Parker Waichman LLP Injury Alerts
PHTHALATES: Serious Concerns Emerging Over the Safety of These Widely-Used ChemicalsNov 1, 2005
There is currently a growing debate regarding the safety of a group of chemicals used in many personal care products and other consumer goods. These chemicals, called phthalates, have been used for the past 50 years for everything from making plastic more flexible to slowing the evaporation process of perfumes to making nail polish that won’t chip away.
Phthalates, pronounced “thallets,” are found in a variety of products such as cosmetics, hair sprays, deodorants, shampoos, nail polish, perfumes, body washes skin creams, prescription pill coatings, insect repellants, detergents, vinyl products, medical equipment, food packaging, plastic and vinyl toys, shower curtains, and building materials such as pipes, vinyl flooring, and wallpaper.
Clearly, when a chemical is used in so many consumer products and personal care items, its safety must be unquestioned. Anything less would unnecessarily expose the public to wide-spread health risks.
Until recently, phthalates (rightly or wrongly) enjoyed that type of universal acceptance as a safe additive in products of all types. Although some consumer advocates had often questioned such wide-spread use of what they believed to be a potentially toxic chemical, no reliable evidence existed to support the conclusion that phthalates were unsafe.
In the past year, however, environmental and consumer advocacy groups have begun to seriously challenge the safety of phthalates. Studies of the effects of phthalates on both animals and humans have now found several serious heath risks traceable to exposure, inhalation, or ingestion of phthalates.
Just a few months ago, the European Parliament voted to permanently ban products containing phthalates citing evidence of damage to the reproductive system and an increased risk of asthma and cancer. A temporary ban had previously existed in Europe since 1999.
While the FDA is currently conducting an ongoing investigation of the safety of phthalates, the agency continues to take the position that no risk is posed to phthalates in cosmetics. Some experts even argue that, despite the evidence generated from studies, there is no measurable health risk related to phthalate exposure.
Study Suggests Pregnant Women and Male Children at Risk
In May 2005, researchers were able to identify a link between a woman’s exposure to phthalates during pregnancy and the development of her male child’s genitals.
Shanna Swan, a researcher at the University of Rochester School of Medicine and Dentistry, studied 85 subjects to determine the correlation between phthalate exposure and the demasculinization of the male reproductive tract, otherwise known as the anogenital index (AGI).
The study indicated that when four particular phthalates are found above certain concentrations in the urine of pregnant women, the reproductive systems of their infant boys were adversely affected. About 25% of women in the United States have concentrations of these four phthalates at this concentration level
Swan and her team found that baby boys who were exposed to higher amounts of phthalates, or multiple phthalates, had smaller AGI measurements than what are considered normal. Baby boys with lower AGIs also had smaller penis volumes and were more likely to have less-developed testicles. Researchers concluded that the chemicals used to make phthalates suppress production of testosterone.
This study was the first to link prenatal phthalate-exposure to adverse effects for the male reproductive system. The results of this study are considered by many experts to be highly valid as they are consistent with similar results in several animal studies.
In rodents, the result of fetal exposure to phthalates is called “phthalate syndrome” which is categorized by a decrease in anogenital distance (AGD), an increased risk of incomplete testicular descent, impaired sperm quality, and an increased risk of cancer in adulthood.
In prior studies, researchers have discovered a pattern of male abnormalities called “testicular dysgenesis syndrome” (TDS) and have hypothesized that phthalates are responsible for this condition.
Swan’s study may be able to provide the missing link between phthalate syndrome and TDS for the first time. The study also suggests that humans may, in fact, be more sensitive to phthalate-induced effects on the male reproductive system than rodents. Researchers have also postulated that phthalate exposure may lead to premature births.
The study was funded by the National Institute of Environmental Health Sciences and the United States Environmental Protection Agency.
Phthalates and Lupus
A recent study conducted by researchers at Indiana State University found a connection between phthalates and the onset of lupus in laboratory mice.
Lupus is an auto-immune disease in which the immune system attacks the body’s own tissues as though they were foreign substances. The disease is potentially fatal and often damages the kidneys, heart, lungs, or blood cells.
Researchers at Indiana State University injected mice with phthalates. They found the injections triggered lupus, caused development of glomerulonephritis, and considerably shortened the lifespan in mice that have a genetic disposition to the disease (but not in other mice that are not pre-disposed to the illness). The research is published in the July 2005 issue of the Journal of Autoimmunity.
“Our findings clearly show that lupus can be caused by an environmental factor like phthalate,” said Swapan K. Ghosh, professor and interim chair of life sciences at Indiana State.
