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Non-Profits Sue FDA to Prohibit Use of Seven Flavors

  • Eight non-profit organizations (Breast Cancer Prevention Partners, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Environmental Defense Fund, Environmental Working Group, Natural Resources Defense Council, and WE ACT for Environmental Justice) are suing FDA to seek a prohibition on the use of various flavors in food.  The lawsuit is the latest non-profit effort to compel FDA action after the Agency has not acted on a citizen petition.  In this case, a citizen petition was filed in 2016 requesting that FDA amend its regulations to no longer authorize the use of the same synthetic flavoring food additives and to establish zero tolerances for the additives.
  • The seven flavors at issue, which are cleared under 21 CFR 172.515 (“Synthetic flavoring substances and adjuvants”), are benzophenone (also known as diphenylketone), ethyl acrylate, eugenyl methyl ether (also known as 4-allylveratrole or methyl eugenol), myrcene (also known as 7-methyl-3-methylene-1,6-octadiene), pulegone (also known as p-menth-4(8)-en-3-one), pyridine, and styrene.  The complaint, filed in the U.S. Court of Appeals for the Ninth Circuit, alleges that these substances cannot be added to food because they are carcinogens under the Delaney Clause, as set out in Section 409(c)(3)(A) of the Federal Food, Drug, and Cosmetic Act.
  • The Styrene Information and Research Center (SIRC)  has submitted a petition to FDA, requesting that the Section 172.515 listing for styrene be removed because its use as a flavoring has been permanently abandoned.  It will be interesting to see whether additional abandonment petitions are filed for any of the other six flavors targeted in the suit.
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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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