From: Nadine Porter [nadineporter@prodigy.net] Sent: Thursday, March 08, 2001 5:31 AM To: fdadockets@oc.fda.gov Subject: Re: Docket Number: 99P-1340/CP 1 March 8, 2001 Dockets Management Branch The Food and Drug Administration Department of Health and Human Services, Rm. 1-23 12420 Parklawn Dr. Rockville, MD 20857 Re: Docket Number: 99P-1340/CP 1 Petition the FDA Have Calvin Klein's Eternity eau de parfum declared "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 affect the health of many people, 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 their parents, caregivers and teachers. When I am exposed to fragrance products, such as "Eternity," I experience: When I am exposed to fragrance products I can experience any of the following symptoms based upon the chemical fragrance product I encounter: X_anaphylaxis/shock X double vision X incoherence _X_nausea X_anxiety, restlessness X__ear pain X_incontinence X_nose bleeds X_asthma X_eczema X_irritability X_rashes X_breathing difficulty X eyes, watery or dry X_joint aches __seizures X_bronchitis X_fatigue X_laryngitis X_short-term mem. loss X_can't concentrate X_flushing X_lethargy X_sinusitis X_coughing X_headaches X_lymph nodes swell X_sneezing X_ reactive depression X_heart beat irregularity X_mood swings X_sores, skin/mouth X_disorientation X_hives X_muscle pain/weakness X_swallowing difficulty X_dizziness X_hypertension X_nasal congestion X_tinnitus _X_other: body swells/angioedema I now am no longer able to maintian my own personal activities of daily living, I cannot clean my own home, let alone return to a work capacity of any type. I have been severely ill for over 4 years with Chemically Induced Immune System Disorder (aka, Multiple Chemcial Sensitivity, Environmental Illness). The largest irony for me is that I "acquired" this poisoning of my body while working as a Case Management Specialist for Workers' Compensation for a major Health Maintenance Organiation. Nonetheless, my detoxification enzyme is damaged beyond repair and there is no was to replace it (enzyme P450). I can no longer visit friends in their homes, go shopping, drive a car further that 12 miles, eat lunch out, vacation with my husband or family, have visitors come in unless they are willing to clean up and come totally fragrance- and chemical-free; I cannot exercise anymore as my body is too worn out from fighting the chemicals, so where I once was a healthy size 6, I now wear size 14-16. I once had beautiful clear skin that is now pock marked with scars from the numerous sores that come and go. I can no longer have a healthy. loving sex life with my husband, because at the age of 45 I am now in menopause, & intercourse is painful related to hormonal imbalances brought on by the chemicals. I am now considered a "universal reactor." This means I could react to anything at any time, even something I've been using for months or years. The majority of my exposures/poisonings that I get accidently are now of the fragrance type. As of this writing I am fighting off a life-threatening exposure to 'Febreze'. Now I must take Prednisone 50mg per day, Benadryl Dye-Free 50-75mg every 4-6 hours around the clock, Dyazide to lower my blood pressure, Potassium Chloride and Magnesium to replace lost electrolytes, Zyrtec twice a day, Pepcid 40mg every 6 hours to keep a hold on acid reflux and gastritis, Armour Thyroid every day, as my thyroid now underfunctions, Ultram 75mg twice a day for the severe pain in my joints and nuscles, and Lorazepam 0.5-3mg as needed to calm down the shaking caused by the high steroid dosing. I also must carry 2 Epi-Pen's (epinephrine for emergency use when airway is closing) & use Oxygen on a daily basis in my home. One small good light was that I was approved for Social Security Disability Income after my first application. Perhaps it was my precise documentation skills acquired over my 24 years of active nursing. 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. Toxic chemicals in fragrances have already ruined countless lives. Thank you. Sincerely, Nadine L, Porter another disabled RN 137 Waterview Drive Lake Orion, MI 48362 (248) 693-7444