Monday July 21, 2014 (foodconsumer.org) -- A recent review published in American Journal of Industrial Medicine has urged regulatory agencies worldwide to re-assess the carcinogenicity of aspartame, an artificial sweetener commonly used in diet beverages.

Morando Soffritti, MD and collegues from Cesare Maltoni Cancer Research Center, Ramazzini Institute, Bologna, Italy suggest that aspartame can be a potential carcinogen after reexamining the adequacy of the design and conduct of the carcinogenicity bioassays on rodents submitted to the U.S. Food and Drug Administration for market approval and also the experimental and epidemiologic studies on the carcinogenicity of aspartame.

Experimental and epidemiologic evidence on the carcinogenicity of aspartame available in 2005 already "motivated the European Commission (EC) to call the European Food and Safety Authority (EFSA) for urgent re-examination of the available scientific documentation (including the Searle studies)," the reviewers reported.

Soffritti et al. found that the studies submitted to the FDA for market approval in the 1970s and other chronic bioassays were not adequately designed to provide evidence to prove that aspartame is non-carcinogenic.

On the other hand, the authors cited life-span carcinogenicity bioassays on rats and mice published in peer reviewed journals and one prospective epidemiologic study to demonstrate that aspartame can be a potential carcinogen. 

Based on the evidence reviewed, the authors suggest that "a re-evaluation of the current position of international regulatory agencies must be considered an urgent matter of public health."

Aspartame has been used in more than 6000 products including more than 500 pharmaceuticals since its discovery in 1965 and its first approval by the FDA in 1981, according to the review.  

Comment:  The review has certainly provided some evidence that suggests that aspartame is a potential carcinogen.  But the review by itself cannot prove that aspartame is a carcinogen.   In the United States, only the National Toxicology Program may have the authority to determine whether a compound is carcinogen. However, this review suggests that the FDA approval may be based on inadequate studies. Then again only the FDA may have the authority to determine whether or not the studies are adequate.  (David Liu, PHD)

Reference: Morando Soffritti MD*, Michela Padovani MPH, Eva Tibaldi PhD, Laura Falcioni DMV, Fabiana Manservisi PhD and Fiorella Belpoggi PhD, The carcinogenic effects of aspartame: The urgent need for regulatory re-evaluation, Article first published online: 16 JAN 2014, American Journal of Industrial Medicine, Volume 57, Issue 4, pages 383–397, April 2014