FDA Revokes Approval For Three Potentially Toxic Chemicals Used in Food Wrappers

In response to a Food Additive Petition filed by several major health organizations, federal regulators have revoked approval for three chemicals for use as grease-proofing agents that coat paper wrappers and containers, due to growing health concerns that the agents may contaminate food items and cause reproductive system complications. 

The FDA issued a notice on January 4, indicating that three long-chain perfluorinated compounds (PFCs) can no longer be used in food wrappers.

The decision follows a comprehensive review of potential health hazards detailed in current literature, which has found the direct contact of the chemicals with food items could lead to contamination and disruption of the male and female reproductive organs.

The FDA banned the three long-chain PFCs in response to a Food Additive Petition filed by the Natural Resources Defense Council, the Center for Food Safety, the Breast Cancer Fund, the Center for Environmental Health, Clean Water Action, the Center for Science in the Public Interest, the Children’s Environmental Working Group, and Improving Kids’ Environment.

The Food Additive Petition was filed with the FDA in October 2014, in an effort to ban the use of diethanolamine salts of mono- and bis,  pentanoic acid, 4,4-bis, and perfluoroalkyl substituted phosphate ester acids that contain perfluoroalkyl ethyl. The petition targeted the use of the PFCs as grease and water repellants for containers and paperboard that come into contact with foods, such as pizza packaged in boxes, microwave popcorn, fast-food packaging, and pet food bags.

PFC Toxicity Concerns

Researchers from the U.S. and Europe say that perfluorinated compounds (PFCs) are a form of contaminant frequently present in the environment, but whose effects on the human body are not well understood.

According to the petition, research has indicated the PFCs coming into direct contact with food products are toxic. The organizations claimed in their petition that evidence presented in a 2010 FDA memorandum indicated PFC exposure was shown to cause reproductive and developmental toxicity in tested animal models.

According to findings published in the Journal of the American Medical Association in 2012, PFC exposure may also suppress the immune system and limit the ability of the body to create antibodies in response to childhood vaccines.

The FDA first authorized the use of several long-chain PFCs as grease proofing agents prior to 2000 before any safety concerns had surfaced. In 2010, when safety concerns and lab tests began indicating the potential toxicity levels PFCs may pose to consumers, the agency reached out to the packaging industry leaders to stop the use of the long-chain PFCs used in the most common food packaging at that time.

Following the petition and further pressure from consumer health organizations, the FDA launched an independent investigation into possible health concerns from long chain PFC exposure. Their results raised significant questions as to whether PFC exposure is safe for consumers.

Given the findings, the FDA ordered the removal of the chemicals due to the “reasonable certainty of no harm” standards used for approving chemicals in food items. Due to the reasonable certainty that exposure to long chain PFCs in food items may cause health problems due to the toxicity, the FDA is revoking its previously approved use of PFCs for food packaging.

Although leaders from the petitioning organizations seem pleased with the FDA’s decision, some say the agency’s actions were delayed and should have been acted upon years ago, noting that it has taken the FDA more than 10 years to figure out these chemicals are harmful to consumers and that the three PFCs officially banned from production are hardly even used any more.