Regarding FDA Petition 99P-1340
It WAS easy to write the FDA regarding adverse reactions to
breathing fragrance chemicals. Alas, this petition seems to have died.
But, do NOT give up!
If you have terrible reactions to breathing perfume chemicals,
PLEASE take a moment to inform the FDA by emailing them via
consumer "at" fda.gov
Comments received by the FDA about
We learn that the FDA's receipt of 100 letters on alpha-hydroxy acids (AHAs) is viewed as "the very tip of a large iceberg" in Time to Review Your Cosmetics, Under Bright Light by Jane Brody, New York Times,May 22, 2001 http://www.nytimes.com/2001/05/22/health/22BROD.html.
Yet, in July 1999 -- just two months after the FDA Petition was filed -- and after logging 166 comments regarding harmful effects of synthetic scents, the FDA still felt it "... has little or no information that would support actions to raise public awareness of possible health risks associated with the use of fragranced products."
While the FDA states its mission is to protect consumers, I see it as actually serving two masters other than consumers: 1) cosmetic manufacturers and 2) distributors. I do not see how the consumer can be protected by the FDA as the FDA states: "Cosmetics are not subject to FDA pre-approval or mandatory establishment registration or ingredient reporting." And, they fail to take public comment on the harmful effects of fragrances seriously. See The Voluntary Cosmetic Registration Program at http://www.cfsan.fda.gov/~dms/cos-regn.html.
We've got to get more comments into the FDA regarding 99P-1340 or the FDA will not act. And, we must support SNIFF (Safe Notification and Information for Fragrances Act), authored by Rep. Jan Schakowsky (D-IL). SNIFF will have to be re-introduced into the 108th Congresshttp://ehnca.org/www/ehnlinx/s.htm#SNIFF. Please join us in writing to the FDA and write to you Representative and Senators.
The more info that comes out regarding the chemicals used commonly in the manufacture of fragrances, the more people should be concerned for their own health and the health of others who come in contact with their voliatilzing scented products. Including their developing fetuses, infants and children. Have you tallied the number of items used on or around your children that contain the benign sounding word, "fragrance"?
Synthetic scents know no boundaries. Synthetic scents contribute mightily to indoor and outdoor air pollution. Chemicals used to make synthetic scents enter your body and the bodies of others through inhalation and absorption. The focus of industry's "thorough" testing is for dermatological effects of a primary user. Checking for a skin reaction of the primary user leaves out all the people who have skin reactions and who do not themselves apply scented products. It also leaves out the acute adverse effects suffered through inhalation, and it ignores the systemic effects of these chemicals upon our bodies and the bodies of our children . . . and, it leaves out any study of the neurotoxic effects of these chemical combo concoctions on primary and secondary users. The NEVER MEASURE, NEVER MANAGE creed seemingly practiced only protects the industry. It does nothing to inform the public, let alone protect the public.
Lack of study does not prove a scented product is safe for use. Remember that there is no managing of that which is not measured. We always hear from industry apologists that "sound science" is needed . . . Let us have some sound -- and that is not spelled "biased" -- science. Purchase an analysis of your favorite fragrance or look to the sites of EHN and Betty Bridges' Fragranced Products Information Network (http://www.fpinva.org)
If you feel that there is not enough known about the tens to hundreds of chemicals used to make any one scent -- out of the industry's inadequately tested repertoire of 3,000 to 5,000 chemicals -- write to the FDA. If you or your loved ones live with the effects of fragrance-sensitization, write to the FDA. If you feel the public has a right to know, write to the FDA. It is easy to write to the FDA, just send an e-mail message, set up thusly:
SUBJECT: Docket Number 99P -1340
Use this golden opportunity to tell the FDA you deserve safer products proved safe before marketing, and in the meantime, the FDA should require its warning message: WARNING: The safety of this product has not been determined. This warning would at least give the public a clue that there is more to meet the eye regarding fragrances than just industry advertising hype and public relations campaigns.
