May 7, 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: Petition to Have Fragrance Misbranded

Dear Sir or Madam:

The Environmental Health Network (EHN) petitions to have Eternity eau de parfum declared misbranded. EHN has selected Eternity for this petition, because it is one of the brands we hear about the most, one that has caused drastic health problems for many, many people. Eternity is also representative of the type of fragrance formulation that is frequently cited as causing problems. The enclosed lab analyses, material safety data sheets, and other information clearly establish the potential dangers of many of the ingredients contained in this product. Eternity is manufactured by Calvin Klein Cosmetics Company, Trump Tower, 725 Fifth Avenue, New York, New York, 10022-2519, USA.

Due to the "trade secret" status of fragrances, little information is available to the consumer as to what is in the product. The consumer is totally dependent on the integrity of the company producing the product and trusts the Food and Drug Administration (FDA) to enforce existing laws. But the ingredients in fragrances are not listed on the labels and there are no warnings. When there are no warnings on the label, the consumer naturally assumes the product has been adequately safety tested via all routes of exposure and is safe for use. Most consumers are not aware that the fragrance industry does not routinely test for neurological, respiratory, or long term effects of the materials and that most fragrance materials have only limited safety testing.

As our petition will show, this particular product contains toxic ingredients and there is no warning label. The FDA's enforcement of the required warning label on the product is essential in order for consumers to make informed choices about its safety. We feel consumers have a right to know the status of safety testing of the ingredients in products such as Eternity so that they might protect themselves from toxic chemicals that may cause or exacerbate acute or chronic health problems.

There are published studies that have previously identified some of the volatile organic compounds (VOCs) commonly used in fragrances and fragrance products. Widespread use of these products contributes substantially to indoor air pollution at work, home, schools, health care facilities, and recreational settings. Like tobacco smoke, the harmful chemicals currently used in these products may effect the health of many people, including:

• people with asthma and reactive airways disease, who may suffer potentially fatal attacks when exposed to these products;
  
• people with chemical sensitivities, chronic fatigue, and other environmental illnesses;
  
• children, who are exposed to and harmed by the toxic chemicals found in products purchased and used by their parents, care givers and teachers.

In some cases, fragrance products have even been used by disgruntled co-workers and students to deliberately attack and harass those who complain about ill effects from exposure to fragrance chemicals. The case of Judith Sanderson, a high school biology teacher with reactive airway disease, is an example. She originally became ill from a formaldehyde spill in her lab, which sensitized her to other chemicals as well. Her condition deteriorated after numerous fragrance attacks from students who objected to her ban on fragrance use in her classroom. Finally, after three years, she won her right to protection and accommodation at the school through binding arbitration handled by her teacher's union (1997). At her school (in Culver City, CA), student fragrance attacks are now considered assaults.

We hope that your consideration of our petition will result in warning and ingredient labels for Eternity fragrance products.

Thank you.

Sincerely,

Amy Marsh
President

enc.