Return to main page of EHN's May 11, 1999 FDA Petition - 99P-1340
http://www.ehnca.org/www/FDApetition/bkgrinfo.htm

FDA Docket Number 99P-1340 is still open as of Sept. 10, 2004. Please write to the FDA about YOUR adverse reactions to perfume, cologne, aftershave, toilet water (don't you love that term?) and fragrances in other scented cosmetics and personal care products. Do not include personal identification information such as your social security number because your letter could appear on the FDA website, and in any case, it is open to public record.

NOTE: Docket Number: 99P-1340, assigned by the FDA to EHN's Citizens' Petition of the Food and Drug Administration, remains open and may continue to receive letters and documentation.

This Citizens' Petition -- 99P-1340 -- was sponsored by the Environmental Health Network (of California) and received by the FDA on May 11, 1999. The FDA had 180 days to respond to the petition, which they did a little late -- December 1999 -- stating that the petition was to remain open. Comments can be filed up until the point the FDA closes the petition. We recommend writing as soon as you learn of this opportunity to tell the US FDA: DO YOUR DUTY! Require your warning on fragrances released to market without substantiation of safety. Labels should be required to carry the FDA message: "Warning--The safety of this product has not been determined."

August 2002 Sept. 2004 --If you've yet to write, please do so now. Get others to write as well. Sample letters are provided. You may copy them , edit them or just use them to get a feel for the letter you wish to write. Remember do not include any information the rest of the world can't know about, as letters to government agencies are public business.

This is truly a grassroots, word-of-mouth campaign, which has seen the FDA log in 1,300 letters. I know there are more than just 1,300 people adversely affected by our modern synthetic scents. But if you don't write, none of us will benefit. It's as simple as that. We have not been 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 inform the public of Petition 99P-1340 and the chemicals found through analysis a "no-brainer."

Modern synthetic fragrances not only can wear at the health of the still healthy, they adversely affect the health of people of all ages who live with asthma and a wide variety of other respiratory diseases, with migraines and other headaches, with AIDS, cancer ... . Now is the chance to inform the FDA, your doctors and healthcare facilities, workplaces, schools, places of worship, city councils, public transportation agencies, etc.

Use the information available to you through EHN's FDA Citizens' petition. Especially important for your validation are all of the toxins found through analyses. Print out that information. Share it. The Analysis Summary confirms your claim that this is not a "preference issue." When anyone -- including your doctor, or health care staff -- talks fragrances up as a personal rights issue, ask them: Whose personal rights come into play when we are really talking about air pollution for all? Have them explain to you why it is more "right" for some to wear chemicals (fragrances) that appear on the EPA's Toxic Substances Control Act (TSCA) Inventory and on the Registry of Toxic Effects of Chemical Substances (RTECS) than it is for everyone to have the right to breathe cleaner air. See http://www.ehnca.org/www/FDApetition/analysis.htm and NIEHS.

Tell the FDA how synthetic fragrances adversely affect your health. If you are a nonuser and develop reactions, be sure to state that! The FDA and the industry have not taken into account adverse events suffered by non-users of fragrances. Those of us who suffer diseases of the skin, asthma and other respiratory diseases, migraines and other headaches, etc., at the secondary and tertiary levels of exposure are totally ignored. We are systematically ignored by both industry and by our various government agencies charged with protecting public health. If they would measure, they would have to manage. Obviously it is better for the industry's economy if they and the government don't measure.

If you are a fragrance user, you deserve to know that you are using safe products proved safe before marketing. Products that are not only safe for you to put on -- and in -- your own body, but that are safe for the bodies of your children, elderly parents, and untold others who are exposed to our modern synthetic scents' volatilizing chemicals. Remember, because fragrance chemicals volatilize (outgas), just breathing them gets them into your body and the bodies of other people.

Adverse reactions to modern synthetic fragrances are a public health issue. The testing done on fragrances is for skin reactions of the primary user! It is outrageous that fragrances, which are made to be inhaled (smelled) and which affect lipids (including our brains), are not tested for health effects of user and non-user via inhalation, via direct pathways to the brain, nor are they tested for systemic effects, nor for effects suffered upon long-term exposure.

There's a lot more testing to be done. The industry and FDA should know about fragrance chemicals' effect upon lungs, upon the blood system, the muscles, the nervous system, the brain -- fragrances have neurotoxic effects. They also should test for effects upon embryonic and fetal development as some of the chemicals found are teratogens. The industry and our FDA should study long-term effects -- maybe some of the carcinogens do lead to some of the "UNEXPLAINED" cancers. Some top researchers see a connection.

