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Aspartame Potentially Subject to Prop 65 Listing

The Carcinogen Identification Committee (CIC) – California’s qualified experts on carcinogenicity for purposes of Proposition 65 (Prop 65)) – pursuant to a meeting scheduled for November 15, 2016, will be providing the state’s Office of Environmental Health Hazard Assessment (OEHHA) with advice on the prioritization of aspartame for possible preparation of hazard identification materials.  While aspartame has undergone some OEHHA appraisal (e.g.,  epidemiologic data screen, animal data screen, preliminary toxicological evaluation) and evaluation already, this CIC meeting essentially will be the first, public step towards  potentially including aspartame prospectively on the Prop 65 List of Chemicals Known to the State To Cause Cancer or Reproductive Toxicity.  Such listing, in effect, ultimately would trigger a requirement that California consumers be warned before purchasing a food product containing aspartame in excess of any “safe harbor” level established by OEHHA for it.

A notice of the CIC meeting will be published on September 9, 2016.  It will provide interested parties with a 45-day (i.e., until October 24, 2016) comment period to submit input to OEHHA on the scientific evidence pertaining to the selection of aspartame for possible preparation of hazard identification materials.   OEHHA is the lead agency for the implementation of Prop 65.  It has made available a compilation of the relevant studies identified during the preliminary toxicological evaluation of aspartame.  No listing decision will be made about aspartame at the November 15th meeting.  OEHHA would announce any such decision in a subsequent notice.

Aspartame is approved by FDA regulation for use in food as a nutritive sweetener.  It does contain calories, but because it is about 200 times sweeter than table sugar, consumers are likely to use much less of it.
FDA originally approved aspartame in 1981 for uses, under certain conditions, as a tabletop sweetener, and in chewing gum, cold breakfast cereals, and dry bases for certain foods (i.e., beverages; instant coffee and tea; gelatins, puddings, and fillings; and dairy products and toppings).  In 1983 FDA approved the use of aspartame in carbonated beverages and carbonated beverage syrup bases, and in 1996  FDA approved it for use as a “general purpose sweetener.”   It is not heat stable and loses its sweetness when heated, so it typically is not used in baked goods.

Aspartame is one of the most exhaustively studied substances in the human food supply, with more than 100 studies supporting its safety.

FDA scientists have reviewed scientific data regarding the safety of aspartame in food and concluded that it is safe for the general population under certain conditions.  However, people with a rare hereditary disease known as phenylketonuria (PKU) have a difficult time metabolizing phenylalanine, a component of aspartame, and should control their intake of phenylalanine from all sources, including aspartame.  Labels of aspartame-containing foods and beverages must include a statement that informs individuals with PKU that the product contains phenylalanine.

In 2006-07, CFSAN’s Office of Food Additive Safety reviewed a long-term carcinogenicity study of aspartame entitled, “Long-Term Carcinogenicity Bioassays to Evaluate the Potential Biological Effects, in Particular Carcinogenic, of Aspartame Administered in Feed to Sprague-Dawley Rats,” conducted by the European Ramazzini Foundation (ERF).  FDA evaluated the study data made available to them by ERF and found that it did not support ERF’s conclusion that aspartame is a carcinogen.  Additionally, such data did not provide evidence to alter FDA’s conclusion that the use of aspartame is safe.

More recently, in 2014, FDA issued a letter denying a Citizen Petition submitted by K. Paul Stoller, M.D., Fellow of the American College of Hyperbaric Medicine, and another letter denying a Citizen Petition submitted by Betty Martini, founder of Mission Possible International.  Both petitions essentially sought a FDA ban of aspartame.

Against this federal backdrop, it will be very interesting to see how California proceeds.

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