The FDA Declares that Bisphenol A is Safe, Despite Scientific Evidence
NOTE: The following is one of a series of case studies produced by the Union of Concerned Scientists' Scientific Integrity Program between 2004 and 2010 to document the abuses highlighted in our 2004 report, Scientific Integrity in Policy Making.
The U.S. Food and Drug Administration (FDA) relied heavily on two industry-funded studies in declaring the chemical bisphenol A (BPA) safe for humans, while ignoring over one hundred scientific studies linking BPA with adverse health effects. In responding to the FDA’s decision, Rep. John D. Dingell (D-MI) stated “The ability of the FDA to protect the American public has been called into question.”1
After receiving harsh criticisms of their analysis—including from the FDA’s own Science Board—the FDA agreed to re-assess the scientific literature on adverse effects of BPA exposure, but has not committed to a timeline for doing so. In the meantime, the agency continues to ignore scientific evidence and declares BPA to be safe for human consumption.
BPA is a mass-produced organic chemical commonly used to produce shatter-proof plastics and protective linings and coatings. As a result, BPA is found in many consumer products, including plastic baby bottles, reusable water bottles, compact discs, DVDs, eyeglass lenses, electronics, dental sealants, and in linings of canned food, including cans of infant formula.2,3
BPA leaches out of these cans and plastics into food and drink and is then ingested by consumers.4,5 In the human body, BPA mimics the hormone estrogen, which affects the endocrine system. BPA has been associated with adverse effects in humans, including infertility, genital tract abnormalities,6 an advance in the onset of puberty, breast cancer,7 an increase in cardiovascular disease, diabetes, and alterations in brain function.8,9,10 Recent testing indicates that BPA exposure in the U.S. is extremely high; in one study 93% of more than 2500 urine samples tested positive for the chemical.11
The FDA statement and controversy
Kicking off the controversy, the FDA stated in November 2007 that their review of current scientific evidence indicated that common levels of BPA exposure are safe for humans.12 Following this statement, the House Energy & Commerce Committee began to investigate the FDA’s reasoning behind their assurance that BPA was safe for consumption, particularly for infants and children.
A series of letters between Reps. John Dingell and Bart Stupak and the FDA revealed that two studies were “pivotal” in the FDA’s declaration of BPA safety.13,14,15 Both studies were funded by the plastics industry and only one was peer reviewed by independent scientists, yet these two studies outweighed the bulk of independent research in FDA’s decision making. The FDA indicated that they were aware of the scientific voices calling into question the safety of BPA, but excluded these studies based upon controversial and poorly defined criteria.
“We would expect FDA to make decisions based on the best available science, especially when the health of infants and children are at stake,” said Rep. Stupak, the Chairman of the Oversight and Investigations Subcommittee.16
Throughout 2007 and 2008, additional compelling scientific evidence was building against the safety of BPA. Scientific assessments were performed by a National Institutes of Health-funded BPA Expert Panel17 and by the National Toxicology Program (NTP, a division within the National Institutes of Health).18 Other studies were published in the prestigious Journal of the American Medical Association19 and the Proceedings of the National Academy of Science.20 All reported health concerns following BPA exposure.21,22 As of January 2009 there are more than 150 published studies describing low dose effects of BPA in animals.23,24
These scientific findings calling BPA safety into question touched off waves of actions and critical assessments of the FDA’s declarations of the chemical’s safety. Congressional committees called on25 the FDA to reconsider their assessment of BPA safety and major retailers began pulling BPA-containing products from their shelves.26,27,28
In August 2008, the FDA released a draft risk assessment of BPA exposure from food packaging, concluding that the levels of exposure to adults and children are below toxic doses—again, ignoring dozens of studies that were used in the NTP’s draft assessment of the chemical’s safety.29 At this time, the FDA’s Chief Scientist asked the FDA’s Science Board Subcommittee on BPA30 to review this draft report, and also to hold a public meeting on the topic of BPA safety.31
