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Entire ending of document sent yesterday, Protest of the National Soft Drink Association from Congressional Record on aspartame. Entire document yesterday meant Part 1. It is now complete with part 2. They knew the gun was loaded before they put aspartame in carbonated beverages.

We hope many will put this on web showing the world that Coke and Pepsi and
others knew exactly what would happen if they put this toxin in their
drinks.  And they knew aspartame would break down in heat before they sent
diet pop to the Persian Gulf to sit for as long as 8 weeks at a time in 120
degree Arabian Sun!   And aspartame causes birth defects even if a man uses
it at the time of conception.  See Dr. Roberts position paper on the
subject on DORway web site.  

Regards,
Betty
>
>~*~*~*~*~*~*~*~*~*~*~*~*~
>(Page S 5509 Continued)
>
>More specifically, to demonstrate that APM is safe for use in soft drinks,
the
>petitioner must reasonably identify what degradation products are formed
under
>those conditions.  Ultimately, of course, the safety of the major degradation
>products must be determined. Under the FDC Act, the data needed to make that
>determination--reliable and competent data--must be provided by the
>petitioner.
>     Objection Two:  Searle has not demonstrated that APM use in soft drinks
>will not adulterate the beverages under Section 402 (a)(3) of the FDC Act.
>
>SUMMARY OF BASIS FOR OBJECTION
>
>     As discussed above, it is well established that the petitioner for
>issuance of a regulation authorizing the use of a food additive bears the
>burden of proving, through reliable and competent data, each element of the
>criteria set forth in section 409 of the FDC Act, 21 U.S.C.  348. for
issuance
>of a food additive regulation.  The present record does not contain data
which
>demonstrate that the use of APM in soft drinks will not result in the
>adulteration of the beverages under section 402 (a)(3) of the FDC Act. 21
>U.S.C.  342 (a) (3), which provides that a food is adulterated if it
contains,
>in whole or in part, "...a decomposed substance or if it is otherwise unfit
>for food."  Indeed, the present record strongly suggests that the rapid
>degradation of APM in soft drinks and the consequent loss of sweetness may
>well result, under certain actual time and temperature conditions, in
products

>which would be adulterated under section 402.  Without data which
demonstrate
>that APM-sweetened beverages will not be adulterated under section 402
(a)(3).
>Searle has not met its burden of proof under section 409 (c) (3) (B) of the
>FDC Act. 21 U.S.C.  348 (c) (3) (B).
>
>FACTUAL BASIS FOR OBJECTION TWO
>
>     The marked and rapid decomposition of APM in soft drinks under
>temperatures known to prevail is apparent from data in the present record and
>discussed above in these objections.  Those data show that it is
reasonable to
>expect APM to decompose in soft drinks sufficiently rapidly under current
>handling and distribution procedures (continued on page S 5510)
>
>
>----------------------------------------------------PAGE
>BREAK---------------------------------------------------
>
>
>S 5510                CONGRESSIONAL RECORD -- SENATE              May 7, 1985
>
>to adversely affect product quality and taste. (17)
>     It is well-established under section 402 (a) (3), that a food which
>contains a decomposed substance (i.e., the decompostion products of APM
which,
>Searle's data show, can readily exceed the quantity of APM itself in a short
>time)--especially where the decomposition has adversely affected product
>quality or made the product unpalatable--is adulterated and subject to
>seizure. FDA would consider beverages which had lost substantial sweetness
>because of APM decomposition and which were therefore not palatable, to be
>adulterated under section 402 (ax3).  The record is devoid, however, of
>evidence which demonstrate that APM used to sweeten soft drinks will not,
>under reasonably anticipated conditions of use, in fact cause the products to
>be adulterated. Without such evidence Searle has not met the burden imposed
>under section 409 (c) (3) (B).
>     (This objection will be expanded.)
>     Objection three:  Selare has not demonstrated that APM is functional for
>use in soft drinks under temperature conditions likely to prevail in the
>United States.
>
>SUMMARY OF BASIS FOR OBJECTION
>
>     In addition to data intended to assess the stability of APM in soft
>drinks, Searle's petition for use of APM in soft drinks contains data
intended
>to show that APM is functional in the beverages, i.e., that it achieves and
>retains the intended technical effect (sweetening) under the conditions of
use
>reasonably anticipated to occur.  Searle has not demonstrated that APM is
>functional in soft drinks because its data show a significant loss of
>sweetness at temperatures to which soft drinks are known to be exposed and
>within the range of time periods between bottling and projected consumption.
>The functionality of an additive cannot be considered to have been
>demonstrated if significant loss of its intended technical effect because of
>temperature and pH dependent degradation may occur under reasonably
>anticipated conditions of handling, storage and use.
>
>FACTUAL BASIS FOR OBJECTION THREE
>
>     To evaluate the functionality of APM, Searle conducted "sensory
>evaluation" tests which used consumer taste panels to assess "perceived
>sweetness" (cola, beverages only) and "overall liking' (or "acceptance") (all

