Howard M. Metzenbaum
Ohio
United States Senate
Washington, D.C. 20510

April 18, 1986

Mr. Paul R. Ruggles
664 Crestwood Road
Wayne, Pennsylvania  19087

Dear Mr. Ruggles:

    Thank you for your communication.  I appreciate hearing from you.

    On August 1, 1985, I introduced a bill entitled, “The Aspartame
Safety Act of 1985.”  I consider this legislation the absolute minimum that
Congress needs to do in order to protect the health and safety of the 100
million American consumers who are using this chemical sweetener under its
better-known brand name of “NutraSweet.”

    This year we will consume over 20 billion cans of diet soft drinks
made with NutraSweet, as well as many other products containing this
sweetener.  We must be sure that the questions which have been raised about
safety are answered.

    In May of this year, I asked the General Accounting Office to
investigate the manner in which aspartame was approved by the Food and Drug
Administration in 1981.  Very serious questions have been raised regarding
the quality of tests used to approve aspartame, questions which must be
resolved if consumers are to have complete confidence in the safety of this
product.  That investigation is now under way, and I have high hopes that it
will shed some light on the questions surrounding the approval process.

    Pending the completion of that report, however, there are a number
of steps which Congress should take in relation to aspartame.  The bill I am
introducing outlines the minimum steps I feel are necessary.

    The bill mandates that independent tests on aspartame be conducted
under the auspices of the National Institutes of Health.  These tests will
focus on the general effects which aspartame has on brain chemistry, as well
as the specific behavioral and neurological reactions experienced by
individuals, including headaches, mood alterations, and memory loss.  The
test will also examine the health effects of aspartame on pregnant women and
fetuses and whether aspartame consumption can lower the threshold for
seizures.

    Under the bill, there will be a moratorium imposed on new uses of
aspartame in foods and drugs pending the completion of independent tests or
for the period of one year--whichever comes sooner.

    In addition to mandating independent tests, my bill will require
labeling which will inform consumers how much aspartame they are ingesting.

    This information is important not only for consumers who  wish to regulate
their intake of aspartame, but also for physicians who may be treating
individuals who feel they have experienced side effects.  The label will also
contain the maximum allowable intake established by the FDA.

    Finally, my bill will establish a Clinical Adverse Reaction
Committee within the FDA.  Consumers who feel they have experienced side
effects from aspartame should have the right to have their complaint
investigated.

    The Food and Drug Administration, along with Members of Congress,
has a responsibility to ensure that all questions surrounding the safety of
artificial sweeteners are investigated.  To this end, I have undertaken these
initiatives on aspartame.

    I appreciate your contacting me, and I am grateful for your views.

Very Sincerely yours,

Howard M. Metzenbaum

United States Senator

                          ***** The Bill *****

Enclosure
-----------
99th Congress, 1st Session         S.1557

To provide the public with information  concerning the use of products
containing aspartame, to provide for the conduct of studies to determine the
health effects of using products containing aspartame, and for other
purposes.
__________

IN THE SENATE OF THE UNITED STATES
    AUGUST 1 (LEGISLATIVE DAY, JULY 16), 1985
Mr. Metzenbaum introduced the following bill; which was read twice and
referred to the Committee on Labor and Human Resources
__________

A BILL

To provide the public with information concerning the use of products
containing aspartame, to provide for the conduct of studies to determine the
health effects of using products containing aspartame, and for other
purposes.

Be it enacted by the Senate and House of Representatives of the United States
of America in Congress assembled, that this Act may be cited as the
“Aspartame Safety Act of 1985”

     LABELING REQUIREMENTS

     SEC. 2. (a) Section 403 of the Federal Food, Drug, and Cosmetic Act is
amended by adding at the end thereof the following new paragraph:
     “(q)(1) If it contains aspartame, unless its label and labeling--

