under

current law, foods are presumed to be safe and there is no need to

prove their efficacy (unlike drugs). The risk here is that the

supposedly " independent " (but most likely biased) Foundation will

consider and assess as risky certain dietary supplements on a case-by-

case basis that will then lead to their removal from the marketplace

by the FDA. The Foundation, and the presumptions behind it, create a

slippery slope and an environment for this to happen. This is quite

dangerous.

While S.1082 as it is presently constituted (and this could change as

events develop) is not an immediate danger to dietary supplements,

the National Health Federation sees the bill as an intermediate and

long-term threat that warrants strong and immediate opposition from

all of its members and supporters. Let's kill this bill in its

cradle.

 

Therefore, we urge all NHF members to immediately contact their

Senators to express their opposition to this bill. If your Senator

will not oppose and vote against it, then suggest that your Senator

sponsor an amendment to eliminate any reference, direct or indirect,

to " food " or " food ingredients " and to express your strong support

for the Dorgan amendment to allow the importation of prescription

drugs from Canada and other countries.

 

If for some reason S.1082 passes the Senate, rest assured that the

NHF will be engaged in grassroots lobbying and professional lobbying

against House consideration of similar legislation. And, even if

this legislation were to pass both houses of Congress, then the NHF

will take action against the FDA's enactment of implementing

regulations.

 

 

 

To view Senate Bill 1082 The Food and Drug Revitalization Act

http://help.senate.gov/Hearings/2007_04_18_E/S1082.pdf

 

To View The Sample Petition Letter: (click here )

 

 

 

Click on this address to find your U.S. Senators:

http://www.senate.gov

 

Click on the following links for individual mailing addresses for

letter writing and other contact info for Congress Members: Senate

Fax | List For Congress

 

 

 

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About the National Health Federation

 

Established in 1955, the National Health Federation is a consumer-

education, health-freedom organization working to protect

individuals' rights to choose to consume healthy food, take

supplements and use alternative therapies without government

restrictions. With consumer members all over the world, and a Board

of Governors and Advisory Board containing representatives from 6

different countries, the Federation is unique is being the only

consumer health freedom organization in the world to enjoy official

observer status with the Codex Alimentarius Commission.

 

 

 

Click here for the permanent link to this press release, use this

link to inform others.

 

 

 

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