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The Environmental Health Network of California
Files Petition With the FDA
in 1999

Note: This petition seems to have died an unnatural death at the hands of the FDA. -- barb


Dockets Management Branch
The Food and Drug Administration (FDA)
Department of Health and Human Services, Rm. 1-23
12420 Parklawn Dr.
Rockville, MD 20857
(Sent via email to fdadockets@oc.fda.gov")

Re: 99P-1340 -- Petition to Have Eternity eau de parfum declared "Misbranded"

To: Butler, Jennie C
From: Barb Wilkie wilworks@LanMinds.Com [now
Sent: Monday, January 24, 2000 10:04 PM
To: fdadockets@oc.fda.gov (Note: this easy way of contacting the FDA is no longer functional. -- bw)

Subject: New evidence to submit in support of Docket Number 99P-1340

Dear FDA Staff:

I request that FDA weigh in on the side of public health as it ponders the great question: Pubic Health or Fragrance Industry?

I'm not pleading only on behalf of the millions who are already aware of the fact that their health and lives have been adversely affected by fragrances. Nor am I pleading only on behalf of the millions more who have yet to learn -- because they refuse to believe -- that their favorite fragrance could be making them ill, or their doctors are not astute enough -- or educated enough* -- to make the diagnosis.

There is an even bigger issue at play here: Is the FDA unaware of all of the dangers fragrances pose and the fact that these chemical formulations DO affect the body's functions? The bodies affected range in age from fetal to elderly, they are male and female, and all races. And, our numbers continue to grow.

The Cosmetic Handbook ** defines cosmetics as "...articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions." [emphasis added].

What do we do with mounting evidence that these chemicals DO affect the body and the brain? Continue to ignore it?

Certainly those of us who are the harbingers know these chemicals adversely affect the human body -- as do our doctors. We also know that it isn't just our bodies and minds that are affected, but the bodies and minds of the fragrance chemical users.

I truly believe that those fragrance users who perpetrate the hateful-hurtful assaults upon those of us who are already ill, are indeed adversely affected by the chemicals they are unwittingly welcoming into their bodies ... and the bodies of their children. The various fragrance chemical formulations do trigger aggressive behavior. Spraying fragrances at an individual, around or on the desk or in the work area of someone who is already ill, is indeed and act of aggressive assault. And such an assault has happened to one who never before was reactive to fragrances . . . but has been since the fragrance wearer's act of aggression.***

We learned in 1986, in a presentation by the National Academy of Sciences to the 99th Congress that fragrances were neurotoxins. (See Neurotoxins: In Home and the Workplace at http://ehnca.org/www/ehnlinx/n.htm#Neurotoxins.)

Now I've found more information that fragrances can affect the brain as do alcohol and tobacco. See "Potentiation of GABAA receptors expressed in Xenopus oocytes by perfume and phytoncid."
Aoshima H, Hamamoto K
Department of Physics, Biology and Informatics, Faculty of Science, Yamaguchi University, Japan.
aoshima@po.cc.yamaguchi-u.ac.jp
http://www.ncbi.nlm.nih.gov/pubmed/10361687

I also make my plea on behalf of our unborn and our infants.

Regarding the unborn, please visit: http://www.chem-tox.com/pregnancy/perfume.htm
where you will see the following topics:

  1. Perfume and Fragrance
    Exposure During Pregnancy

       Links to Learning Disabilities, ADD and Behavior Disorders

  2. Fragrance Exposure Causes Aggression Hyperactivity and Nerve Damage
    Neurotoxicology, Volume 1:221-237, 1979

  3. Common Fragrance Ingredient Damages Connections Between Brain Cells
    Toxicology and Applied Pharmacology, Volume 75:571-575 (1984)


Even a fragrance company states, "Just a note, personally, if someone is pregnant, we would not use any Fragrance, Essential Oil or Aromatherapy items." See The Good Scents Company
http://www.thegoodscentscompany.com/misc/safety.html

While this is sound advice, it is impossible to carry it out. Fragrances are VOLATILE ORGANIC COMPOUNDS, which pollute the air for all to breathe -- to enter our bodies whether we choose to use the toxic fragrance formulations or not. And fragrance formulations contain chemicals that quickly enter the blood stream and cross the blood-placental "boundary" or the blood-brain boundary, leaving me to wonder, WHAT BOUNDARY???

