December 11, 2018

December 10, 2018

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FDA Removes Clearance for 7 Synthetic Flavoring Substances

  • As we previously reported on this blog, a group of non-government organizations (NGOs) sued FDA in an effort to compel the Agency to act on a Food Additive Petition (FAP) concerning seven synthetic flavoring food additives. The FAP, which the NGOs submitted to FDA, requested that FDA remove the clearances for these seven synthetically derived substances in 21 C.F.R. 172.515 (“Synthetic flavoring substances and adjuvants”) because the substance are carcinogens and therefore violate the Delaney Clause of the Federal Food, Drug, and Cosmetic Act.

  • The seven substances that are the subject of the NGOs’ FAP include: benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, styrene and pyridine.

  • We also previously reported that the Styrene Information and Research Center (SIRC) submitted its own FAP to FDA requesting that the clearance for styrene in Section 172.515 be removed because its use as a flavor additive has been permanently abandoned.

  • FDA responded to the NGOs’ FAP, as well as SIRC’s FAP, in two separate notices in today’s Federal Register. In response to the petition from the NGOs, FDA announced that it is amending Section 172.515  to remove the clearances in that regulation for benzophenone, ethyl acrylate, eugenyl methyl ether (methyl eugenol), myrcene, pulegone, and pyridine (83 Fed. Reg. 50490). FDA explained that this action was being taking under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act since the petitioners provided evidence that these substances caused cancer in animals. However, FDA stated in the Federal Register notice:

    • “…the use of these synthetic flavoring substances and adjuvants does not affect the legal status of foods containing natural counterparts or non-synthetic flavoring substances extracted from food, and there is nothing in the data FDA has reviewed in responding to the pending food additive petition that causes FDA concern about the safety of foods that contain natural counterparts or extracts from such foods.”

  • FDA also granted SIRC’s FAP to amend the food additive regulations to no longer provide for the use of styrene as a flavoring substance and adjuvant due to its abandonment by industry. (83 Fed. Reg. 50487). Since styrene was delisted due to abandonment, FDA did not consider whether styrene is a carcinogen.

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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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