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The Honorable Orrin G. Hatch 1/29/96
c/o Tricia Knight
US Senate, RSOB 135
Washington, DC 20510
202-224-5251, FAX 202-224-6331
Re: DSHEA AFFORDS ZERO PROTECTION: PLEASE HELP US!
Dear Senator Hatch:
Several months ago you promised consumers of dietary
supplements that you would once again come to our
assistance if it became apparent that we were not afforded
sufficient protection from the FDA by the Dietary
Supplement Health and Education Act. (DSHEA)
The December 20 '95 letter to you from attorney Milton
Bass of the Nutritional Health Alliance (enclosed) makes it
crystal clear that I was BETRAYED by the 103rd Congress
when it UNANIMOUSLY enacted DSHEA with the false assurance
that DSHEA made it impossible for the Food and Drug
Administration to ever again regulate and ban vitamins as
drugs or prescription drugs.
The ink had barely dried after President Clinton signed
DSHEA into law before the FDA had used DSHEA in court to
claim that vitamin B-12 was a drug because it was absorbed
through the nasal membrane.
It was the FDA's first test case of DSHEA. On April 14,
1995, the U.S. District Court for the Eastern District of
New York permanently enjoined Nature's Bounty from
marketing Ener-B (vitamin B-12) "or any other nasally
administered nutrient" without an approved new drug
application.
On December 19, 1995, the U.S. Court of Appeals for the
Second Circuit upheld the District Court decision. Milton
Bass wrote you December 20. (see enclosed letter).
I realize that Tricia was on vacation and was then out
with an injury and is now facing a huge in basket, so you
may not have responded yet to Milt Bass, but I am helping
Tricia here by providing you with a copy of his letter so
that she won't have to dig through her pile to find it. I
trust that you will agree to sponsor a Senate companion
bill to Congressman Pallone's HR 1951 and that you will
work as diligently to get it enacted as you did to get
DSHEA passed in the last Congress.
H.R. 1951 will correct the fatal defect in DSHEA which
not only allows, but encourages FDA to continue to expand
its 50 year regulatory war against me and millions of other
consumers who do not want vitamins, minerals, amino acids,
herbs, hormones and other dietary supplements regulated as
drugs. If B-12 is better assimilated by some people when
taken as a nasal gel, that in no way changes B-12 to a
drug. If I take Epsom Salt (magnesium sulfate) bath and
assimilate magnesium through my skin, that does not make
magnesium a prescription drug. If I inhale herbs
(aromatherapy) that does not make those herbs "drugs". If I
apply vitamin E oil to prevent or reduce scar tissue, that
does not make vitamin E a "drug." If I apply aloe vera to a
sunburn, that does not make this useful herb a "drug."
The USA vs Nature's Bounty decision is not good,
Senator. In Norway, where draconian regulations were rammed
through in the late 1980's that have outlawed most dietary
supplements and only allow a handful to be sold (at RDA
levels), they began by chipping away at people's freedom in
exactly this way.
The German delegate to the UN/WHO's Codex Alimentarius
Commission's Committee on Nutrition and Foods for Special
Dietary Uses has proposed a very restrictive provision
governing dietary supplements that would reduce the whole
world to Norway's level of servitude to the multinational
pharmaceutical industry, and efforts are being made
internationally to "harmonize" with Codex. In the last
Codex meeting, the German delegate's proposal was accepted
by 16 out of 18 delegates present. Only the US and UK
delegates opposed it. At the next Codex meeting in October,
the US is very likely to be outvoted on this issue, and the
WTO will then attempt to force us into compliance via trade
sanctions. We direly need to pass HR 1951 in order to send
a message to the WTO that we will not yield.
On January 18, 1996, an article titled "World Trade
Group Orders U.S. to Alter Clean Air Act" was published in
the NY Times. The WTO says that our Clean Air Act
"discriminates" against foreign oil refiners who are
currently blocked from importing gasoline containing
"armomatic" chemicals which would contribute to smog. Is it
in America's best interests for foreign judges to be
allowed to override domestic legislation that is in the
best interests of public health? We urge a US withdrawal
from both the UN and WTO.