The very least EHN is asking the FDA to do is to follow their regulations already in place, which would have the FDA then declare, Calvin Klein's Eternity eau de parfum "misbranded" and require warning labels on Eternity and ALL inadequately tested fragrances, which are released to market. Then, and only then, will the consumer -- YOU! -- be given a fair option in making your purchasing decisions.

The already fragrance-sensitized individual is stultified as a chronic complainer. Better we should be viewed as "Human Observational Studies." That might put the brakes on the "UNEXPLAINED" escalating rates of various chronic illnesses and disabilities.

Addressing your letter

Docket Number: 99P-1340 (use this number for all correspondence concerning this Citizens' Petition.)

Your letter must include your name -- anonymous comments will not be accepted.

Use only one form of communication per letter -- you may write several times over if new information becomes available to you. You may send in documentation. You may use information gleaned from EHN's press releases (http://ehnca.org/www/PressReleases/prsrelin.htm#Fragrances)

Mail comments and letters of support to



Division of Dockets Management
Food and Drug Administration
Department of Health and Human Services
5630 Fishers Lane, Room 1061
Rockville, MD 20852

FAX Number for comments/letters: 301.827.6870

Email Address for comments/letters: fdadockets@oc.fda.gov

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 the chemical industry and its apologists wish to offload the burden of fragrance injury to those who live with Multiple Chemical Sensitivities. We are not the only ones affected by fragrances. We need to make people aware of the fact that this is a general health issue, specifically affecting those with respiratory problems. Below are sample letters to send to the FDA. We also recommend contacting your political representatives, newspapers and health and environmental organizations. [See EHN's "Write Now! ( http://ehnca.org/www/ehnhompg/action.htm#Write Now!) for contact information.]

The petition pages, including fragrance analyses, are online at:

• Environmental Health Network (EHN) (this one): http://www.ehnca.org/www/FDApetition/bkgrinfo.htm
  
  
• Fragrance Products Information Network (FPIN)
  http://www.fpinva.org/petition99P1340.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. The FDA was sent their requisite four copies of the entire petition.

This Citizens' Petition provides a golden opportunity to let policymakers, media and healthcare providers, employers, school administrators know about the health hazards in fragrance products and how they adversely affect our lives . . . and the lives of our children and elderly parents.

Thanks for your good work and support!

Betty, Barb and Amy
Betty Bridges, Barb Wilkie and Amy Marsh -- who had been EHN's president at the time of the Petition launch. -- barb

Copy the following letter in to your computer's word-processing software or email software and edit to fit your own situation. Then, print out and mail to address that is part of the letter below, or fax to 301.827.6870 or send via email to fdadockets@oc.fda.gov

Tell the FDA how the use of fragrance products -- used personally or by others -- has adversely affected your life with regards to your family, healthcare, education, employment, civic duties, socially ... Tell the FDA that you expect, at the VERY LEAST, their warning message on labels of fragrances released to market without adequate testing.

Adequate testing includes not only effects to skin of primary users, but also adverse reactions to the skin and bodies of people who suffer secondhand and thirdhand levels of exposure. Also to be considered for adequate testing are adverse reactions upon inhalation; for systemic effects; for effects following long-term exposures, including at the primary, secondary or tertiary levels; for carcinogenic -- cancer-causing -- effects; for teratogenic effects -- adversely affecting unborn babies; and for neurotoxic effects -- adversely affecting your brain and nervous systems. If the industry cannot provide detailed information proving the safety of their products for the general public -- including non-users -- the products are not adequately tested. -- barb

Original Sample Letter:

Your letter must include your name -- anonymous comments will not be accepted.

Date: _____________________

Division of Dockets Management
Food and Drug Administration
Department of Health and Human Services
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Re: Docket Number: 99P-1340
Petition the FDA Have Calvin Klein's Eternity eau de parfum declared "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, which was based upon a purchased analysis, 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, in their healthcare facilities and doctors' offices 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

Without illness check list letter:

Alter to suit your circumstances. Be sure to list your symptoms in the first paragraph, removing the line and the parenthetical statement. Your letter must include your name -- anonymous comments will not be accepted. And, delete this paragraph.

Date: _____________________

Division of Dockets Management
Food and Drug Administration
Department of Health and Human Services
5630 Fishers Lane, Room 1061
Rockville, MD 20852

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

Dear Sir or Madam:

There is no longer any wonder why I live with adverse health events following inadvertent exposure to synthetically scented cosmetics, perfumes, colognes and aftershaves; cleaners too.Look at the chemicals! And these chemical concoctions have not been substantiated for safety. My reactions are: ________________ (list your reactions).

