Petition sample letter

[Guest guest]

For those who have asked me what issues to address in support of the

petition here is a generic template as to what needs to be addressed.

The FDA already knows the health problems we have sustained from fragrances

and those were and are still being accpeted for comment in the EHC's petition

to the FDA 99P-1340. So for those who ish to comment on how fragrances and

the various chemicals affect you, please also file a comment to their

petition. Each of the 2 petitions addreses different aspects of this problem,

so

support is needed for all issues to be addressed according to the individual

petitions.

_http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.CFM?EC

_DOCUMENT_ID=1820 & SUBTYP=CONTINUE & CID= & AGENCY=FDA_

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OCUMENT_ID=1820 & SUBTYP=CO

NTINUE & CID= & AGENCY=FDA)

SAMPLE LETTER:

Dear Commissioner:

After reading the Docket: 2007P-0438, it's clear that this product needs to

be researched and tested further before it is allowed to be sold to the

public. It should not be imported into the US with it's current mislabeling and

ingredients. The public places its trust in the FDA to safeguard people’s

health. People apply fragrances or products with fragrances upon their bodies

thinking that they have been tested and are safe. Most people do not realize

that

the skin acts as both a barrier and as a sponge, allowing substances to be

introduced into the body.

Only recently has there been a semi-disclosed listing of ingredients and

most people still do not have full awareness of exactly what they are applying

to their skin. There is no way to know the amount of the disclosed ingredients

in any product, and most of us will assume the ingredient list is complete.

When we see the term " fragrance " we are not told what that comprises - does

it include carcinogenic ingredients??

We need visible warnings on the packaging of any product that can affect a

person's health or the health of the developing fetus, like we have on

cigarette packaging. Chapter I Subchapter G (Title 21 CFR- Food and Drug

-Subpart A

740.1(a)Sec.740.1 “(a)“… cosmetic product shall bear a warning statement

…

to prevent a health hazard … associated with the product.â€

The ingredient " coumarin " which by the FDA's own definition is a poisonous

substance warrants stricter control and notification. Chapter IX Subchapter

VIII (21`U.S.C. Subchapter VIII Section 381 (a)(3))COUMARIN Violation Code:

Sec. 381 “(a)(3)...contain Coumarin, a poisonous or deleterious substance,

which

may render it injurious to health.â€

I believe that our government has an immediate obligation to warn of any

potential harm to unborn children, so American women can make an informed

decision regarding Angel perfume.

According to the petition it seems that there is a documented risk of injury

to the eyes that the consumer is not apprised of. The report by Clarins

shows that they were aware back in 1999 that Angel Toilette caused necrosis of

the ocular eyes. Why is this important health risk not shown on Angel's

packaging?

Sec. 740.10 “(a)… finished cosmetic product shall be adequately

substantiated for safety …unless it contains … conspicuous

statement…:“Warning--The

safety of this product has not been determined.â€â€

This product is clearly misbranded due to mislabeling, and its importation

into the US must be stopped until it is labeled accurately and the women of

our country have full disclosure of ingredients and associated health risks.

Please require that this product is fully tested and demand notification of

the effects upon the fetus. Another thing I noticed: the FDA requires special

labeling for allergens such as eggs, peanuts etc.; there are a lot of

allergens in this product that need to be appropriately labeled as if they were

food allergens.

Because there is sufficient evidence of the health hazards associated with

this product, I am requesting that FDA immediately enforce the following to

protect the public until its safety has been fully established. Chapter I

Subchapter A (Title 21 CFR –Food and Drug –Subpart A Section 2.5 (a)(1)(2))

Sec.

2.5 “(a) … an imminent hazard to the public health ...evidence is

sufficient

....a product ..posing a significant threat of danger to health, creates a

public health situation ….â€

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