Recent information has become available regarding pregnant women, infants and young children, showing they are adversely affected by air "fresheners." (What a misnomer that is!) Now, I know that the FDA does not handle products such as these, but air "fresheners" do contain fragrances, so therefore I've included them. Please see "Aerosols linked with baby illness"
http://news.bbc.co.uk/hi/english/health/newsid_435000/435652.stm
and, "Study links aerosols to headache, depression" [and ear infections in infants!]
http://www.planetark.org/dailynewsstory.cfm?newsid=3473

One does not have to be an Einstein to figure this out: Fragrances are deleterious to health from fetal development to old age -- as indicated by this information: "Researchers at John Hopkins University are studying the reasons why so many elderly people are dying from asthma." AIRTECH INTERNATIONAL GROUP
http://www.airtechgroup.com/

We must realize that the care facilities for the elderly, be they retirement homes, assistive living or skilled nursing facilities, are loaded with fragrance products, used for personal care and cleaning/maintenance projects. And on still another front: Recently, a mite-cide product was recalled because of fragrances! See EPA: ALLERCARE PRODUCTS RECALLED DUE TO ASTHMA AND RESPIRATORY PROBLEMS at
http://yosemite.epa.gov/opa/admpress.nsf/0/626ac02c8e90400085256866006b3a0e?OpenDocument

Questions & Answers - AllerCareTM Product Recall
http://www.epa.gov/pesticides/citizens/allercareq_a.htm#1 [has become a PDF file:
http://web.utk.edu/~extepp/rnn/Allercare.Q&A.PDF.

ReutersHealth AllerCareDust mite spray, powder recalled WASHINGTON, Jan 14 (Reuters) "S.C. Johnson said that it believed the fragrance of its dust mite spray and powder was to blame for the allergic reactions in consumers. ..."
http://www.reutershealth.com/eline/open/2000011421.html

Fragrance products -- personal care and cleaning/maintenance -- should not be used in the workplace, in schools, healthcare facilities ... recreational facilities. The harbingers -- "canaries" -- and their astute doctors know this. And now even the Institute of Medicine has announced the fact that fragrances in personal care and cleaning products can trigger asthma. [At the very least!] Please see "Study Finds Strong Evidence That Exposure to Some Indoor Substances Can Lead to or Worsen Asthma" at
http://www4.nas.edu/news.nsf/isbn/0309064961?OpenDocument

It is past time due for the fragrance industry to be regulated, but barring full regulation, it is certainly past time due for the FDA to follow its own regulations already in place, and at the very least, require warning labels on products released to market without adequate testing. (Or as stated by the FDA: "... without substantiation of safety.") AND, fragrances should be SAFE to use in the privacy of one's own home, among consenting adults!

    See Prohibited Ingredients and Related Safety Issues
    March 30, 2000
    Substantiation of safety
    " ... It is the responsibility of the manufacturer and distributor to assure the safety of each ingredient and finished product. Without substantiation of safety, Title 21 of the Code of Federal Regulations (21 CFR), Part 740.10 [http://www.cfsan.fda.gov/~lrd/cfr740.html] requires that the product carry the following warning on the label:
    'Warning: The safety of this product has not been determined.' ..."

The FDA owes it to the American public -- and to the economy! -- to, at the very least, require warning labels on fragrances released to market without adequate testing. It is false economy to let this burgeoning fragrance-induced health care crisis continue unabated.

Please remember as you ponder this great question -- "Pubic Health or Fragrance Industry?" -- one cannot assess the dollar amount on human suffering and death.

[Let us look for those neurotoxins and carcinogens, the irritants and sensitizers that the fragrance industry knows exists in fragrances. Let us look for the hormone disrupters and the teratogens. Let us look, truly research, REALLY thoroughly test fragrances. That means to test for more than just what happens to the skin of the primary user.]

Thank you for your time.

Sincerely,
Barbara Wilkie
(My convention is prevention)


*  The information is in a publication by a multiagency group, including EPA, that tells us regarding our modern diseases from environmental -- chemical -- causes: "doctors are likely to have attended the 75 percent of the medical schools that require only seven hours training during their medical schooling." Health Care & Pesticides (a multiagency -- National Strategies for Health Care Providers: Pesticides initiative report's documentation: Schenk M, Popp SM, Neale AV, et al. Environmental medicine content in medical school curricula. Acad. Med. 1996;71(5):27-29.)

Back to letter.


**   FDA's Cosmetic Handbook
1. Regulatory Requirements for Marketing Cosmetics in the United States
" ... The FD&C Act defines cosmetics as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions. Included in this definition are products such as skin creams, lotions, perfumes, lipsticks, fingernail polishes, eye and facial make-up preparations, shampoos, permanent waves, hair colors, toothpastes, deodorants, and any material intended for use as a component of a cosmetic product. Soap products consisting primarily of an alkali salt of fatty acid and making no label claim other than cleansing of the human body are not considered cosmetics under the law. ... "
http://vm.cfsan.fda.gov/~dms/cos-hdb1.html

Something I do not understand is why all cosmetics containing fragrances are not classified as drugs, as they certainly enter bodies via absorption and inhalation, and in my case, it's as if I'm eating them, for I taste the chemical concoctions and they create sores in my mouth. But beyond that, fragances contain chemicals that are known neurotoxins. Why are fragrances not regulated by our government agencies charged with protecting public health? -- barb

Back to letter.


