Pharmaceutical and Medical Packaging News
Magazine
PMPN Article Index
Originally Published May 1999
OUR VIEW
The Phthalate Esters Panel of the Chemical Manufacturers Association
Phthalate Esters Are Safe to Use
Opponents of vinyl say it can leach cancer-causing chemicals into the body, but its proponents argue that vinyl has a 40-year history of safe use.
Recently, activists have launched a media campaign against the use of vinyl medical devices. Some news stories have noted that studies conducted many years ago on vinyl showed liver tumors in rats and mice. However, extensive research conducted over the past two decades shows that the use of vinyl is unlikely to pose a human cancer hazard.
The Greenpeace-led campaign, part of its worldwide attack on all uses of vinyl, focuses on phthalate esters in medical devices. Phthalate esters are a family of plasticizers—plastic softeners— added to rigid vinyl during manufacturing to make flexible products such as intravenous bags.
Flexible vinyl is one of the most commonly used materials for medical devices because of its performance, its low cost, and, most importantly, its safety benefits. It is estimated that there have been six to nine billion patient days of exposure to the plasticizer with no scientifically validated reports of adverse health effects in people.
Phthalate esters have been subjected to extensive health and safety testing. In particular, the primary phthalate ester used in medical devices, called di (2-ethylhexyl) phthalate (DEHP), has been tested for more than 40 years so that it can be used safely in vinyl medical devices.
It has long been known that DEHP can leach out of the medical device and into fluids in very small quantities. In fact, FDA knows and considers this when it approves vinyl medical devices. Bruce Burlington, former director of FDA's Center for Diagnostics and Radiological Health, says, "We believe IV bags, blood administration sets, and other uses of PVC, including dialysis tubing, are safe."
Activists point to an EPA cancer classification that dates back to the 1980s. But since then, numerous independent scientists have joined ranks with government and international organizations, such as Health Canada, the Commission of the European Communities, and the World Health Organization, concluding that the plastic softener used in medical devices is unlikely to pose a cancer hazard to humans.
Activists also point to warnings on a few drugs as evidence that DEHP might pose some kind of risk. But many drugs, even over-the-counter drugs such as pain relievers or cough suppressants, come with a wide variety of warning statements. The fact that a few medical solutions may not be appropriate for use in vinyl containers does not mean that vinyl is inappropriate for many other uses.
FDA has stated publicly that "we would need to see a substantial amount of testing to make sure that we weren't moving from a product with good characteristics to one that we don't know very much about."
The Phthalate Esters Panel of the Chemical Manufacturers Association (Arlington, VA) believes that the claims made by activists are misguided. Such claims would have consumers believe that any amount of this softener is bad. In science, however, the basic principle of toxicology is that the dose makes the poison. It stands to reason that too much of anything can be harmful. Consumers are exposed to many substances in small amounts that are believed not to be harmful; similarly, phthalate esters producers strongly agree that DEHP in small amounts does not pose any discernible human health risk.
For 25 years, the Phthalate Esters Panel has sponsored research on phthalate esters, including DEHP, with the result that they are among the most thoroughly studied and understood chemicals in the world. The Panel believes that the available data as a whole show that DEHP in medical devices, including uses where maximum chronic exposure may occur, does not pose a human cancer hazard.
For more information, visit http://www.phthalates.org.
