Article 4962 of misc.health.alternative:
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From: delisle@eskimo.com (Ben Delisle)
Subject: FDA letters.
Message-ID: <CEwJFF.MLE@eskimo.com>
Organization: Eskimo North (206) For-Ever
Date: Thu, 14 Oct 1993 19:37:47 GMT
Lines: 143
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X-orig-From: Scott.Parks%f70.n343.z1@helix.eskimo.com (Scott Parks)
X-orig-* From : Susan Granquist, 1:343/70 (12 Oct 93 20:54)

One more letter to send, pass along.  I believe that this hits issues
that will be of particular interest to the Committee hearings and those
Senators and House Representatives who are not yet supporting the bill.

Please make copies, pass them along to Health Food Stores, Grocery
Stores...they stand to lose alot too!  Safeway in some areas are letting
people put up a table to collect signatures.  There is a petition form
in the next message.


President Bill Clinton
The White House
1600 Pennsylvania Ave.
Washington, D.C. 20500

Dear President Clinton:

I urge you to actively support and lobby Congress to pass The
Supplement Health and Education Act of 1993. which provides necessary
definitions and direction for the FDA, introduced as bicameral, bipartisan
legislation by by Congressman Bill Richardson (H.R. 1709) and Senator Orrin
Hatch (S.784). Under the Bush Administration the FDA substantially expanded
its scope of operation by misapplying the thirty-five year old amendment to
the Food, Drug and Cosmetic Act (FDCA) passed by Congress to regulate and
ensure the safety of new chemical additives which were entering the market,
to substances which have been traditionally recognized as food or food
supplements.  I believe that the FDA's action warrants specific direction by
Congress. Please lobby Congress to see that these bills are passed.

For example, the FDA seized two barrels of black currant oil (BCO), claiming
it was a food additive because it had been placed in gelatin capsules.
U.S. District Court for the Central District of Illinois denied the
FDA's attempt to dispose of the case without trial on April 10, 1991,
and found in favor of Traco Labs, on the grounds that the FDA had failed
to make its case, and stated that simply adding BCO to gelatin capsules
did not make BCO a food additive.  In November the court dismissed the
FDA's case because the FDA had nothing further to add to its position.

The FDA appealed the decision on October 21, 1992 to the United States
Court of Appeals for the Seventh Circuit.  In its judgment, rendered
January 27, 1993, the appeals court affirmed the lower court decision
and found in favor of Traco.  Writing for the court, Judge Cudahy stated
that "the Act (FDCA) distinguishes between food additives and food in the
generic sense, this distinction being critical... The FDA's food additive
definition is so broad, however, that it would blur this distinction.
_It would classify every component of food--even single active
ingredients--as food additives.  Thus, it would seem, even the addition
of water to food would make the food a food additive_.  The only
justification for this Alice-in-Wonderland approach is to allow the
FDA to make an end-run around the statutory scheme..."

The court decision stated:  "_The FDA's interpretation would also
arbitrarily classify a substance as either a food or a food additive by
how it is marketed rather than by the nature and use of the substance
itself. The FDA concedes that BCO marketed in bottles instead of capsule
form is not a food additive...  How a product is marketed is not a rational
way of determining whether a substance is a food additive._"

An identical case was won in the First Circuit Court of Appeals on
March 3, 1993.  Leslie Kux, the FDA's Associate Chief Counsel for
Enforcement declined comment saying, "the Black Currant Oil cases are
still in litigation.  Suffice it to say that we believe that our legal
position is a sound one."

Even as a layman, it would seem that this legal position is ridiculous.
The FDA regulations, do, as Judge Cudahy suggested, treat herbal teas
as food additives _arguing that the addition of an herb to hot water
constitutes food additive status for that herb_, while at the same time
regulating true food additives that may be mixed into that herb.  It
should be obvious that the FDA needs further direction from Congress
in determining what a food additive is and what constitutes nutritional
substances.

I believe that the Dietary Supplement Health and Education Act of 1993,
is necessary, if for no other reason than to stop the FDA from wasting
valuable tax funds when it has more immediate budget concerns in meeting
its primary function of quality and safety assurance.  I also believe
that an investigation of the FDA's reasons for pursuing such ridiculous
cases in an already over-burdened court system is called for by Congress.
I strongly urge you to support the Dietary Supplement Health and
Education Act of 1993.

Yours truly,






_________________________________  _________________________
Signature                                               Date

____________________________________________________________
Print Name

____________________________________________________________
Address

___________________________________________________________
City, State, Zip


In addition to the above, with which I agree, and which was
written by a private citizen, I wish to add:


>>>>>>>>>>>>>>>>>>>>>divider-cut

Please use this to make petitions and take to public places and get
signatures.  Send as soon as possible to the address at the bottom.
We're running out of time!



             CITIZEN'S PETITION  TO SUPPORT
   THE DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT OF 1993

The undersigned citizens are consumers of dietary supplements and value
their right to choose products important to their health and to have
access to important information on their benefits.  We are aware that
Senator Hatch and Representative Richardson have introduced the
"Dietary Supplement Health & Education Act of 1993" (S.784 and H.R.1709)
and support the views and purposes of these bills.  We ask that you
co-sponsor the appropriate bill in support of our wishes in this matter.

_________________________________________________________________
Print name    Signature    Print your address, city, state, zip
_________________________________________________________________

_________________________________________________________________

_________________________________________________________________


Return petition to: Citizens for Health, P.O. Box 368, Tacoma, WA 98401.

Citizens for Health is a national non-profit consumer health advocacy
organization of concerned citizens.




