From: Nancy Speer [nspeer@stcvcpa.com]
Sent: Thursday, November 30, 2000 1:56 PM
To: fdadockets@oc.fda.gov
Subject: Docket Number: 99P-1340/CP 1

Date: November 30, 2000
Dockets Management Branch
The Food and Drug Administration
Department of Health and Human Services, Rm. 1-23
12420 Parklawn Dr.
Rockville, MD 20857
Re: Docket Number: 99P-1340/CP 1
Petition the FDA Have Calvin Klein's Eternity eau de parfum declared
"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 affect 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, caregivers and teachers. When I am
exposed to fragrance products, such as "Eternity,"
When I am exposed to fragrance products I can experience any of the
following symptoms based upon the chemical fragrance product I encounter:
__anaphylaxis/shock	__double vision 	__incoherence	_X_nausea
__anxiety, restlessness 	__ear pain	__incontinence	_X_nose bleeds
__asthma	__eczema	__irritability	_X_rashes
__breathing difficulty 	_X_eyes, watery or dry	_X_joint aches	__seizures
__bronchitis 	_X_fatigue	_X_laryngitis	_X_short-term mem. loss
__can1/4t concentrate	__flushing	_X_lethargy	_X_sinusitis
__coughing	_X_headaches	_X_ swell in throat and face	__sneezing
__depression	__heart beat irregularity	__mood swings	__sores, skin/mouth
_X_disorientation	__hives	_X_muscle pain/weakness	__swallowing difficulty
_X_dizziness 	__hypertension	__nasal congestion	__tinnitus
_X_other: 2 of my grandchildren are dealing with attention deficit disorder
(one is also hyperactive)

I am an organist and have had so much muscle problems and troubles with
becoming disoriented from the chemical fragrance that I had to give up
playing for a while until I found someone to help me with the muscle
problems and a good allergist and ears, nose and throat man (who had to do
major sinus surgery to open all of the passages that had almost closed). I
am functioning again now and playing, but can easily become disabled from
perfume. It also affects my voice, but the drawing of the muscles in the
throat, legs, arms, neck, etc. is the most painful. Please listen to what we
are trying to tell you. What will happen to my children and grandchildren if
this is allowed to continue. Don't use us as guinea pigs.
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. Toxic chemicals in fragrances
have already ruined countless lives.
Thank you.
Sincerely,

Nancy L. Speer
612 5th Way
Pleasant Grove, Alabama
35127