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 Kleins 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 am exposed to fragrance products, such as Eternity,
I experience: Burning watery eyes and nose, burning throat; hives,
angioedema; shortness of breath, with burning lung sensations; severe
headache; rapid pulse, and other symptoms.
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. I can not leave my home, or invite guests, because of
the fragrances that occur in so very many products. Shopping is only
undertaken if I wear a respirator mask. I have no social life. This is
not fair to me, or millions of other people, who can't tolerate the
harmful chemicals that are contained in fragrances. Thank you.
Donna Hoaglin