News Releases & Statements

Aspartame Safety Affirmed Again

NEWS RELEASE
FOR IMMEDIATE RELEASE    
April 23, 2007

Contacts:  
Tracey Halliday 
(202) 463-6718

Jennifer Tzitzon
(202) 463-6705

RAMAZZINI FAILS AGAIN WITH FLAWED RAT STUDY; NATIONAL CANCER INSTITUTE STUDY OF HUMANS VALIDATES SAFETY OF ASPARTAME FOR CONSUMERS

WASHINGTON – The presentation today of a new rat study on aspartame by the European Ramazzini Foundation is scientifically flawed and its conclusions should be dismissed in the wake of a long-term National Cancer Institute (NCI) study of humans, as well as the substantial foundation of science worldwide, that finds aspartame to be safe and finds no evidence of carcinogenicity. This follows another flawed rat study on aspartame by Ramazzini in 2005, which was widely discredited by scientific bodies internationally for its poor scientific methodology.

In fact, in a statement issued Friday, the U.S. Food and Drug Administration said, “FDA reviewed the study data made available to them by ERF and finds that it does not support ERF's conclusion that aspartame is a carcinogen. Additionally, these data do not provide evidence to alter FDA's conclusion that the use of aspartame is safe.”  (http://www.cfsan.fda.gov/~lrd/fpaspar2.html)

Importantly, the NCI published last year a long-term study of almost 500,000 people that showed no link between aspartame consumption in beverages and cancer.   A separate study published in the Journal of the National Cancer Institute also showed no increased risk for brain cancer in children, including among those whose mothers consumed aspartame during pregnancy and while breastfeeding.  Yet another epidemiological study published in the journal Annals of Oncology also found no indication of an association between sweetener use, including aspartame, and cancer risk.

“The conclusions presented by the Ramazzini Foundation are simply wrong,” said Dr. Richard H. Adamson, scientific consultant to the American Beverage Association.  “The first Ramazzini report was widely discredited worldwide for poor scientific methodology and there is no reason to think this report will fare any better.  Furthermore, presenting data in such an unethical and unusual way—by going around the widely accepted practices of scientific peer review and releasing information directly to the media—does nothing but cause unnecessary alarm among consumers about an ingredient that has repeatedly been confirmed as safe by regulatory agencies around the world.” 

“The bottom line is Ramazzini’s studies are flawed and are conducted on rats that are not pathogen free, while the National Cancer Institute study focuses on humans,” Adamson said. “It is the extensive human studies—as well as the breadth of research on aspartame—that should give consumers complete confidence in aspartame.”

The data presented by Dr. Mirando Soffritti of the Ramazzini Foundation, and its lack of support from the scientific community, stands in stark contrast to the study by the National Cancer Institute – a highly reputable institution that carried out a long-term, peer-reviewed study. And it stands in contrast to hundreds of other peer-reviewed studies affirming aspartame.

“The world-renowned NCI carried out a long-term study on the consumption of aspartame in beverages by almost half a million people and confirmed last spring that aspartame is safe for consumption by humans," Adamson said. 

Aspartame is one of the most thoroughly tested ingredients of all time with more than 200 scientific studies confirming its safety.  Approved for use in some foods in 1981 and for soft drinks in 1983, since that time, the sugar substitute has been repeatedly reviewed and approved by regulatory agencies around the globe, including the U.S. Food and Drug Administration, the European Union Scientific Committee on Food and the Joint Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives. In addition, renowned scientific bodies, including the National Cancer Institute, also have validated its safety for both over-the-counter use and use in food products.

The U.S. Food and Drug Administration last week also said, “Considering results from the large number of studies on aspartame's safety, including five previously conducted negative chronic carcinogenicity studies, a recently reported large epidemiology study with negative associations between the use of aspartame and the occurrence of tumors, and negative findings from a series of three transgenic mouse assays, FDA finds no reason to alter its previous conclusion that aspartame is safe as a general purpose sweetener in food.”
Human studies that affirm the safety of aspartame include:

•  A long-term study by Unhee Lim and co-authors published in Cancer Epidemiology Biomarkers and Prevention in 2006 by the National Cancer Institute on more than half a million people ages 50 to 71 years who consumed beverages containing aspartame and found no increased risk for leukemia or brain cancer, even among those considered heavy users. 

•  A recent study published in 2007 in the peer-reviewed journal Annals of Oncology which also found a lack of association between aspartame and other sweeteners and the risk of several common cancers.  This was a case control study of more than 8,900 cases of common cancer in men and women and more than 7,000 controls. 

•  A case control study of brain cancer in children, including mother’s consumption of aspartame during pregnancy and breast feeding, published in 1997 in the Journal of National Cancer Institute did not find evidence of brain tumor associated with aspartame consumption. 

Dr. Adamson said the human studies and numerous animal studies performed in the United States and abroad give consumers confidence that aspartame is a safe ingredient. And he points to specific flaws in the Ramazzini conclusions.

“It is likely that serious methodological problems in a previous study of aspartame in rats by the Ramazzini Institute also will be found in this study,” Adamson said. “These include infection in the animal rooms that is known to cause pulmonary lymphoma and leukemia, as well as an unconventional study design, a large number of tumors found in untreated animals, lack of verification of the pathology by a peer group, autolysis of tissues and numerous other problems.”

“The beverage industry takes seriously allegations concerning the safety of its ingredients, however, the data presented by Dr. Soffritti on aspartame is contradicted by an extensive body of scientific literature involving both animals and humans, as well as numerous regulatory reviews on this sweetener,” Adamson said.

The beverage industry provides a wide array of beverages that fit consumers’ individual lifestyles, including beverages with low-calorie sweeteners and sugar substitutes. 

Dr. Richard Adamson was formerly director of the Division of Cancer Etiology and scientific director at the National Cancer Institute of the National Institutes of Health.  Adamson also was vice president of scientific and technical affairs for the American Beverage Association until his retirement in 2004.  

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The American Beverage Association is the trade association representing the broad spectrum of companies that manufacture and distribute non-alcoholic beverages in the United States.

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