FDA Petition 99P-1340
Analyses, Complementary, Contact Information and
Sample E-mail and letters
plus SNIFF, too
9/29/03: The FDA has officially begun "Preliminary scientific reviews of the petition."
Write your letter, email or fax to the FDA before it is too late.
CITIZENS' petition, Docket Number: 99P-1340, was filed on behalf of everyone who feels We The People have a RIGHT TO KNOW about the superfluous toxins in our synthetic fragrances.
All YOU have to do is write to the FDA about your adverse reactions -- first-, second or thirdhand -- to synthetic scents. If you've yet to suffer adverse effects, but just want effective labeling, please also write to the FDA. In any case you must
reference Docket Number: 99P-1340.
September 2003: EHN has no idea when the FDA will close the petition, but it may be soon now. Please write your letter, note or email to the FDA as soon as possible about your -- or your children's, or your elderly parents' -- negative reactions to synthetic fragrances. Do not include social security numbers or other such identifying info.
The FDA has written to EHN stating that they have not closed this docket number,
and they are continuing to accept letters and supplemental materials. The FDA
contact information for this petition is in the middle part of this panel.
All letters supporting EHN's petition to require warning labels on fragrance products
must contain: Docket Number: 99P-1340.
The docket number identifies the FDA petition to declare Calvin Klein's Eternity eau
de parfum "misbranded." If the FDA rules favorably on this petition, then it stands to reason that all synthetic scents released to market without substantiation of safety will also have to carry the FDA's required warning label.
It is unlikely that the FDA will move on this topic UNLESS it hears from several hundred thousand people. Remember the USDA and ORGANICS. Let the FDA hear from YOU . . . and please, spread this information far and wide.
Analyses
http://users.lmi.net/~wilworks/FDApetition/bkgrinfo.htm#Analyses
Background information, including Cosmetic Handbook regulations
Petition Index
Product Label
http://users.lmi.net/~wilworks/FDApetition/eterbkpg.htm
Sample letter
http://users.lmi.net/~wilworks/FDApetition/sampletr.htm#Sample
Letters to FDA and other information
Letters of support appearing on EHN's site
http://users.lmi.net/~wilworks/FDApetition/letindex.htm
Search the FDA's Daily Log for 99P-1340
http://www.fda.gov/ohrms/dockets/dailys/dailys05.htm
1,377 Comments received by the FDA
as of May 9, 2003 -- letters by year
http://users.lmi.net/~wilworks/FDApetition/letinfda.htm
Media Covering FDA Citizens' Petition 99P-1340
Select just one method of communication with the FDA.
Please make sure your constituents realize that their comments are in
the public docket, including their names and addresses. They may even
be posted to the web. Also, please ask them to put the docket number in
the subject line of their e-mails as this will help us file it in the proper docket.
Thanks.
Jennie Butler
Director, Division of Dockets Management
YOUR letters or notes supporting 99P-1340 may be
e-mailed, faxed or mailed to the FDA, but please, choose just
one method to inform the FDA. You may write many times over.
Email Address -- fdadockets@oc.fda.gov
FAX Number -- 301.827.6870
Letters may be mailed to:
Division of Dockets Management
Food and Drug Administration
Department of Health and Human Services
5630 Fishers Lane, Room 1061
Rockville, MD 20852
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Correspondence from the FDA:
May 11, 1999: FDA's acknowledging letter (via The Wayback Machine) --
http://web.archive.org/web/20000901221329/
http://www.fda.gov/ohrms/dockets/dailys/051199/ack0001.pdf
November 30, 1999 -- EHN has been informed that the petition is OPEN and accepting letters and documentation supporting your claims that synthetic fragrances adversely affect your health, the health of your children, or the health of your elderly parents. The FDA responded to EHN in a little over its required response time of
180 days from receipt of petition (May 11, 1999).
Inquiries as to FDA progress on EHN's petition:
Subject: Docket Number: 99P-1340
Date: Thu, 28 Sep 2000 14:09:32 -0400
At this time your petition is still open and is receiving comments.
