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Re: Reduced Font Size -- Entire Document - Protest of the National Soft Drink Association against putting aspartame in carbonated beverages, written in l983 and added to the Congressional Record in l985 (long document). They knew the gun was loaded!.

	(and we thank Lisa Anthony, Mission Possible Pennsylvania for typing this
in so many can put it on web, and she did this while she was sick with a
cold!)  This will require spell check since she doesn't have it.  

>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 information 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 NutraSweet'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-  (continued on page S 5508)
>(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)
>*                 *                 *                 *                 *
>     The inability to account for as much as thirty-nine (39) percent of
>decomposition products is significant.  With such a high unknown factor,
>judgements about the safety of APM in soft drinks cannot be made confidently.
>Possible explanations for, and speculation about, the material balance
>discrepancies abound: secondary reactions may be occurring (possibly with the

>flavor components in the beverages): additional, but unidentified
>decomposition products may exist, (as occurred in the case of PM and beta-
>APM): or the inaccuracy and inadequacies of the analytical methods may
>for the gaps in the data.  No explanation for the discrepancies in material
>balances--that is, for the high percentage of unknown material--can, however,
>be supported on the basis of the data submitted by Searle.  The significance
>of the unknown decomposition products simply cannot be determined in the
>absence of complete, careful and reliable analyses--analyses which are not
>currently available because the petitioner failed to conduct or submit them.
>     2.  Searle Has Not Characterized The Decomposition Products of APM in
>Soft Drinks Under Temperature Conditions To Which the Beverages Are Likely To
>Be Exposed In the United States.
>    A suitable assessment of the stability of APM in soft drinks can be
>conducted.  Such
> (continued on page S 5509)
>(2)  The availability of HPLC to detect and quantify APM's decomposition
>products is demonstrated by, among other things, a paper presented by three
>representatives of Searle, (LeVon, Mazur and Ripper "Aspartame (APM) as a
>Sweetener in Carbonated Soft Drinks") (Appendix).  In that paper, Searle
>stated that HPLC was currently used to detect APM. DKP and AP and PHE.
>Nevertheless, the petition does not contain HPLC generated data for AP or
>(3)  Section 171.1 (c) of the agency's regulations. 21 C.F.R. 171.1 (c)
>required that an analytical method for detection of a food additive and
>substances formed in or on food because of its use be practicable and one
>which "can be applied with consistent results by any property equipped and
>trained laboratory personnel."  HPLC is clearly such a method.
>(4)  FN w examples.
>(5)  This figure is derived as follows from Searle data: 13 percent AOM, 21
>percent DKP, 3 percent AP, 8 percent PHE, and 5 percent PM.
>(6)  The increase comes from 10 percent AA and 4 percent methanol.
>(7)  A material balance accounts for the quality of the starting material,
>quantity of identified decomposition products (or by-products, reaction
>produtcs, etc.) and the quantity of unkown material. Because of the
>inadequacies in the analyses documented in section --- above, the figures in
>this table may be inaccurate. Nevertheless, the discrepanices in the material
>balance raise the possibility of significant unknown decomposition products.
>(8)  A tempting, but unsatisfactory, resolution of the material balance
>discrepancy is to assume that the safety of the decomposition products were
>determined in the chronic studies in laboratory animals which Searle
>conducted. This putative resolution does not hold, however, because these
>degradation products would not have undergone testing, since the APM in the
>feeding regimen was in freshly prepared doses.
>May 7, 1985                CONGRESSIONAL RECORD -- SENATE                 S
>an assessment would necessarily involve the use of sample beverages in a
>variety of flavors and varying pH, and, most importantly, involve exposure of

