Was FDA’s Recent Statement On BPA Premature?
BY STEVE HENTGES | MARCH 26TH 2018 11:02 AM

A few weeks ago the U.S. National Toxicology Program (NTP) released the results ofthe largest study ever conducted on bisphenol A (BPA). The CLARITY Core study
was conducted by senior scientists with the U.S. Food and Drug Administration(FDA) in their own laboratory in Arkansas known as the National Center for
Toxicological Research (NCTR).
More important than size is the unprecedented scope of the study for thissubstance. The laboratory animals were exposed to BPA from the beginning ofpregnancy through the full lifetime of the offspring. A wide range of BPA doses wastested, ranging from a low dose near actual human exposure levels to a high dose
approximately 250,000 times above typical human exposure. The world has neverseen a study on BPA of this scope and magnitude.
The results indicate that BPA has very little potential to cause health effects evenwhen we are exposed to it throughout our lives. As stated in the conclusion of
the study report, “BPA produced minimal effects that were distinguishable above
background.”Considering that BPA has been a controversial topic for many years, including
public concerns about the safety of food that contains traces of BPA, it would beinexcusable if FDA did not communicate with the public on what the studymeans. As part of its mission, FDA is “responsible for protecting the public healthby … ensuring the safety of our nation's food supply.”And, very appropriately, FDA did communicate to the public. In conjunction withrelease of the NTP report, FDA released a statement that provided its current
perspective on the safety of BPA. With the new information from the CLARITY Core
study in hand, FDA stated: “our initial review supports our determination thatcurrently authorized uses of BPA continue to be safe for consumers.”
Importantly, the statement also included additional context on the CLARITY study
and a short summary of FDA’s extensive activity related to BPA over many years,
including both scientific review and research. Nevertheless, some have

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criticized FDA as having spoken prematurely, saying that FDA should have waitedfor the results of additional studies.
Taken out of context, FDA’s statement could seem premature. But there is context,
quite a bit of it in fact, that gives FDA a clear basis to make a timely statement
now. Not only does FDA have a strong scientific basis to support its statement, its
mission gives it a mandate to inform its stakeholders – the U.S. public – on mattersrelated to food safety.

The recent FDA statement also included the context that this was the agency’s
initial review of the CLARITY Core study and that FDA would fully participate in theupcoming peer review of the study. And, as noted on its website, “FDA continues
to review the available information and studies on BPA, including the newly
released draft NTP report (CLARITY-BPA), and will update its assessment of BPA
and take additional action if warranted.” As it should be, FDA’s actions now and in
the future are based on science, not speculation.
What Data Was FDA’s Statement Based On?
As noted at the very beginning of FDA’s recent statement, “FDA looks at allavailable scientific evidence when reviewing the safety of foods and food2/4

packaging” and “[w]e base our regulatory decisions on robust science.” That’s notjust empty talk since there is ample documentation of FDA’s intensive review overmany years of the safety of BPA.
Its previous updated safety assessment from June 2014 is readily available on theFDA website along with a series of lengthy reports that document FDA’s detailed
review of numerous studies that are potentially relevant for its assessment. Rather
than being premature, FDA’s recent statement builds on its previous reviews toincorporate significant new information from the CLARITY Core study.
And FDA has done far more than just review scientific evidence. As further noted in
FDA’s statement, “we not only continue to evaluate available data – but also
conduct FDA research on the safety of the use of BPA for food packaging.”
Over the last 5+ years, FDA scientists have generated some of the most importantscientific data on BPA, with the CLARITY Core study being only the most recent of aseries of in-depth studies. For example, from studies in rodents and non-humanprimates, we know that BPA is deactivated and quickly eliminated from the bodyafter exposure. From this data it can be predicted that BPA is not likely to beharmful, which was resoundingly confirmed in the CLARITY Core study.
Along with these important contributions from FDA, scientists from NTP and theU.S. Centers for Disease Control and Prevention (CDC) have also conducted studies
that provide critical support for FDA’s safety assessment. In particular, NTP’s study
on human volunteers confirmed the rapid elimination of BPA from the humanbody. A series of six biennial studies (so far) from CDC confirm that human
exposure to BPA in the U.S. population is extremely low.
What Data Is Yet To Come?
The CLARITY program (Consortium Linking Academic and Regulatory Insights onBPA Toxicity) was designed by a consortium that consists of FDA, NTP, the National
Institute of Environmental Health Sciences (NIEHS) and thirteen academicscientists. The CLARITY Core study, which is the principal part of the program, wasfunded by NTP and conducted by FDA scientists at NCTR. The academic scientists
not only participated in the study design, but each received funding from NIEHS toconduct additional measurements on animals or biological samples that were taken

3/4from the Core study. The funding for the academic studies has all been provided
and the animals or biological samples were all provided 4-5 years ago.
As noted by Dr. John Bucher of NTP: “It would have been nice if we would havebeen able to have all of the grantee information available at the same time as thecore study information, to be evaluated together. The process wasn’toptimal.” That begs the question why the grantee information is not available.
Up to the present time, only four of the thirteen academic scientists have publishedtheir results in the scientific literature, with the first paper published in2015. Similar to the results of the CLARITY Core study itself, the published results
collectively show minimal effects above background.
The other nine academic scientists have not yet published their results, eventhough they have received their funding and all animals or biological samples fortheir research were provided 4-5 years ago. This does not seem to be matter of a
suboptimal process.
Ironically, some of the scientists who have not published their results are ones whohave criticized FDA for a premature statement. Regardless of whether theacademic scientists publish their results or not, all raw data from their research is
now scheduled to become publicly available in August 2018, at which time it can beevaluated by others.
The bottom line is that FDA’s recent statement on BPA is neither premature nor
unfounded. It was simply transparent and responsible. The research and analysis
conducted by FDA scientists, along with supporting data generated by other federal
government scientists, is truly monumental and fully supports FDA’s perspective on
the safety of BPA. Furthermore, the recent statement is timely and fully within
FDA’s public health mission regarding the safety of our food supply.

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