chaired by C. Everett Koop
Posted: Friday, August 6, 2010
Publication Date: June 22, 1999
ACSH's A Blue Ribbon Panel Report: A Scientific Evaluation of Health Effects of Two Plasticizers Used in Medical Devices and Toys was conducted in 1999 and led by C. Everett Coop, the former surgeon general. The independent expert panel examined the use of di(2-ethylhexyl) phthalate (DEHP) and diisononyl phthalate (DINP), two plasticizers used in flexible vinyl products. It found that DEHP, used to make medical devices, "is not harmful to even highly exposed people" and that DINP, used in toys, "is not harmful for children in the normal use of these toys." The panel did recommend further testing of DINP.
A PDF of the report is available by clicking on the icon on the right.
The text of the original press release follows:
The plastic softener found in vinyl toys and medical devices are not harmful to children or adults, according to a distinguished panel of leading physicians and scientists chaired by former U.S. Surgeon General Dr. C. Everett Koop.
The panel, convened by the American Council on Science and Health (ACSH), issued its much-anticipated report after a comprehensive review of the scientific literature concerning the phthalates DEHP and DINP. DEHP and DINP are added to vinyl medical devices and toys, respectively, to provide desirable qualities such as flexibility.
"Consumers can be confident that vinyl toys and medical devices are safe," said Dr. Koop. "The panel's findings confirm what the U.S. Food and Drug Administration and the Consumer Product Safety Commission have been saying about these products all along. There is no scientific evidence that they are harmful to children or adults."
The 17-member expert panel was formed in February in response to questions raised about the safety of DEHP and DINP. The panel reviewed data including primary and secondary scientific literature, risk assessments published by regulators in the U.S., Canada and Europe, and scientific manuscripts still in preparation to ensure their consensus statement reflected the most recent studies.
"When it comes to health concerns, consumers want reliable information," said Dr. Elizabeth Whelan, President of the ACSH. "That's why we convened a panel with the breadth and depth of expertise needed to thoroughly assess the broad body of scientific evidence that's available. The panel's conclusions are grounded in the evidence and the panel's expertise."
Panel member Kimberly Thompson, Sc. D., Harvard School of Public Health, said the panel had a dual mission: To evaluate the science, and protect public health. "As the mother of two children and a specialist in risk analysis, I am confident that our consensus - that these products are not harmful - is true to both of those objectives."
In its recommendations regarding the phthalate DEHP, the panel took the extra step of underscoring the benefits associated with its use in medical applications and devices, and recommended its continued use because of its demonstrated reliability.
"Our report emphasizes that DEHP in medical devices actually provides important physical qualities -- such as transparency and resistance to kinking - that are beneficial to patients. It's important for the medical community and the public to understand that removing the phthalate would actually pose a significant health risk to individuals who depend on these devices," Dr. Koop added.
Nationally and internationally recognized scientists and physicians, with expertise in a range of relevant disciplines, including pediatrics, toxicology, metabolism, epidemiology, risk assessment and medicine, comprised the independent panel. In addition to Drs. Koop and Thompson, those who collaborated to produce the report include, among others, Robert L. Brent, M.D., Ph.D., Jefferson Medical College; Morton Corn, Ph.D., Johns Hopkins University; Paul J. Lioy, Ph.D., Robert Wood Johnson Medical School; George D. Lundberg, M.D., Medscape and Northwestern University, and former editor of the Journal of the American Medical Association.
