I have not heard a word from U.S. Senator Chuck Schumer (NY). But after
many weeks, repeated phone calls, three letters (and then publishing one of my letters and sending their office a copy), I did get the following response from Senator Clinton:

December 23, 2003

Dear Dr. Saul:

"Thank you for taking the time to share with me your concerns regarding the Dietary Supplement Safety Act of 2003. I would like to take a moment to update you on this bill and why this bill is important to protect the health and safety of all Americans.

"Recently the supplement ephedra has been linked to an increasing number of deaths in high school, college and professional athletes and others. The supplement is commonly used by teenagers and young adults to lose weight and optimize physical performance. Had we known the consequences sooner, these deaths could have been averted.

"At the same time, I strongly believe that dietary supplements with a history of safe use can be part of an overall individual program to improve health and wellness, and I oppose attempts to eliminate the availability of important vitamins or other products.

"Under current law, unlike drug manufacturers, dietary supplement manufacturers are not required to prove safety or efficacy prior to marketing a product. Instead, the Food and Drug Administration (FDA) must prove that a supplement poses a significant or unreasonable risk of illness in order to take action. However, the lack of reporting and data about the effects of the supplements make it impossible to prove that a health threat exists.

"This bill ensures that dietary supplement manufacturers continue to be protected from the pre-market testing required of drug companies. It even ensures that the FDA must meet the same standard of showing significant or unreasonable risk of illness before taking action. The only change is that it requires reporting so that the data exists for FDA to examine, and gives the manufacturer a chance to submit alternative data, demonstrating that the dietary supplement is safe.

"I believe that we should preserve a role for healthy lifestyles that include dietary supplements. I also believe that good reporting and collection of data that enable us to monitor the safety of supplements is part of necessary oversight to ensure the health and safety of young people, athletes, and others who rely on manufacturers and the FDA when deciding to use these products. For this reason, I am a co-sponsor of Senator Durbin's Dietary Supplement Safety Act of 2003 modeled after the American Medical Association's recommendations. It requires dietary supplements manufacturers to report serious adverse experiences and to investigate such occurrences.  The New York State Senate is considering similar legislation.

"I also think that existing laws should be properly enforced. Therefore, I am a co-sponsor of the DSHEA Full Implementation and Enforcement Act of 2003,introduced by Senators Harkin and Hatch. This bill provides increased funding so the FDA can have the resources to support DSHEA and protect the health and safety of all Americans.

"I appreciate and respect your strongly held views. Please be assured that I will continue to work on behalf all New Yorkers and all Americans to ensure that the best and most appropriate public health standards are in place.

"Thank you again for contacting me. Please check my website at <http://clinton.senate.gov> for regular updates on this and the many other important health issues being discussed before the United States Senate.


"Sincerely yours,


Hillary Rodham Clinton"
 

ERRORS IN SENATOR CLINTON'S REASONING

First, the ephedra issue is a legislative smokescreen. A simple reading of the so-called "Dietary Supplement Safety Act of 2003 (S. 722) reveals the real FDA agenda: to gain control over all supplements, especially vitamins. Here are actual excerpts from the bill just as it is now being proposed in the U.S. Senate. Only the emphasis is added:

"SEC. 416. ADVERSE EXPERIENCES WITH DIETARY SUPPLEMENTS. (a) DEFINITIONS

(1) ADVERSE DIETARY SUPPLEMENT EXPERIENCE- The term "adverse dietary supplement experience" means an adverse event that is associated with the use of a dietary supplement in a human, WITHOUT REGARD TO WHETHER THE EVENT IS KNOW TO BE CAUSALLY RELATED TO THE DIETARY SUPPLEMENT."

Think about that and re-read it. This is federal legislation based on hear-say. Do you think that is a good idea?

How about this section:

"(d) SAFETY REVIEW FOR POSSIBLY DANGEROUS DIETARY SUPPLEMENTS

(1) IN GENERAL- If a clinical evaluation by the Secretary (of the FDA) of **ONE (1)** or more serious adverse events indicates that a dietary supplement or a dietary ingredient contained in a dietary supplement appears to present a significant or unreasonable risk of illness, the Secretary may require the manufacturers of the dietary supplement, or of a dietary ingredient contained in a dietary supplement, to submit to the Secretary data demonstrating that the dietary supplement containing the dietary ingredient is safe."

This section of the law says that just one single adverse report is enough to trigger FDA crackdown on any supplement. Now take this together with the first section, which states that the supplement does not even have to cause an adverse effect to be considered dangerous.

What have you got? You have this: A single complaint about any supplement, even if such complaint is absolutely groundless and false, automatically hands FDA absolute power to judge and restrict that supplement. As FDA has a long and well-documented history of bias against supplements, FDA supplement rulings can be expected to be favorable to pharmaceutical interests and welcomed by medical societies.