*** Quantum Sufficit : Just Enough.(medical notes)
American Family Physician, July 15, 2001, by Sarah Morgan, Lori Parry
"... This is for anyone who thinks that medical assistants have an easy job. A case study published in the Journal of the American Board of Family Practice describes a 21-year-old medical assistant who suffered an acute anaphylactic reaction and respiratory distress shortly after a patient attacked her by spraying perfume in her face. The employee's adverse reaction was severe enough to warrant a two-day hospitalization along with two weeks of tapering steroid treatment and oral bronchodilator therapy, followed by two months of persistent shortness of breath. The attacker said she had sprayed on extra perfume so the physician would not notice she had been smoking. When questioned by the assistant, she pumped three sprays of perfume directly into the medical assistant's face. ..."
http://www.findarticles.com/cf_dls/m3225/2_64/76414116/print.jhtml

Occupational Acute Anaphylactic Reaction to Assault by Perfume Spray in the Face
James E. Lessenger, MD
"Background: Perfumes have been associated with rashes in employees exposed to scented soaps or with allergic conditions, such as rhinitis or asthma, in employees exposed to perfumes or fragrances in the air. ..." http://www.jabfp.org/cgi/reprint/14/2/137

By the bye, there is a paper on instructing patients who are sensitive to perfume -- reference number 17 in the paper, above. ( J Am Acad Dermatol. 1989 Oct;21(4 Pt 2):880-4. How to instruct patients sensitive to fragrances. By Larsen WG.; Portland Dermatology Clinic, OR 97210.
http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=2689482&dopt=Abstract)

This advice would have killed me off while I was working and subjected to perfume pollution on a daily basis. I wore a mask and used oxygen as needed. Another point, the abstract leads one to believe that the only thought given is to the skin reactions . . . there isn't a hint -- at least in the abstract -- that there are any problems upon inhalation of these poisonous fragrance concoctions. Remember there's about 4,000 chemicals used to make fragrances and tens to hundreds of them are used to manufacture any ONE scent. And while this information is on dermatology, published in 1989, it follows by three years the information presented by NAS to the 99th Congress on the neurotoxic effects of fragrances. (See Neurotoxins: At Home and the Workplace, under EHN's Neurotoxins -- http://ehnca.org/www/ehnlinx/n.htm#Neurotoxins

Also see EHN's category, Assaulted. Then, don't tell me that fragrance wearers are not acting out aggressive behavior. -- barb
http://ehnca.org/www/ehnlinx/a.htm#Assaulted

Back to letter.


+++

barb's views reflect only her opinion and do not necessarily reflect those of the Environmental Health Network or its board.

==

Do you suffer asthma, sinusitis, migraines, leaky beaky?

Have you discovered that no matter what you do to follow doctor's orders to clean away those dreaded dust mites, you still have asthma, et al.?

Think about all of the modern fragrances that enter your life through personal care and cleaning products. Fragrances are made with toxic chemical formulations by an unregulated industry. They are at best "irritants" capable of causing or triggering asthma, and at worse may cause central nervous system disorders and cancer.

See EHN's FDA Petition requesting the FDA require warning labels - the regulations exist, the FDA doesn't enforce them! http://www.ehnca.org/www/FDApetition/bkgrinfo.htm

Reference "Docket Number 99P-1340" and tell the FDA about illness you suffer because of fragrances.

E-mail no longer functioning! fdadockets@oc.fda.gov



Please write to the FDA in support of this petition.
Your note could be just a couple of lines informing the FDA that fragrances
pose a serious health problem for you and/or your family members.

Or, you can copy one of the sample letters to use as the basis for your own.
See Sample Letters at
http://ehnca.org/www/FDApetition/sampletr.htm#Sample

If you'd care to have your letter posted on EHN and FPIN, please copy:
Betty Bridges, FPIN
Barbara Wilkie, EHN

Please put FDA Letter in subject line. Thanks.

To view a sample letter, visit:
http://ehnca.org/www/FDApetition/sampletr.htm#SAMPLE


Return to Index of Letters in Support of Petition

Return to EHN Petitions the FDA


As with all organizations, EHN depends upon your contributions of
time and energy, as well as your membership support.
http://ehnca.org/www/ehnhompg/membship.htm


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Now Barb Wilkie's site. Formerly, the site of the Environmental Health Network (EHN) [of California]. EHN is a 501 (c) (3) non profit agency and offers support and information for the chemically and electromagnetically injured. The URL for EHN's HomePage is http://ehnca.org