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DEAD BILL

********** PLEASE NOTE THE DATE OF THE LETTER **********

Howard M. Metzenbaum
Ohio
United States Senate
Eashington, 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 100million 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

Enclosure

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

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/font>

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)© 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

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/are required or wanted.

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