To the normal eye, it would seem there would be no connection linking asthma, attention deficit hyperactivity disorder, breast cancer, obesity, type II diabetes, low IQ, various neurodevelopmental issues, behavioral issues, autism spectrum disorders, altered reproductive development, anogenital distance, and male fertility issues.
But trained researchers, more and more frequently, see causal links between all of these growing public health concerns. Many scientific researchers connect the dots to phthalates exposure, also known as plasticizers. They have even coined a name, which is now widely recognized among scientific researchers, for some of the health conditions they are most concerned with: the phthalate effect.
Phthalates are a large family of chemicals used to soften and strengthen plastics and increase their flexibility in a wide array of products. They are the chemical that makes a piece of plastic move or bend, rather than crack and break. They can be found in numerous everyday products, which are then released into the environment, from cosmetics and personal care items; infant care products; shower curtains; wallpaper and vinyl mini blinds; plastic wrap; food and food packaging; pharmaceuticals; detergents; adhesives, plastic plumbing pipes, lubricants, medical tubing and fluid bags; solvents; medical devices; inflatable toys; insecticides; building materials; automotive plastics and vinyls; and vinyl flooring.
If that sounds like just about everything, it's true. Phthalates are in many shampoos, body washes, cosmetics, household cleaners. They're in the milk we drink, and in the plastic tubing of a hospital IV. Everything – from the plastic wrap we cover our food with, to the plastic containers we place leftovers in – contains phthalates. Love that new car smell? It's from phthalates. And because of the ubiquitous use of phthalates, and because they are often not listed on product labels, everyone in the United States has phthalates in their system.
It's scary to believe that so many items everyone uses on a daily basis has potentially toxic chemicals hidden within them – unseen, yet leaching into not only the environment but human bodies. According to the U.S. Food and Drug Administration, plasticizers are in products like nail polishes, to reduce cracking by making them less brittle, in hair spray to help avoid stiffness by allowing them to form a flexible film on the hair, and is the chemical in fragrances, from perfumes to cosmetics to automobile products. While the FDA “has not established an association between the use of phthalates in cosmetics and a health risk, the FDA continues to monitor levels of phthalates in cosmetic products,” the organization states on its website.
However, the FDA does warn about infants exposed to infant care products, specifically baby shampoos, baby lotions and baby powder, who showed increased levels of phthalate metabolites in their urine, according to a study published by the American Academy of Pediatrics.
A particularly disturbing aspect of phthalate exposure is that products phthalates are in are not isolated, nor are they unusual “boutique” products. They are some of the most common and popular goods on the shelf in their categories, according to the FDA's 2010 Survey of Cosmetics for Phthalate Content. Included in the survey were Johnson's baby shampoo and baby oil; Dove Deep Body Nourishing Body Wash; Eucerin Plus Intensive Repair hand creme; Aveeno Active Naturals Daily Moisturizing Lotion; Vaseline Body Lotion; Jergens Ultra Healing Extra Dry Skin Moisturizer; Ponds Dry Skin Cream; Lubriderm Daily Moisture Lotion; Nivea; Johnson's Baby Lotion; Dollar General Sleepy Time Baby Lotion; Baby Magic Gentle Baby Lotion; Burt's Bees Baby Bee Buttermilk Lotion; Aveeno Baby; Johnson's Bedtime Lotion; Brut 24-Hour Protection deodorant; Tom's of Maine Natural Lavendar deodorant stick; Old Spice High Endurance deodorant; Speed Stick deodorant; Dove Powder Invisible solid; Secret Powder Fresh; TREsemme No Frizz Shine Spray; White Rain hair spray; John Frieda Collection Frizz-Ease mousse; Johnson's No More Tangles; Garnier Fructis shampoo; Herbal Essences moisturizing shampoo; nipple creams; diaper creams; wet wipes; infant soap, shampoo, and body washes; numerous nail polishes; children's makeups; and baby powder, including Johnson's Baby Powder and Burt's Bees Baby Bee Dusting Powder.
“Under the law, cosmetic products and ingredients, with the exception of color additives, are not subject to FDA approval before they go to market,” the FDA noted. “FDA can take action against unsafe cosmetics that are on the market, but only if we have dependable scientific evidence showing that a product or ingredient is unsafe for consumers or customary conditions of use. At the present time, FDA does not have evidence that phthalates as used in cosmetics pose a safety risk.”
