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Re: Petition filed with the FDA to have "Eternity" by Calvin Klein declared misbranded.
Docket Number: 99P-1340/CP 1

This is a comment on the specific case of the "Eternity" perfume, but this case has more general implications for the following reasons:

1. Perfumes and perfumed products are a well-demonstrated cause of asthma.
2. The incidence of asthma and deaths from asthma have been rising dramatically in recent decades.
3. The use of perfumed consumer products has been rising dramatically in recent decades.
4. A reasonable supposition can be made that perfume and perfumed products account for some of this rise in morbidity and mortality, possibly accounting for a major part of the rise.

The scientific complexity arises here from the multiplicity of ingredients in perfumes, often several hundred. It is likely that the large majority of ingredients in any one perfume are not significant triggers of asthma. However, from my own personal and clinical experience and from review of the literature, it appears that many, but not all perfumes and perfumed consumer products do trigger asthma. Judging from this information, it appear likely that only a small number of ingredients in perfumes are significant triggers of asthma. However, these ingredients are not well characterized, and are certainly unknown to members of the general population. Unfortunately, the correlation between odorous ingredients of a perfume and asthma-triggering ingredients is poor, and the time before onset of symptoms can be minutes to hours, the consumer and others exposed to the consumer's products do not have much basis for identifying or avoiding the hazards themselves.

For the asthma sufferer, this matter is as serious as exposure to other asthma triggers such as smoke. Yet, because the perfume constituents responsible for asthma are so poorly identified or disclosed, the asthma-sufferer does not have the same ability to avoid the asthma trigger. The matter is a complex one because the responsibilities for this type of pollution overlap between the FDA, EPA and OSHA and other agencies. The jurisdictional complexity arises from the multiplicity of situations in which perfumed products are used:

1. By individuals with asthma
2. By second-hand exposure from parents and day-care workers
3. As occupational issues from use in workplaces and hotels.

I propose the following as a minimum for this product and for others:

	A.	The product bear a hazard label warning that the ingredients have not been tested and are suspected of causing asthma.
	B.	To bear a different label, a product could go through a certification process in which propensity to trigger asthma would be judged. A more satisfactory general solution would be:
	C.	To catalog and severely restrict the perfume ingredients which trigger asthma. There are difficulties in that the nature of many ingredients is protected as trade secrets, but this should not prevent the use of mass spectroscopy and related techniques to catalog relevant ingredients that are common or most linked to asthma.

The incidence of asthma is increasing, and the problem preferentially afflicts some groups such as inner city residents, who appear to use perfumed products out of proportion to the use in the general population. Action must be taken. I have spoken out publicly on issues in which too much regulation has been applied to health problems; the issue here is the opposite: there is a failure to act when action is needed. It would be tragic if protection from volatile asthma-triggering chemicals were to fall between the cracks of jurisdiction of different agencies.

Michael M. Segal MD, PhD
Assistant Professor of Surgery
Harvard Medical School
Michael@Segal.org