Jennie Butler
January 2001 -- another check with FDA and the petition is still open. -- barb
February 2002 -- the petition is still open and accepting letters and documentation. -- barb
September 29, 2003 -- The FDA has officially begun "Preliminary scientific reviews of the petition."
October 24, 2003 -- Phthalates are added to California's Prop. 65 list of chemicals.
Phthalates were found in the analyses of the perfumes
that form the basis of EHN'sFDA Petition 99P-1340. (OEHHA:
http://www.oehha.ca.gov/prop65/CRNR_notices/list_changes/6Ddehpnot.html.)
With all the information recently made availab le on the reproductive toxicity of phthalates, one hopes the FDA will keep our future generations in mind as they review the combinations of toxic chemicals used to concoct fragrances we use on/in our bodies. The manufacture of fragrances changed during the past 30 years from largely plants and animal essences to those derived from petrochemicals. In the manufacture of fragrances, phthalates are commonly used to make the scent last. (In the manufacture of plastics, phthalates are used to soften.)
While harmful effects of phthalates are gaining attention, they are not the only worrisome chemicals
commonly used to make our modern scents -- as indicated by analysis. One should also look at the synthetic musks, which are found not only stored in mothers' breast tissue, but downstream in mother's milk. Musks are also found quite literally downstream where they adversely affect wildlife. And then, I'd like to see the coumarins thoroughly investigated. And, this, as the saying goes, is the tip of the iceberg. There are 3,000 to 5,000 inadequately tested chemicals in the industry's repertoire.
I believe that the nformation available on the chemicals used to synthesize modern fragrances, plus record of the diseases and disabilities associated with fragrance sensitization at prmary and secondary levels of contact, warrants -- at a bare minimum -- the FDA's required message: "WARNING: The safety of this product has not been determined." Source: FDA http://vm.cfsan.fda.gov/~dms/cos-206.html. -- barb
Caveat Emptor!
Complementary information:
Folks, I've put some of the information I've found to be most compelling here, in chronological order. I'd like to hear the excuses for why our government agencies, charged with protecting public health, have allowed the various facets of the chemical industry to continue using the population as unwitting guinea pigs. I cannot help but feel the "revolving door" 'twixt and 'tween industry and government plays an interesting role, but one not helpful to public health. -- barb
1977 . . . Doctoral Dissertation: THE COMPARATIVE RESPIRATORY IRRITATION POTENTIAL OF FOURTEEN FRAGRANCE RAW MATERIALS
Unpublished report to RIFM. 1977 References: Troy W.R.
(William Troy is gainfully employed by the fragrance industry.)
Available for purchase through http://wwwlib.umi.com/dxweb/
You'll be taken through three pages where you enter obvious info and click "continue." When you reach the search page, key in the order number 7720819.
Science. 1979 May 11;204(4393):633-5.
Neurotoxic fragrance produces ceroid and myelin disease.
Spencer PS, Sterman AB, Horoupian DS, Foulds MM.
Acetyl ethyl tetramethyl tetralin (AETT), a component of soaps, deodorants, and cosmetics, produces hyperirritability and limb weakness in rats repeatedly exposed
to the compound. Brain, spinal cord, and peripheral nerves are discolored blue, show progressive neuronal ceroid degeneration, and develop spectacular myelin bubbling. These neurotoxic properties of AETT provide the basis for industry's decision to withdraw
the compound from consumer products. In addition, AETT offers the experimentalist a new probe to explore the etiology and pathogeneses of human ceroid and myelin diseases.
PMID: 432669 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=432669&dopt=Abstract
Sept. 16, 1986 -- Neurotoxins: At Home and the Workplace
(Report by the Committee on Science and Technology to the U.S. House of Representatives, Sept. 16, 1986) [Report 99-827]. A few excerpts are keyed in at
http://users.lmi.net/wilworks/ehnlinx/n.htm#Neurotoxins
Feb. 05, 1990: Neurotoxin Concerns, Controversy Escalate
By Elizabeth Pennisi
The Scientist 4[3]:1, Feb. 05, 1990
"Scientists are realizing that substances in the environment
can have devastating effects on the human nervous system"
"... Those substances are everywhere: organic solvents
in the workplace, chemicals in perfumes, pesticides used on
lawns, natural and added chemicals in foods, or prescribed or
illegal drugs. The brain is the body's kingpyn organ; yet,
once damaged or destroyed, nerve cells cannot be replaced.
