Return-Path: smago@mind.net
From: "Ted Susu-Mago" <smago@mind.net
To: <cafmr@pnc.com.au
Date: Wed, 26 Nov 1997 18:14:19 -0800
X-MSMail-Priority: Normal
 
 
John,
 
To whom it may concern,
 
I have been asked to respond to Codex info currently circulating on the web
and through other media.  I've come to believe that although what is
happening at the Codex commission meetings is
critical, in many respects the American public's attention should be
focused on equally important domestic issues which it has a better chance
of constructively influencing.  By this I mean that Codex is being held up
as a bogeyman, which it is, while our own government and supplement
industry quietly work not only to chip away at your freedoms, but to
ultimately harmonize with a set of international trade standards that will
be
synonymous with the intent of regulatory changes currently being enacted
right under our noses that sidestep DSHEA and create a regulatory
atmosphere worse thanwhat we created DSHEA to avoid.  The weapons of
choice?  Administrative rulemaking and good ol' fashioned greed.  
 
I think it helps to first understand that our supplement industry does not
stand four-square behind DSHEA and that many companies are working to
dilute the protections it offers in exchange for a competitive edge in the
market.  The cost is high - your and my right to choose any product we want
at any time, access
to truthful scientific information concerning the benefits of supplements,
and a broad-based free market with a level playing field where advantage is
determined by hard work, not by government bureacrats that can, and do,
write the rules in favor of companies with money.  What is so damaging is
that the FDA loves to gobble up the freedoms these larger companies are
willing to trade for increased market share.  For all the hysteria of the
CODEX info, the substance of the arguments put forward remains intact. 
Yes, many small companies will disappear because their bigger brethren made
deals with the government to restrict your access to truthful information
and legitimate products.  If nothing else, this is a First Amendment
issue, and a segment of the supplement industry is working overtime to
abridge your rights. 
 
Let me give you an example.  Take St. Johns Wort, which is effective with
mild to moderate depression.  There is plenty of adequate, even good
science to verify this.  If an OTC (over the counter) category for herbs
like St. Johns Wort were created, Company X that could afford the OTC
licensing, (which would include compliance with the new Good Manufacturing
Practices guidelines the FDA is now drafting because DSHEA said it could)
would be able to put on its labels that St. John's Wort mitigated mild to
moderate depression, according to studies A,B,C, etc.  Company Y that could
not afford the licensing would be able to say zip, nada, nothing, even
though the science is out there, the science is good, and the science was
NOT funded by Company X.  Well, being the uninformed consumer, whose
product would you buy?  Would you be willing to pay more for the assurances
on the label that this product will work for you?  You bet you would! 
Efficacy is everything in the supplement business.  How long do you think
Company Y would survive in such an environment?  A year? Two, three?  As
the Company Ys of the world fade into competitive insignificance, what do
you think will happen to the price of Company X's product?  After all, it
has to recoup the ongoing licensing costs.  Now, does it serve the consumer
to have Company Y's access to truthful scientific statement for its
labeling limited because it simply can't pay for the proper license?  Is
there any reason for Company Y to strive to produce a better product?  Is
that a free market?  Are your health freedoms enhanced by this
bureaucratically-engineered monopoly?  Haven't Company Y's First Amendment
rights been abridged?  Aren't the consumer's health choices enhanced by
more rather than fewer good choices?
 
At another level, the FDA is working to streamline its regulatory standards
with other signatories to treaties like GATT and NAFTA.  Senate Bill 830,
an FDA reform bill, just sailed through with hardly a ripple
because everyone thinks it's all about reforming the FDA.  However, buried
in this bill are sections that speak to and basically authorize the FDA to
"harmonize" its regulatory standards with foreign ones.  Did you
know of this bill?  Were you aware of these sections?  Section 101 and 202
create language that pave the way for our food and drug laws to sound the
same as the European Union's, where supplements are regulated as drugs and
overly restrictive laws place severe restrictions on potency levels. 
Currently the EU is considering a Discussion Paper on the Addition of
Vitamins and Minerals to Foods and Food Supplements.  At the moment, the
only countries holding out against severe restriction of potency levels to
slight
multiples above the RDA are the UK and Holland.  
 
This is the odor of the regulatory wind blowing across Europe, and this is
the regulatory  standard the FDA intends to harmonize with.  Senate Bill
830's harmonization language is commonly thought to apply just to medical
devices, but this is not the case.  It applies to the entire food, drug,
and cosmetic act, which includes dietary supplements.  I have quoted from
Section 202 below:
 
"Sense of the Committee Regarding Mutual Recognition Agreements and Global
Harmonization Efforts: 
  
	1) The Secretary of Health and Human Services should support the Office of
the United States Trade 	Representative, in consultation with the Secretary
of Commerce, in efforts to move towards the 	regulation of drugs,
biological products, devices, foods (which includes dietary supplements our
	comment) food additives, and color additives, and the regulation of good
manufacturing practices between the European Union and the United States. 
 
 
           2)  The Secretary of Health and Human Services should regularly
participate in meetings with 	representatives of other foreign governments
to discuss and reach agreement on methods and 	approaches to harmonize
regulatory requirements, and; 
 
           3)  The Office of International Relations of the Department of
Health and Human Services (as established under section 803 of the Federal
Food, Drug, and Cosmetic Act (21 USC 383)) should have the responsibility
of ensuring that the process of harmonizing international regulatory 
requirements is continuous."
 
