Irene Ruth Wilkenfeld
SAFE SCHOOLS
205 Paddington Drive
Lafayette, LA 
70508(318) 984-2766FAX: (318) 984-3342
e-mail: ndgb37b@prodigy.com
http://www.head-gear.com/SafeSchools


May 27, 1999

Dockets Management Branch
Food and Drug Administration
Department of Health and Human Services, Room 1-23
12420 Parklawn Drive
Rockville, MD 20852-1745

Re:  DOCKET #99P-1340/CP1

Dear Sir or Madam:

I am writing in resolute support of the petition sponsored by the
Environmental Health Network of California (received by the FDA on
May 11, 1999) to have Calvin Klein’s ETERNITY Eau de Parfum declared
misbranded.  According to your own regulations (21CFR 740.1, 740.2,
740.10 of the Federal Food, Drug and Cosmetic Act), “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.’”

Recent gas chromatography studies performed on ETERNITY by two
different laboratories on two different samples (sent in their
original packaging) indicate that ETERNITY contains 41 chemicals.

· Two were listed as respiratory sensitizers.
· At least five have the potential for Central Nervous System effects.

· At least two are suspected carcinogens.
· One may provoke fetal effects.
· Virtually all ingredients are general irritants.

It is clear that the chemical, physical and toxicological properties
of the ingredients in this fragrance formulation, have not been
thoroughly studied for their full range of (synergistic) effects. 
Evidently the safety of this product is unsubstantiated, yet it does
not currently carry a conspicuous statement of warning, as required
by 21CFR740.10.


I believe that fragrance safety will replace the issue of
Environmental Tobacco Smoke as a major public health priority for the
new millennium.  Although scents are viewed as benign by unsuspecting
consumers, in reality, they are toxic sensitizers and potent indoor
air pollutants that must not escape your scrutiny.  In 1989, the
National Institute of Occupational Safety & Health (NIOSH) recognized
884 poisonous substances (many synthetically derived from
petrochemicals) from a list of 2,983 chemicals used in the fragrance
industry.  Some of them are capable of causing cancer, birth defects,
central nervous system disorders, allergic respiratory reactions,
skin and eye irritations.  In tests conducted at Anderson
Laboratories of West Hartford, Vermont in 1998, researchers
determined that emissions from fragrances caused various combinations
of Sensory Irritation (a brief breath holding at the end of
inspiration - a reflex caused by activation of trigeminal nerve
endings in the eyes, face, nose and throat of test mice), pulmonary
irritation and decreases in a Functional Observation Battery (FOB)
indicative of neurotoxicity.  It should be noted that chemicals that
stimulate the trigeminal nerve system have the capacity to trigger
not just the irritant trigeminal effects mentioned above, but also
excessive neurological firing and excitotoxicity in vulnerable
individuals leading to attention deficit disorders, disorientation,
spaciness, memory problems, concentration difficulties, mental
confusion and cognitive deficits.  Indeed, James Cone, M.D., M.P.H.,
a Berkeley-based indoor air quality consultant and former Chief of
the Occupational Health Clinic at San Francisco General Hospital
describes fragrance chemicals as one of five major contributors to
indoor air pollution.

Given this scientific evidence, it should be clear that fragrances
pose a significant access barrier to educational, employment,
entertainment, healthcare, religious worship, and travel activities,
for a growing subset of the population who have already become
sensitized to scents.  Just as cigarettes carry warning labels,
consumers have a clear-cut right to be forewarned about the
carcinogenic, neurotoxic, and teratogenic chemicals, the respiratory
irritants and the sensitizing agents that comprise fragrance
formulations. 

The history of environmental and occupational health provides a host
of examples in which entire industries have acted in complete
disregard of public health risks and in which government failed to
act until well after disasters were apparent  (DDT, asbestos, tobacco
smoke, dioxin, PCBs, vinyl chloride, flame retardants in children’s
sleepware, Chlordane, Alar, urea formaldehyde foam).  May I
respectfully remind you that protecting the American public is your
constitutionally designated duty.  I urge you to label ETERNITY
misbranded and fulfill your constitutional mandate.

In closing, I will leave you with a quote from Seneca, the great
Roman author of tragedies, who nearly 2,000 years ago wrote:

“Our posterity will wonder about our ignorance of things so plain.”

Sincerely,

Irene Wilkenfeld
Environmental Health Consultant