As a foreword, I regularly donate money To support this activity. I believe our freedom To obtain alternative To
traditional medicine is vital To our health and the future health of every man, woman and child on this planet.
The future is at risk. Carl the Poet

March 24, 2009

Dear Carl,

I have a lot To tell you about… too much for one email.  There is a lot happening in Washington these days!  So I will break up the news into
a series of emails over the several days.

The first few emails will focus on concerning developments (potential problems) in the health care policy field that you need To know about.  
The latest actions of both Congress and the Obama Administration point toward increased government oversight and regulation of food
and nutritional supplements, which is likely To have a negative impact on Natural Health and Health Freedom.

The final emails in the series will focus on what we can do (solutions) To protect Natural Health and Health Freedom.  There is a group of
people that is planning coordinated actions To defend our freedom To choose Natural Health.  I am a part of this group, and I will give you a
summary of what is being planned.

Here is information on the first of the recent developments I am concerned about:

On January 29, 2009, the U.S. Government Accountability Office (GAO) presented a “Report To Congressional Requesters”
entitled, “DIETARY SUPPLEMENTS: FDA Should Take Further Actions To Improve Oversight and Consumer Understanding.”

The GAO’s mission:
the GAO is “the audit, evaluation, and investigative arm of Congress, exists To support Congress in meeting its
constitutional responsibilities and To help improve the performance and accountability of the federal government for the American people.  
GAO… provides analyses, recommendations, and other assistance To help Congress make informed oversight, policy, and funding
decisions.”

Why GAO did this study: four powerful members of Congress requested the report.  In the words of the GAO in the
“Highlights” of the report:

Dietary supplements and foods with Added dietary ingredients, such as vitamins and herbs, constitute multibillion dollar industries.  Past
reports on the Food and Drug Administration’s (FDA) regulation of these products raised concerns about product safety and the
availability of reliable information.  Since then, FDA published draft guidance on requirements for reporting adverse events – which are
harmful effects or illnesses – and Current Good Manufacturing Practice regulations for dietary supplements.  GAO was asked To examine
FDA’s (1) actions To respond To the new serious adverse event reporting requirements, (2) ability To identify and act on concerns about
the safety of dietary supplements, (3) ability To identify and act on concerns about the safety of foods with Added dietary ingredients, and
(4) actions To ensure that consumers have useful information about the safety and efficacy of supplements.

The four “Congressional Requesters:”

1.      Congressman Henry Waxman, Chairman of the Energy and Commerce Committee
2.      Congressman John Dingell, Chair Emeritus of the Energy and Commerce Committee
3.      Congressman Bart Stupak, Chairman of the Energy and Commerce Committee’s Subcommittee on Oversight and Investigations
4.      Senator Richard Durbin
It is important To note that, according To
Citizens for Health, Congressmen Waxman and Dingell, and Senator Durbin “have been skeptics
– if Not outright critics – of DSHEA [the Dietary Supplement Health and Education Act of 1994 – the law that established America as a
‘safe haven’ for dietary supplements] and the dietary supplement industry for years.”

The GAO organized its Comments into four areas:
1.      The FDA has insufficient information from the industry about dietary supplements and manufacturing operations To be effective.
2.      The FDA has applied insufficient resources To properly oversee dietary supplements.
3.      The FDA has insufficient authority To remove products from the market.
4.      The FDA needs To do more To educate the public about dietary supplements.

GAO Comments that cause the most concern:
According To several experts we spoke with, [the FDA's] regulatory approach [To supplements under DSHEA] has fallen short in
protecting U.S. consumers in the past.

[Even though reported adverse events average about 500 per year], the FDA recently estimated that the actual number of total adverse
events… related To dietary supplements per year is over 50,000…
It is important To note that there are no published, proven reports that back up this 50,000 figure.  Nobody knows where this number comes
from.

It is Also important To note that, according To
Citizens for Health, “the average adverse events reported for pharmaceuticals each year for
the past 5 years is over 300,000.”
What GAO Recommends:
From the “Highlights” of the report:

    GAO recommends that the Secretary of Health and Human Services direct the Commissioner of the FDA To request
    additional authority To oversee dietary supplements, issue guidance on new dietary ingredients and To clarify the
    boundary between dietary supplements and foods with Added dietary ingredients, and take steps To improve consumer
    understanding of dietary supplements.  In commenting on this report, FDA generally agreed with GAO’s
    recommendations.
    In greater detail from the body of the report:
    1.      Dietary supplement companies should be required To identify themselves as a dietary supplement company as
    part of the existing registration requirements, and they should be required To update this information annually; they
    should be required To provide a list of the products they sell and a copy of the labels, updated annually; and they
    should be required To report all adverse events related To dietary supplements, Not just major events.
    2.      The FDA should issue guidance To clarify when an ingredient is considered a new dietary ingredient, the evidence
    needed To document the safety of new dietary ingredients, and appropriate methods for establishing ingredient identity.
    3.      The FDA should provide guidance To industry To clarify when products should be marketed as either dietary
    supplements or conventional foods formulated with Added dietary ingredients.
    4.      The FDA should work better To educate consumers about the safety, efficacy, and labeling of dietary supplements.
The Full report is here: GAO Report on Supplements Jan2009.pdf
My take on this: these powerful members of Congress requested this report in order To set the stage for a new attack on DSHEA, the
current law that protects our freedom To buy and consume dietary supplements, free from government interference.
Watch for more in the next update…
Thanks for your help. It's an honor To represent you in Washington !


Warmest regards,
Greg
Greg Mitchell
Representing the
American Wellness Coalition in Washington , D.C.
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