Already, the congressional Office of Technology Assessment
(OTA) estimates that the care and treatment of neurological
disorders and accompanying loss of productivity can cost the
U.S. as much as $300 billion a year. No one knows how much
neurotoxins contribute to that cost. The longer we live, the
more evident the damage, and the more burdened the health care
system will become to people with behavioral, mental, and
neurological problems. "The measure of the problem is huge,"
says Spencer. {Peter Spencer, director and senior scientist at
the Center for Research on Occupational and Environmental
Toxicology at the Oregon Health Sciences University in Portland} ..."
http://www.the-scientist.com/yr1990/feb/pennisi_p1_900205.html
September 1994: MCS: A Sensitive Issue
Environmental Health Perspectives, Volume 102, Number 9
Perfume and effects are included in the discussion. -- barb
http://ehp.niehs.nih.gov/docs/1994/102-9/focus1.html
July 20, 1995: "Multiple Chemical Sensitivities (MCS):
What It Is, What It Is Not, And How It Is Manifested"
By Shelia Bastien, PhD; ©
Contains information on perfumes. By the way, I went from increasing sensitization to perfumed products into MCS. I didn't go gently. I struggled for 20 years to educate, while trying to protect my health to the extent possible in a highly perfume polluted workplace -- barb
" ... Claudia Miller points out that many of the patients often attribute the onset of
their illness to specific exposures (Vol. 10) such as repeated exposures to
solvents, chemical, pesticides in sick buildings, or combustion products.
" Patients report more problems and greater difficulties indoors where air
fresheners, perfumes, and cleaners are used and where there are such things
as particle board and carpets which outgas. The outgassing releases VOC
compounds (Toxicology and Industrial Health, page 257).
" These patients are often funneled off to psychiatrists and psychologists by
physicians who are not familiar with MCS. "From the patient's perspective,
they have lost their health, their livelihood, their friends and sometimes even
family. Individuals with professional careers are likely to view their cognitive
difficulties as most disabling," Dr. Miller added. They are often mislabeled as
malingerers or given a psychiatric diagnosis. ... "
http://users.lmi.net/wilworks/newreact/sbastien.htm
January 1997 -- The National Institute of Environmental Health Sciences (NIEHS)
Fragrance products and pesticides are recognized as Common Indoor Air Pollutants
http://www.niehs.nih.gov/external/faq/indoor.htm
March-April, 1998: "Acute toxic effects of fragrance products."
By Rosalind C. Anderson, Julius H. Anderson, Anderson Laboratories
Archives of Environmental Health
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9577937&dopt=Abstract
http://static.highbeam.com/a/archivesofenvironmentalhealth/march011998/acutetoxiceffectsoffragranceproducts/
March 24, 1999 . . . Toledo Blade
Synthetic musk linked to environmental risks
BY MICHAEL WOODS; BLADE SCIENCE EDITOR
[Excerpted]
"ANAHEIM, Calif. - Synthetic fragrances used in perfumes, soaps, laundry detergents, fabric softeners, cosmetics, and scores of other consumer products have become a new and unexpected group of environmental contaminants, scientists said.
"The chemicals are accumulating in human fat tissue, blood, breast milk, drinking water supplies, lakes and streams, fish and wildlife, and elsewhere in the environment, according to scientists interviewed here. They are presenting scientific reports at a national meeting of the American Chemical Society.
" 'I think there is reason for public concern about possible effects of these fragrances,' said Dr. Sebastian Kevekordes of the University of Gottingen in Germany.
"One compound, musk xylene, has carcinogenic, or cancer-causing, effects in laboratory mice, Dr. Kevekordes said. Another, musk ketone, damages genes in animal experiments and has other worrisome effects.
"Many of the studies identifying synthetic musk compounds in human tissue and the environment have been done in Europe and Japan. Dr. Kevekordes said that synthetic musks are used just as widely, or more so, in the United States, where fragrances have been used even in trash bags and product packaging. ..."