In late October 2008 the BPA Subcommittee released their peer-review report of the August FDA draft, which raised “significant concerns” with the agency’s safety assessment, and reported that the FDA had not proven an adequate margin of safety for exposures to the chemical. The BPA subcommittee criticized the FDA’s cherry-picking of studies stating that “the draft FDA report does not articulate reasonable and appropriate scientific support for the criteria and methods employed in the draft assessment and the Subcommittee does not agree that the large number of non-GLP [good laboratory practice] studies should be excluded from use in the safety assessment.”32
The subcommittee’s findings were unanimously supported by the FDA’s Science Board,33 who agreed that the FDA must to go back to the drawing board to re-assess the safety of this chemical by utilizing a greater number of studies on low dose BPA exposure in infants and related health effects.34,35 Not surprisingly, the American Chemistry Council criticized the FDA BPA subcommittee’s findings.36 The FDA has agreed to continue investigating BPA, however as of January 2009 stands by its earlier declaration that this chemical is safe.37
In response to BPA safety concerns, Rep. Edward Markey (D-MA) encouraged38 the FDA to follow Canada’s lead in moving to ban the use of BPA in the production of baby bottles39 and announced plans to re-introduce a bill in Congress in January 2009 that would ban the use of BPA in food and beverage containers.40 In addition, Attorneys General from Connecticut, New Jersey, and Delaware have urged 11 infant formula and baby bottle-makers to stop using BPA in their production.41
From 2003 to 2006, global consumption of BPA42 has increased nearly 10% on average each year,43 and it is predicted that BPA global consumption may exceed 5.5 million metric tons by 2011.44,45 While in the U.S., demand for BPA will increase at a slower rate than globally, it is estimated to reach 1.25 million metric tons by 2010.46 A chemical with these sorts of production and usage statistics should rank in the top priority of federal attention and regulation, but unfortunately, it appears that the FDA, for now at least, has dropped the ball.
1. House Committee on Energy and Commerce. 2008. Press release, “Dingell, Stupak Request Interview with Von Eschenbach on Bisphenol A.” October 15. Rep. John Dingell (D-MI) is the former chair of the House Committee on Energy and Commerce, Rep. Bart Stupak (D-MI) is the chair of the Subcommittee on Oversight and Investigations of the Energy and Commerce Committee, and Dr. Andrew von Eschenbach is the former FDA Commissioner.
2. International Chemical Information Service (ICIS), Bisphenol A (BPA) Uses and Market Data. (accessed 17 Dec 08).
3. SRI Consulting. 2007. Chemical Economics Handbook Report Bisphenol A. November. (accessed 17 Dec 08).
4. National Toxicology Program (NTP), Center for the Evaluation of Risks to Human Reproduction (CERHR). 2007. NTP-CERHR Expert Panel Report on the Reproductive and Developmental Toxicity of Bisphenol A. November 26.
5. European Union. 2003. Risk Assessment Report - 4,4'-isopropylidenediphenol (Bisphenol A).
6. Okada, H., Tokunaga, T., Liu, X., Takayanagi, S., Matsushima, A. & Shimohigashi, Y. 2008. Direct Evidence Revealing Structural Elements Essential for the High Binding Ability of Bisphenol A to Human Estrogen-Related Receptor-γ. Environ Health Perspect 116:32–38.
7. Vandenberg, L.N., Hauser, R., Marcus, M., Olea, N. & Welshons, W.V. 2007. Human exposure to bisphenol A (BPA). Reprod Toxicol, 24: 139-177.
8. Richter, C.A., Birnbaum, L.S., Farabollini, F., Newbold, R.R., Rubin, B.S., Talsness, C.E., Vandenbergh, J.G., Walser-Kuntz, D.R. & vom Saal, F.S. 2007. In vivo Effects of Bisphenol A in Laboratory Rodent Studies. Reprod Toxicol, 24:199-224.
9. Lang, I.A., Galloway, T.S., Scarlett, A., Henley, W.E., Depledge, M., Wallace, R.B. & Melzer, D. 2008. Association of Urinary Bisphenol A Concentration With Medical Disorders and Laboratory
Abnormalities in Adults. Journal of the American Medical Association 300(11):1303-1310.
10. Vandenberg et al. 2007.
11. Calafat, A.M., Ye, X., Wong, L.Y., Reidy, J.A. & Needham, L.L. 2008. Exposure of the U.S. Population to Bisphenol A and 4-tertiary-Octylphenol: 2003-2004. Environ Health Perspect 116(1):39-44. (accessed 22 Dec 08).
12. U.S. Food and Drug Administration (FDA). 2007. FDA Statement on Bisphenol-A and Microwaving Food. November 20. Not found on fda.gov.
13. Dingell, J.D. & Stupak, B. 2008. Letter to Dr. Andrew von Eschenbach. January 17.
14. Mason, S.R. 2008. Letter to Rep. John D. Dingell, February 25. Stephen R. Mason was the former Acting Assistant FDA Commissioner for Legislation.
