Lawsuit Seeking Phthalates Ban For Food Packaging Filed Against FDA By Environmental Groups

Several prominent environmental groups have filed a lawsuit against the U.S. Food and Drug Administration (FDA) and its acting Commissioner, demanding regulatory action be taken to ban toxic and potentially harmful phthalates and plasticizers in food packaging and processing materials.

The complaint (PDF) was filed in the U.S. District Court for the District of Columbia on December 7, seeking a court order requiring the FDA to form a decision on whether they will issue a phthalates ban or continue to allow more than two dozen hormone-disrupting chemicals to be used in food packaging, preparation, storage and processing. The lawsuit was filed by the Environmental Defense Fund, Learning Disabilities Association of America, and Center for Food Safety and other environmental and health advocacy groups.

Phthalates include a group of chemicals used to help make plastic flexible or more durable. They are commonly used as part of the packaging, preparation, storage and processing of food products, but are also found in a wide range of other items, including toys, cosmetics, detergents, PVC tubing, medical devices, and pill coatings.

The chemicals are known to disrupt hormones and affect human health. Phthalates have been linked to reproductive problems, increasing a woman’s chance of fibroids and endometriosis and miscarriage. Studies have also linked the chemicals to lower IQ in children if exposed during pregnancy, as well as reduced male fertility.

According to the complaint, the group of food and environmental safety organizations filed two petitions in 2016, both introducing a robust body of scientific evidence linking human exposure to phthalates with serious adverse health consequences, including birth defects, infertility, miscarriage, and irreversible damage to the developing brain. The petitions requested the FDA reevaluate the authorized use of phthalates in the food industry, raising concerns that phthalates can leach into the food products we consume, directly introducing the toxic chemicals into consumer’s bodies.

However, the complaint claims nearly six years have passed without any response to the 2016 petitions, accusing the regulatory agency of not fulfilling its designated responsibility to protect public health by failing to take action to address the urgent public health threats posed by phthalate exposure.

The phthalates ban lawsuit claims “because of FDA’s failure to act on the 2016 citizen petition, Plaintiffs’ members and supporters and their children have experienced and continue to experience dietary exposure to FDA-approved phthalates that endangers their health.”

Plaintiffs are requesting the court deem the FDA’s failure to respond unreasonable, and order the FDA to issue a final order granting or revoking the use of phthalates in the food industry within 60 days.

Phthalate Exposure Concerns

Phthalates food supply contamination often occurs when food contacts certain materials. This can occur during industrialized production, but it can even enter the food supply when preparers wearing rubber gloves handle food.

In August, the “Preventing Harmful Exposure to Phthalates Act” (PDF), was introduced in the U.S. House and Senate. It seeks to prevent phthalates from contaminating the U.S. food supply. If passed, the bill would ban the use of phthalates in any material that comes in physical contact with food, and would require any materials replacing phthalates currently in use be proven safe.

Health risks from phthalates may include high blood pressure, increased risk of obesity and diabetes, and increased risk of allergic reaction and asthma in children exposed during pregnancy.

Other studies have shown phthalates are potent endocrine disruptors which affect the function of hormones, including thyroid hormones, increased risk of miscarriage, and reduced male fertility, even for generations after initial exposure.