• 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.
Sincerely,
Edmund Mierzwinski
Consumer Program
Director
U.S. Public Interest
Research Group12
(202) 546-9707 edm@pirg.org
Rachel Gibson
Environmental Health
Advocate & Staff Attorney Environment California Research & Policy
Center13 (415) 622-0086
rgibson@environmentcalifornia.org
Meghan Purvis
Environmental Health
Advocate
(202) 546-9707 mpurvis@pirg.org
Alison Cassady
Research Director
U.S. Public Interest
Research Group
(202) 546-9707
acassady@pirg.
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
Attachments:
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.
NOTES
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
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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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