GENTECH archive


Re: Part 1 A -- Congressional Record, Protest of the National Soft Drink Association - they knew the gun was loaded BEFORE they ever put aspartame (NutraSweet) in pop! Keep these posts as they are typed in for those who want the information for their web sites.

Dear Lisa:  You're wonderful.  As you type it in I'll put it on the list so
anyone who wants to reserve it so it can be put on their web page they can.
 I can't tell you how much this is going to help.  People need to know that
Coca Cola and Pepsi knew ahead of time what would happen if they put
aspartame in carbonated beverages.  This is great.  Somebody will have
spell check and they can put it together as you type it.  

I'll also let people know that you are typing in pages S 5507 through S5511
of the Congressional Record dated May 7, l985.  These pages contain the 30
pages of protest by the National Soft Drink Association.  For this reason
the beginning of the page starts in the middle of a sentence.  

Consider that the NSDA and pop companies knew in advance what would happen
if they put aspartame in soft drinks and did it anyway!!!!   

I will put them on lists as you type it in.  Thank you so much, Lisa!  Now
the world will know that Coke and Pepsi and anyone else have no excuse! we
hope others will pass them on.

BettyAt 03:52 PM 6/15/98 -0400, you wrote:
>Dear Betty:
>Betty, thought I'd send along Part I--the e-mail space wouldn't let me type
>anymore and when I went to e-mail it, I had to break it down even further so,
>I thought that was probably a good place to stop for now.  I intend to finish
>up tomorrow afternoon.  I do not have the ability to superscript text, so, I
>italicized and put into parenthesis the reference numbers.  If you would like
>any format changes or corrections, just holler.  I don't have spell check
>either so beware!  In addition, when they refer to specific Sections they use

>a symbol which looks like a "C" on top of an inverted "C".  I do not have
>ability to make that symbol on the computer so, if you would like something
>substituted, let me know.
>May 7 1985               CONGRESSIONAL RECORD -- SENATE                 S
>heachaches, mood alterations, and behavior changes."
>     The report language accompanying this bill directs the FDA to ensure
>these tests are undertaken.
>     At mark up, I proposed an amendment which would require the
>of diet soft drinks to include on their label how much aspartame (NutraSweet)
>each serving contains.
>     I believe consumers have a right to this informaiton given the questions
>which have been raised about NutraSweet and the extraordinary increase in
>consumption levels of this product since its introduction in 1981 (last year
>per capita consumption increased 66%).
>     The National Soft Drink Association has lobbied strongly against this
>proposal.  However, this is the same association which, in 1983, prepared a
>draft legal document objecting to NutraSwseet's being allowed on the market,
>citing serious and unresolved questions about the public health. Though that
>document was not filed, it indicates the organization had significant health
>concerns relating to the amount of aspartame consumed before this product was
>approved for soft drinks.  The following quotes are from a document entitled
>"Objections of the National Soft Drink Assocation to a Final Rule Permitting
>the Use of Aspartame in Carbonated Beverages and Carbonated Beverage Syrup
>Bases and a Request for a Hearing on the Objections."  The document is dated
>August 8, 1983, and was prepared by Patton, Boggs and Blow and the General
>Counsel for the National Soft Drink Association:
>     "G. D. Searle and Company has not demonstrated to a reasonable certainty
>that the use of aspartame in soft drinks, without quantitative limitations,
>will not adversely affect human health as a result of the changes such use is
>likely to cause in brain chemistry and under certain reasonably anticipated
>conditions of use."
>     "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. Wurtman are significant because 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-groups, such s children, pregnant women and
>   "Specifically, Searle has not met its burdens under section 409.... to
>demonstrate that aspartame is safe and functional for use in soft drinks."
>      "Collectively, the extensive deficiencies in the stability studies
>conducted by Searle to demonstrate that aspartame and its degradation
>are safe in soft drinks intended to be sold in the United States, render
>studies inadequate and unreliable."
>        There have been hundreds of reports from consumers around the country
>suggesting a possible relationship between their consumption of NutraSweet
>subsequent symptoms including headaches, aberrational behavior, slurred
>speech, etc.
>     During the Labor Committee hearing on saccharin, NutraSweet and
>held on April 2, Dr. Richard Wurtman of M.I.T., testified as follows:
>     "The problem at present is that it is difficult if not impossible for
>patient or  his physician to know how much aspartame it contains....I believe
>it is essential that companies which include aspartame in their products be
>required to indicate on the labels (in readable print) how much of the
>sweetener is present in each can or serving. This simple change in labeling
>practice would, I believe, sharply reduce the number of consumers who believe
>without probable foundation that they have suffered aspartame-related side-
>effects.  Perhaps more importantly, it would also enable phsyicans to
>those patients who might really have had such responses, so that such people
>might then undergo controlled clinical testing."
>     Since 1981, the FDA has attached an ADI (acceptable maximum daily
>to NutraSweet.  That ADI is currently 50 milligrams per kilogram of body
>weight.  While an adult weight in 154 pounds would not meet that limit before
>he consumed 5 liters of diet soft drink, a four-year-old weight in 25 pounds
>would hit that limit at three cans of diet soda.  Consumers have no way of
>knowing if they have reached the FDA limit without knowing how much is in the
>can. Ideally, we should have the ADI on the can as well, but it will take
>time to figure out how that could be done effectively. In the meantime we
>should ensure that the quantity is on the label.  We must start somewhere,
>this is an important first step.
>     Many questions must be resolved concerning aspartame. The FDA should
>an active role to ensure that tests are conducted to determine whether
>individuals, particularly children, are likely to experience side-effects
>NutraSweet at current and projected consumption levels.  The FDA should also
>run tests on how NutraSweet affects those who might be taking different types
>of medication.
>     Finally, given the serious questions which remain regarding the FDA
>approval process for NutraSweet, the FDA should ensure that certain key
>pivotal animal tests are repeated. Only when all of these questions are
>resolved can consumers be certain that they are receiving the full protection

