June 27, 1999

Dockets Management Branch
The Food and Drug Administration (FDA)
Department of Health and Human Services, Rm. 1-23
12420 Parklawn Dr.
Rockville, MD 20857
(Sent via email fdadockets@oc.fda.gov)

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

Dear Sir or Madam:

I am writing in strong support of the petition submitted May 11, 1999 to the FDA by the Environmental Health Network (EHN). The petition asks that your administration execute the very regulations already in place -- and specifically, 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."

Reporting to the FDA in those days was another drama as the staff did not have a mechanism in place for taking complaints about a product that was not contaminated. I could not convince them that the products were contaminated with toxic chemicals. To further flummox FDA staff, I wanted them to record a complaint from a non user. That was unheard of -- no matter how many times I had tried! They didn't have the proper forms. I always suggested they use forms as if I had a "legitimate" complaint. I was assigned a number and when I never heard back, I'd call them. They never heard of the number. Interesting. It became even more of a nightmare when I tried to report blacking out from extremely low levels of fabric softeners wafting on the breeze. I was informed that I should report that to the EPA (Environmental Protection Agency) who informed me I was supposed to report that to CPSC (Consumer Products Safety Commission), who informed me I was supposed to inform either the FDA or the EPA, but certainly not them! Fragmentation of jurisdiction over fragrance products has worked well to keep the numbers of complaints down. As has lacking proper forms.

A few of the fragrance products I learned the names of, along with some of my adverse reactions, are:

Boucheron	felt like millions of burning needles all over my skin; noticeably flushed
Eternity	severe asthma with coughs so deep it felt as though lung tissue was being ripped asunder
Giorgio	assault of the sinuses and this one set me up for sinus infections
Obsession	Sledgehammer to the forehead and face, sinusitis followed
Poison	Burning meat cleavers being whacked at the top of my head, settling into an excruciating pain behind the left eye; sometimes it would happen to the right side of my head instead of the left
Sunflowers	tremendous pain behind the breast bone

. . . And other unknown toxic chemical substances. It is difficult for the ill to gain knowledge of another's signature scent. Other symptoms -- always worse in a meeting where more than one odorovector is present -- include: asthma, immediate and delayed onset; acne-like skin eruptions; immediate severe laryngitis; sore throat; sores in mouth, tongue swelling; migraines; sinus headaches; sinusitis; bronchitis; nausea; swollen lymph nodes; muscle pain and joint ache; dizziness; confusion, incontinence; impaired motor skills so I'd stumble and fall. I often had more than one reaction at a time, never all of them at the same time, for which I am most thankful.

My other frightening reactions came from the fragrances et al. in fabric softeners -- blackouts in which my last memory was as if the pavement came up to meet me. I've not blacked out since I learned to protect myself from seemingly inconsequential amounts of fabric softeners, nor have I had the numbing from temple to jaw bone on the right side -- for which the doctors knew no cause. One thing for sure, with the lack of help from governing agencies and the medical industry, most of us have done a pretty good job of turning into super sleuths. We've all kept score. You all should have developed databases.

We, who are living with EI/MCS have been chemically injured. But we are not alone. Those who have been diagnosed with asthma, cluster headaches, migraines, sinusitis, chronic bronchitis or other respiratory diseases including chronic laryngitis, as well as those living with diseases such as Parkinson's, rheumatoid arthritis, emphysema, cancer and ever so many more debilitating and/or disabling illnesses, may very well have been chemically injured also. And we all -- including AIDS patients -- can suffer severe adverse reactions to fragrances. Our illnesses reflect chemical injury. Just watch the headlines. Recently the experts discovered that Parkinson's was also environmentally caused. How will the next headline read?

We all have a right to know about the toxic chemicals in synthetic fragrance products. Fragrance products are in common daily use and therefore are applied to bodies and released into the air to affect users and non users alike. The users certainly have a right to know what they are putting on their bodies and the bodies of their children. Without the right to know there is not informed consent. And we who are adversely reacting to the toxic chemicals in fragrance products have a right to know what is causing our bodies these Multiple Chronic Symptoms. Ergo, warning labels at the very least. We are the harbingers. We'd best be listened to.