Sound innocuous?  Consider the FDA policy statement from its own website in
regard to Codex and other bodies of international regulation, which states:
 
 	"It is the intent of this policy to enable FDA to continue to participate
in international standards activities that assist it in implementing
statutory provisions ..."  and,
 
	"The development of an international standard that achieves the agency's
public objectives is 	generally, but not always, given a higher priority
than the development of a domesticstandard..." and, 
 
	"Where a relevant international standard exists or completion is imminent,
 it will generally be used in preference to a domestic standard.."
 
This from an agency which over the years has tried its best to hold the
public's freedoms of choice to a minimum.  Seriously, would you interpret
these policy statements to be in your best interests, given who is making
them?  With the advent of an OTC category for herbs and botanicals in this
country, the door that DSHEA was supposed to keep shut to further erosion
of our health freedoms will be ajar.  Blurring the distinction between
foods and drugs, reducing competition in the market to larger players who
are more concerned about market share than your right to choose, and
harmonizing domestic standards with harsh international ones - these
trends, these events all spell the eventual demise of DSHEA.  The weapons
we handed to the FDA and others AS A PART OF DSHEA are 1)  the Presidential
Commission on Dietary Supplement Labeling (CDSL) with its power to greatly
influence congress with recommendations, 2)  the right to draft new GMP's,
which it is currently doing, and 3)  giving the FDA the power to determine
what "significant scientific agreement" is in making structure/function
claims.  These are all the tools it needs to gut DSHEA.  I can just see the
SWAT teams pounding on manufacturer's doors again, as they have done so
many times before.  Do you really doubt that the FDA would act, given that
a short-sighted supplement industry and an unaware public are handing it
exactly what it has wanted for so long?
 
As for the Codex proposal(s), they seek to establish restrictive regulatory
standards for international trade similar or identical to those in place
domestically in Germany and other countries today.  Working hand in glove,
the FDA is saying it will harmonize with these standards.    But, you say,
DSHEA protects us.  In this extraordinarily powerful economic maelstrom,
DSHEA will become increasingly irrelevant.  Propelled by the greed and
short-sightedness of American and foreign companies intent on capturing
market share,  the establishment of an OTC category will begin the erosion
of DSHEA protections, as the evil genius of those who have sought to
undermine DSHEA by turning the supplement industry upon itself begins to
yield results.  Make no mistake, Henry Waxman knew what he was doing.  
 
Conversion of herbals and other supplements to OTC drugs will work against
American exporters to countries where these products would otherwise
sidestep many unfair trade practice challenges from local competitors,
while simultaneously opening the door to foreign companies to flood the
American markets with products which, because they have had years of
practice at meeting regulatory standards of this nature, will capture
market share not just from larger American companies that are learning the
OTC drill, but also from smaller American companies that won't be able to
afford the OTC regulatory costs.  We are witnessing the early stages of the
demise of a very large segment of our American supplement industry, and
our government is giving it away to large companies, both domestic and
foreign.
 
Well, maybe not giving it away.  One is compelled to ask why the
administration is so willing to give away American industry, to enact such
legislation, to take steps so damaging to our economy.  It is
reasonable to speculate that because they are politicians that there are
trade-offs.  Possibly segments of our economy will gain greater accesss to
certain world markets in exchange for relaxing the protections of our
citizens' health freedoms and enabling the encroachment of foreign
companies well
capitalized enough to compete in this more-regulated and expensive market. 
The Clintons tried socialized, government-monopolized medicine through
Hillary's health care reform bill where the beneficiaries would
have been the insurance companies;  one wonders what the insurance
companies promised her in return for this bonanza.  Now we wonder who the
beneficiaries of this sell-out would be.  
 
A law suit challenging the CDSL (Commission on Dietary Supplement
Labelling) and its final report has been filed by Jonathon Emord and
Associates on behalf of several active proponents of health freedom, to
include Dr. Julian Whitaker, Durk Pearson, and Sandy Shaw.  The suit
contends that because this commission was not authorized to make the
recommendations that it made, that any congressional or other rulemaking
based on these recommendations is illegal.  However, conspicuous by their
absence are the large supplement companies as supporters of this
lawsuit.  Why? Because they favor the creation of an OTC category for herbs
and botanicals which CDSL is illegally recommending, and they are not about
to support a lawsuit that would retard advancement of their agenda to
capture market share.  Think about it.   
 
How ironic that DSHEA may be destroyed in part by the greed of the very
industry it was designed to protect.  Defense of our fundamental health
freedoms is left to the consuming public, the player in this drama that is
least organized and least informed about its intricacies and its
implications. That's you and me.  Frankly, we'd better get the lead
out-now.   
 
Update 11-27-97
 
John Hammell, Suzanne Harris, and others have managed to change the
harmonization language in the FDA reform bills that would have helped the
FDA create rules to regulate our supplements as they are being regulated
overseas in an increasingly draconian manner.  Our hats are off to these
people for their 11th hour effort that has slowed the FDA's march toward
total control of your health freedoms.  Call your representatives and
senators and demand they support Ron Paul's bill, HR 2868, the Consumer
Health Free Speech Act which will remove food from the overly broad
definition of drugs in the Food, Drug, and Cosmetic Act, thereby ensuring
that foods are not mistaken for or regulated as drugs in this country.  
 
 
Ted Susu-Mago