>provided by our food and drug laws.
>(Docket No. 82F-0305)
>DRAFT:  JULY 28, 1983
>     Objection One:  Searle has not demonstrated to a reasonable certainty
>that aspartame and its degradation products are safe for use in soft drinks.
>Without quantitative limitations, under temperature conditions likely to
>prevail in the United States.
>     Aspartame is inherently, markedly and uniquely unstable in aqueous
>In a liquid, such as a soft drink, APM will degrade as a function of
>temperature and pH.  Higher temperatures and more acidic liquids increase the
>rate of degradation.  Higher temperatures may also affect the degradation
>products which are formed. Given the circumstance of APM's unusual
>instability, reliable and comprehensive analyses of APMs degradation in sof
>drinks--both as to the rate of degradation (and the subsequent loss of
>sweetness) and to the confirmed idenfication of the major degradation
>products--is crucial to establish the safety of the use of APM.  Without
>adequate identification of AMP's significant decomposition products, it is
>possible to find, to a reasonable certainty, that APM is safe.  The data and
>information submitted by Searle in support of its petition to amend 21 C.F.R.
>172.804 to permit APM use in soft drinks, however, do not demonstrate that
>is safe for use in soft drinks.  These data are insufficient to establish
>safety because the petition lacks comprehensive, reliable and accurate
>analytical data on APM and the products "adversely affected' by the issuance
>of the regulation authorizing the use of aspartame ("APM") in soft drinks.
>the national trade association representing the soft drink industry in this
>country, NSDA's member soft drink manufacturers and soft drink franchisers
>directly and immediately affected by the issuance of a regulation which
>authorizes the use of a new sweetener in its products.  Approximately
>six percent of the nations 1600 soft drink manufacturers are active
members of
>the Association.  These members account for more than ninety percent of the
>soft drink production in this country.  In addition, the vast majority of
>drink franchisers which manufactur the concentrates and syrups from which
>drinks are made are associate members of the Association.
>(To be added).                                                       
>     In the Federal Register of July 8, 1983 (48 Fed. Reg. 31376), the Food
>and Drug Administration ("FDA") issued a regulation amending section 172.804
>of its regulations, 21 C. F. R. 172.804 to authorize the use of aspartame in

