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Environmental Health Network
EHN [of California]
P.O. Box 1155
Larkspur, California, 94977-0074
Support and Information Line
(SAIL) 415.541.5075
A 501 (c) (3) non profit agency.

The Environmental Health Network of California Files Petition With the FDA

How to Communicate With the FDA and Sample_Letter

NOTE: Docket Number: 99P-1340/CP 1 assigned EHN's petition of the Food and Drug Administration remains open and may continue to receive letters, per letter from the FDA to EHN, December 1999.

(If you've yet to write, please do so now. Get others to write as well. We are not getting mainstream news coverage on this important public health issue. But then a look at all the fragrance advertising makes understanding why the media won't touch it a "no-brainer." Fragrances adversely affect the health of people who live with a wide variety of respiratory diseases, with migraines and other headaches, with AIDS, cancer ... . Now is the chance to inform the FDA, your doctors, your churches, workplaces, schools, etc. Use the information available to you in EHN's FDA petition. -- barb) (thru Robbie)

Petition the FDA to have Calvin Klein's Eternity eau de parfum declared "misbranded"

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

Mail comments and letters of support to:

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: 301.827.6870
Email Address for comments/letters:
fdadockets@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. [See EHN's "Write Now! ( http://users.lanminds.com/~wilworks/ehnhompg/action.htm#Write Now!) for contact information.]

The petition pages are online at:
Environmental Health Network (EHN) (this one):
http://users.lanminds.com/~wilworks/FDApetition/bkgrinfo.htm

Fragrance Products Information Network (FPIN)
http://www.ameliaww.com/fpin/petition%20index.htm

If you are sending information to people offline, 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 policymakers, 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

(Copy onto your computer and edit to fit your own situation. Please tell the FDA how the use of fragrance products -- used personally or by others -- has adversely affected your life with regards to your healthcare, education, employment, civic duties, socially ...)

Date: _____________________

Dockets Management Branch
The Food and Drug Administration
Department of Health and Human Services, Rm. 1-23
12420 Parklawn Dr.
Rockville, MD 20857

Re: Docket Number: 99P-1340/CP 1
Petition the FDA Have Calvin Klein's Eternity eau de parfum declared "misbranded"


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 affect 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, caregivers and teachers.

When I am exposed to fragrance products, such as "Eternity," I experience:

When I am exposed to fragrance products I can experience any of the following symptoms based upon the chemical fragrance product I encounter:

__anaphylaxis/shock
__double vision
__incoherence
__nausea
__anxiety, restlessness
__ear pain
__incontinence
__nose bleeds
__asthma
__eczema
__irritability
__rashes
__breathing difficulty
__eyes, watery or dry
__joint aches
__seizures
__bronchitis
__fatigue
__laryngitis
__short-term mem. loss
__can't concentrate
__flushing
__lethargy
__sinusitis
__coughing
__headaches
__lymph nodes swell
__sneezing
__depression
__heart beat irregularity
__mood swings
__sores, skin/mouth
__disorientation
__hives
__muscle pain/weakness
__swallowing difficulty
__dizziness
__hypertension
__nasal congestion
__tinnitus
__other:

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. Toxic chemicals in fragrances have already ruined countless lives.

Thank you.

Sincerely,

YOUR NAME
address
city/st/zip

Please write to the FDA in support of this petition. Copy (if you care to do so for publication on EHN's and FPIN's web sites):
Betty Bridges, FPIN
bcb56@ix.netcom.com
Barbara Wilkie, EHN
wilworks@lanminds.com

Please put FDA Letter in subject line. Thanks .

As with all organizations, EHN depends upon your contributions of time and energy, as well as your membership support.

Return to EHN's homepage (http://users.lanminds.com/~wilworks/ehnindex.htm)

http://users.lanminds.com/~wilworks/FDApetition/sampletr.htm 12/20/99

The Environmental Health Network (EHN) [of California] is a 501 (c) (3) non profit agency and offers support and information for the chemically injured. EHN brings you topics on this page that need your immediate attention The URL for this page is http://users.lanminds.com/~wilworks/FDApetition/sampletr.htm