Guest guest Posted January 6, 2004 Report Share Posted January 6, 2004 SENATOR CLINTON FINALLY RESPONDS TO MY LETTERSI have not heard a word from U.S. Senator Chuck Schumer (NY). But after manyweeks, repeated phone calls, three letters (and then publishing one of myletters and sending their office a copy), I did get the following responsefrom Senator Clinton:"December 23, 2003"Dear Dr. Saul:"Thank you for taking the time to share with me your concerns regarding theDietary Supplement Safety Act of 2003. I would like to take a moment toupdate you on this bill and why this bill is important to protect the healthand safety of all Americans."Recently the supplement ephedra has been linked to an increasing number ofdeaths in high school, college and professional athletes and others. Thesupplement is commonly used by teenagers and young adults to lose weight andoptimize physical performance. Had we known the consequences sooner, thesedeaths could have been averted."At the same time, I strongly believe that dietary supplements with ahistory of safe use can be part of an overall individual program to improvehealth and wellness, and I oppose attempts to eliminate the availability ofimportant vitamins or other products."Under current law, unlike drug manufacturers, dietary supplementmanufacturers are not required to prove safety or efficacy prior tomarketing a product. Instead, the Food and Drug Administration (FDA) mustprove that a supplement poses a significant or unreasonable risk of illnessin order to take action. However, the lack of reporting and data about theeffects of the supplements make it impossible to prove that a health threatexists."This bill ensures that dietary supplement manufacturers continue to beprotected from the pre-market testing required of drug companies. It evenensures that the FDA must meet the same standard of showing significant orunreasonable risk of illness before taking action. The only change is thatit requires reporting so that the data exists for FDA to examine, and givesthe manufacturer a chance to submit alternative data, demonstrating that thedietary supplement is safe."I believe that we should preserve a role for healthy lifestyles thatinclude dietary supplements. I also believe that good reporting andcollection of data that enable us to monitor the safety of supplements ispart of necessary oversight to ensure the health and safety of young people,athletes, and others who rely on manufacturers and the FDA when deciding touse these products. For this reason, I am a co-sponsor of Senator Durbin'sDietary Supplement Safety Act of 2003 modeled after the American MedicalAssociation's recommendations. It requires dietary supplements manufacturersto 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, Iam a co-sponsor the DSHEA Full Implementation and Enforcement Act of 2003,introduced by Senators Harkin and Hatch. This bill provides increasedfunding so the FDA can have the resources to support DSHEA and protect thehealth and safety of all Americans."I appreciate and respect your strongly held views. Please be assured that Iwill continue to work on behalf all New Yorkers and all Americans to ensurethat the best and most appropriate public health standards are in place.Thank you again for contacting me. Please check my website athttp://clinton.senate.gov for regular updates on this and the many otherimportant health issues being discussed before the United States Senate."Sincerely yours,Hillary Rodham Clinton"ERRORS IN SENATOR CLINTON'S REASONINGFirst, the ephedra issue is a legislative smokescreen. A simple reading ofthe so-called "Dietary Supplement Safety Act of 2003 (S. 722) reveals thereal FDA agenda: to gain control over all supplements, especially vitamins.Here are actual excerpts from the bill just as it is now being proposed inthe 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 dietarysupplement experience" means an adverse event that is associated with theuse of a dietary supplement in a human, WITHOUT REGARD TO WHETHER THE EVENTIS KNOW TO BE CAUSALLY RELATED TO THE DIETARY SUPPLEMENT."Think about that and re-read it. This is federal legislation based onhear-say. Do you think that is a good idea?How about this section:"(d) SAFETY REVIEW FOR POSSIBLY DANGEROUS DIETARY SUPPLEMENTS `(1) INGENERAL- If a clinical evaluation by the Secretary (of the FDA) of **ONE(1)** or more serious adverse events indicates that a dietary supplement ora dietary ingredient contained in a dietary supplement appears to present asignificant or unreasonable risk of illness, the Secretary may require themanufacturers of the dietary supplement, or of a dietary ingredientcontained in a dietary supplement, to submit to the Secretary datademonstrating that the dietary supplement containing the dietary ingredientis safe."This section of the law says that just one single adverse report is enoughto trigger FDA crackdown on any supplement. Now take this together with thefirst section, which states that the supplement does not even have to causean 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, automaticallyhands FDA absolute power to judge and restrict that supplement. As FDA has along and well-documented history of bias against supplements, FDA supplementrulings can be expected to be favorable to pharmaceutical interests andwelcomed by medical societies.Here is what FDA can do next:(2) APPROVAL OR DISAPPROVAL OF CONTINUED MARKETING- As soon as practicableafter receiving data required under paragraph (1), the Secretary shallreview the data and issue a determination that-- `(A)(i) the dietarysupplement is safe; and `(ii) the continued marketing of the dietarysupplement is approved; or `((i) the dietary supplement is not safe or hasnot 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 toregulate all supplements. Do not be fooled.WHY IT'S NOT ABOUT EPHEDRA:FDA WANTS TO GRAB CONTROL OF YOUR VITAMINSMany of my readers, who have become letter-writing citizen activists, haveindicated that many a misguided Senator supporting S. 722 is making much ofthe alleged dangers of ephedra. Do you see the word "Ephedra" anywhere inthe proposed law as quoted above?Here is the bill in its entirety: http://www.doctoryourself.com/limitUSA.htmDo 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 becausethis proposed law, and all laws like it, have broad purpose. They arewell-planned, premeditated power-grabs intended to usurp the rights of afree people to freely purchase nutritional supplements.By slyly not targeting any particular supplement, FDA stands to gain totalcontrol over all of them."SAFETY" or DOLLAR SIGNS?The proposed so-called "Dietary Supplement Safety Act of 2003" (S. 722) isunnecessary to ensure public safety. Here is evidence why: FDA has alreadygone ahead and banned ephedra! As I have said for a long time, FDA hasalways had the power to remove any suspected harmful product from theshelves at any time. No delays are involved: FDA can pull any dangerous foodor drug immediately.FDA's ephedra ban proves it. Even though S. 722 is still a bill pending inSenate committee, FDA banned ephedra anyway, without it.And in this instance, I do not completely disagree with this individual FDAaction. But I most strongly oppose handing the Secretary of the FDA theabsolute 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 isnot about safety, as deceptively claimed. "Safety" is the excuse offered upto the public to hide a broad-based power grab that can and will limit youraccess 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" athttp://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'sDietary Supplement Safety Act of 2003 modeled after the American MedicalAssociation's recommendations." Is that supposed to be a persuadingendorsement? It sure doesn't do it for me. To ask the AMA for advice aboutsupplements 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. FOODAND DRUG ADMINISTRATION ABSOLUTE, BLANKET POWER TO REGULATE YOUR ACCESS TOEVERY SINGLE SUPPLEMENT YOU MAY USE.Do you think that is right? If you do, then you need do nothing. But if youoppose FDA regulating your access to supplements, and S. 722 would do noless, then you have a task in front of you: write your senators, again, andback 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) proposedlaw at http://thomas.loc.gov . In this case, type in "S. 722" into thesearch box.)SOME HEADLINE HOCUS-POCUSHear are two actual headlines that recently appeared, concurrently, in thenews media:1) "FDA BANS EPHEDRA"2) "FDA PANEL RECOMMENDS OVER-THE-COUNTER 'MORNING AFTER' PILL"To quote Moe of the Three Stooges, "Is everybody dumb?" Here is analmost comical but entirely real-life oxymoronic situation, rendering anycommentary I could offer pretty much superfluous.I've said it before and I'll say it again: FDA really stands for "FavorsDrugs Always." Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.