April 13, 2001

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 to Have Calvin Klein's Eternity eau de parfum declared "misbranded"

"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."

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 that 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 and environmental sensitivities. Children are particularly vulnerable to toxic chemicals found in products purchased and used by their parents, caregivers and teachers.

When I am exposed to fragranced products, such as "Eternity," I experience rashes, hives, asthma, hoarseness, sore throat, post-nasal drip, coughing, sneezing, itchy eyes, racing pulse, and central nervous system symptoms such as weakness, fatigue, headache, irritability, anxiety, poor concentration, confusion, and crying spells.

I am a lawyer employed by the Canadian government and am forced to work out of my home to accommodate my disability, which is an entirely preventable one, if people would cease their use of scented and other sensitizing products. I am unable to work in my office because of my environmental sensitivities, triggered by, among other things, co-workers wearing fragrance. I have a 2 and a half year old daughter. When her caregiver takes her to play with other children and caregivers, she often comes home with residues of scented products in her hair and clothing. I find myself reacting to the residual volatile organic chemicals that have attached themselves to my daughter in my own home.

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 environmental sensitivities. Toxic chemicals in fragrances have already ruined countless lives.

Thank you.

Sincerely,
Debra