In an article, Scents and sensitivities, written for MSNBC, February 6, 2002, Francesca Lyman states: "An FDA spokesperson says it [the FDA Petition] is still 'under review,' but not considered a priority." Get that? Our letters beseeching the FDA to act upon this petition because fragrances are making us and our loved ones sick and this petition requesting the FDA to follow the regulation already in place on its books, are NOT a priority.
By the way, in this same article, an industry representative states, "Products are thoroughly tested before being marketed to assure their health and safety," yet goes on to add they've just "begun the first study to examine fragrance inhalation." Ah, er, ummmm, aren't these synthetic scents made to be inhaled (smelled)? So why is it after all of these years of the public's increasing illnesses associated with the myriad of synthetically scented products, the industry -- self regulated and further protected by trade secret laws -- is just NOW stating they are starting to "examine fragrance inhalation"? (Mirrored on EHN with the kind permission of Ms. Lyman and MSNBC. at http://ehnca.org/www/FDApetition/flscents.htm. Formerly at http://www.msnbc.com/news/702445.asp
Remember ORGANICS and the USDA? Over 200,000 people got on the bandwagon. There are more than 200,000 people who claim they suffer from headaches, rhinitis (leaky-beaky), asthma, sinusitis, laryngitis, dizziness, forgetfulness, nosebleeds, muscle pain and joint aches, ataxia, swollen lymph nodes, etc., etc. when they come into contact with the chemicals in synthetic scents. Let us all write the FDA about our adverse health events suffered as a result of the concoctions of chemicals used in the manufacture of synthetic scents. Letters from 200,000 people might begin to convince the FDA that they must take fragrance sensitization seriously and make it a HIGH priority.
IF you are living with the effects of fragrance sensitization, you've got to inform the FDA. They will not act to protect public health until they hear it is a public health issue. From YOU. YOU are the public. If you no longer have your health and well being due to synthetic scents, gratuitously added to a wide array of consumer products, you've simply got to tell it to the FDA. Reference Docket Number 99P -1340. E-mail them at firstname.lastname@example.org . . . or you could reach them via fax or snail mail. That contact information is at http://www.ehnca.org/www/FDApetition/bkgrinfo.htm
In my case, and the case of so many others, we aren't the primary users of scented products. Our reactions to synthetic scents are at the secondary and tertiary levels. For example, I don't use scented products but am subjected to the chemicals volatilizing from the scented products used by another. I am the non-user who suffers an adverse reaction at the secondary level. But what if the others have truly dressed "scent-free" for the occasion and I still react because scents clinged to their body and clothes from being around others who were highly scented. At that point, I am reacting at the third -- tertiary -- level of exposure. My asthmatic attacks don't care if I'm subjected to these irritants and sensitizers at the secondary or tertiary level of exposure . . . for the chemicals outgas (volatilize) regardless. And the same could be happening to you.
Because if is relatively cheap to concoct synthetic scents, scents have become ubiquitous. During the past two decades, synthetic scents have been crafted to waft further, last longer -- we can thank phthalates for that. Because synthetic scents are relatively inexpensive to manufacture, it's been affordable to add them to a great array of personal care, as well as to household and janitorial cleaning and maintenance products. To increase the market, they've been advertised widely, so that people feel they have to use and wear more synthetic scents. Therefore, people are going more places, throughout the day and night, with more scents volatilizing from their bodies and clothing than ever before. Is there any wonder that the rates of various chronic illnesses are escalating?
Can we not look more closely at the correlation between increased sales of synthetically scented products and the skyrocketing rates of asthma and other chronic diseases?
Without a lot of help from mainstream media, the FDA has received over 1,300 comments on a single topic: Adverse health effects suffered as a result of synthetic scents. If this were any other topic, I can't help but believe it would be seen as newsworthy by the NY TImes. Why? Because Jane E. Brody, in the Times, wrote about the FDA receiving 100 reports regarding alpha-hydroxy acids ( AHAs).
