May 23, 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: Docket # 99P-1340/CP-1

Dear Sir or Madam: In May 1999, the Environmental Health Network (EHN) submitted the above petition to have the FDA declare Calvin Klein's "Eternity eau de Parfum" misbranded. Please place this letter on public record, attesting that I fully support this petition and request that the FDA give it prudent attention to your already-existing regulations 21 CFR Sec. 740.1, 21 CFR Sec. 740.2, and 21 CFR Sec. 740.10. 21 CFR 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 outlined in the petition, "Eternity" perfume contains toxic ingredients and other potentially harmful ingredients whose safety have not been substantiated. There is no warning label on its packaging.

Every consumer or nonconsumer has a right to know the status of safety testing of the ingredients in products such as "Eternity," so we can protect ourselves and our families from toxic chemicals that cause health problems. The general public is 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 and/or defensive when people complain.

Like tobacco smoke, the harmful chemicals currently used in these products may effect the health of many individuals, including those with asthma, chemical sensitivities, chronic fatigue, and other respiratory 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: acute respiratory distress, nausea, vomiting, burning and tearing eyes, extreme lethargy/fatigue, dizziness, migraine headache (with a duration of one to three days post exposure), neuropathy, and disorientation.

Since being affected by perfume products, I have suffered permanent injury in the form of short-term memory loss, chronic fatigue and other brain dysfunction (at the young age of 42). I am now considered unemployable and disabled.

Please act on behalf of the millions of people who suffer physical illness and injury resulting from fragrance exposure at work, at school, in medical treatment facilities, and in social settings. These toxic chemicals act as powerful barriers to people disabled by asthma and chemical sensitivities. The toxic chemicals contained in fragrances have already ruined countless lives.

Thank you.

Sincerely,

Hollie Hoffman

:hah