May 26, 1999

Dockets Management Branch
The Food and Drug Administration
Department of Health and Human Services, Rm. 1-23
12420 Parklawn Dr.
Rockville, MD 20857

Dear Sir or Madam:

Re: 99P-1340/CP 1
Petition to Have Eternity eau de parfum declared misbranded

I am writing in support of the petition submitted this month by the Environmental Health Network (EHN) to have Calvin Klein's Eternity eau de parfum declared misbranded. I hope that the FDA will approve this petition in light of regulations 21CFR Sec. 740.1, 21CFR Sec. 740.2, and 21CFR Sec. 740.10. Regulation 21CFR Sec. 740.10 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: "WarningQThe safety of this product has not been determined."

Eternity contains ingredients shown to be toxic yet has not conducted the necessary tests or labeled its product in compliance with the law. I request that you hold Calvin Klein accountable for complying with the law as written.

Many people enjoy perfume but have no idea what they are exposing themselves (and the adults and children around them) to. We all have the right to make informed decisions about the products we buy and come into contact with. This is the point of labeling laws. Perfume manufacturers should not be able to skirt the law under the guise of "trade secrets." The tobacco companies got away with this for decades; they were untouchable until there was enough public sentiment against them for manufacturing a toxic product. A similar consciousness is now forming about perfume.

I have an allergy to perfume so severe it disables me. I must wear a respirator mask when I leave my home. I can not work outside my home (I collect Social Security), use public transportation, attend religious services, or go to most public places without risking medical symptoms. I have difficulty shopping, using public facilities, or going to my doctor's appointments (even medical professionals wear perfume).

For me, even a few seconds of exposure brings on frightening reactions. On the "mild" side I get migraines, asthma attacks, a foggy head, and trouble with cognitive processing. My more severe reactions include collapsing on the ground unable to sit up or breathe properly for an hour or more, inability to function intellectually at a level beyond that of a child, and Multiple Sclerosis like symptoms (such as muscle weakness or difficulty with balance and coordination) that can last as long as a month after the exposure.

I hope you will treat this petition with the seriousness that it deserves. My symptoms are extreme but I am not alone. I meet more and more people all the time who do not consider themselves to have "chemical sensitivities," or even an allergy to perfume, but when I mention my own problems they understand immediately. Perfume "gives them headaches" or "affects their breathing." For all of us, those of us with disabilities and those who are "ordinary people" who can't be around perfume without getting sick, please act on this petition.

Sincerely,
Cynthia Alison Norman

[address and phone deleted; I am in Oakland, California]