March 24, 2001

Dockets Management Branch
The Food and Drug Administration (FDA)
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."

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, I experience: incoherence, nausea, restlessness, irritability, breathing difficulty, headaches, dizziness.

When I am exposed to fragrance products I can experience any of the following symptoms based upon the chemical fragrance product I encounter: incoherence, nausea, anxiety, restlessness, ear pain, incontinence, irritability, breathing difficulty, eyes, watery or dry, joint aches, fatigue, short-term memory loss, canít concentrate, flushing, lethargy, sinusitis, coughing, headaches, lymph nodes swell, heart beat irregularity, disorientation, muscle pain/weakness, dizziness, hypertension.

Please consider 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 made it difficult for me to go to church, go to my Doctor's. office, attend the ballet that my daughter was starring in (she played Clara in the nutcracker), go out to eat, go to the restroom in most public places (try doing without that necessity when traveling), fly on an airplane, or visit in friendsí homes when they use plug-in air fresheners or scented candles.

Thank you.

Sincerely,

Susan Parker Leigh, M.Ed., C.C.N.
(Certified Clinical Nutritionist)
Beaumont, Texas