May 22, 1999

Dockets Management Branch
The Food and Drug Administration
Department of Health and Human Services, Rm. 1-23
12420 Parklawn Dr.
Rockville, MD 20857

Re: 99P-1340/CP 1
Petition to Have "Eternity eau de parfum" 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 to give my full support to this petition and request that the FDA give it careful attention. FDA regulations 21CFR Sec. 740.1, 21CFR Sec. 740.2, and 21CFR Sec. 740.10. Regulation 21CFR Sec. 740.10 state:

"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 and data submitted therewith shows, "Eternity" contains toxic ingredients and ingredients, of which the safety has not been substantiated. And it contains no warning label on its packaging.

Calvin Klein claims their products "are manufactured with extreme care, under strict quality control procedures" and that "all ingredients and finished products are carefully evaluated before use." They further claim that while "it has been well documented that there are people [like me] who respond to scented items with like reactions" that reactions such as mine are "occasional." See enclosed letters to and from Calvin Klein dated May 30, 1990 and July 12, 1990, respectively. The data included with this petition shows these claims to be false.

As consumers of products designed to be inhaled and absorbed into the body through the skin, 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 effect the health of many people, including: people with asthma, chemical sensitivities, chronic fatigue, and other environmental illnesses. Small children are particularly vulnerable to toxic chemicals found in products purchased and used by their parents, care givers and teachers. When I am exposed to fragrance products, such as "Eternity," I experience asthma symptoms and severe coughing attacks that leave me too weak to function; a lack of ability to concentrate; burning in the eyes, nose and chest; facial nerve and TMJ problems; migraines; and at times tremors and loss of motor control. These symptoms are not uncommon. You have only to look on Internet sites such as the following to read testimonials of others who suffer similar symptoms from exposures to fragrances.

Just last week, a woman at work (who is not allergic to perfumes) told me that someone gave her Eternity as a gift. She sprayed on "one spritz"; she and her coworker were so overcome by the fumes that she went to the bathroom and washed it off.

http://members.aol.com/enviroknow/wall/index.html

http://www.users.globalnet.co.uk/~aair/perfume_corr.htm

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 the workplace, public buildings, hospitals and doctor offices, grocery stores, etc. by people disabled by asthma and chemical sensitivities. Because of this, toxic chemicals in fragrances have already ruined countless lives and will ruin those who unwittingly use or suffer symptoms from second-hand exposure to those toxic substances.

Sincerely,

Betty J. Kreeger

Enclosures
bc: Barbara Boxer (email)
Senator Diane Feinstein (email)
Congresswoman Anna Eshoo (email)