Here is what FDA can do next:

(2) APPROVAL OR DISAPPROVAL OF CONTINUED MARKETING- As soon as practicable after receiving data required under paragraph (1), the Secretary shall review the data and issue a determination that-- (A)(i) the dietary supplement is safe; and (ii) the continued marketing of the dietary supplement is approved; or (B)(i) the dietary supplement is not safe or has not been shown to be safe under ordinary or frequent conditions of use; and (ii) the continued marketing of the dietary supplement is disapproved."

This section confirms the bill's intent to give FDA absolute power to regulate all supplements. Do not be fooled.


WHY IT'S NOT ABOUT EPHEDRA:

FDA WANTS TO GRAB CONTROL OF YOUR VITAMINS

Many of my readers, who have become letter-writing citizen activists, have indicated that many a misguided Senator supporting S. 722 is making much of the alleged dangers of ephedra.  Do you see the word "Ephedra" anywhere in the proposed law as quoted above?

Here is the bill in its entirety:

<http://www.doctoryourself.com/limitUSA.htm>

Do you see the word "ephedra" anywhere in the text of S. 722? That's right, you don't. It is not there at all, not even once. Yet alleged ephedra deaths are the clear focus of Senator Clinton's letter, as well as that of many other Senators who have provided responses.

The reason you do not see the word "ephedra" anywhere in S. 722 is because this proposed law, and all laws like it, have broad purpose. They are free people to freely purchase nutritional supplements.

By slyly not targeting any particular supplement, FDA stands to gain total control over all of them.

"SAFETY" or DOLLAR SIGNS?

The proposed so-called "Dietary Supplement Safety Act of 2003" (S. 722) is unnecessary to ensure public safety. Here is evidence why: FDA has already gone ahead and banned ephedra! As I have said for a long time, FDA has always had the power to remove any suspected harmful product from the shelves at any time. No delays are involved: FDA can pull any dangerous food or drug immediately.

FDA's ephedra ban proves it. Even though S. 722 is still a bill pending in Senate committee, FDA banned ephedra anyway, without it.

And in this instance, I do not completely disagree with this individual FDA action. But I most strongly oppose handing the Secretary of the FDA the absolute and dictatorial control as S. 722 would provide. It is overkill, and intentionally so.

Senator Clinton's response fails to show that she comprehends this. Euphemistically named "The Dietary Supplement Safety Act of 2003," S.722 is not about safety, as deceptively claimed. "Safety" is the excuse offered to the public to hide a broad-based power grab that can and will limit your access to vitamin supplements. If you do not believe this, look at what has already happened in Britain, Australia and in most of Europe.

A site search for "CODEX" at <http://www.doctoryourself.com> will provide background information.

I think it is really all about money: medical industry money.

Here is one reason why I say so. Senator Clinton wrote, "Senator Durbin's Dietary Supplement Safety Act of 2003 modeled after the American Medical Association's recommendations." Is that supposed to be a persuading endorsement? It sure doesn't do it for me. To ask the AMA for advice about supplements is like asking the devil what church you should attend.

Here, then, is the real story: S. 722 GIVES THE SECRETARY OF THE U.S. FOOD AND DRUG ADMINISTRATION ABSOLUTE, BLANKET POWER TO REGULATE YOUR ACCESS TO EVERY SINGLE SUPPLEMENT YOU MAY USE.

Do you think that is right? If you do, then you need do nothing. But if you oppose FDA regulating your access to supplements, and S. 722 would do no less, then you have a task in front of you: write your senators, again, and back them down with the truth. Do your senator (and the nation) a favor: write today! And please send me a copy of your response.

(Remember that you can read the full text of this (and any other) proposed law at <http://thomas.loc.gov> . In this case, type in "S. 722" into the search box.)

SOME HEADLINE HOCUS-POCUS

Hear are two actual headlines that recently appeared, concurrently, in the news media:

1) "FDA BANS EPHEDRA"

2) "FDA PANEL RECOMMENDS OVER-THE-COUNTER 'MORNING AFTER' PILL"

To quote Moe Howard of the Three Stooges, "Is everybody dumb?" Here is an almost comical but entirely real-life oxymoronic situation, rendering any commentary I could offer pretty much superfluous. I've said it before and I'll say it again: FDA really stands for "Favors Drugs Always."

Reprinted with permission from the DOCTOR YOURSELF NEWSLETTER and the http://www.doctoryourself.com website. Copyright 2004 and previous years Andrew W. Saul. All rights reserved. Email: drsaul@doctoryourself.com  Andrew Saul is Contributing Editor for the Journal of Orthomolecular Medicine http://www.orthomed.org. He is the author of the book "DOCTOR YOURSELF: Natural Healing that Works." His DOCTOR YOURSELF NEWSLETTER is free of charge by email. To subscribe: dynews-subscribe@doctoryourself.com