>flavors) over time periods up to 52 weeks and at three temperatures: 5
degrees
>C (41 degrees F), 20 degrees C (66 degrees F) and 30 degrees C (86 degrees F)
>Beverages sweetened with APM only (5, 20 and 30 degrees C) and APM with
>saccharin (20 degrees C) were tested; beverages sweetened with sucrose
(______
>C) and saccharin (_______C) were used as references.  The beverages were
rated
>at different time periods by the panelists. (18)
>     Although no temperature used in Searle's sensory evaluation tests
>approached the actual product temperatures which soft drinks will reach (see
>section ____ above), significant loss of sweetening and overall liking
>occurred for beverages sweetened with APM only within extraordinarily short
>time periods. For example, APM-sweetened cola beverages stored at 30
degress C
>(86 degrees F) received on overall liking score of less than 20 on a 0-100
>scale after only 290 weeks (after 20 weeks the product was apparently
>unplatable, since Searle did not present sensory evaluation data beyond this
>time). For an orange beverage, overall likeness after 20 weeks at 30
degrees C
>(86 degrees F) approached 5 ( on a nine point hedonic scale), the "neither
>like nor dislike" or mean rating.  Again, sensory evaluations were apparently
>not conducted beyond 20 weeks.
>     Searle's characterization of the results of the sensory evaluation tests
>avoid the clear implication  of those tests:  That APM has not been shown to
>retain sufficient sweetness at temperatures which are known to occur for APM-
>sweetened beverages to retain an acceptable "overall liking" rating.
Instead,
>Searle emphasizes an interesting, but legally irrelevant finding: That APM
>sweetened beverages tested after holding at relatively low termperatures were
>preferred to beverages sweetened with alternative sweeteners. This
>characterization misses the statutory purpose for which the studies were
>undertaken, that is, to demonstrate that APM is a functional sweetner in soft
>drinks.
>     Of particular importance is the fact that Searle's sensory evaluation
>tests do not explore the effects on either sweetness or overall likeness of
>APM-sweetened beverages exposed, either consistently or intermittently, to
the
>higher temperatures which prevail in much of the United States. What is the
>effect on these two measures, for example, of product temperatures of 100 to
>120 degrees F?  Is the degradation greatly accelerated and the overall liking
>therefore diminished in even shorter time periods?  Will APM-sweetned
>beverages stored in warehouses and carried on open route trucks or stored in
>warehouses and displayed in open air service station promotions in the
>southern states be acceptable when the consumer attempts to consume them
>several weeks later?  Is APM a functional sweetener for soft drinks if APM-
>sweetened beverages in certain parts of the country would, during the summer
>months, have to be treated as if they were perishable commodies?19
>      (To be expanded with age distribution data.)
>     Objection No. Four:  G. D. Searle and Company Has Not Demonstrated To A
>Reasonable Certainty That The Use of Aspartame In Soft Drinks. Without

