Seven Deadly(?) Substances: FDA Removes Seven Food Additives from Approved List Due to Cancer Risk

The FDA has revised its food additive regulations to block the use of seven synthetic flavoring substances in food products that may increase cancer risk in humans. Evidence submitted to the FDA by the Breast Cancer Fund, the Center for Environmental Health, the Center for Food Safety, and others, demonstrated that six of the synthetic substances caused cancer in lab animals under study conditions. The seventh flavor, styrene,  is being removed from the food additive list because it is no longer widely used by the industry.

The six substances include synthetically-derived benzophenone, ethyl acrylate, eugenyl methyl ether (methyl eugenol), myrcene, pulegone, and pyridine. These substances are being removed from the food additive regulations under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (section 409(c)(3) of the FD&C Act). This clause requires that the FDA cannot approve of the use of any food additive that has been found to cause cancer in humans or animals in any dose.

The FDA held that despite their adherence to the Delaney clause, its own scientific analysis has shown that the additives do not pose any actual risk to public health, as they are often only used in miniscule doses. The animal testing that resulted in the petitions exposed the animals to much higher doses of the chemicals than what would be added to human food. The FDA is revoking the listing of these substances as a matter of law, and not because of any true threat to public food safety and human health.

Benzophenone, one of the additives removed from the list, is used as a food flavoring agent and in some food packaging applications. It has also been used as an additive to paints, adhesives and sealants, pest control products, and inks. Based on evidence presented by the petitioners that it causes cancer in lab animals, the FDA is amending its regulations to bar its use as a plasticizer in rubber articles that would come in repeated contact with food. Styrene is being removed from the additives list because the food manufacturing industry no longer uses it as a flavoring substance.

Any manufacturer currently using the six flavoring substances has been given two years to reformulate their food products and/or find a suitable replacement ingredient so they are compliant with section 409(c)(3) of the FD&C Act. The six substances banned by the FDA’s findings have natural counterparts in food and/or nature, and the use of the natural versions of each ingredient are not affected by the rulings.

It also remains to be seen whether this regulatory action sparks any increase in litigation against any food product manufacturers.

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