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California's Proposition 65: All Eyes on Aspartame

California is considering adding aspartame to its Proposition 65 Listing. Proposition 65 is the California state law requiring labeling warnings on products containing substances “known by the state of California to cause cancer.”

  • Aspartame is an artificial, low-calorie, non-saccharide sweetener used as a sugar substitute and flavor enhancer in certain foods and beverages.  One of the most extensively studied substances in the human food supply – aspartame was originally approved by FDA in 1981 for uses, under specific 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 aspartame for use in carbonated beverages and carbonated beverage syrup bases, and in 1996 FDA approved it for use as a “general purpose sweetener”.  In addition, numerous studies conducted by the FDA, the Joint Expert Committee on Food Additives (JECFA) of the World Health Organization and Food and Agriculture Organization, and the Scientific Committee on Food of the European Union (SCF) – among others – support the safety of aspartame.

  • Despite an abundance of studies from regulatory agencies in more than 100 countries supporting aspartame’s safety, aspartame will be the subject of an upcoming November 15, 2016 meeting in which the Carcinogen Identification Committee (CIC) – California’s qualified experts on carcinogenicity for purposes of Prop 65 – 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.  The potential listing of aspartame comes against the backdrop of FDA’s 2014 denial of two Citizen Petitions, available here and here, that sought a ban of aspartame; in denying the petitions, FDA noted that numerous studies support the safety of aspartame for use in human food among the general population.  See FDA’s denial letters here and here.

  • Given the substantial scientific literature favoring the safety of aspartame, and FDA’s fairly recent denial of petitions seeking to ban aspartame, it remains to be seen whether California will ultimately add aspartame to its Prop 65 listing.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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