But scientists, both in the United States and Europe, as well as public health and consumer advocacy groups, such as the Center for Health, Environment & Justice and the non-profit Environmental Working Group, disagree. The Virginia-based Environmental Working Group launched the Not Too Pretty campaign to work for safe cosmetics.
“Major loopholes in federal law allow the $20-billion-a-year cosmetics industry to put unlimited amounts of phthalates into many personal care products with no required testing, no required monitoring of health effects, and no required labeling,” the Environmental Working Group said in a statement, noting that phthalates can be absorbed through the skin or inhaled, and have shown damage to the liver, kidneys, lungs and reproductive systems in animal studies.
According to the National Institute of Environmental Health Sciences, phthalates can be removed from the products by exposure to heat or with organic solvents, from leaching from the products themselves, or just from general environmental contamination. Americans who have been tested by the Centers for Disease Control have shown metabolites for multiple phthalates in their urine. Numerous research studies on both animals and humans have shown that high doses of phthalates change hormone levels, can cause birth defects and may cause cancer.
“In the U.S., basically, everyone is exposed on a daily basis. We know this based on work by the Centers for Disease Control (CDC), and the multiple uses of exposure simultaneously,” said Robin Whyatt, professor emeritus in the department of environmental health sciences, Mailman School of Public Health at Columbia University.
Another area of concern is that many medical devices, such as catheters and intravenous equipment, are made of PVC, including ones used in neonatal intensive care units. Phthalates can leach out of the devices into stored liquids, like blood, plasma and intravenous fluids. In 2002, the FDA recommended that healthcare professionals avoid using IV bags, tubes and other devices containing DEHP when treating premature babies and women pregnant with male fetuses.
“Phthalates can seep in through equipment used in processing plants such as tubing, gloves, conveyer belts, lids, adhesives and plastic wraps,” said Olivia Koski with Natural Resources Defense Council. “Dozens of types of phthalates still lurk in a dizzying number of everyday products. And it's impossible to know which ones, exactly, because manufacturers don't have to tell you. Until Congress makes further moves to regulate phthalates or mandates more research on their health effects, you can take steps to avoid them.”
The CDC notes that phthalates are a group of chemicals used to make plastics more flexible and harder to break. “People are exposed to phthalates by eating and drinking foods that have been in contact with containers and products containing phthalates. To a lesser extent, exposure can occur from breathing in air that contains phthalate vapors or dust contaminated with phthalate particles. Once phthalates enter a person's body, they are converted into breakdown products (metabolites) that pass out quickly in urine,” according to the CDC website. “CDC researchers found measurable levels of many phthalate metabolites in the general population. Human health effects from exposure to low levels of phthalates are unknown.”
Researchers, such as Whyatt, disagree with the CDC. “Probably the issue that got people most concerned was the discovery of the phthalate effect. Phthalates are an endocrine disrupter, which means it changes the hormone levels. It was seen first in animal studies, but now it's seen in epidemiological studies as well,” Whyatt noted.
Phthalates are a large group of chemicals, and not all of them show the same danger signals. Nor have they all been tested. It's been said that people can name a major public health concern over the past two decades, and it can likely be tied to exposure to phthalates. BPA, which was banned from plastic, notably water bottles, in 2014, was singled out as the sole chemical of concern in the bisphenol group, but its replacements, BPS and some phthalates, are considered at least as concerning as what they replaced.
There are approximately six that wave the strongest, most dangerous red flags to scientists – di-2ethylhexyl phthalate (DEHP); butyl benzyl phthalate (BbzP); diethyl phthalate (DEP); benzyl butyl phthalate (BBP); diisononyl phthalate (DiNP); and di-isononyl phthalate (DINP). The worst of the worst, most concur, is DEHP, which was replaced in some consumer products, only to be replaced with DiNP – which researchers then discovered correlated to male genital birth defects and impaired reproductive functions in adult males. DEHP has been banned in Europe since 2004, but is still used in the United States, although some manufacturers are replacing it in some products.
Today, while bottled water no longer has BPA, which was banned in the U.S in 2014, there are concerns about the soft plastic they are bottled in, and that they contain estrogenic chemicals. Since 1973, when a DuPont chemist created polyethylene terephthalate (PET), it has been used for bottled water, including Dasani water, and other substances. Multiple studies are consistently showing that water from PET bottles are changing estrogen levels, and that the concentration of phthalates from PET bottles was more than 12 times higher in PET than in glassed bottled water. Ice Mountain water is bottled in HDPE plastic, which is also used in milk jugs, refillable plastic bottles, and plastic bags, and has the 2 recycling number, which is currently considered one of the less dangerous plastics.
