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 au 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,
chemical sensitivities, chronic fatigue, and other environmental illnesses.
Children are particularly vulnerable to toxic chemicals found in products
purchased and used by their parents, care givers and teachers.
When I was recently exposed to the fragrance product, "Eternity," I
experienced what was thought to be almost stroke-like symptoms and had to
be driven home 45 miles.
I had been standing talking to the storeman of a tractor sales yard, just
inside his store room when I began to become dizzy and realised that
something was wrong. I turned to find a lady machinery representative was
just outside the door behind me [afterwards I was told she was wearing
Eternity] . I held my breath and used the walking stick I'd been carrying to
stagger to my van 12 yards from where I had been standing. I could not get
in to it as my brain was already fogged and my left side had became very
weak. The storeman saw me in trouble and came to help lift me in to my seat,
I could not talk by that time. His boss realised that I would need to be
brought home, where I was put to bed with hot water bottles to raise my
temperature the 2F lost because of the chemicals. Five days later my voice
is back, my brain is less fogged, I do not need the wheel chair but I still
have arthritis-like pain in my joints and stiff muscles. I have not been
able to do any work since this exposure. I have been MCS for 8 years and
this store is one of the few that I have been able to enter during this
time. Her 'Eternity' has poisoned me and I cannot understand how it can be
sold as a perfume.
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.
A.R.H.Perceval
Temple House,
Ballymote.
Co. Sligo.
Ireland