May 1999 -- EHN filed this Petition, 99P-1340, with FDA.
Analyses of perfumes
http://users.lmi.net/~wilworks/FDApetition/bkgrinfo.htm#Analyses
Safe Notification and Information For Fragrances act (SNIFF)
September 21, 2000 -- SNIFF (Safe Notification and Information For Fragrances act): Thanks to efforts of her constituent, Lynn Lawson, Rep. Jan Schakowsky (D IL) introduced SNIFF in the 106th Congress, 2d Session, bill number: H. R. 5238; Co-sponsor: Rep Shelley Berkley.
May 22, 2001: SNIFF -- Reintroduced by Rep. Jan Schakowsky (D IL) for herself and Ms. Berkley in the 107th Congress, bill number: H. R. 1947; Co-sponsor:
Rep Fattah, Chaka - 7/18/2001 [PA-2]
September 14, 2001 -- Occupational Acute Anaphylactic Reaction to Assault by Perfume Spray in the Face by James E. Lessenger, MD, From a private practice.
[J Am Board Fam Pract 14(2):137-140, 2001. Đ 2001 American Board of Family Practice]
http://www.familypractice.com/references/referencesframe.htm?main=/journal/2001/v14.n02/1402.07/art-1402.07.htm
2001 - 2003 . . . Date unknown, but based on work Janitorial Products Pollution Prevention Project, the US Department of the Interior has laid guidelines for "green" cleaning in its "Guidance and Training on Greening Your Janitorial Business," CHAPTER 2: Traditional Versus "Green" Cleaning Products
Excerpted from "Green products" --
- "Must not contain any carcinogens, mutagens, or teratogens designated by federal law."
- "Must not contain any ozone-depleting compounds, greenhouse gases, or substances
that contribute to photochemical smog and poor indoor air quality." ... Also,
- "Must not contain petrochemical-derived fragrances." [Emphasis added.]
http://www.doi.gov/greening/sustain/trad.html
Feb. 6, 2002 -- "Scents and sensitivities
What to know before buying a Valentine's Day perfume"
By Francesca Lyman; MSNBC CONTRIBUTOR
And, I might add, Mother's Day or Father's Day perfume, et al. In this article, the industry admits it has begun the first study to test fragrances for effects upon inhalation and for systemic effects . . . as it also claims it always thoroughly tests before marketing. -- barb
Mirrored by kind permission of Ms. Francesca Lyman and MSNBC
http://users.lmi.net/~wilworks/FDApetition/flscents.htm
Had been at: http://www.msnbc.com/news/702445.asp
July 10, 2002 --Not Too Pretty
A report on phthalates, including information about their effect on developing male fetuses.
This is a MUST read. -- barb
http://www.NotTooPretty.org
Dec. 9, 2002 -- Sperm Damage Linked to Phthalate Used in Fragrances, New Study by Harvard Researchers Finds
http://www.NotTooPretty.org/ms_en_spermdamage.htm
Jan-Feb 2003 -- [US Access] Board to Undertake Project on Indoor Environmental Quality
"The Access Board is an independent Federal agency devoted to accessibility for people with disabilities. "
http://www.access-board.gov/news/Access%20Currents/Jan-Feb03.htm#Board
Note: Tue, 8 Apr 2003 -- Contract with NIBS has been signed for the IEQ (Indoor Environmental Quality) project.
Feb. 12, 2003 -- "What the nose knows"
By Francesca Lyman; MSNBC CONTRIBUTOR
Still available 9/4/03 . . . get it while you can! MSNBC removes articles after some months.If the
entire story doesn't come up, click on "Print" and it should appear in a separate window. -- barb
http://msnbc.msn.com/id/3076635/
Also at:
http://www.mindfully.org/Pesticide/2003/Nose-Knows12feb03.htm
Mar-Apr 2003 -- Breathing Better: Action Plans Keep Asthma in Check
By Michelle Meadows; U.S. Food and Drug Administration; FDA Consumer magazine
"...Common asthma triggers include dust, pollen, cockroaches, cold air,
smoke, and other strong odors, such as paint, cleaning fluids, perfume,
hair spray, and powder. ..." [emphasis added]
http://www.fda.gov/fdac/features/2003/203_asthma.html
April 7, 2003 -- Health Care Without Harm's The Issue
You'll be able to click out to information on Cleaners and Disinfectants, Fragrances, Pesticides and Resources. All worth printing out and sharing with your doctor and healthcare facilities, schools, workplaces, places of worship, government entities, etc. -- barb
http://www.noharm.org/pesticidesCleaners/issue
September 7, 2003 -- New York Times
WHAT THEY WERE THINKING
Julianna Martin, 25, Syracuse, N.Y., Aug. 24, 2003
" 'I don't shop without my respirator on. I've got extreme hypersensitivity to everyday chemicals -- fragrance, perfume, shampoo, candles, cleaning products. It's hard to do anything.' ..."
