Consumer groups ask FDA to ban 8 synthetic flavors.

  • Over the years, various consumer groups have urged legislators and regulators to take specific actions that they allege are necessary to strengthen the safety of the U.S. food safety supply.  To highlight one prominent example in recent years, consumer groups have mounted and maintained a steady attack on the GRAS process.
  • On June 10, 2015, the Center for Science in the Public Interest, Natural Resources Defense Council, Center for Food Safety, Consumers Union, Improving Kids’ Environment, Center for Environmental Health, and Environmental Working Group filed a petition with FDA requesting that the Agency ban eight (8) synthetic flavors currently permitted for use in a variety food products.  The petition alleges that the substances are now known to be carcinogens and thus are unsafe for use under the “Delaney Clause” (a provision of the Federal Food, Drug, And Cosmetic Act that precludes a finding of safety for food additives that are found “to induce cancer in man or animal”).  Specifically, the consumer groups seek the prohibition of the following substances:
    1. Benzophenone (also known as diphenylketone);
    2. Ethyl acrylate;
    3. Eugenyl methyl ether (also known as 4-allylveratrole or methyl eugenol);
    4. Myrcene (also known as 7-methyl-3-methylene-1,6-octadiene);
    5. Pulegone (also known as p-menth-4(8)-en-3-one);
    6. Pyridine;
    7. Styrene; and
    8. Trans,trans-2,4-hexadienal.
  • The petition highlights the challenge inherent in strict interpretation of the Delaney Clause.  All eight substances have been marketed for decades in the U.S. and are used at low levels in food, suggesting that the risk of carcinogenicity may be attenuated in real-life conditions.  Nevertheless, the petition urges adoption of a strict “zero tolerance” standard that would ignore any “dose makes the poison” argument and would result in the ban of any substances that induce cancer in humans or animals.  If the Delaney Clause were to be enforced as strictly as the petition urges, one wonders how many food additives and GRAS substances would find themselves on the chopping block in future.