Health Supreme by Sepp Hasslberger

Networking For A Better Future - News and perspectives you may not find in the media

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September 17, 2006

S 3546 Adverse Event Reporting Bill - A Trojan Horse?

The US Senate is considering a bill that would require mandatory AER (adverse event reporting) by manufacturers of food supplements. The opinions about the bill and the eventual effect of such new rules are diverse - even within the supplements universe.

One of the better reports about this can be found on the site of AHHA, the American Holistic Health Association. Here is what they published in July:

- - -

The U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) has approved Senate Bill 3546, a measure to require manufacturers and distributors of dietary supplements and over-the-counter (OTC) drugs to disclose all serious adverse event reports (AER) to the Food and Drug Administration (FDA). AERs are defined as events involving death, hospitalization, disability, or birth defects. With bi-partisan support, this bill is expected to pass the Senate and House.

It is interesting that the dietary supplement industry supports the bill, while the majority of health freedom groups oppose it. Industry members appear to feel they have safe products, so "no problem." Health freedom groups, however, point out how this new legislation deals with supplements as drugs, not as food (their current status). Other precedents that could be set by this legislation might be used by anti-supplement groups to erode current consumer access to dietary supplements that is unique in the U.S.

Since it is difficult to locate information on this bill, we have used our network to compile a number of sources. You can review the opposing positions. If you wish to work to support or oppose this bill, many of these organizations have lobbying efforts supporting their positions.

PRO S 3546
National Nutritional Foods Association
NNFA Statement on Adverse Event Reporting Legislation

NPI Center
Introduction of S 3546 The Dietary Supplement and Non-Prescription Drug Consumer Protection Act

Citizens For Health
Dietary supplements are safe. Senate Bill 3546 makes them even safer

CON S 3546
American Association For Health Freedom
The Dietary Supplement AER Bill - Do not support S 3546

National Health Federation
NHF Opposes S 3546

National Health Alliance
AER = 'Trial Lawyer Enrichment Act'

There is a great saying in America: "If it's not broken, don't fix it!" Of course that also means, if there is not a big problem, why make a law about it. And it seems to me we are seeing an egregious violation of that principle here.

There are documented deaths in great numbers from FDA approved and doctor prescribed medicines in the range of at least 100,000 a year in the US alone, and there is no mandatory adverse events reporting. It's voluntary for the drug companies.

In contrast, there are essentially NO deaths attributable to supplements. An exception is ephedra, but even here the attribution is more than doubtful. Aspartame in drinks for athletes is a much better candidate for having caused the sudden heart attacks that were seen in the US. Yet we have a proposal that adverse events on supplements must be reported and records kept.

Perhaps the intention is - as many in the industry seem to believe - honorable and proper. Perhaps there will not be a flood of false complaints causing supplements to be taken off the market or heavily restricted.

I believe it is good to be circumspect however. When pharmaceutical manufacturers with all their lobby power have nothing more urgent in mind than the elimination of that pesky competition from supplements to their billion dollar business, and when we see the FDA in the pockets of these pharma giants, it is hard to ascribe honorable motives to such a legislative move.

I would therefore urge you to take heed - if you care about having diverse options for your health - and inform yourself. And if you are living in the US, you might as well get into the fray and start contacting your senators and congressional representatives to let them know what you think about this new legislative move.

Here are some useful links:

S. 3546 IS GOING to the SENATE FLOOR this WEEK!

Vitamin Supplements Under Fire Again. Supplement Consumers Need To Call Their Senators Now To Stop This Dangerous Bill

House version of Adverse Events Reporting bill introduced
by Brenna Hill of - 28 September 2006

Rather unexpectedly, the House has introduced their AER bill, HR 6168. The lead sponsor is Chris Cannon, (R-UT), along with 8 other Republicans and 2 Democrats. The bill has been referred to the Energy and Commerce Committee, with little chance for consideration this year. We are finding out more information and will keep you informed.

Expect a follow-up early next week with an action alert.

Brenna Hill
Executive Director
Health Freedom Foundation and American Association for Health Freedom
4620 Lee Highway, Suite 210
Arlington, VA 22207
Fax: 703.294.6380

November 12, 2006
Hatch & Durbin plan to sneak this bill through during the NOVEMBER 13th Lame Duck session! Don't allow them to reverse our DSHEA rights.

Sources tell us that Hatch plans on passing the AER bill in the Senate on Thursday (12/7/06) in order to get this passed in the House on the suspended calendar without a hearing. It is imperative that we deluge John Boehner (House Majority leader) with e-mails, calls, and letters opposing the passage of this harmful legislation.


posted by Sepp Hasslberger on Sunday September 17 2006
updated on Friday December 17 2010

URL of this article:


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Readers' Comments

Recovered comment (some of them got swallowed up by the system)...

This will somehow be used to bring in the Codex Ailmentarius, the international control (and ban of some) vitamins.

Truly a nightmare.

By making supplements the same as drugs, I think you will see the supplement industry disappear and be taken over by big pharma.

And you won't be able to get vitamins without a prescription.

Also, the amount you get will be severely restricted.

Posted by: ??? on October 6, 2006 06:13 AM


Found on the Alt Med Forum yahoo group:

Lame Duck Congress Threatening To Pass Anti-Supplement Bill

It is a regrettable fact that our legal-political system is so often characterized by deception and ambush.

During the heated political campaigns prior to November 7, members of Congress would not dare pass a bill that would interfere with consumers' free access to dietary supplements.

Now that the election is over, there is an attempt to attach a new law onto an existing bill that would give the FDA greater powers to remove dietary supplements from the marketplace and put a heavy burden on smaller dietary supplement companies.

This ominous Senate Bill - S.3546 - is deceptively titled Dietary Supplement and Non-Prescription Drug Consumer Protection Act. The charade behind this title is that it would largely function to protect pharmaceutical companies against the low cost competition they are encountering from makers of natural alternatives to their toxic drugs.

As many of you know, this year's election was one of the closest on record. If the re-elected members of Congress know how outraged citizens will be if S.3546 is passed, it will almost certainly be killed.

To conveniently inform your members of Congress to vote NO on S.3546 and any House companion bill, just click on the "take action now" button below.

Please know that members of Congress now prefer email as the most efficient way to hear from their constituents. Life Extension has set up a super-convenient email network that enables consumers to readily identify their members of Congress and then send them prepared messages urging them to vote NO on S.3546.

Posted by: Sepp on November 16, 2006 06:10 AM


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The Individual Is Supreme And Finds Its Way Through Intuition


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