Petition to have a fragrance misbranded

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ACTIVIST KIT:
Petition to FDA to Have Calvin Klein’s Eternity eau de parfum “misbranded”

Docket Number: 99P-1340/CP 1 (use this for all correspondence)

Mailing Address for comments and letters of support:
Dockets Management Branch
The Food and Drug Administration
Department of Health and Human Services, Rm. 1-23
12420 Parklawn Dr.
Rockville, MD 20857

FAX Number for comments/letters: (310)827-6870
Email Address for comments/letters:  fdadockets@test.oc.fda.gov

The petition was sponsored by the Environmental Health Network (in 
California) and received by the FDA on May 11, 1999. The FDA has 180 days to 
respond to the petition. Comments can be filed up until the point the FDA 
responds so there is not a specific deadline and the FDA could respond much 
sooner, so we recommend writing ASAP. Comments can be sent by e-mail or 
regular mail. The preferred route for the FDA is regular mail as they have to 
print out all comments they get by e-mail. Anonymous comments will not be 
accepted.

We need to get as many people as we can to make comments in support 
of the petition. This is our chance to let the FDA and the fragrance industry 
know this is an important issue. All comments become part of public record. 
The more people we can get involved the better. Remember those with chemical 
sensitivities are not the only ones affected by fragrances. We need to make 
people aware this a general health issue. Attached is a sample letter to send 
to the FDA. We also recommend contacting your political representatives, 
newspapers and health and environmental organizations

Right now the information is online at the Fragrance Products Information 
Network site:
http://www.ameliaww.com/fpin/petition%20index.htm
and will soon be online at the Environmental Health Network site:
http://users.lanminds.com/~wilworks/ehnindex.htm

If you are sending information to people off line you can download 
and print the information. Some of the supporting information is not online 
and it is copyrighted so it cannot be posted to the web site(s), but we will 
provide a reference for it. Much of the supporting information is available 
online.
This is our best chance to let policy makers, media and healthcare 
providers know about the health hazards in fragrance products and how they 
affect our lives.
Thanks for your good work and support!
Betty, Barb and Amy


SAMPLE LETTER
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

Dear Sir or Madam:
In May, 1999, the Environmental Health Network (EHN) submitted the 
above petition to have Calvin Klein’s “Eternity eau de parfum” declared 
misbranded. I am writing because I fully support this petition and request 
that the FDA give it careful attention with regard 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."

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. Most 
people are not aware that most fragrance materials have only limited safety 
testing. They wrongfully assume these products are safe to use in any setting 
and are surprised when people complain.
Like tobacco smoke, the harmful chemicals currently used in these 
products may effect the health of many people, including: people with asthma, 
chemical sensitivities, chronic fatigue, and other environmental illnesses. 
Children are particularly vulnerable to toxic chemicals found in products 
purchased and used by their parents, care givers and teachers.
When I am exposed to fragrance products, such as “Eternity,” I 
experience (list here):
Please act on behalf of the millions of people who have suffered 
physical illness and injury resulting from fragrance exposure at work, at 
school and in social settings. These toxic chemicals act as powerful barriers 
to people disabled by asthma and chemical sensitivities. Because of this, 
toxic chemicals in fragrances have already ruined countless lives. Thank you.

YOUR NAME



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