>the beverages to temperature conditions which approximate those which are
>reasonably expected to occur in practice (or under conditions which permit
>reasonable projections to be made to actual conditions). (9)  Unless the
>sample APM-sweetened beverages are exposed to realistic temperature
>conditions, the temperature-sensitive degradation characteristics of APM, and
>in particular its potentially significant decomposition products, cannot be
>known.  The data submitted by Searle are not derived from appropriate test
>conditions.  Judgements about the extent of APM instability and its
>degradation products in soft drinks under actual conditions of use cannot,
>therefore, be inferred from the limited laboratory data.
>     To assess APM's instability in soft drinks, Searle exposed bottles of
>ready-to-drink beverages in four flavors (cola, root beer, lemon-lime and
>orange) to consistent temperatures of 55, 40, 50, 20 and 5 degrees C. (10)
>According to Searle's petition, "(I)n each flavor a loss of APM occurred with
>the rate of degradation directly related to the storage temperature for the
>carbonated beverages.  The rate of APM loss from beverages was pH dependent."
>Moreover, Searle noted that "as the temperature increases, the rate of
>degradation becomes more pronounced." (11)  Some of the effects on APM
>degradation in soft drinks are illustrated in a table in the Searle petition.
>(12)  In that table, for example, after 20 weeks at 30 degrees C (86 degrees
>F), a beverage with a pH between 2.5 and 3.0 contained less than 40
percent of
>the original amount of APM.  For beverages with similar pH, but kept at 40
>degrees C (104 degrees F) for 20 weeks, less than ten percent of the original
>APM remained.  Less pronounced degradation is seen at higher pH and/or at
>lower temperatures.
>     Although these stability tests shown signification degradation of APM at
>consistent temperatures over relatively short time periods, they shed
>virtually no light on the probably degradation rate and products for soft
>drinks exposed to a variety of temperatures--including temperatures higher
>than any used in Searle's studies--during storage, handing, sale and use,
>temperatures which are known to occur and to which sof drinks are known to be
>exposed.  Without stability studies conducted under such conditions, APM
>cannot be said to be appropriately stable in soft drinks, nor can its
>degradation products be considered to be adequately identified (assuming that
>analytical techniques were used which would yield complete and reliable
>results) nor can it be considered to have been shown to be safe.
>     The range of temperature conditions to which soft drinks are exposed
>during the summer months in the southern United States (13) is illustrated by
>a study conducted by the Coca-Cola Company's Corporate Packaging
Department in
>1976 and submitted to the Consumer Product Safety Commission. (14)    That
>study shows that during the summer months, soft drinks are often exposed to
>relatively high temperatures for certain time periods in the course of
>distribution from the bottling plant to the consumer.  High temperatures do,

>of course, routinely occur in much of the United States, including the
>southern regions; conditions of storage and distribution for soft drinks can
>elevate these temperatures signficiantly.
>     In summary, the study assessed: (1) warehouse temperatures in Marietta,
>Georgia and Wichita Falls, Texas: (2) route truck temperatures in Wichita
>Falls; (3) full sun and outside ambient temperatures in Wichita Falls; (15)
>and (4) parked car temperatures in Atlanta, Georgia and Wichita Falls.
Each of
>these test environments is known to occur in practice and the tests were
>performed under actual, as opposed to laboratory conditions.
>     Several significant conclusions can be drawn from this study.  First, in
>those situations where the bottled beverage is heated only by conduction from
>the surrounding air (shaded location in a warehouse or in the automobile
>parked indoors) the ratio of product temperature to the temperature of the
>surrounding air would be 0.92 to 0.94.  In enclosed environments exposed to
>sunlight, however, ratios much greater than one would be expected.  For
>example, a ratio of product temperature to air temperature of 1.45 was found
>for a test car parked in full sunlight. In other situations where sunlight
>a direct heating factor (e.g., open air service station promotions or open
>delivery trucks) typcial ratios were 1.10 to 1.15.
>     The effects of these ratios on product temperature are demonstrated by
>using summer temperatures for Phoenix, Arizona, where the average daily high
>in July is 40 degrees C (104 degrees F).  During July in Phoenix, a soft
>in full sunlight coud reach a temperature of 49 degrees C (120 degrees F)
>degrees x 1.15).  The same product in a car parked in full sunlight could
>reach 66 degrees C (151 degrees F) (104 degrees F x 1.45) (16); soft
drinks in
>a warehouse with an ambient temperature of 110 degrees could reach
>temperatures of 38 degrees C (101 degrees F) to 39 degrees C (103 degrees F)
>(0.92-0.94 x 110 degrees F).
>     Overall, the study, considered together with representative historical
>temperature data (Appendix ___) show that soft drinks will frequently be
>exposed to temperatures of 32 degrees C (90 degrees F) to 49 degrees C (120
>degrees F).  In some cases product temperatures as high as 66 degrees C (151
>degrees F) (especially n the southwestern United States) can be reached.
>     The effects of these high product temperatures on APM degradation and
>formation of degradation products, and the effects of temperature variation
>(for example, soft drinks displayed at a service station may reach
>temperatures of 49 degrees C (120 degrees F) for most of the afternoon, drop
>in termpature overnight, and heat up again during the following day)
cannot be
>determined from the data submitted by Searle to the FDA.
>     What those data do suggest, however, is that significant APM degradation
>at high temperaures occurs within a short period of time.  For exmaple, in
>Searle's stability tests, an orange beverage held at 40 degrees C (104
>F) average daily high for Phoenix during July) for eight weeks, contained

>fifty (50) percent of the original amount of APM.  A cola beverage held
>the same conditions contained only forty (40) percent of the original APM
>amount. And beverages exposed to higher temperatures degrade even more
>rapidly.  And, or course, because of the temperature elevation ratios,
>temperatures could easily be much higher during actual conditions than the
>stable temperatures used in the Searle laboratory studies.
>     Thus, it is known that APM will degrade rapidly at high temperatures,
>including temperatures to which soft drinks are known to be exposed
>intermittently during the summer.  What is now known, although the FDC Act
>requires the proponent of use to demonstrate it, is what effects of
>degradation occur by virtue of exposure to these temperatures. 
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