          “(A) specify the total number of milligrams of aspartame contained
in each serving;
          “(B) specify the allowable daily intake of aspartame (in
milligrams) for each kilogram of human body weight, as established by the
Secretary; and
          “C) bear the following statement:  “THIS PRODUCT CONTAINS
ASPARTAME, WHICH IS NOT INTENDED FOR USE IN INFANT FEEDING’”.
     “(2) The Secretary shall be regulation require that the information
required by subparagraph (1)(B) to be specified on the label and labeling of
any food containing aspartame be included on such label and labeling in a
manner which is the most useful to individuals who consume such food.
     “(3)  The statement required by subparagraph (1)(C) shall be located in
a conspicuous place on the label and labeling of each food containing
aspartame as proximate as possible to the name of such food and shall appear
in conspicuous and legible type in contrast by typography, layout, and color
with other printed matter on such label and labeling.”.
     (b)(1) Section 502 of such Act is amended by adding at the end thereof
the following new paragraph:
     “(u)(1) If it is a drug containing aspartame, unless--
          “(A) its label and labeling--
                “(i) specify the total number of milligrams of aspartame
contained in each dosage;
                “(ii) specify the allowable daily intake of aspartame (in
milligrams) for each kilogram of human body weight, as established by the
Secretary; and
                “(iii) bear the following statements:
      ‘THIS PRODUCT CONTAINS ASPARTAME, AND IS NOT INTENDED FOR USE BY
INFANTS’, PHENYLKETONURICS:  CONTAINS PHENYLALANINE’;
and
           “(B) the manufacturer, packer, or distributor (including all
retail establishments) thereof includes in all advertisements and other

printed and descriptive matter issued or caused to be issued by the
manufacturer, packer, or distributor with respect to such drug the
information described in clauses (A)(i) and (A)(ii) and the statements
specified in clause (A)(iii).”.
     “(2) The Secretary shall by regulation require that the information
required by subparagraph (1)(A)(ii) to be specified on the label and labeling
of drugs containing aspartame be included on such label and labeling in a
manner which is the most useful to individuals who consume such drugs.
     “(3) The statements required by subparagraph (1)(A)(iii) shall be
located in a conspicuous place on the label and labeling of each drug
containing aspartame as proximate as possible to the name of such drug and
shall appear in conspicuous and legible type in contrast by typography,
layout, and color with other printed matter on such label and labeling.”.
      (2) The first sentence of section 503(b)(2) of such Act is amended by
striking out “and (1),” and inserting in lieu therefore of “(1), and
(u)(1)(B),”.

MORATORIUM

     SEC. 3.  During the period beginning on the date of enactment of this
Act and ending--
         (1) on the date which is one year after the date of enactment of
this Act, or
         (2) the date on which all studied required under section 4 are
completed, whichever is earlier, the Secretary of Health and Human Services
(hereinafter referred to as the “Secretary”) shall not approve or permit any
use of aspartame in any food or drug if such use was not approved or
permitted on the date of enactment of this Act.

RESEARCH

     SEC. 4 (a) The Secretary, through the Director of the National
Institutes of Health, shall request proposals for, and make grants and enter
into contracts for the conduct of, clinical studies on aspartame, including
studies concerning--
     (1) the effect of the consumption of aspartame on brain chemistry;
     (2) the health effects of the consumption of aspartame on pregnant women
and fetuses;
     (3) behavioral and neurological effects experienced by individuals who
have consumed aspartame, especially by children who have consumed aspartame;
     (4) the interaction of aspartame with drugs, including monoamine oxidase
inhibitors, alpha-methyl-dopa, and L-dihydroxphenylalanine; and
     (5) the effect of the consumption of aspartame in increasing the
probability of seizures.
  (b) In making grants and entering into contracts under subsection (a), the
Secretary shall provide for the completion of the studies required under such
subsection with one year after the date of enactment of this Act.
  (c) To carry out this section, there are authorized to be appropriated such
sums as may be necessary.
  (d) The authority of the Secretary to enter into contracts under this
section shall be to such extend or in such amounts as are provided in
appropriation Acts.

CLINICAL ADVERSE REACTION COMMITTEE ON ASPARTAME

       SEC. 5. (a) The Secretary, through the Commissioner of the Food and
Drug Administration, shall establish a Clinical Adverse Reaction Committee on
Aspartame.  The Committee shall collect reports of individual reactions the
consumption of foods containing aspartame, including reports of reactions
from individuals taking various medications, and shall evaluate and prepare
appropriate responses to such reports.
       (b) The Secretary shall announce the establishment of the Committee
under subsection (a) through the mailing of written notices to physicians and
other health care providers and through advertisements in medical journals
and in publications read by the general public.  Such advertisements shall
include the telephone number of the service established pursuant to
subsection (c).
       (c) The Secretary shall establish a telephone service for the
reporting by individuals of reactions to the consumption of products
containing aspartame.  Calls on such telephone service shall be without
charge to the caller.


   *************************************************************

   Note 1:  It is my understanding that this bill was bottled up in
   committee and essentially killed by Senator Orrin Hatch.

   Note 2:  It is also my understanding that by virtue of the FDA
   classification of this substance, NO reports of adverse reactions
   were required or wanted.