From: Helthcom@aol.com
Sent: Tuesday, May 01, 2001 3:13 PM
To: fdadockets@oc.fda.gov
Subject: re: regulations on chemicals in products
Name: ____Shelley Kramer _________________________
Street Address: 6841 Dume Drive_______________________
City, State, Zip: Malibu, CA 90265_______________________
Today's Date: _May 1, 2001______________________
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
Petition to Have "Eternity eau de parfum" Misbranded and to have other
chemicals and carcinogens in personal hygiene and and beauty products labeled
with warning labels
Dear Sir or Madam:
I am writing because I fully support the petition submitted in May 1999 by
the Environmental Health Network (EHN) to have Calvin Klein's "Eternity eau
de parfum" declared misbranded. "Eternity" contains known toxic chemicals, as
well as chemicals that have not been tested for consumer safety. The
chemicals in many common fragrance products can be dangerous to a child's
growth and future health. Uninformed parents, teachers, day-care workers, and
others can buy "Eternity" and not know they are injuring the children in
their care. Most people don't realize that perfume or cologne can cause these
health problems; that is why any product that contains dangerous chemicals,
or chemicals whose health effects are unknown, must be labeled.
I request that the FDA give careful attention to your regulations 21CFR Sec.
740.1, 21CFR Sec. 740.2, and 21CFR Sec. 740.10. Regulation 21CFR Sec. 740.10
specifically states:
"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."
Also due to new studies done on cocoamide DEA, diethanolamine, TEA,
triethanolamine, mineral oil, petrolatum, sls, pg, and others, warning labels
should be on products containing these.
As the petition shows, "Eternity" contains toxic ingredients and ingredients
whose safety have not been substantiated. There is no warning label on its
packaging.
We all have a right to know the status of safety testing of the ingredients
in products such as "Eternity" so that we can protect ourselves and our
families from toxic chemicals that may cause health problems.
Like tobacco smoke, the harmful chemicals currently used in these products
may affect the health of many people. Children are particularly vulnerable to
toxic chemicals found in products purchased and used by their parents, care
givers and teachers. We all have a right to know whether the product we
purchase may cause damage to ourselves or our children. Also seen and
touched on by the Bill Moyers Trade Secrets Show which aired on PBS on March
26th, about the chemicals and carcinogens in our daily products.
Please see to it that this petition -- and the issue it represents -- get the
careful scrutiny they deserve. The public has a right to know and protect the
health of our families.
Sincerely,
Shelley Kramer
Your
Right to Know
Healthy Communications.com
Health, Awareness and Harmony
310 457 5176
Fax 310 883 2082