“Since phthalates are not chemically bound to the plastic resin polymer (they're just 'mixed in'), they are free to migrate or leach out under certain conditions,” said Sarah Mosko, PhD of California. She noted that in 1986, the U.S toy industry switched from DEHP to DINP in plastic PVC toys in response to a “voluntary” agreement between the industry and the Consumer Product Safety Commission, but did it without any safety testing. Then toys around the world were revealed to have high concentrations of other phthalates.
In 2008, the Consumer Protection Agency banned six types of phthalates from children's toys. “An example of a product that may have phthalates is a product like a children's rubber duck – the flexible plastic feel may be from the use of phthalates in the manufacturing process,” the agency said. In June 2015, Congress permanently banned three phthalates – DEHP, DBP, and BBP – in any amount greater than .1 percent that could be placed in a child's toy, or in a child care product designed to aid in sleep for a child under three, or to help with sucking or teething. Congress has an interim ban on another three phthalates – DINP, DIDP, and DnOP – for the same uses.
“The policies, in the United States, are very difficult to get activated,” said Dr. John Meeker, professor of environmental health sciences at the University of Michigan School of Public Health. “Broad sweeping policy is difficult to enact. But consumer activism helps. It's how some (phthalates) have been banned in certain toys – but it's a small group of what could be banned. People looking for 'phthalate free' products have an impact on manufacturers, and are an advantage for the consumer.”
While many parents would note that any toy will likely end up in a child's mouth, there are numerous toys and categories of toys that are not covered by the bans, including sporting goods, those made with untreated wood, metal, natural fibers, natural latex and mineral products; its component parts; children's socks and shoes; mattresses; and packaging.
Yet, beyond toys that go in children's mouths, they are exposed to phthalates through numerous other products. DINP and DIDP were introduced as “safer” chemicals in the manufacturing of plastic wrap, food containers, soap, and cosmetics, a 2015 study done by researchers at NYU Langone Medical Center noted. “Our research adds to growing concerns that environmental chemicals might be independent contributors to insulin resistance, elevated blood pressure and other metabolic disorders,” Dr. Leonard Trasande said.
Their study looked at over 1,300 children and teens between 8 and 19, measuring their blood pressure and levels of DINP and DIDP in their urine, and they found that with an over 10-fold increase in the levels of the two chemicals, blood pressure levels increased about a point on average.
Another study in 2015 looked at teens 12 to 19 to examine these chemicals and their risk of insulin resistance, which can be a precursor to type II diabetes. They found that increased concentrations of DINP and DIDP were linked to increased risk of insulin resistance, and among the teens with the highest levels of DINP, one in three had insulin resistance.
The Breast Cancer Fund concurs with Dr. Meeker, to look for plastic products marked “phthalate-free” or “PVC-free” and to avoid plastics with the recycling code of 3. They state that a 2012 study found that women working in the automotive and food-canning industries have a fivefold increase in risk of premenopausal breast cancer, which they tie to their exposure to phthalates, BPA and flame retardants. They also recommend women avoid household cleaners and cosmetics with “fragrance” on the label.
The 2012 study indicated that there were higher levels of phthalates, notably DEP, which is often used in fragrance, in women with breast cancer, and it was most profound in pre-menopausal women. Besides cosmetic fragrances and perfume, healthychild.org wrote, “Do a 'Sniff Test.' That 'new car' or 'plastic' smell from soft plastic toys, backpacks, raincoats, and other products usually comes from phthalates. Avoid microwaving in plastics and plastic wraps.”
The American Chemistry Council noted that automobile interiors, vinyl seat covers and interior trim use phthalates because of its ability to withstand high temperature, and flexible vinyl is used in cars and trucks to make them lighter and more fuel efficient.
“Phthalates are considered to be endocrine disruptors because of their complex effects on several hormonal systems, including the estrogen and androgen hormone systems,” the Breast Cancer Fund said.
The American Chemistry Council, which represents many manufacturers, counters that “Phthalates are primarily used to make PVC or vinyl flexible and are used in hundreds of product in our homes, hospitals, cars and businesses. Colorless, odorless phthalates are not only cost effective, but also highly suitable for many flexible vinyl products. Some of their key characteristics include: durability, flexibility, weather resistance and ability to withstand high temperatures...The total economic contributions of three phthalates plasticizers manufacturers and the purchaser industries generate nearly $35 billion in economic output. Removing phthalates from the products could mean the loss of essential properties in consumer and industrial products that we rely on every day. Phthalates make up 90 percent of the plasticizer market, and while there are some potential substitutes in development, there are no drop in replacements available for current applications that would provide similar performance, durability and cost.”
