Aspartame: review of safety.
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.
Medical and Scientific Affairs, The NutraSweet Company, Mt Prospect, Illinois 60056, USA. harriett.h.butchko@nutrasweet.com
Harriett H
HH
Butchko
W Wayne
WW
Stargel
C Phil
CP
Comer
Dale A
DA
Mayhew
Christian
C
Benninger
George L
GL
Blackburn
Leo M J
LM
de Sonneville
Raif S
RS
Geha
Zsolt
Z
Hertelendy
Adalbert
A
Koestner
Arthur S
AS
Leon
George U
GU
Liepa
Kenneth E
KE
McMartin
Charles L
CL
Mendenhall
Ian C
IC
Munro
Edward J
EJ
Novotny
Andrew G
AG
Renwick
Susan S
SS
Schiffman
Donald L
DL
Schomer
Bennett A
BA
Shaywitz
Paul A
PA
Spiers
Thomas R
TR
Tephly
John A
JA
Thomas
Friedrich K
FK
Trefz
D000339:Affect / Q000187:drug effects; D000818:Animals; D001218:Aspartame / Q000008:administration & dosage / Q000009:adverse effects* / Q000378:metabolism / Q000633:toxicity; D001519:Behavior / Q000187:drug effects; D001932:Brain Neoplasms / Q000139:chemically induced; D003071:Cognition / Q000187:drug effects; D004353:Drug Evaluation, Preclinical; D004342:Drug Hypersensitivity / Q000209:etiology; D004569:Electroencephalography / Q000187:drug effects; D004703:Endocrine System / Q000187:drug effects; D006261:Headache / Q000139:chemically induced; D006801:Humans; D000432:Methanol / Q000378:metabolism; D010649:Phenylalanine / Q000378:metabolism; D011358:Product Surveillance, Postmarketing; D012640:Seizures / Q000139:chemically induced; D013549:Sweetening Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000378:metabolism / Q000633:toxicity; D015431:Weight Loss / Q000187:drug effects
D013549:Sweetening Agents; D010649:Phenylalanine; D000432:Methanol; D001218:Aspartame