Errors-To: <>
Date: Mon, 02 Nov 1998 15:04:02 -0500
To: Ron J Birckhead <>
From: John Hammell <>
Subject: The KEY to FDA's Letter to Congress on Codex- HOW FDA is
  Misleading Everyone!!

At 07:04 PM 11/1/98 -0500, you wrote:
>Your lengethy message refers to a letter from the FDA which you have
>totally omitted. If you include the FDAs letter then it makes sence to read
>shuch a lengethy message from you Without it, any intllegent person is not
>gointg to read your letter, since they can not put it into context for the
>reader without the FDAs orginal letter. Since this is now at a critical
>point please furnish a copy of the FDA letter your complaint is about so
>readers can see what it is. This will also get alot of people who have not
>taken the time to read your message to take the time to read it, once they
>have the complete story.
I will try to scan the FDA's 4 page letter so people can see what I was
responding to, but I have summarized their position succinctly below. I
didn't have time to transcribe it, and scanning is difficult too due to OCR

In a nutshell, FDA is saying to Congress that whats happening at Codex will
never effect the domestic regulation of dietary supplements in the USA,
they're trying to tell Congress that whats happening at Codex ONLY effects
the ability of American supplement manufacturers to enter foreign markets
(which is, of course, a big lie!!)

FDA is saying to Congress that:

A) FDA is against the draft proposal for vitamins at Codex and stated so in
their comments.


B) That since it appeared likely they would be outvoted (they were), that
they had to have a fallback position in order to "protect" US interests vis
a vis the creation of maxiumum potency limits, (since if they didn't have
an alternative position to the Germans, what we'd be stuck with would be
arbitrary dietary limits, such as 3x RDA.)

FDA is arguing that the Risk Assessment model which they've brought to the
table, and which was generated by the National Academy of Sciences, is
preferable to what the Europeans want, because it bases upper limits on
"scientific considerations" (we're expected to accept the determinations
coming out of the NAS even though they are academics, operating in
University research settings, with no clinical experience, who are biased
due to being paid by pharmaceutical grant money...)

There is nothing "scientific" about the NAS Risk Assessment document! It
calls for a 35 mg upper daily limit on niacin, for example! Sure, niacin
causes flushing in some people at low doses like that, but so what!
Flushing isn't harmful! Its annoying, sure, but not harmful!

The KEY SENTENCE to understanding the agenda in the 55 page so called "Risk
Assessment" document, (which CRN has stupidly bought into, along with this
new lobby group called "IADSA" International Association of Dietary
Supplement Trade Associations) is THIS:

 "The UL (upper limit) is not meant to apply to individuals who are treated
with nutrient or food component under MEDICAL SUPERVISON."

Did you catch that? "Medical Supervision". They want to impose prescription
control on niacin above 35 mg, and CRN, NNFA and IADSA are mindlessly going
along with it instead of doing what they SHOULD be doing, which is to
question the scientific validity of the Risk Assessment document! Its as
though they've been offered a choice between a pigshit sandwich and a
horseshit sandwhich and they've decided to eat the horseshit, because it
doesn't smell quite as bad! Well,,, I don't buy it! I REFUSE to eat a
horseshit sandwhich, and here is why:

You see, what CRN, NNFA, and IADSA don't seem to realize is this:

When the FDA says that events at Codex won't effect domestic US
regulations, they're lying through their teeth!! They don't want the
industry to know about the ANPR which they put in the July 7, 1997 Federal
Register in which they stated their intention to harmonize their regs to
emerging Codex standards. This ANPR can be viewed on my website at The FDA don't want American vitamin companies
to consider the implications of the Mutual Recognition Agreements that the
USA signed with the EU regarding sectoral annexes for pharmaceutical GMP
manufacturing. For a legal analysis of this see Harris' comments at

They don't want us to examine how harmonization is occurring. They have to
DECEIVE the industry into believing that they MUST accept the Risk
Assessment document as the "lesser of 2 evils" or risk losing big in the
foreign markets, but what the American industry DOESN'T grasp is that right
now, they are digging their own graves(!) They are _BLINDLY_ pushing for
this Risk Assessment document, and they don't realize that they are setting
up the passage of the draft proposal for vitamins and minerals at Codex,
and that the FDA is ALL SET to harmonize their regs to the final Codex

I've been trying to point this out to them, but they are blind to it. They
don't see the way they're being suckered. Please go to and read the FDA's ANPR in which they
expressly state their intention to harmonize their regs to Codex standards.

American vitamin companies are currently moving to slit their own throuts.
They haven't been paying attention to whats going on outside their field of
view. They're busy running their businesses and haven't been paying
attention. The only thing that can stop this is a Congressional Oversight
Hearing in which expert witnesses, such as Matthias Rath, MD, and other
orthomolecular doctors with clinical experience in using these vitamins and
KNOW of their properties testify to the bogusness of the NAS Risk
Assessment Document.

Massive public pressure must force the withdrawal of that Risk Assessment
document, and the US withdrawal from the whole Codex process, otherwise, we
will be destroyed by the shell game they're playing. The shell game must
be exposed in an Oversight Hearing.

The FDA is bound by Constitutional Constraints which they're violating, and
they must be ordered to obey the will of Congress. In October of '97 the
FDA was told in no uncertain terms not to harmonize our laws pertaining to
dietary supplements. One thing that helped me to get this amendment was
showing Congress the FDA's ANPR (discussed above). The FDA was sent the
message to NOT HARMONIZE when we got dietary supplements specifically
removed from the harmonization language in the FDA Reform Bill, and now the
FDA has violated US law by ignoring letters from 5 members of Congress
which ordered them to remove the 2nd paragraph from their comments on
vitamins and minerals because they set us up for harmonization. FDA also
violated US law by putting the Risk Assessment document on the table at
Codex, and by agreeing to be part of a working group for the purpose of
adopting the EC's Green Paper to the current situation at Codex in an
effort to build consensus. By working to build consensus at Codex on this
issue FDA is violating US law.

Call your congressman and Senator today to demand an oversight hearing in
the next session of Congress to examine the FDA's illegal Codex comments
from the Berlin meeting, to get Yetley fired from her job, and to expose
the threat to public health and the lack of sound science underlying the
NAS's Risk Assessment Document. Congress needs to hear the expert testimony
of such orthomolecular physicians as Dr.Rath in Germany, who is also trying
to expose whats going on. Congress needs to learn of Rath's effort to get a
hearing at the International Court of Justice, where he intends to lay
criminal charges of genocide and crimes against humanity against a number
of pharmaceutical companies which he considers to be behind the German
Codex proposal. (See Dr.Rath's website at Reach Congress via
888-898-7177 (Capital Switchboard) and if the toll free line has been
disconnected, try via 202-225-3121.

-John Hammell

International Advocates for Health Freedom
2411 Monroe St. #3 Hollywood, FL 33020 USA
800-333-2553, overseas 954-929-2905
fax 954-929-0507,,
Donations Needed For Trips to DC
To Get FDA Oversight Hearing
Due to Illegal FDA Codex Comments
& for Trips to Europe to Assist
Dr.Rath in Getting Hearing at
International Court of Justice
Against the Pharmaceutical Cartel