For the last 15 years, Dr. Shanna Swan, an epidemiologist with Mt. Sinai Icahn School of Medicine, has conducted studies of pregnant women to determine fetal exposure to phthalates. Swan is best known for, and pioneered, looking at how phthalates have affected male genital development, “and we're now seeing it in women, as well. We have taken blood and urine studies to analyze their exposure during pregnancy. We don't use a questionnaire, because it's a silent exposure. We want to see what women are exposed to,” Swan said.
Swan's research, first on animals, and now on humans, show that certain phthalates impact the developing male fetus in a way that he gets an inadequate amount of testosterone. “If there's not enough testosterone, their development is not complete,” Swan said, noting that incomplete masculinization had first been documented in animals.
“In 2005, the term phthalate syndrome was coined. Central to that is shortening in critical measurement distance from the anus to the genitals, which is called anogenital distance,” Swan said. Anogenital distance (AGD) is considered significant in both animals and humans because it is a non-invasive method to determine male feminization, and allows the ability to predict neonatal and adult reproductive disorders. She said it's a measurement that has been used in animal studies for more than 100 years.
The anogenital distance in healthy males should be twice as long in males as females. But babies with high total exposure to phthalates, in Swan's studies, are 90 times more likely to have a short AGD, and with that, lower semen volume, lower sperm count, decreased fertility, the likelihood of undescended testes, and testicular tumors in adulthood.
Women who had high levels of phthalates in their urine during pregnancy gave birth to sons who were 10 times more likely to have shorter than expected AGDs.
“It's the most sexually dysmorphic measurement we have. It is a very good measure to separate males and females,” Swan said. “When mothers are exposed to certain phthalates, that distance is not as long. That fetus is feminized, or not as masculinized. We showed it in two studies, and now there is one from Sweden.”
Swan decided to expand her research arena. “The androgens of testing are needed in other parts of the body – the brain,” she said. “We chose to study the region of where they play,” studying boys aged 4 to 7, looking at preschool activities as the instrument in children whose mothers had been exposed to DEHP or DBP in high doses.
“We found they played less male, meaning they chose less guns or trucks or cars, and chose more dolls and tea sets,” she said. “We also saw that often boys who had shorter anogenital distances had feminized play, and lower masculine play. They also had smaller penis sizes and often, their testes didn't descend.
“It isn't just this one neurodevelopmental area, but others as well. We saw it in other areas that are influenced by testosterone are showing to be influenced as well,” Swan said. She and her fellow researchers have not studied sexuality.
Whyatt has looked extensively at behavioral, mental and motor effects in humans from prenatal exposure to phthalates. “It seems to be the most sensitive time for exposure,” she said. “For some phthalates, it decreases mental and motor development. We check it at age three, as well as behavioral problems at age three. We also follow the children to age seven. IQ, learning, athletics are all key at elementary school, and we're seeing
significant reductions, including decreases in short term memory and poor working memory. The teacher will often think it's because they're not paying attention, but that's not it.”
She said that poor working memory is often considered more important to success in elementary development than verbal comprehension, nonverbal questions, behavior and motor development.
“We are still determining if this follows them through their school years. We still don't know,” she said. “It seems that it is apparent, but we're not certain.”
A serious male birth defect can also be linked to phthalate exposure, Swan said, called hypospadias, where the opening of the urinary tract, the urethra, is not located at the tip of the penis, but partway up. It must be surgically corrected at around eight months of age, under general anesthesia.
“More dramatically, a short anogenital distance male will likely be infertile, have lower testosterone (as an adult), have lower testicle volume, and lower sperm count. So it matters,” she emphasized.
Robin Whyatt, of Columbia, observed, “These are at levels that people are generally exposed to in the United States. Phthalates cause changes, and it's thought now it's what's happening in the human population.”
Swan noted over the years of studying phthalate syndrome that DEHP, “long considered the worst of the worst,” has been present in food, making containers softer, “was the only one regulated in drinking water. Then regulations were put in place in the U.S. and Europe, and taken out of children's toys.” Between her first and second study, she and her fellow researchers found a 50 percent drop in DEHP as a result of its partial removal.
