Document Detail


Aspartame: review of safety.
MedLine Citation:
PMID:  12180494     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Over 20 years have elapsed since aspartame was approved by regulatory agencies as a sweetener and flavor enhancer. The safety of aspartame and its metabolic constituents was established through extensive toxicology studies in laboratory animals, using much greater doses than people could possibly consume. Its safety was further confirmed through studies in several human subpopulations, including healthy infants, children, adolescents, and adults; obese individuals; diabetics; lactating women; and individuals heterozygous (PKUH) for the genetic disease phenylketonuria (PKU) who have a decreased ability to metabolize the essential amino acid, phenylalanine. Several scientific issues continued to be raised after approval, largely as a concern for theoretical toxicity from its metabolic components--the amino acids, aspartate and phenylalanine, and methanol--even though dietary exposure to these components is much greater than from aspartame. Nonetheless, additional research, including evaluations of possible associations between aspartame and headaches, seizures, behavior, cognition, and mood as well as allergic-type reactions and use by potentially sensitive subpopulations, has continued after approval. These findings are reviewed here. The safety testing of aspartame has gone well beyond that required to evaluate the safety of a food additive. When all the research on aspartame, including evaluations in both the premarketing and postmarketing periods, is examined as a whole, it is clear that aspartame is safe, and there are no unresolved questions regarding its safety under conditions of intended use.
Authors:
Harriett H Butchko; W Wayne Stargel; C Phil Comer; Dale A Mayhew; Christian Benninger; George L Blackburn; Leo M J de Sonneville; Raif S Geha; Zsolt Hertelendy; Adalbert Koestner; Arthur S Leon; George U Liepa; Kenneth E McMartin; Charles L Mendenhall; Ian C Munro; Edward J Novotny; Andrew G Renwick; Susan S Schiffman; Donald L Schomer; Bennett A Shaywitz; Paul A Spiers; Thomas R Tephly; John A Thomas; Friedrich K Trefz
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Regulatory toxicology and pharmacology : RTP     Volume:  35     ISSN:  0273-2300     ISO Abbreviation:  Regul. Toxicol. Pharmacol.     Publication Date:  2002 Apr 
Date Detail:
Created Date:  2002-08-15     Completed Date:  2002-12-13     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  8214983     Medline TA:  Regul Toxicol Pharmacol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  S1-93     Citation Subset:  IM    
Affiliation:
Medical and Scientific Affairs, The NutraSweet Company, Mt Prospect, Illinois 60056, USA. harriett.h.butchko@nutrasweet.com
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MeSH Terms
Descriptor/Qualifier:
Affect / drug effects
Animals
Aspartame / administration & dosage,  adverse effects*,  metabolism,  toxicity
Behavior / drug effects
Brain Neoplasms / chemically induced
Cognition / drug effects
Drug Evaluation, Preclinical
Drug Hypersensitivity / etiology
Electroencephalography / drug effects
Endocrine System / drug effects
Headache / chemically induced
Humans
Methanol / metabolism
Phenylalanine / metabolism
Product Surveillance, Postmarketing
Seizures / chemically induced
Sweetening Agents / administration & dosage,  adverse effects*,  metabolism,  toxicity
Weight Loss / drug effects
Chemical
Reg. No./Substance:
0/Sweetening Agents; 22839-47-0/Aspartame; 63-91-2/Phenylalanine; 67-56-1/Methanol

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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