Bisphenol A (BPA): The FDA's Position

Oct 02, 2018

Bisphenol A (BPA) is an industrial chemical and is a component in polycarbonate plastic and epoxy resins. Almost all inner plastic linings of food cans and beverage containers are manufactured using BPA. Usually, plastic bottles that contain BPA are clear and tough.

Some studies have proven that the bisphenol A can migrate into the beverages or food from the containers that are made up of plastic manufactured using this compound. Exposure to BPA may cause harmful health effects in adults and infants. People should be aware of the effects of BPA because even a very little quantity of BPA leached from food containers can be dangerous.

FDA Evaluation

The Food and Drug Administration (FDA) is a government agency regulated by the US Department of Health and Human Services. It works to ensure the effectiveness and safety of human and veterinary vaccines, drugs, medical equipment, and biological products.

Chemical substances (like BPA) that may leach out of food containers into food require premarket approval from FDA. Regulatory changes may be made by the FDA based on the usage and safety of the product.

Factors that are considered during the FDA’s safety evaluation include safe exposure levels, the nature of the chemical substances used for food packaging, and exposure to chemical substances in food containers that migrate into foods and beverages.

Historical FDA view of BPA

In 1960, BPA received its original approval, under the food additive rules and regulation of the FDA.
In 2008, a documentation named “Draft Assessment of Bisphenol A for Use in Food Contact Applications” was released by the FDA. In October 2008, the FDA’s Science Board Subcommittee reviewed this documentation and released a report on it. In the same year, a monograph dealing with the potential human reproductive and developmental effects of BPA was released as part of the assessment of risk factors to human reproduction, by the National Toxicology Program Centre (NTPC).
In 2009, reassessments by various researchers who were referred to in the NTPC paper were released by the FDA. Their relevance was evaluated to generate a risk analysis. In addition, five federal government scientific experts submitted independent reviews of these research studies in the same year.
In April 2010, the independent evaluation results were released, followed by the report of the Center for Food Safety and Applied Nutrition (CFSAN). All relevant information was made available for public knowledge through the FDA.

BPA in Biology and Metabolism

Rising consumer interest in the safety of BPA has led the FDA to support various research trials and to provide additional information and correct inconsistencies in technical literature with respect to BPA. Many studies have provided information about the migration and metabolism of BPA in the human body.

The FDA’s regulatory center and the National Center for Toxicological Research (NTCR) continues their research on further issues that might arise from BPA through different avenues of exposure of the human body to this chemical.

NCTR Findings Under FDA

Rodent studies conducted by the National Centre for Toxicological Research indicated that the level of BPA that is carried from the mother to the fetus was too low to be measured. In this research study, pregnant rodents were dosed with 100 to 1000 times the amount of BPA that humans may expect to be exposed to from food.
No detectable BPA was present in unborn offspring even eight hours after exposing the pregnant rodent to BPA.

Results demonstrated that the oral administration of BPA led to rapid metabolism of it into an inactive form.
It has been observed that the metabolism and excretion of BPA in humans occurs more efficiently and rapidly than in rodents.

Prohibiting BPA-Based Materials for Infant Feeding

BPA-based polycarbonate resins: Amendments have been made in the FDA regulations to ban baby sippers and bottles that are made of BPA-based polycarbonate resins. This amendment was made in response to the American Chemistry Council’s (ACC) food additive petition.

BPA-based epoxy resins: The FDA has revised its regulations in order to stop the use of infant formula packaging that was made up of BPA-based epoxy resins. This revision was made in 2013 in response to Congressman Edward Markey’s food additive petition.

Current Situation

Based on the hazard assessment of BPA conducted by the US Food and Drug Administration’s Center for Food Safety and Applied Nutrition (CFSAN), it has been concluded that the BPA exposure due to food contact does not cause harm in humans. This conclusion was made based on the internal review of FDA’s most recent research data.