• U.S. PIRG • 218 D Street SE • Washington, DC • 20003 • (202) 546-9707 • www.uspirg.org •
November 21, 2005
The Honorable Deborah Platt Majoras, Chairman
Federal Trade Commission
600 Pennsylvania Ave. NW
Washington, DC 20580
Re: Request for Investigation:
Toxic Phthalates Found in “Phthalate-Free” Products
Dear Chairman Majoras:
We are writing to alert you to the potentially deceptive labeling of some children’s products as “phthalate-free” and ask you to protect consumers by using the Commission’s authority under the Federal Trade Commission (FTC) Act to take enforcement action against unfair or deceptive marketing practices.
Phthalates are a class of chemicals used to “plasticize” or soften otherwise brittle PVC plastic material used in a range of consumer items, including toys, teethers, and other children’s products. Numerous scientists have documented the potential health effects of exposure to phthalates in the womb or at crucial stages of childhood development, including reproductive defects, early onset puberty, and even cancer.1 Please refer to Attachment A for a summary of the potential health effects of phthalates.
Over the last decade, consumer pressure has mounted to remove phthalates from children’s products. In December 1998, the U.S. Consumer Product Safety Commission (CPSC) asked the toy and baby products industry to voluntarily remove one specific type of phthalate (diisononyl phthalate, or DINP) from soft rattles and teethers.2
The European Union (EU) has gone much farther, agreeing in September 2004 to impose wide restrictions on the use of six phthalates in toys and childcare products.3 The EU banned three phthalates it classified as reproductive toxicants – diethylhexyl phthalate (DEHP), butyl benzyl phthalate
(BBP), and dibutyl phthalate (DBP) – in all toys and childcare articles. The EU banned three other phthalates – DINP, diisodecyl phthalate (DIDP) and di-n-octyl phthalate (DNOP) – in toys and childcare articles that can be put in the mouth and are intended for children under three years of age.4
The “Phthalate-Free” Label
Given growing consumer concerns in the U.S. and abroad about the health effects of phthalates exposure, many manufacturers claim to have stopped using phthalates in toys and childcare articles for children under the age of three.5 Some manufacturers even have started labeling their products as “phthalate-free,” ostensibly giving parents the information they need to make wise purchasing decisions for their children.
Unfortunately, in the course of doing research for a report on toxic chemicals in baby products, we discovered that a popular soft vinyl book manufactured by Sassy, labeled as “phthalate-free,” actually contained phthalates.6 For that reason, we decided to put the “phthalate-free” label to a broader test. We commissioned an independent laboratory, accredited by the Environmental Protection Agency in accordance with the National Environmental Laboratory Accreditation Program, to test eight children’s toys and childcare articles—all labeled as “phthalate-free”—for the presence of phthalates. Six of these eight products actually tested positive for phthalates, making the “phthalate-free” label unfair and deceptive for parents trying to purchase safer products for their children. Please see Attachment B for a
list of the products tested and the test results.
The “Phthalate-Free” Label Misleads Consumers
The Federal Trade Commission (FTC) Act declares “unfair or deceptive acts or practices in or affecting commerce” unlawful.7 The FTC Act gives the Commission the power to bring law enforcement actions against false or misleading marketing claims, including environmental or “green” marketing claims.8 The “phthalate-free” label qualifies as an environmental or green marketing claim, as the label implies that the product is less toxic than products containing phthalates. As stated in the FTC’s Guides for the Use of Environmental Marketing Claims, codified at 16 CFR 260, consumers assume that a product labeled as “non-toxic” or “essentially non-toxic” is safe for human health and the environment. If a product poses a significant risk to humans or to the environment, a nontoxic type of claim would be deceptive. 9 The case against products containing phthalates that are labeled “phthalate-free” is even more clear-cut. While scientists and politicians can quibble over what qualifies as a “toxic” or “non-toxic” chemical and what does not, a label claiming that a product does not contain a chemical that it in fact does is clearly deceptive.
