Congressional Record continued, Protest of National Soft Drink Association - Coke and Pepsi knew the gun was loaded before they put aspartame in their products.
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- Subject: Congressional Record continued, Protest of National Soft Drink Association - Coke and Pepsi knew the gun was loaded before they put aspartame in their products.
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Continuation. 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.
>* * * * *
> 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
>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
> 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
>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.
>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
>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)
>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 under
>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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