WHY SENATE BILL 1082 IS A DANGER TO SUPPLEMENTS

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:

1. 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.
   
   
2. 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.
   
   
3. 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.
   
   
4. 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 )

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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.

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