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EHN Files Citizens' Petition With the FDA

Analysis Summary Foreword
Opinion piece by Barb Wilkie,
not part of the petition submitted to the FDA.


Calvin Klein's Eternity eau de parfum

What you think you are buying:

    "A romantic floral fragrance. Freesia, mandarin and sage accent the top note which combines with muguet, white lily, marigold and narcissus from the white floral bouquet that is the middle note. Patchouli with exotic notes of sandalwood and amber complete the background." The Fragrance Foundation 2002 Reference Guide, page 185. Eternitywas created by the Calvin Klein Cosmetics Company in 1988. UNILEVER COSMETICS INTERNATIONAL

What you are buying:



In May 1999, the Environmental Health Network of California, filed a Citizens' Petition with the US Food and Drug Administration (FDA). It was logged in and assigned Docket Number 99P-1340. This petition requests that the FDA follow its regulation for warning labels, which is already in place on its books. Included with the petition were the results of analyses of six popular scents. Because the identity of the six scents was not revealed, an analysis was then purchased for Calvin Klein's Eternity eau de parfum. See The Analysis of Perfumes and Their Effect on Indoor Air Pollution, By John J. Manura; November 1998. http://www.sisweb.com/referenc/applnote/app-73i.htm. and Analysis Summary by a member of RIFM (Research Institute for Fragrance Materials). http://ehnca.org/www/FDApetition/analysis.htm

When you visit the Summary, pay close attention to the right-hand column of the table of chemicals found in that analysis. This phrase, taken from MSDS (Material Safety Data Sheets) for the chemicals, is repeated throughout: "The chemical, physical, and toxicological properties have not been thoroughly investigated." Also notice all the chemicals listed on EPA's Toxic Substances Control Act (TSCA) Inventory and the Registry of Toxic Effects of Chemical Substances (RTECS). You'd think the EPA would be interested in the fragrance chemicals found through analysis even if FDA is not. (See ChemAlliance's "Background: TSCA," which states in part:

    "... A major objective of TSCA is to characterize and evaluate the risks posed by a chemical to humans and the environment before the chemical is introduced into commerce. TSCA accomplishes this through the requirement that manufacturers perform various kinds of health and environmental testing, use quality control in their production processes, and notify EPA of information they gain on possible adverse health effects from use of their products. Under TSCA, "manufacturing" is defined to include "importing", and thus all requirements applicable to manufacturers apply to importers as well.

    "EPA has authority to ban the manufacture or distribution in commerce, limit the use, require labeling, or place other restrictions on chemicals that pose unreasonable risks. Among the chemicals EPA regulates under TSCA are asbestos, chlorofluorocarbons (CFCs), and polychlorinated biphenyls (PCBs). ..." http://www.chemalliance.org/Handbook/background/back-tsca.asp.

You'll surely notice that some of the chemicals found are known irritants and/or sensitizers. (Hello, asthma rate increases!) But the findings don't stop there, as bad as that is. We also found that some of the chemicals are known or suspected neurotoxins (capable of adversely affecting the Central Nervous System), teratogens (capable of causing adverse effects on embryonic or fetal development) and carcinogens (capable of causing cancer). Some chemicals -- for example, phthalates -- are hormone disruptors that could affect developing embryos and fetuses, children and adults. That is quite a heady brew. And remember, fragrances are manufactured to be "shared" with others . . . without regard to their health conditions, including pregnancy.

Now, keep that information in mind as you read the following statements provided by our FDA.

FDA's "Authority Over Cosmetics"

Lynn Lawson informs us in her book, Staying Well in a Toxic World ... "Due to some adroit lobbying years ago by the cosmetics industry, the FDA has to beg for safety rather than demand it" is Ralph Nader's acerbic observation. [Noble Press, Inc; 1993, page 287, The FDA.]

The FDA tells us in its own words:

    "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
       'WARNING: The safety of this product has not been determined.' "

    "FDA does not have the authority to require manufacturers to register their cosmetic establishments, file data on ingredients, or report cosmetic-related injuries. ..."

    "Recalls are voluntary actions taken by the cosmetic industry to call back products that present a hazard ..."

But, the FDA CAN REQUIRE WARNING LABELS!

    "[I]f ... the safety of a cosmetic product has not been substantiated, the product's label must read:
      "WARNING: The safety of this product has not been determined."

    Source: FDA Authority Over Cosmetics
    http://vm.cfsan.fda.gov/~dms/cos-206.html

So, why do we have an FDA not doing the one thing it can do in regard to the unleashing of toxic chemical brews on an unsuspecting public by a self-regulated industry? I don't have an answer , but I do wonder . . . Is it strictly economic considerations of the industry or does negligence play a part? Negligence defined (according to American Heritage Dictionary):

    "Failure to exercise the degree of care considered reasonable under the circumstances, resulting in an unintended injury to another party.

