Posted: 14 Oct 2018 04:47 PM PDT
As we previously speculated might come to pass, FDA announced that it is amending the food additive regulation for synthetic flavoring substances and adjuvants (21 C.F.R. § 172.515) to remove six substances found to induce cancer in animals, namely benzophenone, ethyl acrylate, eugenyl methyl ether (methyl eugenol), myrcene, pulegone, and pyridine. FDA’s action is not predicated on concerns about the safety of the uses of the substances in question.
FDA’s rule responds to a 2015 food additive petition (FAP) by a group of non-government organizations (NGOs), which provided evidence that the flavoring substances cause cancer in laboratory animals. Based on FDA’s review of safety data, the Agency concluded that these substances do not pose a public health risk as a human carcinogen under the conditions of their intended use. The substances appear in food items at very low levels, and the studies presented by the NGOs involved exposing laboratory levels to much higher doses. Additionally, with the exception of the data concerning methyl eugenol, the data from the animal studies demonstrated that the modes of action of carcinogenicity of the substances are not relevant to humans. Nevertheless, the Delaney Clause requires that FDA consider these substances to be “unsafe” as a matter of law. FDA noted that “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.” Companies have until October 9, 2020 (i.e., two years from publication of the final rule) to identify suitable replacement ingredients and reformulate food products that contain any of the six substances.
In an accompanying rule, FDA also removed styrene from the list of approved synthetic flavoring substances and adjuvants, without reviewing its safety. That action was taken in response to a 2016 FAP submitted by the Styrene Information and Research Center that requested the removal of styrene because its use has been permanently abandoned. Thus, a safety review would have been irrelevant.
The NGOs also had requested that FDA establish zero tolerances in § 172.515 for the seven additives. However, as FDA explains, a food additive regulation is not the appropriate vehicle for establishment of a “zero tolerance.” Consequently, FDA did not further address this request in either rule.
FDA’s rule responds to a 2015 food additive petition (FAP) by a group of non-government organizations (NGOs), which provided evidence that the flavoring substances cause cancer in laboratory animals. Based on FDA’s review of safety data, the Agency concluded that these substances do not pose a public health risk as a human carcinogen under the conditions of their intended use. The substances appear in food items at very low levels, and the studies presented by the NGOs involved exposing laboratory levels to much higher doses. Additionally, with the exception of the data concerning methyl eugenol, the data from the animal studies demonstrated that the modes of action of carcinogenicity of the substances are not relevant to humans. Nevertheless, the Delaney Clause requires that FDA consider these substances to be “unsafe” as a matter of law. FDA noted that “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.” Companies have until October 9, 2020 (i.e., two years from publication of the final rule) to identify suitable replacement ingredients and reformulate food products that contain any of the six substances.
In an accompanying rule, FDA also removed styrene from the list of approved synthetic flavoring substances and adjuvants, without reviewing its safety. That action was taken in response to a 2016 FAP submitted by the Styrene Information and Research Center that requested the removal of styrene because its use has been permanently abandoned. Thus, a safety review would have been irrelevant.
The NGOs also had requested that FDA establish zero tolerances in § 172.515 for the seven additives. However, as FDA explains, a food additive regulation is not the appropriate vehicle for establishment of a “zero tolerance.” Consequently, FDA did not further address this request in either rule.
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