Sample Quotes from Cancer Experts’ Letters on Acesulfame Testing
|These data do not permit an assessment that use of this compound would provide a
reasonable certainty of no harm. In fact, there are indications that it might be
carcinogenic. I would strongly suggest that a properly designed long term study in both
mice and rats be conducted before Acesulfame K be considered for approval.
David Rall, M.D., Ph.D. Assistant Surgeon General, United States Public Health Service (retired). Former director, United States National Institute of Environmental Health Sciences (NIEHS/NIH). Former director, United States National Toxicology Program (NTP).
|There are several serious flaws in the design and conduct of the tests.... The
only conclusion one can draw from looking at the available results is that acesulfame
should be tested in a proper way before an evaluation of its carcinogenicity can be
Lorenzo Tomatis, M.D. Former director, International Agency for Research on Cancer (IARC), a World Health Organization agency.
|These studies are inadequate to assess the carcinogenic potential of the compound.
In the face of inadequate study design and conduct, which would tend to obscure a
carcinogenic effect if it were there, nevertheless there was at least equivocal evidence
for carcinogenic activity in several studies.
Franklin E. Mirer, Ph.D. Director, Health and Safety Department, United Automobile Workers. Member of the Board of Scientific Counselors of the National Toxicology Program (NTP).
|In view of the intended very wide use of acesulfame for the general population, I
agree that well conducted, rigorous bioassays should be performed. Reading the reports of
the tests on acesulfame brought back to me the ’flavor’ of the bad testing practices that
were common in those years, such as the use of poorly defined animal colonies, diffuse
respiratory infections, lack of randomization in the assignment of the animals, limited
sampling for histopathology, uncertainties as to what was the appropriate dose range to be
tested, high background incidences of various tumors. I believe that now -- twenty years
later -- such poor quality tests should not be considered as acceptable evidence for an
important public health evaluation....
Umberto Saffiotti, M.D. Chief, Laboratory of Experimental Pathology, National Cancer Institute, Bethesda, Maryland. (Personal views do not represent the National Cancer Institute.)
|I find the actual studies and the data analysis seriously flawed. New tests,
properly designed, executed, and analyzed are needed. The usual consequences of poor tests
is to make it harder to find any effects. Despite the low quality of the studies reported
to you, I find that there is evidence of carcinogenicity.
Marvin Schneiderman, Ph.D. Former Associate Director of Field Studies and Statistics at the National Cancer Institute.
|...(T)he available data on this compound is at best incomplete.... Because of the
widespread consumption of ’diet’ colas in the U.S., I concur with your position that FDA
should require comprehensive testing prior to granting this additional use. The data on
carcinogenicity are not negative.... (T)he findings are consistent with potential
Ellen K. Silbergeld, Ph.D. Professor of Epidemiology and Toxicology, University of Maryland at Baltimore. Former member, Board of Scientific Counselors of the National Toxicology Program (NTP).
|We agree with your proposal to suggest more modern carcinogenicity tests on
acesulfame K and acetoacetamide prior to the widespread use of this sweetener.
J.D. Wilbourn Acting Chief, Unit of Carcinogen Identification and Evaluation, International Agency for Research on Cancer, a World Health Organization agency.
|...(I)t is clear that questions arising in earlier -- extremely inadequate --
studies about the additive’s cancer-causing properties have not been resolved.... Given
the likelihood that millions of Americans would be exposed to acesulfame were the additive
to be approved for beverage use, the questions about its carcinogenicity must be resolved
before a scientifically supportable regulatory decision can be made.
Sidney M. Wolfe, M.D. Director, Public Citizen’s Health Research Group. Former member of the NCI Carcinogenicity Clearinghouse.