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The Food and Drug Administration
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E-mail: fdadockets@oc.fda.gov

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 issue is a complex one, from scientific, regulatory and
intellectual property perspectives. I bring some important perspectives to
this matter as a physician/scientist on the faculty of Harvard Medical School, an
individual with mild-moderate asthma, one who has written publicly on
chemical safety regulatory matters (e.g. Wall Street Journal 9 July 91) and
one who holds copyrights and has patents submitted.

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.
Yet we can not allow this regulatory complexity to deter us from acting in
face of the rising epidemic of asthma that we face.

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