Dockets Management Branch
The Food and Drug Administration
Department of Health and Human Services, Rm. 1-23
12420 Parklawn Dr.
Rockville, MD 20857

Re: 99P-1340/CP 1
        Petition to Have “Eternity eau de parfum”   Misbranded

Dear Sir or Madam:
        In May, 1999, the Environmental Health Network (EHN) submitted
the above petition to have Calvin Klein’s “Eternity eau de parfum”
declared misbranded. I am writing because I fully support this petition
and request that the FDA give it careful attention with regard to your
regulations 21CFR, Sec. 740.1, 21CFR Sec. 740.2, and 21CFR Sec. 740.10.
Regulation 21CFR Sec. 740.10 specifically states:

        “Each ingredient used in a cosmetic product and each finished
cosmetic product shall be adequately substantiated for safety prior to
marketing. Any such ingredient or product whose safety is not adequately
substantiated prior to marketing is misbranded unless it contains the
following conspicuous statement on the principal display
panel: "Warning--The safety of this product has not been determined."

        As the petition shows, “Eternity” contains toxic ingredients and
ingredients whose safety have not been substantiated. There is no
warning label on its packaging.

        We all have a right to know the status of safety testing of the
ingredients in products such as “Eternity” so that we can protect
ourselves and our families from toxic chemicals that may cause health
problems. Most people are not aware that most fragrance materials have
only limited safety testing. They wrongfully assume these products are
safe to use in any setting and are surprised when people complain.

        Like tobacco smoke, the harmful chemicals currently used in
these products may effect the health of many people, including: people
with asthma, chemial sensitivities, chronic fatigue, and other
neurological/immunological illnesses, respiratory illnesses and
environmental illnesses.

Children are particularly vulnerable to toxic chemicals found in
products purchased and used by their parents, care givers and teachers.
Furthermore, like the tobacco companies, Calvin Klein targets young
consumers, and for this reason school buildings, which are often already
riddled with indoor air quality problems, have the added mixture of
perfume toxicants for students and staff to deal with. In this time of
concern over school violence we should be looking for every way possible
to decrease the neurotoxic load on school children. How can we begin to
do this effectively without full disclosure of toxic ingredients and
labeling of all products for which safety has not been proven?        
When I am exposed to fragrance products, such as “Eternity,”I experience
(list here): immediate irritability that worsens to anger as the
exposure time lengthens, headaches, asthma, sinusitis, numbness in
extremities, disorientation, dizziness, brain malfunction and muscle
spasms. If the exposure lasts for 30 minutes or more, the effects can
last for days or more.

My daughter experiences neurological symptoms and upper respiratory
symptoms with exposures. She becomes depressed and starts crying or gets
angry, has a headache, and these experiences have greatly hampered her
ability to get an education. She was almost failed in high school, not
because of grades, but because of absences and an ignorant staff that
refused to believe that chemical exposures could incapacitate human
beings.

This ignorance in 1996 in light of the 1986 Congressional Report
by the Committee on Science and Technology on neurotoxins at home and in
the workplace, is unexcusable. The report states on the first page:
"Millions of people are exposed everyday to neurotoxic industrial
chemicals, including solvents, pesticides, drugs, food additives and
cosmetics. People who have experienced acute exposures to neurotoxins
show the readily recognizable symptoms of dizziness, nausea, muscle
weakness, and blurred vision. But, symptoms of chronic exposure - such
as increased irritability, loss of memory, inability to concentrate, and
sexual dysfunction- may go unnoticed, or be ascribed to social pressures
rather than to neurological damage." Dr. Spencer, witness on health
effects, who testified to the Committee insisted on adding fragrance raw
materials to the list of priorties to be examined fo neurotoxicity.
"....because of my experience with regard to fragrance raw materials",
he said, "..I strongly suspect the American public would like to know
what is applied to their skin voluntarily..." (p 13 of the report). In
the findings of the report, the Committee states under (e) that
"Neurotoxins may deserve a higher regulatory priority [than carcinogens]
due to the fact that chronic exposure to neurotoxins at levels that show
no signs of being carcinogenic may have often crippling and irreversible
neurological effects." (p. 28)

     I believe you have more than enough evidence: benzenmethanol,
phenol, benzeneethanol, and 1,3- Benzodioxole-5-carboxaldehyde, to name
only a few  of the poisonous ingredients in "Eternity" - to justify
action (the misbranding of "Eternity eau de parfum") on this petition as
well as enough evidence to discontinue allowing any fragrance product on
the market that does not prove its safety and provide full-disclosure of
all hazardous ingredients to the public.  Please act on behalf of the
millions of people who have suffered physical illness and injury
resulting from fragrance exposure at work, at school and in social
settings. These toxic chemicals act as powerful barriers to people
disabled by asthma and chemical sensitivities. Because of this, toxic
chemicals in fragrances have already ruined countless lives. Thank you.

Susan Wells Vaughan