From: McCord, Marsh D [Marsh.McCord@PSS.Boeing.com] Sent: Friday, February 09, 2001 4:25 AM To: 'fdadockets@oc.fda.gov' Subject: Docket 99P-1340/CP 1 --- Testing/Labeling for Fragrances ("Eternity" by Calvin Klein declared misbranded) Importance: High Follow Up Flag: Follow up Flag Status: Flagged February 9, 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" To Whom It May Concern: We support the subject docket/petition fully. My family recently discovered we've been exposed to toxic mold in our indoor environment (home) for some time, likely over 8 years. During this time, I have become extremely sensitized to fragrances and other smells and odors. Although my symptoms are not nearly as extreme as a lot of people I've read about that have become chemically sensitive, it creates significant problems for me-- since I'm already dealing with numerous health issues (many apparently related to the mold exposure). Other members of my family have started becoming much more sensitive the fragrances as well. A couple of times when I've had to revisit our home to see how well the remediation of the toxic mold is progressing, I've developed heightened temporary sensitivities beyond the level I normally deal with. In one case this past fall, after being exposed to airborne toxins in our home during a very brief visit-- my ability to detect and tolerate chemical smells suddenly changed dramatically. I was detecting bill statements two rooms away that had been stuffed by people wearing perfume/cologne but which were still sealed. My family could not detect them when smelling the outer envelope an inch from their nose. I could smell unscented / fragrance free Dove soap in the next room shortly after somebody would lift the cover off the soap dish-- even though it was technically free of fragrances. My family had to immediately stop using any shampoo, and spending time with people with fragrances on. After about a week my sensitivity decreased a fair amount... but I'm still more sensitive than I was before that particular incident. This incident convinced me that it wasn't anything psychological, or otherwise explanable. How else could I find evenlopes in other rooms that were still sealed that nobody else could detect? I felt like I was suddenly a human blood hound. ----- Back to the subject docket in question.... In May, 1999, the Environmental Health Network (EHN) submitted the above petition to have Calvin Klein's "Eternity eau de parfum" declared misbranded. I support this petition and request that the FDA give it immediate and careful attention with regard to your regulations, including 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. The citizens of the United States of America have a right to expect their government to act in their interest, to ensure that the safety testing status is well known for ingredients in products such as "Eternity." This is essential to give them the fair opportunity to take all necessary actions to protect themselves and their families from toxic chemicals known to cause health problems - or for which safety has not yet been demonstrated. Most people are unaware that most fragrance chemicals have received only limited safety testing. They assume these products are safe . . . after all, the foods that we eat are all carefully controlled for specific toxic substances . . . and toxic substances used in the workplace require extensive safety literature and precautions. Like tobacco smoke, the harmful chemicals currently used in fragrance products may affect the health of many people. Those most sensitive include 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: These symptoms are immediate from exposures I can detect of many fragrances: X headaches X sore throat X dizziness X nausea (depending on level of exposure) These symptoms* are frequent, and are often present when I can't detect (smell) fragrances nearby: ? joint aches ? fatigue ? sinusitis ? rashes ? sores, skin/mouth ? hives ? nasal congestion ? tinnitus * -- I have had these problems, which may or may not be from fragrances. They may be solely from toxic mold exposure, and/or other problems. Please act on behalf of the countless individuals that suffer from Physical illness and injury from exposure to fragrances at work, school, social settings, and even at home. These toxic chemicals can be insurmountable barriers to people disabled by asthma and chemical sensitivities. Toxic chemicals in fragrances have already destroyed countless lives. Thank you. Sincerely, Marsh D. McCord 253-657-8712 | marsh.d.mccord@boeing.com