Story with picture: http://www.nytimes.com/2003/09/07/magazine/07WTWT.html
Printer friendly: http://www.nytimes.com/2003/09/07/magazine/07WTWT.html?pagewanted=print&position=
I hope Julianna Martin knows about EHN's petition 99P-1340 and takes the time to
write to the FDA. -- barb
December 2003: SNIFF -- We are awaiting re-introduction of this bill into the 108th Congress; now it seems to be on hold for a bit longer. Follow its progress via THOMAS Legislative Information on the Internet at http://thomas.loc.gov/home/thomas.html
or by information on EHN's site under SNIFF.
2004
February 19, 2004 (last update)
Sources of Indoor Air Pollution - Organic Gases (Volatile Organic Compounds - VOCs)
Excerpted:
"Organic chemicals are widely used as ingredients in household products. Paints, varnishes, and wax all contain organic solvents, as do many cleaning, disinfecting, cosmetic, degreasing, and hobby products. Fuels are made up of organic chemicals.
All of these products can release organic compounds while you are using them, and, to some degree, when they are stored.
"EPA's Total Exposure Assessment Methodology (TEAM) studies found levels of about a dozen common organic pollutants to be 2 to 5 times higher inside homes than outside, regardless of whether the homes were located in rural or highly industrial areas. Additional TEAM studies indicate that while people are using products containing organic chemicals, they can expose themselves and others to very high pollutant levels, and elevated concentrations can persist in the air long after the activity is completed.
"Sources
"Household products including: paints, paint strippers, and other solvents; wood preservatives; aerosol sprays; cleansers and disinfectants; moth repellents and air fresheners; stored fuels and automotive products; hobby supplies; dry-cleaned clothing."
http://www.epa.gov/iaq/voc.html
The EPA mentions "cosmetic" in the first paragraph and "air fresheners" (what a misnomer that word is!) in the last paragraph, adroitly circumvented the word FRAGRANCE.
Fragrances: the ubiquitous chemical pollutant affecting air, bodies of users and nonusers, land and water. Amazing how FRAGRANCE cannot say its name out loud. -- barb
March 26, 2004 -- Environmental Working Group's Campaign for Safe Cosmetics
Survey: Personal care products
http://www.ewg.org/survey
April 2004 -- Environmental Health Perspectives
"Grand Rounds in Environmental Medicine: Information on MCS Needed"
Excerpted from letter by Barb Wilkie in response to "Grand Rounds in Environmental Medicine: Cases from an Emerging Discipline, by Howard Hu (2003) [EHP]"
" ... As Hu (2003) also noted, other factors are beginning to be accepted as
environmental health hazards, such as cockroach allergen and violence.
"Hu (2003) continues:
" Some [Grand Rounds cases] pertain to illnesses arising from occupations that
entail combinations of exposures that may have acted synergistically. Some arise
out of new research on illnesses and exposures that had not previously been linked together, such as infant pulmonary hemorrhage/Stachybotrys mold and possible estuary-associated syndrome. Others explore illnesses that are still of uncertain etiology and biology, such as multiple chemical sensitivities.
" I would be even more pleased if modern flavors and fragrances appeared in the list.