>carbonated beverages and carbonated beverage bases (collectively referred to
>as "soft drinks").  This action was taken in response to a food additive
>petition (FAP 2A3661) filed on October 15, 1982 by the Searle Research and
>Development Division of the G. D. Searle Co. ("Searle").
>     In these objections, NSDA demonstrates that there exist genuine and
>substantial issues of fact material to FDA's amendment of its regulatios to
>permit aspartame use in soft drinks.  Specifically, Searle has not met its
>burdens under section 409 of the Federal Food, Drug and Cosmetic Act, 21 U.S.
>C. 348 ("FDC Act") to demonstrate that aspartame is safe and functional for
>use in soft drinks NSDA therefore objects to the Commissioner's order
>21 C. F. R. 172.804 and requests that a hearing as provided under section 499
>(f) of the FDC Act, 21 U.S.C. 348 (f) be convened.
>     NSDA is a party that is, within the meaning of section 409(f)(l) of the
>FDC Act. 21 U.S. C. 348 (f)(l). methyl ester (PM) and beta-aspartame (beta-
>APM). (1)    (Searle FAP at 13) Only in the cases of APM and DKP did Searle
>use high pressure liquid chromotography (HPLC). For the other four known
>principal breakdown products, Searle used thin-layer chromotography (TLC).
>      HPLC is a far superior analytical method relative to TLC (cites) and
>numerous SPLC methods exist for the detection and quantification of amino
>acids (cites. Searle's choice of TLC over HPLC adversely affected the quality
>and type of analytical data generated on APM and its decomposition
products in
>soft drinks   The unfortunate and inepli-
>(1)   The importance of comprehensive and reliable analyses of APMs
>decomposition products is demonstrated by the fact that based on the chemical
>structure of APM, one would ont expect PM or beta-APM to be degradation
>products, indeed, initially Searle di dnot look for either one.  Other
>unexpected decomposition products of unrpvoen safety could of course, also be
>present when APM degrades.
>S 5508                  CONGRESSIONAL RECORD -- SENATE             May 7,
>cable choice (2) of an inferior analytical technique, when superior and
>recognized methods are available, has resulted in inadequate characterization
>of APM's decomposition products.
>     HPLC is a practicable, well-accepted analytical method (3) which is
>commonly-employed by FDA.  When the safety and suitability for use of a food
>additive such as APM with an acknowledged degradation problem (and
>high consumption) is under evaluation, HPLC is clearly the analytical method
>of choice.
>     TLC, on the other hand, produces good qualitative results, but is, at
>best, only semi-quantitative, since the quantification used is based on
>comparisons of spot sizes and intensities. (cite) Indeed, Searle itself has
>acknowledged the inadequacy of the analytical method that it chose when it
>described, in the petition, the quantity of degradation products identified
>using TLC as "estimates." (cite)
>     The inappropriateness of using TLC as a principal analytical method is
>compounded by the fact that the values of APM degradation products being

>measured are close to the limits of detection of the methed (cite). (4)
>the values purportedly obtained by the TLC method cannot be considered to be
>very precise. Finally, an important decomposition product of APM, aspartic
>acid (AA) cannot be detected at all using TLC.
>      In short, for reasons which are not apparent, the petitioner chose to
>use a semi-quantitative analytical method to analyze for numerous major APM
>breakdown products close to the limits of detection, when that method is not
>the best method available. The quality of the analytical data presented are,
>therefore, substantially inferior to those which could have reasonably been
>     (b) The Searle Analyses for APM Decomposition Products are Deficient.
>   Aside from its choice of TLC over HPLC, the analyses conducted by the
>petitioner to identify and quantify the breakdown products of APM in soft
>drinks are plagued by numerous significant deficiencies which result in clear
>and unmistakeable inadequacies in the detection and quantification of the
>major decomposition products of APM in soft drinks.  In the face of these
>deficiencies, Searle has not reasonably identified substances formed in soft
>drinks because of the use of APM, as required under section 409 (c) (5)
(A) of
>the FDC Act 21 U.S.C. 348 (c) (5) (A).  The safety of this use of APM cannot
>be said to have been shown to a reasonable certainty in the face of these
>     There are at least six significant deficiences in the HPLC analyses
>undertaken by Searle to identify and quantify APM and DKP in soft drinks:
>     (a) The standards for use of HPLC to detect APM and DKP were prepared in
>buffered aqueous solutions.  A far better technique would have been to
>the standards using beverage matrices.  The use of beverage matrices would
>have reduced the danger of interfering compounds coeluting with the compounds
>of interest.
>     (b) Searle does not appear to have submitted to FDA to HPLC
>of the blanks (unsweetened beverages); without these chromatograms, the
>results obtained in sweetened beverages cannot be evaluated.
>    (c)  The chromatograms of the beverages which were submitted by Searle
>contain peaks which can cause difficulties with quantification.  For example,
>the DKP in the root beer chromatograms is badly overlapped by another peak.
>     (d)  No recovery data for DKP were presented and the precision of the
>concentrations was only determined for standard solutions.
>     (e) The purity of the initital APM was not established, although it can
>contain at least five percent impurities, as calculated from the zero time
>values in Searle's studies.
>     (f)  Searle analyzed only single bottles at any given time and
>temperature.  This aspect of the study design fails to account for
>bottle-to-bottle variations.  Single bottle analytical data cannot, under any
>circumstances, amount to a comprehensive and reliable characterization of the
>decomposition products of an additive with a well-known instability problem.
>     Likewise, the TLC analyses are deficient (these deficiencies are in