“Phthalate-Free” Label Has a Material Effect on Consumer Behavior
The deceptive “phthalate-free” label has a material effect on consumer decision-making. A ‘material’ misrepresentation or practice is one which is likely to affect a consumer’s choice of or conduct regarding a product.10 Express claims and representations are material, as are representations or omissions involving health, safety, cost, or “other areas with which the reasonable consumer would be concerned.”11
The “phthalate-free” label makes an express claim about a product’s relative safety; in effect, the manufacturer is representing its product as safer for children than products not labeled as such. Much as “organic” labels are intended to draw in consumers concerned about pesticide exposure, manufacturers apply the “phthalate-free” label to attract parents and consumers who are concerned about exposing children to this particular class of chemicals. In fact, consumer groups and environmental groups, including PIRG and Environment California, in the past have encouraged parents and consumers to purchase products labeled “phthalate-free” when given the choice. Therefore, a deceptive “phthalatefree” label misleads consumers into modifying their purchasing decisions.
We ask the FTC to work with the Consumer Product Safety Commission to investigate manufacturers’ claims that their products are “phthalate-free” and take immediate action to ensure that this label guides, rather than deceives, consumers, using your full authority under the FTC Act. Please contact us at your earliest convenience to notify us of your plans to address this problem. We look forward to working with you and your staff on this important matter.
Consumer Program Director
U.S. Public Interest Research Group12
(202) 546-9707 firstname.lastname@example.org
Environmental Health Advocate & Staff Attorney Environment California Research & Policy Center13 (415) 622-0086
Environmental Health Advocate
(202) 546-9707 email@example.com
U.S. Public Interest Research Group
cc: FTC Commissioners Thomas Leary, Jon Liebowitz, and Pamela Jones Harbour
Lydia Parnes, Director, Bureau of Consumer Protection, FTC
The Honorable Hal Stratton, Chairman, Consumer Product Safety Commission
CPSC Commissioners Thomas Moore and Nancy Nord
Marc Schoem, Director, Director, Recalls and Compliance Division, CPSC
Attachment A. Summary of Scientific Studies Linking Phthalates to Health Problems
Attachment B. Results of Laboratory Testing of Products Labeled “Phthalate-Free”
Scientists began studying the toxicity of several phthalates as early as the 1950s and discovered significant evidence of environmental and human contamination in the early 1970s, including the leaching of phthalates into human blood from PVC bags used in hospitals.14 Today, phthalates are pervasive in the environment and in human bodies. In 2000, Dr. Benjamin Blount at the Centers for Disease Control (CDC) found high levels of phthalates and their transformation products (known as metabolites) in every one of 289 adult Americans tested, including women of childbearing age.15 CDC confirmed widespread exposure with a larger study in 2003, finding high levels of phthalates in practically every person they tested.16
Phthalate Exposure Linked to Health Effects
Numerous scientists have documented the potential health effects of exposure to phthalates in the womb or at crucial stages of development, including (but not limited to):
• Reproductive Defects. In the last three decades, the number of children born with hypospadias
(a birth defect causing the opening of the urinary tract to develop on the underside of the penis) and cryptorchidism (a birth defect disrupting the descent of the testicles into the scrotum) has doubled.17 A recently published study by Dr. Shanna Swan and her colleagues reveals that normal exposure to phthalates can harm the genital development of unborn baby boys. Mothers with the highest levels of phthalates in their urine late in their pregnancies had babies with a shorter anogenital distance (the span between the anus and penis that forms into the scrotum in males), smaller penises, and more instances of incompletely descended testicles.18 In 2000, Dr. L. Earl Gray and his colleagues at EPA reported that three types of commonly used phthalates (DEHP, BBP, and DINP) disrupt sexual development in male rats.19 In 2004, Dr. Gray and others at the EPA followed up on this finding, showing that the phthalates DEHP, BBP, and DINP reduce the levels of insulin-like hormone #3. Reduced activity of this hormone is another known cause of undescended testicles in mice.20 Other research groups have implicated another common phthalate, dibutyl phthalate or DBP, as a direct cause of hypospadias and cryptorchidism in rodents. When female rats are fed DBP during the third week of pregnancy, 60% of their male offspring suffer cryptorchidism, hypospadias, infertility, and/or other testicular defects.21 Most recently, an independent panel of scientists convened by the National Institute of Environmental Health Sciences and the National Toxicology Program released its review of one type of phthalate, diethylhexyl phthalate (DEHP), in October 2005. The panel reconfirmed that DEHP poses a risk to reproductive and developmental health.22
• Premature Delivery. Rates of pre-term birth (defined as giving birth after 37 or fewer weeks of gestation) have been steadily rising at least over the last two decades.23 A study published in November 2003 by a group of Italian scientists suggests a link between exposure to phthalates and pre-term birth. The scientists found phthalates and their breakdown products in the blood of newborn infants, with higher levels leading to a higher incidence of premature delivery.24 They reported that babies exposed to common phthalates enter the world a week earlier on average than babies with less exposure. The scientists concluded that “human exposure to DEHP can begin in utero” and “phthalate exposure is significantly associated with a shorter pregnancy duration.”25
• Early Onset Puberty. One study of Puerto Rican girls suggests that phthalates may be playing a role in trends toward earlier sexual maturity.26 Puerto Rican girls suffer from the highest rates of premature breast development ever recorded. Dr. Ivelisse Colon at the University of Puerto Rico and her colleagues searched for a link between chemical exposures and this phenomenon. They looked for foreign chemicals in blood samples from a set of very young girls with premature breast development, girls with an average age of 31 months. They found high levels of phthalates in these girls compared with normal children. In particular, levels of DEHP were seven times higher in girls with premature breast development than levels in normal girls.
