38-page petition was filed Wednesday with the U.S. Food and Drug Administration (FDA) calling for a total ban on eight synthetic flavorings that may currently be used in minute amounts in baked goods, candy and ice cream. Petition sponsors say the substances have been known to cause cancer in lab animals and should be subject to a “zero tolerance” policy banning substances that induce cancer in humans or animals. grasFDA_406x250The eight substances are: Benzophenone, Ethyl acrylate, Eugenyl methyl ether, Myrcene, Pulegone, Pyridine, Styrene and Trans,trans-2,4-hexadienal. The Flavor and Extract Manufacturers Association (FEMA) has recognized seven of the eight as “generally recognized as safe,” or GRAS, since 1965, and Trans,trans-2,4-hexadienal as GRAS since 1974. The maximum amounts of these substances that may be used as GRAS are mostly tiny. Pyridine, for example, can legally be used at just 1 part per million in ice cream. But petition sponsors say zero tolerance should be the standard and the eight should be taken off the GRAS list. “The explicit prohibition is essential because their use has been allowed by FEMA for more than 40 years in food and clarity is necessary to prevent their continued use,” the petition states. “Mere revocation of approved food additive status would be insufficient under current law and rules to assure that companies would stop using them pursuant to a private GRAS determination regarding a particular condition of use.” Individuals signing the petition represent the following organizations: Center for Science in the Public Interest, National Resources Defense Council (NRDC), Center for Environmental Health, Environmental Working Group, Center for Food Safety, Consumers Union, Improving Kids’ Environment, and individual scientists Maricel Maffini and James Huff. The approved uses are outlined in detail in the petition, but it does not make any claims about the current use of the “carcinogenic flavors” in any specific products currently on the market. It simply states that the flavorings “may be found” in ice cream, baked goods, candy and beverages, and that neither FDA nor the public knows which of the additives might be added to a food product. In a statement, NRDC said it is impossible for informed consumers to protect themselves from the “harmful chemicals.” “Consumers are vulnerable, the government isn’t doing its job and the food industry is calling the shots,” said Erik Olson, NRDC’s director of health programs. “The FDA should be doing much more to ensure our food is safe, and that should start with obeying the law by banning these synthetic flavorings known to cause cancer in animals, rather than just continuing to let the food industry have its way.” The groups filing the petition urge FDA to revoke its 1964 approval allowing seven of the flavorings to be used in food, and overturn the industry’s 1974 self-approval of the eighth synthetic flavor, which they assert can be used under a loophole in the law for chemicals that are GRAS. Second, the groups urge FDA to formally ban the eight flavorings from use in food. They were allowed on the market long before animal studies showed that the chemicals cause cancer. Each of the synthetic flavorings has been found by the National Institutes of Health’s National Toxicology Program to induce cancer in humans or animals. The petition states that the flavorings, which have been allowed for more than 40 years in food, should be prohibited immediately to prevent their continued use.

  • Mike_Mychajlonka_PhD

    There would appear to be a couple of points in this article that should be explored further. The first of these is whether the length of time a substance has been listed as GRAS should somehow protect a given material from losing its GRAS status. Certainly, all scientific data, including safety data, should be open to challenge in terms of methods, results and interpretations. The other item for consideration is the exact meaning of “Generally Recognized as Safe.” A study to determine acute toxicity is easy to do and reasonably quick. It seems to me that if the acute toxicity of a substance is quite low the finding should state simply that the tested substance has a low acute toxicity. In this example, using acute toxicity date to justify GRAS status seems a clear case of over-interpretation, extrapolating well beyond what the data show us. Safety claims should state exactly what they mean and be taken to mean no more than what the data behind them clearly allow. If regulatory management and compliance is not up to this task then litigation will have to be the alternative. The latter is not the best choice.

  • Luke Grocholl, PhD

    Zero tolerance for the materials is an extreme measure. All eight substances are found naturally in foods ranging from eggs, to coffee to pineapples and bananas. It stands to reason that some level of intake of these substances have no significant health risk. To simply state that any substance found to have a link to cancer in certain instances should be banned is not only hyperbolic, but nearly impossible.