>addition to the inherent limitations of the TLC method):
>     (a) Standards for the TLC analyses were prepared in distilled water.  As
>in the case of the HPLC analyses, the better technique would have been to
>prepare them in beverage matrices.
>     (b) Searle did not submit (and apparently did not attempt) any recovery
>or precision data for its TLC analyses.
>    (c) In the TLC analyses, only single aliquots of single bottles were
>analyzed at any given time and temperature, thus rendering the putative
>quantitative results inherently unreliable.
>     (d) Measurable levels of beta-APM and PM may have existed in the
>material, but were not quantified at the beginning of the anaylses
>because they were unexpected decomposition products).  Moreoever, it is
>unclear from Searle's data how the spots on the TLC plates were identified.
>If, as appears to be the case, identification was based solely on the
>comparison of R values, the identications can only be called tentative.
>Confirmation of the identifications by spectroscopic methods should have been
>undertaken. The failure to confirm these identifications undermines many of
>the major assumptions made by Searle throughout its analytical studies.
>    Collectively, the extensive deficiencies in the stability studies
>conducted by Searle to demonstrate that APM and its degradation products are
>safe in soft drinks intended to be sold in the United States, render those
>studies inadequate and unreliable.  It is not possible on the basis of these
>studies to conclude that the petitioner has demonstrated that,
>its inherent instability, APM is safe for use in soft drinks.  The failure of
>proof by Searle is even more evident, as is shown in the following section of
>these objections, when one considers the extent to which the decomposition
>products of APM in soft drinks are not known or identified.
>     (c) APM Decomposes Extensively in Soft Drinks Under Moderate Conditions.
>But Searle's Data Fail to Identify Adequately the Decomposition Products.
>     Notwithstanding the multiple and serious deficiences in the stability
>studies conducted on the APM in soft drinks, one conclusion does emerge:
>moderate conditions, extensive decomposition of APM may occur in soft drinks.
>Moreover, a substantial portion of the decomposition products are not known.
>APM cannot be considered to be shown to be safe for use in soft drinks when
>the results of its known decomposition phenomenon--marked breakdown in liquid
>beverages--are not well identified.
>     For example, in Searle studies, a cola beverage was kept at 10 degrees C
>(86 degrees F) for 40 weeks. (cite)  In analyses conducted at that time, only
>fifty (50) percent (weight basis) of the original starting material was
>(5)  Even if one accepts one of Searle's main assumptions about APM
>decomposition in soft drinks--that is, that aspartic acid (AA) is formed in
>amounts equal to the PHE and PM (mole basis) (cite)--the percent recovery to
>sixty-four (64) percent. (6)  Thus, even when viewed most favorably, the
>analyses fail to account for over one-third of the original material.

>     This startling deficiency in the stability studies is further
>demonstrated by this table, also drawing from Searle data of beverages stored
>at 30 degrees C (86 degrees F), which illustrates the material balances
>obtained: (7)
>*                 *                 *                 *                 *
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