June 11, 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

Dear Sir or Madam:

There are very few laws in place concerning the safety of
fragranced products. Most people use fragranced products on a
daily basis with no thought as to whether they are safe or not.
This is because people mistakenly assume such products must be
fully safety tested before they are marketed. It is further
assumed that if they were not safe they would be quickly removed
from the market by regulatory agencies such as the FDA.

How unfortunate that this is not the case. The reality is that
products do not have to be tested before marketing and the FDA
rarely tests them after marketing. The few laws that are in place
are rarely enforced. The majority of the substances used in
fragranced products have not been fully safety tested; yet the
required warning label is not on the products.

Fragranced products can negatively impact both the user and those
in contact with "second hand" fragrance. Those with allergies,
asthma, sinus problems, chronic lung disease, migraines, and
other health problems are negatively impacted by fragrance. In
addition fragrance chemicals can be absorbed through the skin and
stored in fat tissue. It is present in mother's milk. Synthetic
musk compounds are found in waterways and aquatic wildlife.
Avoidance of exposure to these products is virtually impossible.

In spite of the impact on health and the environment, the
fragrance industry continues to deny there is a problem. As a
self regulated industry, it is felt there is little to fear.
Products designed to be inhaled are not tested for effects on the
lungs. Even though fragrance materials used in the past were
severely neurotoxic, there is no routine testing for neurological
effects. Increased concerns over the potential of phthalates as
hormone disrupters have not prevented the industry from using
phthalates. In Eternity eau de parfum, diethyl phthalate is
present at over 10%. Diethyl phthalate has a low level of
volatility and remains on the skin where it can be absorbed.

There is a lifetime of exposure to fragranced products. The
accumulation in body tissues and long term effects has to be
considered. Fragrance companies are targeting children as young
as three. Children are especially venerable to the effects of
chemicals. There skin is thinner so there is more potential for
absorption. They are smaller so the dosages are higher. Their
systems are immature and are more susceptible to damage. Their
lungs and nervous system are damaged more easily. A child that
develops allergy or sensitization to a fragrance chemical usually
has to deal with that sensitization for life.

I have compiled information on fragrances, chemicals used in
them, and their effects on health for the past four years. I have
much of this information up on a website. Because of this people
tend to think I may have some answers as to what to do when
coworkers' perfumes make them ill and they are having a terrible
time being able to work. I receive several letters a week from
people that are made ill by others use of fragranced products.

The fragrance industry is doing a very poor job of regulating
itself. It is essential the FDA start monitoring the contents and
safety of these products. I urge the FDA to grant petition #
99P-1340/CP 1 and declare Eternity eau de parfum misbranded. This
will send a strong message to the fragrance industry that
existing laws will be enforced and the industry must be
accountable for the products that are marketed.

Betty Bridges, RN
Fragranced Products Information Network (FPIN)
For information on health effects of fragrances, visit:
http://www.ameliaww.com/fpin/fpin.htm