• Lower Sperm Counts. In 2003, Drs. Susan Duty and Russ Hauser of the Harvard School of Public Health published one of the first studies linking phthalate exposure with harm to human reproductive health.27 They analyzed semen and urine samples from more than 150 men with no unusual exposure to phthalates in the Boston area. Men who had monobutyl or monobenzyl phthalate in their urine tended to have lower sperm counts, with the highest concentrations leading to the lowest sperm counts.
1 For a summary of the scientific studies linking phthalates to health effects, see U.S. PIRG Education Fund, The Right Start: The Need to Eliminate Toxic Chemicals from Baby Products, October 2005, available at http://www.safefromtoxics.org/reports/therightstart.pdf .
2 Consumer Product Safety Commission, “CPSC Releases Study on Phthalates in Teethers, Rattles and Other Children’s Products,” press release, December 2, 1998.
3 “Results of Competitiveness Council, Brussels, 24th September 2004,” Memo/04/225
4 Bette Hileman, “EU Bans Three Phthalates from Toys, Restricts Three More,” Chemical and Engineering News, July 11, 2005.
5 See, for example, U.S. PIRG Education Fund, Trouble in Toyland: The 18th Annual Survey of Toy Safety, November 2003, available at http://toysafety.net/2003/TroubleinToyland2003.pdf . Attachment D of this report includes PIRG’s 2003 Survey of Company Policies on Phthalates.
6 U.S. PIRG Education Fund, The Right Start: The Need to Eliminate Toxic Chemicals from Baby Products, October 2005, available at http://www.safefromtoxics.org/reports/therightstart.pdf .
7 Federal Trade Commission (FTC) Act, 15 USC 45 (a)(1).
8 FTC, “Complying with the Environmental Marketing Guides,” www.ftc.gov/bcp/conline/pubs/buspubs/greenguides.htm .
9 FTC, Guides for the Use of Environmental Marketing Claims, www.ftc.gov/bcp/grnrule/guides980427.htm .
10 Letter from James C. Miller, FTC Chairman, to John D. Dingell, Chairman, House Comm. on Energy and Commerce, pages 5-6 (Oct. 1984), at http://www.ftc.gov/bcp/policystmt/ad-decept.htm .
11 Letter from James C. Miller, FTC Chairman, to John D. Dingell, Chairman, House Comm. on Energy and Commerce page 5 (Oct. 1984), at http://www.ftc.gov/bcp/policystmt/ad-decept.htm.
12 U.S. Public Interest Research Group (U.S. PIRG) is the national advocacy office of the state PIRGs and affiliated environmental groups. The state PIRGs are a nationwide network of nonprofit, nonpartisan, state-based public interest advocacy organizations. The state PIRGs’ mission is to deliver persistent, result-oriented activism that protects the environment, encourages a fair marketplace for consumers, and fosters responsive, democratic government. Visit the organization’s website at www.uspirg.org .
13 The Environment California Research and Policy Center is a nonprofit organization dedicated to protecting California's environment through research, public education, and organizing. Visit the organization’s website at www.environmentcalifornia.org .
14 CP Carpenter et al, “Chronic Oral Toxicity of Di-(2-ethylhexyl) Phthalate of Rats, Guinea Pigs, and Dogs,” AMA Archives of Industrial, Hygiene and Occupational Medicine 8: 219-226, 1953; FL Mayer et al, “Phthalate Esters as Environmental Contaminants,” Nature 238: 411-413, 18 August 1972; AR Singh et al, “Teratogenicity of Phthalate Esters in Rats,” Journal of Pharmacological Science 61: 51-55, January 1972; RJ Jaeger and RJ Rubin, “Migration of a Phthalate Ester Plasticizer from Polyvinyl Chloride Blood Bags into Stored Human Blood and its Localization in Human Tissues,” New England Journal of Medicine 287: 1114-1118, 30 November 1972.
