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Codex Alimentarius Update: Strategic steps by
Pharmaceutical Giants
Page created 6/4/09
    Dear Members,

    Since 2004, WINHS has been providing information to our members, the media and to legislators regarding the
    anti-vitamin legislation that passed into law in Europe in 2002 and the strategic efforts of the United Nations' Codex
    Alimentarius Commission to incorporate the same anti-vitamin legislation into its own agenda for non-European
    nations.

    Many of our earlier alerts and newsletters are available  on the winhs.org web site for those of you who are new to
    WINHS. To refresh yourselves on the background simply go to http://www.winhs.org/members/newsletter_archive.
    htm

    The recent recall of the diet product "Hydroxycut" which is manufactured by Health Sciences Inc., has caused quite
    a stir in the media and, manipulated by the enormous advertising revenue from the pharmaceutical companies, the
    media focus has now turned to the U.S. main line of defence against the drug company promoted anti-vitamin
    legislation - the  Dietary Supplement Health and Education Act (DSHEA) of 1994.

    If we look at this from the earlier beginning, the true intentions may become quite clear.

    In the early 1990's a bill was proposed to harshly regulate herbs in the U.S. At that time the much smaller natural
    health industry, observing how such a law would eventually expand to target other natural health products, went
    ballistic with millions of dollars of public relations and lobby activities and phone and letter writing campaigns that
    the U.S. Congress had never run up against - before or since.

    Major celebrities came on board to defend the natural health community including actor Mel Gibson who filmed his
    own opinion of what was going on. See the 1993 PSA he taped in defence of  basic vitamins and supplements:
    http://www.youtube.com/watch?v=IV2olDA0w8U

    The result?

    A complete reversal and a new vanguard for the natural health industry was established through the passage of the
    Dietary Supplement Health and Education Act (DSHEA), signed into law in 1994.

    Clearly defeating the drug company vested interests at that time, the new pro-vitamin law enabled enormous
    expansion in areas of natural health research, clinical study and innovation which continues even today.  

    Since its passage a comparatively small boutique styled industry grew to become a $27 billion dollar major force
    and a new worldwide "safe haven" was established in the United States. Those who lived in countries that enforced
    their own anti-vitamin laws (a drug company strategy step) and reclassified vitamins and other natural products as
    medicines (another drug company strategy step) or completely disallowed their local manufacture (yes, yet another
    drug company strategy step) at least could obtain natural products from outside their own countries through mail
    order and the emerging proliferation of the internet.

    ...and all was relatively good.

Recently however, there have been numerous articles and blogs describing a situation involving death, mayhem, lawlessness, 'evil doers'
and a government's inability to protect its own citizenry.

Afghanistan? Iraq? Iran? North Korea?

No, these articles are targeting the U.S. dietary supplements industry.

And, they are not focused on "snake oil" scams or "miracle" waters - they are once again targeting VITAMINS, HERBS, AMINO ACIDS
and TRADITIONAL MEDICINES.

Notwithstanding recent high profile media reports involving Hydroxycut's contamination recall, as we reported last month, the Food and
Drug Administration
(FDA) issued 47  "cease and desist" warning letters to supplement makers last year for their product benefit
claims. You can claim a benefit from a drug, but NOT a vitamin!???!!

However, claims that dietary supplements pose an immediate threat to the American public; that the Food and Drug Administration (FDA)
is unable to protect us from an "out of control" empire; and the frantic demands for drastic and immediate action against DSHEA is simply
another strategic step, pushed by the same vested interests, to eliminate a perceived and growing "competitor" - food supplements and
other natural health products.

The vested interests?
The pharmaceutical companies - who will be the only ones legally able to manufacture vitamins - in
severely reduced dosages and in completely chemical form while making pretty much any claim they like as they do with products like
Vioxx and other potentially lethal drugs.

Open debate on topics of public health is essential, but it is equally important to watch out for intentional attempts to mislead the public into
believing that the entire dietary supplement industry consists of snake oil salesmen who are left completely unregulated by the FDA or
existing regulations when in fact the exact opposite is true.

The problem being; who ever reads anything anymore? The U.S. passed laws under this and the previous administration that have
generated increases in the national debt into the stratosphere and yet even the legislators publically claimed not to have read the bills
proposed to them.


Let's actually take a look at DSHEA (you can see the actual DSHEA document in full: http://www.fda.gov/opacom/laws/dshea.html

DSHEA was enacted in 1994 to provide a framework for the complete regulation of dietary supplements. It resolved regulatory
inconsistencies, provided definitions and established sound ground rules for dietary supplement manufacturers and marketers. It also
established standards for dietary supplement ingredients safety, labelling claims, and the communication of accurate and useful
information to consumers.

In addition to the general prohibition against selling adulterated or misbranded products, dietary supplements are subject to DSHEA's
special provision for New Dietary Ingredients (NDI), which are ingredients not marketed prior to 1994. Unless certain exceptions are met,
companies distributing such ingredients must provide evidence to FDA documenting their safety.

With respect to benefit claims, DSHEA mandates that manufacturers have substantiation for benefit claims they make about their
products, and the FDA has provided detailed guidance on what type of scientific evidence is required to support benefit claims.

DSHEA also requires that manufactures notify the FDA about benefit claims they are making, and FDA has an opportunity to object to
claims that would cause the dietary supplement to be a drug, such as claims that the product is intended to prevent or treat a disease.

Bad news tends to grab the headlines; however, the fact of the matter is since DSHEA was passed, most of the 'news' has been quite
good - for the consumer and the natural health industry as a whole. DSHEA has allowed countless safe and effective products to be
developed and made available to the public including calcium, omega-3 fatty acids, vitamin D, folic acid, and iron, just to name a few.

Moreover, since DSHEA was enacted, Congress and the FDA have taken several important measures to improve the regulation of dietary
supplements. For example, Congress closed an important loophole when it enacted the Dietary Supplement and Non-Prescription Drug
Consumer Protection Act of 2006, which, for the first time, requires that manufacturers of dietary supplements report serious adverse
events associated with their products to FDA. This didn't exist at all before 1996.

The FDA has also created Good Manufacturing Practices (GMP) requirements for dietary supplements. The GMP rules require, again for
the first time, that companies have sophisticated systems in place to ensure that their products are consistently manufactured so that the
label accurately reflects what is in (and what is NOT in) their products.

And one last note:

What industry seems more out of control and an actual threat to the American consumer; the vitamin supplement manufacturers or the
companies who are routinely found by Congress investigators to be providing payola to their hired researches and professional experts,
falsifying and even fabricating their clinical studies, hiding their potentially lethal side effects and paying over $2.5 billion dollars in criminal
and negligence settlements?

Yeah, you get the idea!

Utilize the information contained here as well as the actual DSHEA document available on the
WINHS.ORG web site to handle any attempt to propagate the false representations against DSHEA
that are certain to increase through the media as we move closer to the implementation phase by
Codex Alimentarius.
Their end game is that the US fully adopt the same anti-vitamin legislation
scouring Europe.

I'd rather enjoy good and sustainable health.
All the best,

Rudi

Rudi C. Loehwing
Managing Director
World Institute of Natural Health Sciences
www.winhs.org
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