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For Immediate Release May 1999
Contact: Amy Marsh Messages:
(415)541-5075
canaryclub@aol.com
Fax: (415)824-1003
TOXIC CHEMICALS FOUND IN DESIGNER FRAGRANCE
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.
Why:
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.
Quotes:
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 http://users.lanminds.com/~wilworks.ehnindex.htm
Page 2
Statement of Grounds For Petition
•21CFR Sec. 740.1 states: The label of a cosmetic product shall bear a
warning
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
prominently
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
following
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,
physical,
and toxicological properties have not been thoroughly investigated. Many of
the
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
different
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
materials.