There is a pervasive myth, particularly in the online social media world, that consumers in the United States should be concerned about food containers and packaging made with bisphenol A, otherwise known as BPA. However, an objective examination of the facts and research reveals that again and again, federal regulators and scientific experts have concluded that BPA does not pose a human health risk at the levels in food-contact materials (FCMs).
The primary federal agency that regulates FCMs, the U.S. Food & Drug Administration, stated unequivocally:
FDA’s current perspective, based on its most recent safety assessment, is that BPA is safe at the current levels occurring in foods. Based on FDA’s ongoing safety review of scientific evidence, the available information continues to support the safety of BPA for the currently approved uses in food containers and packaging.
BPA is among the most heavily researched and regulated chemistries used in the manufacturing industry today. Overall regulation of BPA is a multi-faceted endeavor involving several federal agencies, with FDA overseeing its use in FCMs. BPA is also subject to state-level oversight and regulations across the United States.
Spanning more than 75 years, BPA has long been a critical element in the manufacture of countless products thanks to its high-impact resistance, transparency, thermal stability, and lightweight nature. BPA is widely valued in such diverse industries as automotive, medical devices, protective gear for military and law enforcement, and construction, among others.
BPA has also been used since the 1960s in food containers and packaging to help form a barrier between the food and the surface of the container or packaging. For example, BPA is used in food and beverage can linings to help prevent corrosion of the can and the migration of the metal into its contents.
FDA regulation of BPA is a comprehensive, stringent, and multi-faceted process aimed at ensuring the safety of consumers. The agency regulates BPA in food packaging through the Food Contact Notification (FCN) program, which involves pre-market review of food packaging materials, ensuring that any potential BPA migration from packaging into food occurs at safe levels.
This review evaluates the likely degree of BPA migration, considering factors like the nature of the migrating components, cumulative dietary exposure, and safe levels of exposure. The agency also conducts safety assessments based on submitted information and other relevant data, including testing data on BPA migration.
This oversight is bolstered by extensive and robust research initiatives, conducted by FDA in its laboratories in collaboration with the U.S. National Toxicology Program (NTP) and U.S. National Institute of Environmental Health Sciences. Multiple studies, including those conducted by FDA as well as many other countries’ regulatory bodies, have found that the levels of human exposure to BPA from food packaging are far too small to pose a health risk.
Of particular note is FDA’s initiative called the Consortium Linking Academic and Regulatory Insights on BPA Toxicity, or CLARITY, a multipronged U.S. federal government research program designed to assess the potential health effects of long-term exposure to BPA. The key element of the program — the Core Study — is the largest study ever conducted on BPA, undertaken by expert scientists at FDA laboratories. The results of the Core Study were released on September 28, 2018 in a final report published by the NTP.
In presenting its findings, the CLARITY Core Study’s principal investigator stated in a webinar that, “BPA did not elicit clear, biologically plausible, adverse effects …” at levels even remotely close to typical consumer exposure levels. Similarly, in a statement released in conjunction with the study, Dr. Stephen Ostroff, FDA Deputy Commissioner for Foods and Veterinary Medicine said: “Our initial review supports our determination that currently authorized uses of BPA continue to be safe for consumers.”
Importantly, the draft Core Study report was peer-reviewed in draft form by a panel of independent scientists convened by NTP. After a thorough review of the draft, the panel discussed their findings in a public meeting and issued a report with their recommendations, which generally endorsed the design and execution of the study as well as FDA’s interpretation of the results.
FDA’s oversight of BPA’s use in FCMs provides a robust and comprehensive regulatory and scientific framework that helps ensure use of this critical chemistry is safe for consumers. FDA’s regulation of BPA will continue to be a dynamic process with rigorous safety assessments and regulatory actions that demonstrate its dedication to safeguarding the health and safety of consumers.