July 20, 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"

Overview

I am expressing my whole-hearted support for the petition submitted in May of this year by the Environmental Health Network (EHN) to have Calvin Klein's "Eternity eau de parfum" declared misbranded, based on FDA regulations 21CFR Sec. 740.1, 21CFR Sec. 740.2, and 21CFR Sec. 740.10.

My support for this petition is specifically based on the portion of regulation 21CFR Sec. 740.10, which 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"

My Main Concern

Exposure is harmful and virtually impossible to avoid

In general, consumers freely use products containing fragrance, unaware that "Eternity" and other fragrances (1) contain toxic ingredients, and (2) are synthetic by-products of petroleum. This unthinking exposure impacts many people, some of whom are incapable of explaining their discomfort. For example, newborns are placed on sheets which carry fragrance from detergents and fabric softeners, and are cared for by perfumed adults. A baby's nervous system is extremely sensitive; how much of a baby's crying is caused by exposure to the chemicals in fragrance is anybody's guess.

However, even when people old enough to know what is bothering them complain about toxic reactions to fragrance, people who like and use fragrance are surprised, can even be offended, and may assume these complaints are either unfounded or unreasonable. It is difficult to discuss with most people, and fragrance in the workplace presents an especially difficult problem for many. How often have we heard from, or about, people who suffered headaches, nausea, or respiratory problems because someone nearby wore "too much" perfume?

For many of us who know we are chemically sensitive and have identified the substances we must avoid, going to work may be out of the question. But we are also severely restricted in our ability just to get around town, go shopping, or perform any ordinary daily activities outside our homes. Even medical and dental offices where we have to go and the staff in hospital emergency rooms are often fragrant.

The debilitating effects of exposure

When I am exposed to "Eternity" and other fragrances, I experience the following:

• Pain in my nostrils and sinuses, and immediate headache
• Sudden fatigue
• Steep decline in mental functioning, as if I had been drugged; I can't follow what others say to me, can't remember anything for a while, and may have trouble expressing myself
• Partial-complex seizures

I was a teacher for 29 years. As with many people who react badly to perfume, my sensitivities began with another substance, then quickly spread to perfume.

My perfume sensitivity was well-known at school, but I found it very difficult to avoid daily exposures. Finally, after a student sprayed my desk and work area heavily with perfume as a practical joke, I became too ill to work, and most importantly this major exposure caused my sensitivities to spread to other substances.

Today, I can't read books, newspapers, or even photocopied materials because my sensitivities spread to the chemicals in newsprint, ink and toner. I can't use a computer because the CPU and monitor outgas chemicals that I now react to. I can't safely go out of the house without a mask because of the risk of exposure to perfume and other fragrant products. And I can't drive, because of the risk of seizures.

In other words, watching TV and social contact are about the only remaining sources of pleasure and enrichment that I have, and my ability to be with other people is seriously compromised by: 1) other people's unawareness of the danger their perfume and other fragrant products pose, and 2) the incredible number of exposures to fragrance I encounter whenever and wherever I go outside my own home, such as from personal care products, detergents and fabric softeners blown out of laundry vents, household and industrial cleaning agents, vehicle and building air fresheners, and so on.

Doctors who treat the chemically sensitive know there is only one sure way for someone who is chemically sensitive to improve, and that is by avoiding the substances that cause a reaction. The most dangerous effect of exposure is that it decreases immunity while increasing sensitivity:

Exposure decreases tolerance across the board, even to substances to which a small exposure used to be tolerable

Exposure increases the total number of substances that cause toxic reactions; that is, it results in new sensitivities

Not properly labeling products that contain known toxic ingredients is a serious public health issue. Although some people do not currently react to the toxic ingredients in products like "Eternity," the FDA (not to mention the EPA* see the attachments) knows that these ingredients are dangerous. And when it comes to perfume, no one knows how much is "too much." At the very least, the public has a right to know what is in the products they purchase, and the manufacturers of those products have a duty to provide that information. I ask that your office carefully consider the EHN petition to misbrand "Eternity"and thereby help protect us all.

Sincerely,

Juleen R

Attachments (2) by Julia Kendall

Fabric Softeners = Health Risks From Dryer Exhaust and Treated Fabrics
http://www.ehnca.org/ehnfs.htm

Twenty Most Common Chemicals Found in Thirty-One Fragrance Products
http://www.ehnca.org/ehn20.htm