[Update] FDA Removes 7 Synthetic Flavors from Food Additives List


In response to two food additive petitions, the FDA has announced that seven synthetic flavoring substances and flavor enhancers will be removed from the list of acceptable food additives.

Following an analysis of data submitted by the Natural Resources Defense Council, the  Breast Cancer Fund, Center for Environmental Health, Center for Food Safety and other organizations, the FDA has removed the following synthetic ingredients:

  • synthetically-derived benzophenone,
  • ethyl acrylate,
  • eugenyl methyl ether (methyl eugenol),
  • myrcene,
  • pulegone
  • and pyridine.

In the data presented in one of the petitions, it was shown that these ingredients at a much higher dosage induce cancer in lab animals during case studies; whereas the de-listed ingredients, which are present in a lower dosage in US products, are safe to use. 

Per the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (section 409(c)(3) of the FD&C Act), the FDA cannot approve of any food additive linked to cancer risk in humans or animals at any dose and has moved to remove these ingredient. A separate petition by the Styrene Information and Research Center asked for the removal of styrene as a synthetic flavoring substance due to its infrequent use in the industry.

According to the FDA's press release, "The FDA’s rigorous scientific analysis has determined that they do not pose a risk to public health under the conditions of their intended use."

In response to the removal of these ingredients and to the findings of the FDA's case studies, FEMA commented that, "The Delaney Clause demonstrates a limited interpretation of animal studies and cancer by failing to address risk or relevance in humans. It limits FDA’s scientific discretion and requires the FDA to ban any food additive found to induce cancer in laboratory animals."

FEMA also emphasized the basis of FDA's decision on the basis of law. The FDA's statement also added: "While the FDA’s recent exposure assessment of these substances does not indicate that they pose a risk to public health under the conditions of their intended use, the petitioners provided evidence that these substances caused cancer in animals who were exposed to much higher doses. As such, the FDA is only revoking the listing of these six synthetic flavorings as a matter of law. The FDA has concluded that these substances are otherwise safe.”

Following the publication of the rule in the Federal Register, the FDA will provide 24 months for companies to identify suitable replacement ingredients and reformulate products that contain the de-listed ingredients.   



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