I am often displeased to see articles in mainstream newspapers in which doctors advise patients with asthma to rid their homes of the "usual suspects"--cats, cockroaches, and dust and dust mites, sometimes including mouse feces and mold for good measure-- without mentioning the potential harm that fragrance chemicals can cause for people with asthma or other diseases exacerbated by fragrance products. ..."
http://ehp.niehs.nih.gov/docs/2004/112-5/correspondence.html
April 2004 . . . AB 2025 (Chu) Remove Chemical Hazards from Cosmetics
http://www.leginfo.ca.gov/pub/bill/asm/ab_2001-2050/ab_2025_bill_20040415_amended_asm.html
Alas, withdrawn because Chairwoman of the Health Committee, Rebecca Cohn, refused support.
If you wish to thank Assemblymember Chu for her efforts, and encourage her to revisit this much needed endeavor, please write to her via her contact page at http://democrats.assembly.ca.gov/members/a49/contacts.htm
or by mail at:
Capitol Office
State Capitol
P.O. Box 942849
Sacramento, CA 94249-0049
Phone: 916-319-2049
FAX: 916-319-2149
April 2004 -- Anderson Laboratories makes available a brochure in text format.
"Perfumes and Asthma - donžt mix" was a collaborative effort by:
Julius H. Anderson, M.D.Ph.D.(ALI);
Betty Bridges, R.N.(FPIN);
Lynn Lawson, M.A. (Chronic Fatigue Syndrome, Fibromyalgia,
& Chemical Sensitivity Coalition of Chicago).
Lawrence A Plumlee, M.D. (Chemical Sensitivity Disorders Association); and
Barbara Wilkie (EHN).
May 2004 -- Air-fresheners cause a stink
Fears raised as plug-ins linked to cancer compounds.
Mark Peplow Đ Nature News Service / Macmillan Magazines Ltd 2004
"A potentially harmful smog can form inside homes through reactions between air-fresheners and ozone, say researchers at the US Environmental Protection Agency (EPA). The reactions generate formaldehyde, classed as a probable carcinogen, and related compounds that many experts believe are responsible for respiratory problems.
"The researchers studied the reactions between ozone gas and fragrance molecules such as pinene and limonene, which are emitted by air-fresheners that plug into electrical outlets. Ozone, produced at ground level when vehicle exhaust emissions react with sunlight, is a common urban pollutant, and environmental bodies have set limits on outdoor levels of it. ..."
A HREF="http://www.nature.com/nsu/nsu_pf/040503/040503-11.html">http://www.nature.com/nsu/nsu_pf/040503/040503-11.html
June 2004 -- The Honorable Judy Chu
P.O. Box 942849, Room 2148
Sacramento, CA 94249-000
California AB 2012 -- June 18, 2004; pending legislation
The following quotes from letter of support by the National Environmental Trust.
AB 2012 for the first time requires full content disclosure of
ingredients in common personal care products, giving California
consumers the ability to make more informed choices about the
cosmetics they purchase. The bill also prohibits the use of the
hazardous coal tar and phthalates.
While AB 2012 doesnžt deal specifically with the topic of fragrance pollution, it does talk to phthalates, which are commonly added to fragrances to make the scent last.
Not only do women of child bearing age frequently use products
containing such chemicals, they also transfer many of these chemicals
across the placental cord to the developing fetus.
Alas, defeated in August 2004 because of strong chemical and fragrance industry pressure . . . and walking Democrats. -- barb
June 14, 2004 -- Environmental Working Group's investigation: A safety assessment of ingredients in personal care products . . . Fragrances <
A HREF="http://www.ewg.org/reports/skindeep/report/allergies.php">http://www.ewg.org/reports/skindeep/report/allergies.php
"... Based on their experience in treating people sensitized to cosmetics, the American Academy of Dermatology recommends that sensitized patients use only fragrance-free products, and avoid all perfumes, colognes, after-shaves, fingernail care products, and hair spray (AAD 2000). ..." The Petition begins at
http://www.ewg.org/reports/skindeep/petition/index.php
EWG files petition with FDA: SKIN DEEP -- June 4, 2004
I'd add: . . . And BEYOND!, for these chemicals go into your body via absorption and inhalation. Fragrances adversely affect user and nonuser, who really is an nonconsenting secondhand user. -- barb
http://www.ewg.org/reports/skindeep/report/executive_summary.php
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