Those of us who have tried to remain gainfully employed, get an education, conduct business, seek health care, what have you, while living with MCS, have been put through a living hell by the uninformed with whom we've had to deal. Our stories are all too similar. We hear of like experiences from total strangers that validate our own experiences. And why? Because there are no warning labels on fragrance products. It would be begging the issue to suggest that products should have been tested for neurotoxicity, inhalation, systemic damage BEFORE being released to market. But to not require at least a warning label is a dereliction.

We also could be helped by publication of the fact that both the American Lung Association (http://www.lungusa.org/press/association/asnairt.html) and the American Medical Association (http://www.ama-assn.org/special/asthma/support/educate/triggers.htm) list fragrances as triggers of asthma, but that is not publicized except in the newsletters written for people suffering adverse reactions to fragrance products. Mainstream media will not touch it -- they are all too happy rounding up the usual suspects: cats, cockroaches and dust mites. That ties in nicely with advertising pesticides and more fragrance cleaning products as people are told to clean, clean, clean to help prevent asthma. Nowhere do they mention to clean with fragrance-free products. People are not told by mainstream doctors, nor by the media, that to reduce asthma, headaches, et al. they should give up fragrances -- at least for a trial run -- and keep a diary. The industry has been coddled while the occurrences of asthma, asthma deaths, EI, ... have increased.

I cannot begin to tell you the number of times I was told by my employer and others that if fragrances were really as dangerous as I was saying they were, they would be regulated by the FDA. Trying to convince them otherwise was an exercise in futility. As I neared the end of gainful employment (forced retirement October 1998), while still struggling mightily for health and the job I had loved, I tried another tactic. I showed folks your web page: FDA AUTHORITY OVER COSMETICS on http://vm.cfsan.fda.gov/~dms/cos-206.html.

That page did nothing to dispel their misguided assumptions. They saw all the proof they needed to see in these very words:

"FDA cannot require companies to do safety testing of their cosmetic products before marketing. If, however, the safety of a cosmetic product has not been substantiated, the product's label must read: " 'WARNING: The safety of this product has not been determined.' "

OBVIOUSLY. Indeed!

We all deserve honest, thorough testing of any product that has the potential to harm, as do fragrances. You have before you the analysis of Eternity as an example of fragrance products. I sincerely hope you will declare not only Eternity misbranded, but all synthetic fragrance chemical products that have not been properly and thoroughly tested. They should be tested for neurotoxicity -- as recommended before the 99th US Congress in September 1986 -- as well as for inhalation and for entering the body by way of the eyes and the skin. Synthetic musk is now acknowledged by the members of the American Chemical Society as showing up in adipose (fatty) tissue, mother's milk, wildlife, streams, lakes. The poison seemingly lives on for an eternity.

As the industry has not lived up to its responsibility, FDA must live up to its and declare all untested fragrance products "MISBRANDED." All such products should at least carry your prescribed statement: "WARNING: The safety of this product has not been determined." And I do believe it would be a good time to start a nationwide educational campaign about new packaging being required for fragrance products. Get the word out. Spare millions more damaged health, death.

Health, lives, family structures, education, gainful employment, and so much more, depend upon your doing the right thing. We all have a stake in breathing.

Sincerely,

Barbara Wilkie
(My convention is prevention)

cc: EHN and FPIN, President Clinton, Vice President Al Gore,
Sen. Boxer, Sen. Feinstein, Rep. Lee,
San Francisco Chronicle, Berkeley Voice, East Bay Express
Lark Lambert, FDA, Charles Haynes, FDA
E/The Environmental Magazine

The views expressed above reflect my personal opinion and in no way should be construed as reflecting the official opinion of any other person or organization.