Aspartame: scientific evaluation in the postmarketing period.

Prior to marketing, the safety of the high-intensity sweetener aspartame for its intended uses as a sweetener and flavor enhancer was demonstrated by the results of over 100 scientific studies in animals and humans. In the postmarketing period, the safety of aspartame was further evaluated through extensive monitoring of intake, postmarketing surveillance of anecdotal reports of alleged health effects, and additional research to evaluate these anecdotal reports and other scientific issues. The results of the extensive intake evaluation in the United States, which was done over an 8-year period, and the results of studies done in other countries demonstrated intakes which were well below the acceptable daily intakes set by the FDA and regulatory bodies in other countries, as well as the Joint FAO/WHO Expert Committee on Food Additives. Evaluation of the anecdotal reports of adverse health effects, the first such system for a food additive, revealed that the reported effects were generally mild and also common in the general population and that there was no consistent or unique pattern of symptoms that could be causally linked to consumption of aspartame. Finally, the results of the extensive scientific research done to evaluate these allegations did not show a causal relationship between aspartame and adverse effects. Thus, the weight of scientific evidence confirms that, even in amounts many times what people typically consume, aspartame is safe for its intended uses as a sweetener and flavor enhancer.

Effect of chewing gums on plaque pH after a sucrose challenge.

The objective of this study was to determine whether sugarless chewing gums sweetened with different sweeteners differ in their ability to reduce an acidogenic response from a 10 percent sucrose-rinse challenge. Five commercially available chewing gums and two control regimens ("no gum" or paraffin) were tested using a plaque pH telemetry system. The gums were sweetened with sucrose, high-intensity sweeteners (aspartame, saccharin, or acesulfame-K), or a polyol (xylitol). Using a seven-period randomized block design, eight adult panelists were challenged with a 10 percent sucrose solution and then randomly used one of the test regimens during each of the seven test sessions. Each two-hour test session was divided into five periods: resting baseline (five minutes); sucrose rinse challenge (two minutes); postsucrose challenge (ten minutes); gum chewing (ten minutes); post gum chewing (ninety-three minutes). The factors analyzed were: the area of the curve (pH X Time) below pH 5.5, the minimum plaque pH attained, the changes in plaque pH over relevant intervals, and the length of time the plaque pH remained below pH 5.5. The various response variables showed a similar pattern of statistically significant differences. All of the sugarless gums were effective in significantly increasing plaque pH and in reducing the area under the curve after the sucrose challenge compared with "no gum" treatment. No statistically significant differences were noted among the sugarless gums. The response to sucrose gum was intermediate between sugarless gums and "no gum" but was not statistically different from "no gum" or three of the sugarless gums.(ABSTRACT TRUNCATED AT 250 WORDS)

Acidogenicity of high-intensity sweeteners and polyols.

PURPOSE: To evaluate the plaque pH responses to sucrose, fructose, xylitol, sorbitol, acesulfame-K, aspartame, and saccharin at equal sweetness levels (equivalent to 10% sucrose) and water using an indwelling plaque pH telemetry system. MATERIALS AND METHODS: Eight adult panelists used each sweetener once in a Latin square study design. Plaque was allowed to accumulate for 3-6 days before each challenge period, and the panelists fasted for 12 hours prior to the 2-minute test rinse. Plaque pH was monitored for a 2-hour period after the rinse exposure. The parameters examined were area of the curves under pH 5.5 (pH X Time), pH changes from baseline, lowest pH attained and time below pH 5.5. RESULTS: The the high-intensity sweeteners (aspartame, saccharin and acesulfame-K) and the polyols (sorbitol and xylitol) were all non-acidogenic and were not significantly different from each other while both sucrose and fructose were highly acidogenic.

Postmarketing surveillance of food additives.

Postmarketing surveillance of consumption and of anecdotal reports of adverse health effects has been recognized by a number of regulatory authorities as a potentially useful method to provide further assurance of the safety of new food additives. Surveillance of consumption is used to estimate more reliably actual consumption levels relative to the acceptable daily intake of a food additive. Surveillance of anecdotal reports of adverse health effects is used to determine the presence of infrequent idiosyncratic responses that may not be predictable from premarket evaluations. The high-intensity sweetner, aspartame, is a food additive that has been the subject of extensive evaluation during the postmarketing period and is thus used as an example to discuss postmarketing surveillance.

Acceptable daily intake vs actual intake: the aspartame example.

This article discusses the acceptable daily intake (ADI) and the postmarketing surveillance of consumption levels for a food additive, using the widely used food additive aspartame (APM, L-aspartyl-L-phenylalanine methyl ester) as an example. The safety implications of the ADI and consumption levels are also discussed. Aspartame has been assigned an ADI of 40 mg/kg/day by the World Health Organization and regulatory authorities in Europe and Canada, and of 50 mg/kg/day by the US Food and Drug Administration. A number of different methods have been used to measure consumption levels of food additives. Consumption estimations for aspartame from one such method, the food intake survey, have been done in the United States, Canada, Germany, and Finland. APM consumption in all age groups and selected subpopulations, even at the 90th percentile, is approximately 2-10 mg/kg/day and is thus well below the ADI.