15 BC Blount et al, “Levels of Seven Urinary Phthalate Metabolites in a Human Reference Population,” Environmental Health Perspectives 108: 979-982, 2000.
16 Manori J Silva et al, “Urinary Levels of Seven Phthalate Metabolites in the U.S. Population from the National Health and Nutrition Examination Survey (NHANES) 1999-2000,” Environmental Health Perspectives 112: 331-338, March 2004.
17 Leonard J. Paulozzi, National Center for Environmental Health, Centers for Disease Control and Prevention, “International Trends in Rates of Hypospadias and Cryptorchidism,” Environmental Health Perspectives 107: 297-302, March 1999.
18 Shanna H. Swan et al, “Decrease in anogenital distance among male infants with prenatal phthalate exposure,” Environmental Health Perspectives 113: 1056-1061, August 2005.
19 LE Gray et al, “Perinatal Exposure to the Phthalates DEHP, BBP, and DINP, but not DEP, DMP, or DOTP, Alters Sexual Differentiation of the Male Rat,” Toxicological Science 58: 350-365, December 2000.
20 Vickie Wilson et al, “Phthalate Ester-Induced Gubernacular Lesions are Associated with Reduced Insl3 Gene Expression in the Fetal Rat Testis,” Toxicology Letters 146: 207-215, 2 February 2004.
21 JS Fisher et al, “Human ‘Testicular Dysgenesis Syndrome’: A Possible Model Using in-utero Exposure of the Rat to Dibutyl Phthalate,” Human Reproduction 18: 1383-1394, 2003.
22 NIEHS, “Independent Panel to Evaluate a Chemical Used in Some Plastics (Di (2-ethylhexyl) phthalate) for Hazards to Human Development or Reproduction,” press release, October 5, 2005. The draft report, NTP-CERHR EXPERT PANEL UPDATE on the REPRODUCTIVE and DEVELOPMENTAL TOXICITY of DI(2-ETHYLHEXYL) PHTHALATE, is available at
http://cerhr.niehs.nih.gov/news/dehp/DEHP-Update- Report-08-08-05.pdf; accessed November 7, 2005.
23 AM Branum and KC Schoendorf, “Changing Patterns of Low Birthweight and Preterm Birth in the United States, 1981-98,” Paediatric and Perinatal Epidemiology, 16: 8-15, January 2002; Cande Ananth et al, “Rates of Preterm Delivery among Black Women and White Women in the United States over Two Decades: An Age-Period-Cohort Analysis,” American Journal of Epidemiology 154: 657-665, 2001.
24 G Latini et al, “In-Utero Exposure to Di-(2-ethylhexyl)-phthalate and Human Pregnancy Duration,” Environmental Health Perspectives 111:1783-1785, 2003.
25 G Latini et al, “In-Utero Exposure to Di-(2-ethylhexyl)-phthalate and Human Pregnancy Duration,” Environmental Health Perspectives 111:1783-1785, 2003.
26 I. Colón, D Caro, CJ Bourdony and O Rosario, “Identification of Phthalate Esters in the Serum of Young Puerto Rican Girls with Premature Breast Development,” Environmental Health Perspectives 108: 895-900, 2000.
27 SM Duty et al, “Phthalate Exposure and Human Semen Parameters,” Epidemiology 14: 269-277, 2003; SM Duty et al, “The Relationship Between Environmental Exposures to Phthalates and DNA Damage in Human Sperm Using the Neutral Comet Assay,” Environmental Health Perspectives 111: 1164-1169, 2003.
Fun Ice Soothing Ring Teether UPC: 35282 74601 Munchkin This product does not contain PVC with phthalates. < 10,000 < 10,000 < 10,000 53,000 < 10,000 < 10,000 < 10,000
Just Animals! (Pink Pig) 9111246
Small World Toys/IQ Baby No Phthalate (printed on bottom of toy) < 10,000 < 10,000 110,000 < 10,000 < 10,000 < 10,000 < 10,000
Rub a Dub Squirters for the Tub (Snail) 700G ALEX Phthalate Free. 57,000 < 10,000 < 10,000 < 10,000 < 10,000 < 10,000 < 10,000
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