If the Codex Commission adopts the German delegates
proposal regarding dietary supplements, the WTO will
attempt to sanction the US in order to force us into
compliance, just as they are currently attempting to
scuttle our Clean Air Act. It is therefor IMPERATIVE that
you sponsor a Senate companion bill to HR 1951, as well as
urge a national pull out from the WTO.
I respectfully request a copy of your reply to Milton
Bass, as well as a reply to this letter. Will you sponsor a
companion bill to HR 1951? Will you urge a US pullout from
the WTO? Do you see the threat to health freedom posed by
Codex?
Sincerely yours,
(Letter from Milton Bass follows. This letter prepared
for my convenience by John C. Hammell, legislative
advocate, Life Extension Foundation, 1534 Polk St.
Hollywood, FL 33020, USA. Form letter to be sent to Senator
Hatch- not to LEF!)
LETTER FROM MILTON BASS of BASS and ULLMAN, PC
Counselors at Law 747 3rd Ave. NY, NY 10017 (Milt Bass is
the attorney for the Nutritional Health Alliance)
December 20, 1995
- via facsimile (202) 224-6331
- and first class mail
- The Honorable Senator Orrin G. Hatch
- United States Senate
- Russell Senate Office Building
- Room 135
- Washington, D.C. 20510
Re: Dietary Supplement and Health and Education Act of
1994
(DSHEA)
Dear Senator Hatch:
I wish to bring to your attention a very important
decision which has just been handed down by the United
States Court of Appeals for the Second circuit.
You will recall that when the Senate passed the bill,
you put a provision in that bill which stated that the FDA
cannot make dietary supplements into drugs. That provision
was removed when it went to the House of Representatives,
and a different provision was put in its place. The Court
has now interpreted the new provision and has ruled that
the statute has provided a wide open door for the FDA to
make dietary supplements into drugs, and prohibit their
sale.
This interpretation of DSHEA by FDA and the Court not
only reinforces the significance of the provision which was
originally in the bill, as passed by the Senate, but it
changes even the prior law wherein FDA was strictly limited
to the provisions of 321(g)(1) as a basis for making
dietary supplements into drugs. You will note in the
enclosed copy of the opinion that I have underlined the
words "for other reasons, such as its method of intake"
(page 5,line 8), which is not what the original 321(g)
- (1) provided nor the way this section was interpreted
before DSHEA by the same Court of Appeals.
I believe this is a very serious and urgent matter, and
respectfully request your assistance in correcting this
problem by getting back the provision we originally has in
the Senate bill to prevent the FDA from making dietary
supplements into drugs.
With kindest regards,
Respectfully,
Bass and Ullman, P.C.
Milton A. Bass
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Information Provided by John C. Hammell, Legislative
Advocate, The Life Extension Foundation, LEF Political
Office 1534 Polk St. Hollywood, FL 33020 USA
jhammell@ix.netcom.com, 800-333-2553, 954-929-2905, FAX
954-929-0507.
DONATIONS URGENTLY NEEDED TO FUND THE I.H.A
(International Health Alliance)Make out checks to Life
Extension Foundation, send to above address. Funds will be
used to operate our Think Tank on Codex in order to
strategize the most effective grass roots monkey wrenching
effort. Former law professor Suzanne Harris, GATT expert,
will be conducting this all important Think Tank. Funds
will also go to Ron Birckhead, our European Liason who is
working hard to build a grass roots anti Codex army in
Europe. We have 8 short months to monkey-wrench Codex. We
are all that stands between you and the tyranny of the
UN/WHO's Codex Alimentarius Commission which seeks to
destroy health freedom world wide as they seek total
control over the world's food supply, including dietary
supplements. Permission granted to reprint. Media contacts
urgently needed. Am doing radio shows to solicit urgently
needed donations and to discuss the Codex threat to health
freedom. Call your Congressman today: Get cosponsors on HR
1951, help get a Senate companion bill to it, get the US
out of the UN/WTO!!!
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