Toxic chemicals in fragrance

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For Immediate Release May 1999
Contact: Amy Marsh Messages: 
Fax: (415)824-1003

Environmental Health Network Petitions FDA to Have Eternity “Misbranded”

Who & What:
The Environmental Health Network has just submitted a lengthy 
petition to the Food and Drug Administration to declare Calvin Klein’s 
“Eternity Eau de Parfum” misbranded because the product contains toxic 
chemicals but has no warning label to notify consumers.

When & Where:
The petition was priority mailed on Friday, May 7, 1999, to the 
Dockets Management Branch, Food and Drug Administration, Department of Health 
and Human Services, rm. 1-23, 12420 Parklawn Drive, Rockville, MD, 20857.

Independent laboratory analysis of this product identified such 
chemicals as diethyl phthalate (suspected hormone disrupter with ability to 
accumulate in the fatty tissues of the human body through skin absorption); 
phenols (suspected carcinogens, may cause reproductive harm); benzeneethanol 
(rated toxic, readily absorbed via skin, central nervous system effects); 
synthetic musks (recently in the news as substances which accumulate in human 
and animal tissues) and skin and respiratory irritants. The petition contains 
the laboratory analyses and material safety data sheets for most of the 
identified chemicals. 

The petition states: “The materials in Eternity have not been 
adequately tested for safety. There are legitimate concerns over the safety 
of this product. The product does not carry the required warning label.” 

“Most people think fragrances are harmless. This is not true. Most 
fragrance ingredients have only been tested for skin irritation and not for 
their short or long-term effects on any other part of the human body. We are 
announcing the submission of this petition to activate consumer concern that 
will convince the FDA to put this matter on the front burner where it 
belongs. We intend to do everything we can to inform unwary consumers about 
the chemicals in this product,” said Amy Marsh, president of Environmental 
Health Network.

See Page 2 for Statement of Grounds For Petition and 
Basis of Identity of Materials in “Eternity.”
Also see

Page 2
Statement of Grounds For Petition
•21CFR Sec. 740.1 states: The label of a cosmetic product shall bear a 
statement whenever necessary or appropriate to prevent a health hazard 
that may be associated with the product. 
•21CFR Sec. 740.2 states: A warning statement shall appear on the label 
and conspicuously as compared to other words, statements, designs, or
devices and in bold type on contrasting background to render it likely
to be read and understood by the ordinary individual under customary
conditions of purchase and use, but in no case may the letters and/or
numbers be less than \1/16\ inch in height, unless an exemption pursuant
to paragraph (b) of this section is established.   
•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 
conspicuous statement on the principal display panel:

"Warning--The safety of this product has not been determined."
The perfume "Eternity" contains substances in which the chemical, 
and toxicological properties have not been thoroughly investigated.  Many of 
substances in "Eternity" have known adverse effects on health. The packaging 
does not carry the required warning label. 
"Eternity" has been reported by consumers as having neurological and 
respiratory effects. (See FDA Consumer Complaints for Cosmetic Products 1995 
Annual Report)
Due to the trade secret status of fragrances fragrance ingredients 
are not listed on the label. This makes it extremely difficult to pinpoint 
substances in a fragrance
that may trigger adverse reactions. Gas Chromatography studies are able to 
detect most of the materials in a fragrance. This testing is expensive and 
beyond the scope of most consumers. However, it is used routinely within the 
industry to develop and copy fragrance formulas. 

Basis of Identity of Materials in “Eternity” 
Gas Chromatography studies were performed on "Eternity" by two 
laboratories on two different samples that were sent in original packaging. 
The second laboratory is a member of the Research Institute of Fragrance 
Materials and
specializes in fragrance and flavors. The laboratory analyses are included in 
the petition.
Available safety data was obtained from chemical companies, Toxline, 
Medline, RTECS, and other sources of information. Chemicals are listed in the 
petition in descending order of prominence in the formula. Chemical Abstract 
Services numbers are provided. Information was not readily available on all 

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