>Quantitative Limitation.  Will Not Adversely Affect Human Health As a Result
>Of The Changes Such Use Is Likely To Cause In Brain Chemistry And Function
>Under Certain Reasonably Anticipated Conditions of Use.
>
>SUMMARY OF BASIS FOR OBJECTION
>
>     In its July 8 Federal Register notice, FDA acknowledged receiving a
>comment expressing concern about the effect on plasma and brain phenylalanine
>(PHE) and tyrosine (TYR) levels when aspartame is fed in combination with a
>carbohydrate.  498 Fed. Reg. at 31379.  The comment included data
>demonstrating that in both rats and humans the feeding of a carbohydrate with
>aspartame significantly enhances aspartame's positive effect on the ratio of
>PHE and TYR to other large neutral amino acids (LNAA) in the blood.  The data
>submitted with the comment also demonstrate that brain PHE and TYR levels in
>the rat are significantly increased by the aspartame/carbohydrate
combination.
>     The concern of the commenter, Dr. Richard J. Wurtman, Professor of
>Neuroendocrine Regulation at the Massachusetts Institute of Technology, was
>that, increased brain levels of PHE and TYR are likely to affect the
synthesis
>of certain neurotransmitters--substances vital to the regulation of brain
>function--and that changes in the levels of neurotransmitters could in turn
>cause adverse physiological effects (by, for example, modifying the function
>of the autonomic nervous system) and/or behavioral effects.
>     FDA responsed to Dr. Wurtman's comments by stating that it "...believes
>that the comment's conclusion regarding potential phenylalanine induced
>changes in neurotransmitter function appear to be unwaranted
>extrapolations..." (48 Fed. Reg. at 31379; emphasis added) and by concluding
>that "...the data supplied with this comment do not provide suport for its
>hypothesis that the injestion of aspartame and carbohydrate will alter the
>brain levels of neurotransmitters and thereby produce behavioral
>modifications."  48 Fed. Reg. at 31380, FDA cites as support for its
>conclusion several studies submitted by Searle: FDA did not discuss, however,
>much of the data submitted by Dr. Wurtman (inluding those demonstrating
>significantly elevated brain levels of PHE and TYR), and it apparently
>overlooked the significance of aspartame's demonstrated blocking effect on
>glucose-induced elevation of brain serotonin levels.
>     In light of the allocation of the burden of proof and the nature of the
>safety standard in food additive proceedings (discussed above).  FDA's
>handling of Dr. Wurtman's concerns was unusual.  The tone of the July 8
notice
>suggested that the burden was on Dr. Wurtman to demonstrate that aspartame is
>harmful and that, absent affirmative demonstration of harm (which
obviously is
>lacking at this point), aspartame must be approved. To the contrary, however
>the burden is on Searle to prove to a reasonable certainty that no harm to
>human health will result from aspartame. Thus, the question for FDA in
>evaluating Dr. Wurtman's conern is whether, in the minds of competent
>scientists, the questions posed by Dr. Wurtman, and his data are sufficiently

