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The Environmental Health Network of California
Files Petition With the FDA


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."

As the petition shows, "Eternity" contains toxic ingredients and ingredients whose safety have not been substantiated. There is no warning label on its packaging.

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 effect the health of many people, including: people with asthma, chemial sensitivities, chronic fatigue, and other neurological/immunological illnesses, respiratory illnesses and environmental illnesses.

Children are particularly vulnerable to toxic chemicals found in products purchased and used by their parents, care givers and teachers. Furthermore, like the tobacco companies, Calvin Klein targets young consumers, and for this reason school buildings, which are often already riddled with indoor air quality problems, have the added mixture of perfume toxicants for students and staff to deal with. In this time of concern over school violence we should be looking for every way possible to decrease the neurotoxic load on school children. How can we begin to do this effectively without full disclosure of toxic ingredients and labeling of all products for which safety has not been proven?

When I am exposed to fragrance products, such as "Eternity," I experience: immediate irritability that worsens to anger as the exposure time lengthens, headaches, asthma, sinusitis, numbness in extremities, disorientation, dizziness, brain malfunction and muscle spasms. If the exposure lasts for 30 minutes or more, the effects can last for days or more.

My daughter experiences neurological symptoms and upper respiratory symptoms with exposures. She becomes depressed and starts crying or gets angry, has a headache, and these experiences have greatly hampered her ability to get an education. She was almost failed in high school, not because of grades, but because of absences and an ignorant staff that refused to believe that chemical exposures could incapacitate human beings.

This ignorance in 1996 in light of the 1986 Congressional Report by the Committee on Science and Technology on neurotoxins at home and in the workplace, is unexcusable. The report states on the first page:

    "Millions of people are exposed everyday to neurotoxic industrial chemicals, including solvents, pesticides, drugs, food additives and cosmetics. People who have experienced acute exposures to neurotoxins show the readily recognizable symptoms of dizziness, nausea, muscle weakness, and blurred vision. But, symptoms of chronic exposure - such as increased irritability, loss of memory, inability to concentrate, and sexual dysfunction- may go unnoticed, or be ascribed to social pressures rather than to neurological damage."

    Dr. Spencer, witness on health effects who testified to the Committee, insisted on adding fragrance raw materials to the list of priorties to be examined for neurotoxicity. "....because of my experience with regard to fragrance raw materials", he said, "..I strongly suspect the American public would like to know what is applied to their skin voluntarily..." (p 13 of the report).

    In the findings of the report, the Committee states under (e) that "Neurotoxins may deserve a higher regulatory priority [than carcinogens] due to the fact that chronic exposure to neurotoxins at levels that show no signs of being carcinogenic may have often crippling and irreversible neurological effects." (p. 28)

I believe you have more than enough evidence: benzenmethanol, phenol, benzeneethanol, and 1,3- Benzodioxole-5-carboxaldehyde, to name only a few of the poisonous ingredients in "Eternity" - to justify action (the misbranding of "Eternity eau de parfum") on this petition as well as enough evidence to discontinue allowing any fragrance product on the market that does not prove its safety and provide full-disclosure of all hazardous ingredients to the public.

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. Because of this, toxic chemicals in fragrances have already ruined countless lives.

Thank you.

Susan Wells Vaughan


Please write to the FDA in support of this petition.
Copy:
Betty Bridges, FPIN bcb56@ix.netcom.com
Barbara Wilkie, EHN (Barb's email is no longer valid, please contact EHN)

Please put FDA Letter in subject line. Thanks .

To view a sample letter, visit:
http://www.ehnca.org/www/FDApetition/sampletr.htm#SAMPLE LETTER


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http://www.ehnca.org/www/FDApetition/lsusanwv.htm -- 6/17/99

The Environmental Health Network (EHN) [of California] is a 501 (c) (3) non profit agency and offers support and information for the chemically injured. EHN brings you topics on this page that need your immediate attention The URL for this page is http://www.ehnca.org/www/FDApetition/lsusanwv.htm