15. Mason, S.R. 2008b. Letter to Rep. John D. Dingell, June 5.
16. House Committee on Energy and Commerce. 2008b. Press release, “Committee Urges FDA to Reconsider Safety of Bisphenol A.” April 15.
17. vom Saal, F.S. et al. 2007. Chapel Hill Bisphenol A Expert Panel Consensus Statement: Integration of Mechanisms, Effects in Animals and Potential to Impact Human Health at Current Levels of Exposure. Reprod Toxicol 24:131–138. Subscription required.
18. National Toxicology Program (NTP), Center for the Evaluation of Risks to Human Reproduction (CERHR). 2008. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A. September.
19. Lang et al. 2008.
20. Leranth, C., Hajszan, T., Szigeti-Buck, K., Bober, J. & MacLusky, N.J. 2008. Bisphenol A Prevents the Synaptogenic Response to Estradiol in Hippocampus and Prefrontal Cortex of Ovariectomized Nonhuman Primates. Proceedings of the National Academy of Science, 105(37): 14187–14191.
21. Layton, L. 2008. Study links chemical BPA to health problems. The Washington Post, September 17. (accessed 7 Jan 09).
22. Layton, L. 2008b. Chemical in plastic is connected to health problems in monkeys. The Washington Post, September 4.
23. Vandenberg et al. 2007.
24. Sekizawa, J. 2008. Low-Dose Effects of Bisphenol A: A Serious Threat to Human Health? J Toxicol Sci 33(4):389-403.
25. Energy and Commerce Committee Press Release, 2008b.
26. Mui, Y. 2008. Wal-Mart to pull bottles made with chemical BPA. The Washington Post, April 18.
27. Canadian Broadcasting Corporation News. 2008. Toys 'R' Us to phase out bisphenol A baby bottles. (accessed 9 Jan 09).
28. Austen, I. 2008. Bottle maker to stop using plastic linked to health concerns. The New York Times, April 18.
29. U.S. Food and Drug Administration (FDA). 2008. Draft Assessment of Bisphenol A for Use in Food Contact Applications. August 14. (accessed 6 Jan 09).
30. Science Board to the Food and Drug Administration. Webpage.
31. U.S. Food and Drug Administration (FDA). 2008. Press release, “FDA’s Chief Scientist Asks Science Board Subcommittee to Review Research on Bisphenol-A.” June 6. (accessed 6 Jan 09).
32. FDA Science Board Subcommittee on Bisphenol A. 2008. Scientific Peer-Review of the Draft Assessment of Bisphenol A for Use in Food Contact Applications. October 31. (accessed 6 Jan 09).
33. Shin, A. 2008. FDA panel accepts findings on BPA. The Washington Post, November 1. (accessed 6 Jan 09).
34. Hopkins Tanne, J. 2008. FDA’s Science Board says the plastics chemical bisphenol A gives reason for concern,” British Medical Journal, 337:a2404.
35. Parker-Pope, T. 2008. Panel faults F.D.A. on stance that chemical in plastic is safe. The New York Times, October 30. (accessed 7 Jan 09).
36. American Chemistry Council. 2008. Press release, “ACC Statement: FDA Science Board Bisphenol A Meeting.” October 31. (accessed 6 Jan 09).
37. Layton, L. 2008c. FDA will continue to study chemical: No action planned on bisphenol A. The Washington Post, December 16. (accessed 6 Jan 09).
38. Markey, E. 2008. Letter to Andrew Von Eschenbach. October 23. (accessed 6 Jan09).
39. Health Canada. 2008. Press release, “Government of Canada Protects Families With Bisphenol A Regulations.” October 17. (accessed 6 Jan 09).
40. Rust, S. & Kissinger, M. 2008. Lawmakers to seek ban on BPA. Journal Sentinel (Milwaukee), November 17. (accessed 6 Jan 09).
41. Connecticut Attorney General’s Office. 2008. Press release, “Attorney General Calls on Manufacturers to Stop Using Toxic Chemical in Baby Bottles, Formula Containers.” October 13. (accessed 6 Jan 09).
42. Okada et al. 2008.
43. ICIS Chemical Business (ICB) Chemical Profile.
45. SRI Consulting 2007.
46. ICIS Chemical Business (ICB) Chemical Profile.