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.
The harmful chemicals currently used in these products effect the
health of many people, including: people with asthma, chemical sensitivities,
chronic fatigue, and other environmental illnesses. I am one of those people.
Children are particularly vulnerable to toxic chemicals found in
products purchased and used by their parents, care givers and teachers.
When I am exposed to fragrance products, such as Eternity, I
experience: an asthma cough and sometimes wheeze; temporary loss of
muscle strength; sinus pain and, frequently, continued muscle tiredness
for up to two weeks; sleep disruption because of breathing and sinus
problems and pain; sore throat and, at times, infection; excessive
thick mucous production.
In April, multiple exposures in a waiting room resulted in paramedics
being called to my aid. In March, I had to delay completing important
business when an elevator ride with people wearing fragrances resulted
in my collapse in a hallway from temporary loss of muscle strength. It
took me nearly four weeks to recover completely.
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 those such as myself.
Thank you.
Patricia M. Williams