>significant from a safety standpoint that they should be more thoroughly
>addressed by Searle in order ot provide the statutorily required "reasonable
>certainty" that no harm will result from aspartame's use.
>     We object to the approval of aspartame for unrestricted use in soft
>drinks (which could be as high as 550 mg/liter, or higher) on the ground that
>Searle has not made the required showing. This objection is supported by (1.e
>following points, which are discussued farther below and supported by the
>accompanying affidavits: (1) available evidence demonstrates that the
>consumption of aspartame/carbohydrate combinations by rats in amounts
>comparable to those likely to be encountered by humans under certain
>(continued on Page S 5511)
>
>_______________________________
>(References for Page S 5510)
>
>(17)   FDA acknowledges this distinct possibility when it states its "belief"
>that changes in these procedures will avoid the problem.   Section 409 cb3 B
>does not comtemplate that a "belief" in unspecified, but fundamental changes
>in industry practice are adequate to assure that wildepread use of a food
>additive will not adulterate the food.  
>
>(18)  Fn stating rating periods    
>
>(19)   In the preamble to the APM regulation, FDA dismissed summarily the
>concern about the functionality of APM in soft drinks at temperatures
above 30
>degrees C (86 degrees F): "The agency believes, however, that storage at
these
>times and temperatures can be avoided by attention to handling and
>distribution." (48 Fed. Reg. at 31377).  This summary resolution of the
>functionality issued is inconsistent with the FDC Act for two reasons.
First,
>it is based on the agency's "belief" and not on any objective evidence. The
>Act requires the agency to resolve material issues based on facts, not on
>beliefs. Moreoever, the facts--actual temperature conditions to which the
>beverages are exposed and actual beverage temperatures--suggest that
>degradation and consequent loss of sweetness and overall liking (and hence
>functionality) may occur within even shorter periods than the agency appeared
>to find acceptable.
>     Secondly, the purported resolution of the functionality issue by
assuming
>that significant loss of sweetness "can be avoided by attention to handling
>and distribution" is an assumption unsupported by any evidence in the present
>record (none is cited by the agency).  In all likelihood, the agency's
>"resolution" is entirely impracticable. To assume that fundamental changes in
>handling and distribution will occur to avoid an acknowledged functionality
>problem turns the FDC Act on its head.
>
>---------------------------------------------------PAGE
>BREAK--------------------------------------------------
>
>May 7, 1985               CONGRESSIONAL RECORD -- SENATE                S
5511
>
>reasonable anticipated conditions of use elevates plasma ratios of PHE and
TYR
>significantly and brain PHE and TYR levels by factors of 3.0 and 3.5,
>respectively; (2) available evidence from human studies demonstrates that
>consumption of aspartame/carbohydrate combinations in amounts likely to be to

>be encountered under certain reasonable anticipated conditions of use
elevates
>human plamsa levels of PHE significantly beyond the normal range: (3) there
>are sound scientific reasons to believe that human brain levels of PHE and
TYR
>will respond to aspartame consumption in a manner similar to rats: (4) there
>are sound scientific reasons to believe that increased brain levels of PHE
and
>TYR could affect the synthesis of neurotransmitters and in turn various
>physiological functions and/or behavior: for example.  TYR is a known
>precursor of the catecholamine neurotransmitters, and tyrosine levels have
>been shown to affect several bodily functions controlled by the autonomic
>nervous system (including regulation of blood pressure): and (5) the
>demonstrated ability of aspartame to inhibit the glucose induced release of
>serotonin has the potential to affect important serotonin-mediated behaviors,
>such as satiety, food choice and sleep.
>     Despite the potential effects of aspartame/carbohydrate combinations,
the
>present record is devoid of readily obtainable evidence that could resolve
>whether the effects are in fact likely to occur. As will be demonstrated the
>data cited by FDA in its July 8 notice are not sufficient to resolve the
>issue. It would be possible, however, to perform within approximately six
>months studies in rats that would resolve conclusively whether levels of
>aspartame and carboyhydrate corresponding to those likely to be consumed by
>humans would affect the synthesis of neurotransmitters and in turn cause
>detectable physiological and behavioral effects. It also would be possible to
>perform additional short-term studies in humans to determine whether
>aspartame/carbohydrate combinations have observable effects on physiological
>parameters (such as blood pressure) or behavior.
>     For these reasons, Searle has not met its burden of demonstrating to a
>reasonable certainty that the unlimited use of aspartame, especially in
>combination with carbohydrates, will not adversely affect human health.  The
>questions posed by Dr. Wurthman are signficant becaue of the seriousness of
>the potential effects (e.g., changes in blood pressure) and because of
>aspartame's anticipated widespread use--use that includes consumption by
>potentially vulnerable sub-groiups, such as children, pregnant women, and
>hypertensives. Dr. Wurtman's concerns are shared by other distinguished
>scientists expert in this field (affidavits attached).  It is Searle's legal
>burden to submit data sufficient to resolve the concerns.
>
>FACTUAL INFORMATION SUPPORTING OBJECTION FOUR
>
>     1.  FDA has underestimated the amount of aspartame that can be consumed
>through its use in soft drinks because the agency has focused on adult users
>(assumed to average 60 kilograms in weight).  FDA relied upon an intake value
>of 34 mg/kg/day in assessing the possible risks of aspartame, describing that
>level as the "...highest obtained from any estimate of potential consumption
>and exceeding) the 99th percentile consumption (25 mg/kg) for all age
>groups..." 48 Fed. Reg. at 31377.  For a 30 kg child, however, it would
not be