In the May 22, 2001; PERSONAL HEALTH article, "Time to Review Your Cosmetics, Under Bright Light," By Jane E. Brody, at http://www.nytimes.com/2001/05/22/health/22BROD.html you will find stated:
Although 100 reports may not sound like much, you can be sure they represent the very tip of a large iceberg since fewer than 1 percent of problems involving such over-the-counter products are ever reported to the agency. The agency estimates that it receives only one in 50 reports of cosmetic-related complaints made to the industry.
Be a Vigilant Consumer ...
UN, OH! Another bit of a sticky wicket for the person who is already chemically injured and/or those who seek to use fragrance-free products for their health and the health and well being of others. How can checking the label be a sticky wicket??? Why? What's wrong with checking a label? Isn't that great advice?
Yes, but when it comese to synthetic scents, it doesn't mean diddly. Why? (I'm sounding like my two-year-old granddaughter!) Because . . .
. . . It is allowable and legal to add synthetic scents as a "masking" scent to hide the other chemicals in a product AND still label the product, UNscented or Fragrance-FREE. See U. S. Food and Drug Administration, FDA Consumer, November 1991; revised May 1995, by Dori Stehlin, Cosmetic Safety: More Complex Than at First Blush. Stehlin states: " ... fragrance-free products so labeled may still contain small amounts of fragrances to mask the fatty odor of soap or other unpleasant odors ..." http://vm.cfsan.fda.gov/~dms/cos-safe.html
In an effort to accommodate colleagues, family members and/or friends, people have bought products they thought were unscented or fragrance-free. The products they bought to have available in their home for use, or they planned to use around an already sensitized individual, were clearly marked "Unscented" or "Fragrance-free." Friends and spouses have bought such products even while they thought it strange that they were still smelling scent through the packaging or when using the product. However, not being already sensitized to the chemicals in synthetic scents, and therefore not being fully aware of the false labeling that is allowed, the still gullible, not yet sensitized folks, figured it had to be OK.
OK, that is, until that supposedly scent-free product caused their family member, friend or colleague a severe reaction. (That happened to me when a friend bought a bar of Dove "UNscented" soap that was heavily scented. The person couldn't understand why she smelled the scent, but felt it had to be all right, for the label told her so. My friend was very apologetic. She vowed to never again buy that product, and has since been mindful of detectable scents from products with misleading label information. But her kind attempt at accommodating my health needs led to my rapid onset asthmatic attack and incontinence. The soap was in the bathroom, which ironically I then had to visit, for as soon as I first opened the door I was engulfed in the noxious vapors emanating from the "unscented" soap. There was no denying my reactions, so to avoid bigger, more embarrassing problems, I tucked my nose into my blouse, breathed as lightly as I could through the fabric, used tissue as a filter over my nose, completed my mission and then began the process of quelling the asthma and educating my friend.)
Some manufacturers are even more subtle in their application of synthetic scents to products labeled unscented or fragrance-free. And that creates another problem arising from misleading information on a label. This problem not only deals with the health issue for the already chemically sensitized individual, but it is also a social one. This one brings up those "attitudinal barrers" in nothing flat.
There are many experiences, some mine, some of others. The shared theme is: Family members, friends, colleagues have bought and used products clearly marked "Unscented" or "Fragrance-free" in an effort to improve the air quality for those of us who are already chemically injured, or folks otherwise sensitized to synthetic scents. We are grateful for their willingness to change products on our behalf. As they are using a clearly marked "unscented" product, they then assume they are safe to be around. They also assume they can use or apply the product in the presence of the already sensitized individual. That would be a natural assumption for the uninfomed. However, the already chemically injured or sensitized individual will suffer adverse reactions to the masking scent in such products. How little poison is little enough?
It seems to me such a scenario would prove beyond a shadow of a doubt that our reactions are real and should be believed AND STUDIED. It isn't as if we know ahead of time that a scent is used and therefore our mind determines we're going to have an adverse reaction. Our mind is convinced we're around a safe product because we've been told ahead of time that the individual has bought a scent-free product. However, if they've bought a product that has the misleading words on the label, we learn the hard way that there's another one to add to our personal list of products to avoid to the extent possible.
