Dockets Management Branch
The Food and Drug Administration
Department of Health and Human Services, Room 1-23
12420 Parklawn Drive
Rockville, MD 20857
Re: 99P-1340/CP 1 Petition to Have "Eternity eau de parfum" Misbranded
Dear Sir or Madam:
I am writing in support of the above entitled petition submitted by the
Environmental Health Network (EHN) to have Calvin Kleins Eternity eau de
parfum declared misbranded.
Please enforce your regulations 21 CFR Sec. 740.1, 21 CFR Sec. 740.2 and 21
CFR Sec. 740.10.
Specifically in 21 CFR Sec. 740.10, it 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 outlined in the petition, "Eternity" perfume contains toxic ingredients
and other potentially harmful ingredients whose safety have not been
substantiated. There is no warning label on its packaging.
Many consumers feel that if a product is on the market it must be safe or you
would not allow it to be sold. They are completely unaware what fragrances
such as Eternity are comprised of. Now that we know, thanks to the EHN what
is in Eternity and that many of its ingredients have not been tested or are
harmful to humans, it is your job to enforce your regulations that will allow
consumers to make a choice of whether to buy a product that has not been
established to be safe.
We must be concerned about the health of all our citizens. People who do not
buy these products are nonetheless exposed to these toxic chemicals. It is
imposssible to live in todays world, go anywhere in public, including
medical facilities, without being overcome with a plethora of fragrances.
This makes many of us unable to work or go to school as well. I have asthma,
headaches, nausea, muscle weakness, dizziness and irritated eyes when I
encounter Eternity and other fragrances.
Please follow your existing regulations and declare Eternity misbranded. If a
product has untested ingredients, the package should clearly state that.
Protect the millions of Americans who have been made sick by the use of
these untested products. Clean air must come before profits.
Sincerely,
Janine Melrose