>unusual for that level to be achieved or, in terms of the effect on
plasma PHE
>levels, even exceeded. For example, if a 30 kg child consumed on a warm day
>after excercise approximately two-thirds of a two-liter bottle of soft drink
>sweetened solely with aspartame, that child would be consuming approximately
>approximately 700 mg. of aspartame, or approximately 23 mg/kg.  This alone
>roughly equals what FDA considered the 99th percentile consumption level.  If
>during the day this child consumed other aspartame sweetened products,  the
>exposure level could quickly approximately FDA's so called "loading dose" of
>34 mg./kg.  18 Fed Reg. at 31377.  In addition, however, data derived from
>rats and humans demonstrate that concurrent consumption of a modest amount of
>carbohydrate (approximately 3 grams per kg. or, for a 30 kg child perhaps
>several cookies) approximately doubles the effect of the aspartame on the
>ratio of plasma PHE to other large neutral amino acids (LNAA)  (Wurtman
>affidavit).  Thus, in terms of effect on the PHE/LNAA ratio in the blood, the
>above described concurrent consumption of aspartame and a carbohydrate is
>equivalent to an asparatme dose of as much as 50 to 60 mg./kg.
>   2. Aspartame has been tested in rats to determine the effect of aspartame
>and aspartame/carbohydrate combinations on the plasma ratios and brain levels
>of various amino acids (Wurtman affidavit). In rats fed 200 mg/kg aspartame,
>the plasma PHE/LNAA ratio increased to 0.185 from 0.110 in the controls, and
>the brain PHE level increased from 52 n-moles/g in the controls to 110 in the
>treated animals.  When the same amount of aspartame was fed with 3 g/kg
>glucose, however, the plasma PHE/LNAA ratio increased sharply again to 0.240,
>while the brain PHE level increased to 143 n-moles/g.  In addition, there was
>a 3.5 fold increase in brain TYR levels.
>     3.  Aspartame and aspartame/carbohydrate combinations have also been
>tested in humans by Searle and Dr. Wurtman (cite to Searle petition and
>Surtman affidavit).  An aspartame dose of 34 mg/kg significantly elevated the
>plasma PHE/LNAA ratio, an effect that is almost doubled by the addition of 30
>g of carbohydrate (equivalent to 4 or 5 cookies).
>     4.    It is not possible to measure in vivo human brain levels of amino
>acids resulting from consumption of aspartame or subsequent effects on
>neurotransmitter synthesis. There are sound theoretical reasons, however, far
>considering the rat to be an appropriate model for assessing possible human
>effects (Wurtman affidavit). Moreover, there is empirical evidence to support
>the use of the rat as a model for evaluating possible effects of aspartame on
>human brain chemistry (Wurtman affidavit).
>     5.  There is scientific evidence suggesting that increases in brain PHE
>and TYR levels of the order seen in the rat studies can effect synthesis of
>neurotransmitters, which themselves can effect important physiological
>functions and potentially behavior.  (Wurtman affidavit should catalogue this
>evidence.)  Readily available tests could determine whether aspartame has
such
>neurotansmitter effects in rats or effects the rat's physiological functions

>or behavior. (Wurtman affidavit should describe tests.)
>     6.  Aspartame has been demonstrated to inhibit the carbohydrate-induced-
>synthesis of the neurotransmitter serotonin (Wurtman affidavit).  Serotonin
>blunts the sensation of craving carbohydrates and thus is part of the body's
>feedback system that helps limit consumption of carbohydrate to appropriate
>levels.  Its inhibition by aspartame could lead to the anomaious result of a
>diet product causing increased consumption of carbohydrates.
>
>Also it should be noted that this was written in l983 and put in the
>Congressional Record in l985.  After protesting the NSDA turned around and
>lobbied for NutraSweet.
> 
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** 
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