This study is still tentative in terms of its implications for humans, but it is yet another potential hazard to factor in to the ongoing list of problems associated with phthalates.
Phthalates and Children
Phthalates are currently used to make many different kinds of children’s toys that require bendable plastic or vinyl. These products can become dangerous if children bite or chew on them (which is not unforeseeable) or if the products come in extensive contact with their skin (which is likely).
Children’s exposure to phthalates can occur from mouthing or chewing vinyl products, eating contaminated food, inhaling chemicals released from vinyl products into indoor air, drinking water containing phthalates, or being hooked to intravenous tubing used for hospitalized infants or children.
Some precautions that parents or guardians can take to prevent their children from being exposed to unsafe levels of phthalates include checking to see whether toys are made of polyvinyl chloride (PVC), reading labels on personal care products, avoiding well water and unfamiliar water systems, and performing a “sniff test” to check for the “plastic smell” from soft toys, backpacks, teethers, or raincoats.
Consumer advocacy groups also recommend that PVC teethers and toys be discarded. These items are generally soft and flexible making it enticing for children to chew and bite on them. Parents and guardians should look for new items that do not contain phthalates.
It is also a good idea to reduce or eliminate the use of perfumes, nail polishes, or other phthalate-containing cosmetics around children. Pregnant women, women thinking of getting pregnant, and women who are nursing should be particularly cautious about overexposure to these products.
Other Potentially Serious Health Risks
In August 2000, scientists in Puerto Rico discovered a link between exposure to phthalates and premature breast development in young girls. The implications of these findings could lead to further studies regarding the connection between phthalates and puberty in both girls and boys.
In late 2002/early 2003, three studies were conducted to focus attention on the effects of phthalates on semen quality. The men participating in the study were exposed to average environmental levels of phthalates. One study found DNA damage in sperm while the other two studies found reduction in sperm quality in males with slightly elevated phthalate levels.
While the evidence of health-related risks associated with phthalate-exposure continues to mount, there are still some who argue that there is no ‘measurable” risk. On October 21, a panel assembled to examine the connection between exposure to phthalates and damage to the reproductive system of infants.
This U.S. government panel concluded that the recent study of infant males conducted this past summer did not successfully prove that phthalates caused harm. They recommended that further studies be conducted with a larger sample size before any more warnings are drafted relating to phthalates and genital development in male children.
Consumer advocates and concerned scientists view this as nothing more than an ostrich-like approach to the mounting evidence that phthalates present serious health risks to humans. Thus, delaying the recognition of the risks by insisting on “further studies” is regarded as irresponsible since already completed human and animal studies have proven a link exists between phthalates and a number of serious long-term health problems. The burden should therefore be to prove phthalates are not dangerous rather than the other way around.
In addition, the American Council on Science and Health, an industry public relations firm masquerading as a public health organization, put together another panel to review the safety of phthalates. The panel, led by former Surgeon General C. Everett Koop, produced what is regarded by many experts as a faulty report claiming that phthalates were safe.
The report from this so-called “panel” did not examine the various recent publications and misrepresented one study which had indicated the existence of a link between phthalate usage and kidney damage. The biggest error committed by the panel, however, was that they accepted the mere absence of significant data as proof that phthalates were actually safe.
The Phthalate Information Center (PIC) suggests that while advocacy groups claim that phthalate exposure is harmful on several levels, government data from the Centers for Disease Control and Prevention (CDC) indicate that human exposure levels are well below minimum safety levels set by regulatory agencies.
The PIC also suggests that since phthalates have been in existence for such a long time, they are actually well understood and have been studied efficiently and consistently. The PIC argues that there is no reliable evidence that phthalates have caused a health problem for a human when used properly and that consumer advocacy groups and environmental organizations have “cherry picked” certain results from human and animal studies to create unprecedented concern about these products.
Still, the list of adverse health risks associated with phthalates continues to grow. It would be faulty thinking indeed to assume people should continue to use such suspect chemicals without further examination of their effects on men, women, children, and infants.
While the results from completed studies may not yet be as strong or conclusive as they need to be in order to convince the FDA to issue a severe warning about phthalates, the European Parliament saw fit to issue a ban on phthalates which indicates that these chemicals are not as safe and harmless as the multi-billion dollar plastic industry would like us to think.
As always, if you believe you or a loved one has suffered an injury as the result of exposure to a toxic substance please do not hesitate to contact Parker & Waichman at www.yourlawyer.com to arrange for a free case evaluation.