I have lived with fragrance sensitization for years, but I've always been told that it's only my problem. I have since come to learn that our modern synthetic scents pose great health concerns for people of all races and all ages. A look at the analyses accompanying 99P-1340 gives clear indication why our health is being so routinely compromised. As the petition shows, "Eternity" contains toxic ingredients and ingredients whose safety have not been substantiated. Additionally, many of its chemicals appear on both the EPA's Toxic Substances Control Act (TSCA) Inventory and on the Registry of Toxic Effects of Chemical Substances (RTECS). Many of these chemicals are known or suspected hormone disrupters, carcinogens, teratogens, neurotoxins, irritants and sensitizers, yet there is no warning label on its packaging. Nor do any other synthetically scented products carry such warning. See http://www.ehnca.org/www/FDApetition/analysis.htm.

I write in strong support of the Citizens' Petition -- 99P-1340 -- submitted by the Environmental Health Network (EHN) back in May 1999. See http://www.ehnca.org/www/FDApetition/bkgrinfo.htm. This petition, based upon an analysis purchased from a member of the industry, requests that Calvin Klein's "Eternity eau de parfum" be declared misbranded per 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."

We all have a right to know the status of safety testing of the ingredients in all fragrance products and perfumes such as "Eternity" so that we can protect ourselves and our families from toxic chemicals that may cause health problems, including reproductive problems. People are not aware that most fragrance materials have only limited safety testing -- for skin reactions suffered by the primary user. The public naively trusts government agencies to thoroughly test all products marketed for personal use. Most of us are quite surprised to learn what all the FDA cannot do regarding its role of authority over the cosmetic and fragrance industries. It follows that people wrongfully assume all fragrance products are safe to use in any setting and are taken aback when already chemical-sensitized people complain.

Like tobacco smoke, the harmful chemicals currently used in synthetically scented products can adversely affect the health of many people, user and nonuser. For example, health is adversely affected for those living with diseases such as asthma, emphysema and other respiratory diseases, chemical sensitivities, cancer, migraines and other headaches, chronic fatigue, Attention Deficit Disorder, Alzheimer's and various other environmental illnesses. Children are particularly vulnerable to toxic chemicals found in products purchased and used by their parents, caregivers and teachers. School children are now developing severe reactions to these products so that schools are having to institute fragrance-free policies.

The FDA should alert the general public about potential for harm, caused by our modern synthetic fragrances, which adversely affect secondhand users, just as does tobacco smoke. It is time for a change. Implement your labeling requirement so fragrances not adequately tested -- substantiated for safety -- prior to marketing carry your required warning message.

Please act to PREVENT illness and injury due to these toxic products. Act in honor of the millions of people who have already suffered premature death or physical illness and injury resulting from fragrance exposure at work, at school, in their healthcare facilities and doctors' offices, places of worship, and in social settings. These toxic chemical concoctions have ruined countless lives and also act as formidable barriers to people disabled by them.

Thank you.

Sincerely,


YOUR NAME
address
city/st/zip

E-mail note:

Your letter must include your name -- anonymous comments will not be accepted.

TO: fdadockets@oc.fda.gov
FROM:
SUBJECT: Docket Number: 99P-1340

Dear Sir or Madam:

My reactions to fragrances in perfumes and other scented products include: _______________ (please list your symptoms).

I strongly support of the Citizens' Petition -- 99P-1340 -- submitted by the Environmental Health Network (EHN) back on May 11, 1999. This petition, based upon a purchased analysis performed by a member of RFIM, requests that Calvin Klein's "Eternity eau de parfum" be declared misbranded, per your regulations 21CFR Sec. 740.1, 21CFR Sec. 740.2, and 21CFR Sec. 740.10. I specifically draw your attention to regulation 21CFR Sec. 740.10, which 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."

Like tobacco smoke, the harmful chemicals currently used in the manufacture of synthetically scented products can adversely affect the health of many people, user and nonuser. For example, fragrances can cause, exacerbate and trigger asthma, and fragrances cause adverse events for people living with other respiratory diseases, chemical sensitivities, cancer, migraines and other headaches, chronic fatigue, and other environmental illnesses. Some of the chemicals like phthalates are capable of harming developing fetuses, especially males. Musks and coumarin can cross the placental barriers. Musks and coumarin are thought to be carcinogenic. Let's do the research! Children are particularly vulnerable to toxic chemicals found in products purchased and used by their parents, caregivers and teachers.

Please act on behalf of the millions of people who have suffered physical illness and injury resulting from fragrance exposure at work, at school, in their healthcare facilities and doctors' offices 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. It is time to consider PREVENTION, for only then may we halt those "UNEXPLAINED" escalating rates of various chronic diseases, including asthma and other upper and lower respiratory diseases and cancers. Perhaps, a fragrance-free nursery will also reduce the numbers of SIDS cases and then babies can go back to sleeping in their "normal" position. On their stomachs.

Thank you.

Sincerely,


YOUR NAME
address
city/st/zip