So what happens beside the adverse events one suffers around synthetic scents? One would think the already sensitized individual who goes into reaction from these products, which are obviously labeled with misleading information, would be one of concern, contriteness, a rush to clear the air of the offending chemical assualt. In some cases, that's exactly what happens. Certainly that was the case six years ago with my Dove soap experience, related earlier. But what happens all too often is the individual in reaction will be labeled a hypochondriac beyond accommodating, one given to somatizing, a real bellyacher, a malingerer, a chronic complainer, ... Pick your own pejorative. I'm certain if you live with chemical injury, you've been the recipient of at least as many comments as I've had used vituperatively against me.(But if our doctors, employers, colleagues ... considered our life's history, then they'd see considering us neurotic would be far-fetched and far from the truth. Alas, just try to convince contemptuous doctor, management, colleague, ... of that fact.)
And so it goes. I'm waiting for the day the FDA, and our other government agencies charged with protecting public health and well being, begin to actually follow the words of their various mission statements, which would lead to their protecting the consumer first, and then industry. Should I live so long! Or should SNIFF ((Safe Notification and Information for Fragrances Act at http://ehnca.org/www/ehnlinx/s.htm#SNIFF be passed by Congress.
We are all stakeholders when it comes to breathing. -- barb
For FDA dockets entered daily, visit
2005 at http://www.fda.gov/ohrms/dockets/dailys/dailys05.htm
2006 at http://www.fda.gov/ohrms/dockets/dailys/dailys06.htmhttp://www.fda.gov/ohrms/dockets/dailys/dailys08.htm
Click on the year above to get to the FDA's site for daily logs for that year. Then select the month and a date, and using the FIND or SEARCH command of your web browser,
have your computer look for "99P-1340" or "Eternity." Not every day shows an entry for this docket.
Also, keep in mind that most letters appearing are in PDF format. I've found that some letters haven't been entered into their system for electronic storage and appear just listed by their number. Some letters you can still get to by use of the Wayback Machine at www.archive.org.
My question of the FDA: HOW can you read any of these letters and not do something about warning the public that modern, petrochemically derived concoctions benignly named FLAVORS or FRAGRANCES can be deleterious to one's health. And that applies to primary user as well as secondhand users! -- barb
To search the FDA website, go to
You can find all sorts of interesting things by exploring the daily docket. For instance,
I came upon this:
C 2 The Cosmetic, Toiletry & Fragrance Assn Vol#: 1
In the letter by E. EDWARD KAVANAUGH, President, The Cosmetic, Toiletry, and Fragrance Associationit, it is stated:
Notice that word "encouraged." See
FDA AUTHORITY OVER COSMETICS
FDA cannot require companies to do safety testing of their cosmetic products before marketing. If, however, the safety of a cosmetic product has not been substantiated, the product's label must read
And if all of this isn't enough, the industry is also protected by trade secret laws. Now trade secret laws do nothing to protect the industry from "rip-off" scents being manufactured and sold. Obviously. But trade secret status does a fine job of shielding the industry from an informed consumership, astute doctors, lawyers, . . . the FDA.
-- barb Dec. 13, 2001
Links to comments on the FDA site
Although 100 reports may not sound like much, you can be sure they represent the very tip of a large iceberg since fewer than 1 percent of problems involving such over-the-counter products are ever reported to the agency. The agency estimates that it receives only one in 50 reports of cosmetic-related complaints made to the industry. ..."
Return to the FDA Petition
(Barb's email is no longer valid, please contact EHN) Please put WWW in subject line. Thanks.
Please check back often as we are always adding valuable links to our pages of Links.
As with all organizations, EHN depends upon your contributions of
time and energy, as well as your membership support.
As with all organizations, EHN depends upon your contributions of
ehnindex.htm -- 11/29/99
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. Keywords: Docket Number 99P-1340, 99P-1340,letters, support, petition, FDA, Eternity, Calvin Klein, misbranded, chemicals, toxic.The URL for this page is http://ehnca.org/www/FDApetition/letinfda.htm.
EHN's homepage is www.ehnca.org