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Dockets Management BranchThe Food and Drug AdministrationDepartment of Health &Human Services, Rm. 1-2312420 Parklawn Dr.Rockville, MD 20857

Re: 99P-13401CP l- *l 3 t2etition to Have Etenlify euu de parfum declared “Misbran ed Jm Jllfv 12 &I Ia3

Dear Sir or Madam:

In May 1999, the Environmental Health Network (EHN) submitted the above petition to have Calvin Klein’sEternity eau de parfum declared “misbranded.” I am writing because I fully support this petition and requestthat the FDA give it careful attention with regard to your regulations 21CFR Sec. 740.1,21CFR Sec. 740.2, and21CFR Sec. 740.10. Regulation 21CFR Sec. 740.10 states:

Each ingredient used in a cosmetic product and each finished cosmetic product shall be adequately sub-stantiated for safety prior to marketing. Any such ingredient or product whose safety is not adequatelysubstantiated prior to marketing is misbranded unless it contains the following conspicuous statement onthe 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 substan-

tiated. 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 peopleare not aware that most fragrance materials have only limited safety testing. They wrongfully assume theseproducts 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 affect the health of manypeople, including: people with asthma, chemical sensitivities, chronic fatigue, and other environmental illnesses. Children are particularly vulnerable to toxic chemicals found in products purchased and used by theirparents, caregivers and teachers. When I am exposed to fragrance products I can experience any of the follow-ing symptoms based upon the chemical fragrance product I encounter:

0 anaphylaxis/shock 0 double vision 0 incoherence 0 nauseaCl anxiety, restlessness 0 ear pain 0 incontinence 0 nose bleeds0 asthma 0 eczema

%

0 irritability 0 rashesbreathing difficulty 0 eyes, watery or dry 0 joint aches 0 seizures

0 bronchitis ;ar fatigue 0 laryngitis 0 short-term mem. loss

Fcan’t concentrate 0 flushing 0 lethargy 0 sinusitis

0 coughing ‘pa headaches 0 lymph nodes swell 0 sneezing0 depression 0 heart beat irregularity 0 mood swings 0 sores, skin/mouth0 disorientation 0 hives 0 muscle pain/weakness 0 swallowing difficulty

v-d izziness 0 hypertension 0 nasal congestion 0 tinnitus

b other: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 topeople disabled by asthma and chemical sensitivities. Toxic chemicals in fragrances have already ruinedcountless lives. Thank you.

Murgure t Frank1485Ca

Rmcore CodWay

, C.2 94521-2622

NeWsletterS ana everyone wno feels people nave a ngnt to mow, FWW? copy, snare, reu your menas ana VVIU 11 the FDA.. . today!

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