Tell the FDA what you think

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http://www.ameliaww.com/fpin/petition%20index.htm

The Environmental Health Network of California has filed a petition with the

FDA to have the fragrance Eternity by Calvin Klein declared misbranded. The

basis of this petition is the lack of a warning label on the product

informing consumers that all the materials in the product and the product

has not been adequately tested for safety.

Cosmetics which includes personal care products, hair dyes, make-up,

lotions, creams, deodorants, toothpaste, perfumes, and colognes are not

required to be safety tested before marketing. However, if each individual

ingredient in the product and the final product has not been adequately

tested for safety the product is to carry a warning label to that effect.

http://ncchem.com/activist_kit.htm

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@...

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