Wed, 3 Nov 1999

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."

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:

Within 5 minutes I will have stomache-sickness and have to rush to a bathroom. After 10-15 minutes of exposure I am light-headed and if I am forced to endure longer periods of time, my symptoms range from mild headaches, sore throat, fatigue to severe migraine headaches and regurgation where I have to seek medical treatment. There are times where I've hardly been able to reach the safety of my home and bed due to such dizziness and nausea I can hardly keep my head up straight. My mental alertness is diminished, so much so that many times it is impossible to drive safely.

Please understand this is not a "preference" to wear or not wear perfume. This is a bonafide, servious health problem. I have experienced progressly worse symptoms for 25 of my 40 years. I've had to seriously alter my employment and social life because of this problem. I have been subjected to ridicule and unfriendly statements more times then I can count causing increased stress.

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.

Please act on behalf of the children who cannot protect themselves. Educate the parents so they do not unknowningly harm their children. Educate the parents and physicians so that if a child presents with problems, they look at perfume as a possible source of their ailment and treat accordingly.

Thank you for your time and concern.

Sincerely,

Susan Colletta