“With DEHP, most people are exposed through diet and food packaging. It's still unclear how,” said U-M's Meeker.
Whyatt disagrees. “A lot of people are concerned about DEHP, but we haven't found it to be the worst. This is such a huge category of chemicals. That was one chemical, and it is in so many products, still. I always caution – there haven't been enough interventional studies to know (what the worst is). They're just everywhere.” While it's good, she notes, that they have been removed from children's toys, “The window of greatest susceptibility appears to be during pregnancy.”
Swan concurs. “Genital changes are specifically tied to the first trimester, especially month two and three, when the exposure happens early in pregnancy. Neurological developmental changes likely occur mid-pregnancy, and preterm birth is likely to be associated to late exposure. So the best time to avoid phthalates is likely the entire pregnancy, because they're dangerous throughout,” she said.
Lisa Dry, senior director, product communications with the American Chemistry Council, countered, “Phthalates have been thoroughly studied and reviewed by a number of government scientific agencies and regulatory bodies worldwide and these agencies have concluded that phthalates used in commercial products do not pose a risk to human health at typical exposure levels. Information collected by the Centers for Disease Control and Prevention over the last 10 years indicates that, despite the fact that phthalates are used in many products, exposure is extremely low – significantly lower than any levels of concern set by regulatory agencies. In addition, all studies have limitations that impact the interpretation of the findings.”
Meeker said that he, in collaboration with Dr. Russ Hauser of the Harvard T.H. Chan School of Public Health, have been studying women's reproductive health following exposure to phthalates. “We started with the male population, and then also looked at women. Now we're hoping to look at children,” he said. “Seventeen years ago, we began looking at male reproductive health, at their semen samples, and then their female partners, in relation to in vitro fertilization, with hopes to continue following the children born.”
He said they published a study in 2015 that showed for men with phthalate exposure, they had a decrease in semen quality, an increase in DNA damage in their sperm cells, and altered circulating hormone levels. “On average, with those with greater phthalate levels, had decreased testosterone levels,” Meeker said.
“On the female side, those associated with increased phthalate levels had decreased egg yields and decreased chances in having a successful pregnancy,” he said. “It is consistent with research on laboratory animals.”
Further studies are indicating the increased odds of early pubertal development (early menses) among girls, and delayed puberty among males, Meeker said.
“We do see some variability in the chemicals, so we are continuing studying (them),” he said. “They are endocrine disrupters. It's looking at how are these things happening to these chemicals for people who are already exposed, and looking at the strongest predictors of exposure in order to avoid. Right now, it's pretty tough for someone to just decide to avoid these chemicals. We have to work to the next level to provide the best science to inform for the best policy decisions.”
Consumers have power, and have proved the power of the purse, as evidenced by pushing large flooring retailers to stop selling flooring products with phthalates. In 2014, researchers found that of 65 vinyl flooring tiles tested from flooring samples purchased from major home improvement stores, including Lowe's, Home Depot, Ace Hardware, Menards, and Lumber Liquidators, 38 samples – 58 percent – contained phthalates. Lumber Liquidators and Ace Hardware had phthalates in 100 percent of their flooring samples; Lowe's samples contained phthalates in 48 percent of their samples; and Menards, 23 percent of their samples.
In 2015, researchers from the Ecology Center linked the phthalates in these flooring tiles to asthma, birth defects, learning disabilities, reproductive problems, liver toxicity, and cancer. Most of the vinyl tile flooring samples contained one or more hazardous chemicals, and the phthalates found in them are currently subject to a pending ban by the European Union. Following this study and consumer outcries, Home Depot made a commitment to phase out phthalates by the end of 2015, and Lumber Liquidators reported it is working with suppliers to transition to alternative products, although it has not set a deadline for when that will be completed.
“When the industry is moving away from a compound, it is imperative they don't replace it with another one that is also toxic, or that is not tested,” said Columbia's Whyatt. “At least two-thirds of phthalates are not tested. We have to replace them with chemicals we know are not dangerous.
“There's almost no successful regulations in the United States that a chemical that is taken off the market will not be replaced with one that is (also) a hazard because they are not tested. Our regulatory system is broken,” she emphasized. “There are probably safer compounds. When you have a group of chemicals that every single human in the United States is exposed to, including every single pregnant woman has in their body and passes through to their fetus, with multiple health outcomes, it's time to take action. It's a pretty obvious outcome. We don't want our children to be our guinea pigs.”