In the early 1990s I hadn't believed for a minute that we all were intended victims, hence I chose the word "negligence." But, as the FDA has heard from people down through the years, and especially following the FDA Petition, and still considers fragrance sensitivity a low priority, I'm wondering more and more if "dereliction of duty," is more the point? According to my same dictionary source, it means:
    "1.    Willful neglect, as of duty or principle.
    "2.a.  The act of abandoning; abandonment. b. A state of abandonment or neglect. "

And lastly, there's the information that John Bailey PhD,1 the former head of FDA's cosmetics branch, is now with the Cosmetic, Toiletry, and Fragrance Association (CTFA), having joined them January 2002. Without trying to cast aspersions on his eschutcheon, I cannot help but wonder: Has he finally followed his heart?

Will a change in FDA top staff create an opportunity for the already chemically injured to be heard, to be listened to? For only in listening to the harbingers -- we are ignored Human Observational Studies -- will the FDA learn that they should begin requiring their warning message be affixed to labels of fragrances released to market without adequate testing. Let the industry explain how it "thoroughly tests" by testing dermatological reactions of primary users, while not taking into account second- and thirdhand adverse events, including but not limited to:

  • dermatological reactions;

  • reactions via inhalation, affecting upper and lower respiratory system;

  • neurotoxic reactions despite the fact that testing for neurotoxicity of fragrances was recommended to the 99th Congress by the National Academy of Sciences, back in September 1986;

  • systemic effects; and

  • long-term effects.

And then there is this FDA position statement found by renowned researcher, Betty Bridges, RN, who has developed the Fraganced Product Information Network (www.fpinva.org). The following FDA Q&A on fragrances is located at the very bottom of an FDA FOOD page:

    Q. Inhalation of fragranced products is known to trigger asthma and migraine headaches in some individuals. The EPA names "the use of chemically formulated personal care products" along with pesticides and household cleaners as contributors to indoor air pollution. How do you propose to raise public awareness of possible health risks from use of these products?

    A. FDA has little or no information that would support actions to raise public awareness of possible health risks associated with the use of fragranced products. Current regulations do require that products that contain added fragrance ingredients must be labeled in the product ingredient statement as containing "fragrance." FDA is aware of concern about this issue and encourages continued participation by its stakeholders in gathering data to address the possible health risks associated with the use of fragranced products. FDA is committed to fostering such participation by its continued sponsorship of stakeholder outreach initiatives, e.g. public meetings. These public forums not only provide interested persons with an opportunity to comment on the potential health risks associated with fragranced products, but also help identify possible solutions to address these risks." (Web page updated by clb 1999-JUL-16. )
    http://www.fda.gov/oc/fdama/fdamawebcast/stakeholdersquestions/foods.html.

To put this statement further into perspective: On June 11, 1999, comments 52 - 104 were logged and included the work of the doctors Anderson of Anderson Labs (C 97 Anderson Laboratories Inc Vol#: 3 -- a PDF file downloadable from http://www.fda.gov/ohrms/dockets/dailys/061199/c000097.pdf -- now available through http://web.archive.org/web/20000831232855/http://www.fda.gov/ohrms/dockets/dailys/061199/c000097.pdf. (The Anderson's site is http://www.andersonlaboratories.com/.) By July 14, 1999 -- two days before the above info was uploaded to the FDA's site -- the FDA had logged comments 165 and 166. That means that in just two month's time the FDA logged well over 100 comments regarding fragrances. Yet, not only did the FDA do nothing about it, the agency had the audacity to state 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." You can reach EHN's index of FDA-logged comments by visiting http://ehnca.org/www/FDApetition/letinfda.htm#comments. The FDA Dailys page for 2002 is http://www.fda.gov/ohrms/dockets/dailys/dailys02.htm

By George!, millions upon millions of us have been abandoned by our FDA. And here I'm only thinking of those already living with the effects of fragrance sensitization. What about all the other people who have yet to become ill, or who have yet been able to track their sometimes insidious illnesses to their reliance upon scented products? Remember, medical doctors receive an extraordinarily limited amount of training when it comes to environmental illnesses. No wonder there seems to be skyrocketing rates of various chronic illnesses leading some to use the word "epidemic," which then begs remembering that epidemics are not associated with genetic traits. We are talking environmental illnesses and as such, be they cancers or asthma, headaches or aphasia, reproductive or fetal development problems, many, if not most, could be prevented. Caveat Emptor!

 
Fragrance industry's assurances

Now let's look at what the industry has publicly stated.

  • Some say a popular perfume is a health danger!! 02/00
    http://www.wsfa.com/Global/story.asp?s=58076

    • "After contacting Calvin Klein for a response to the petition that the group [EHN] filled [sic] with the FDA the company had this statement: 'All of Calvin Klein's products meet or exceed the requirement of the Federal Public Food, Drug and Cosmetics Act.' "

    A savvy consumer, who has taken the time to look up FDA regulations, might ask: What requirements? It is easy to meet or exceed the FDA authority as outlined above.


  • Common Sense About Scents - A fragrance industry ad
    http://www.scentedproducts.on.ca/hdnad.jpg

    Doubts are dispelled by the Scented Products Education and Information Association of Canada (SPEIAC) in an ad published following their press conference in Halifax, Nova Scotia, June 20, 2000.2 SPEIAC assures us:

    • All fragrance ingredients have been tested for safety.
      The Research Institute for Fragrance Materials is an international
      independent body dedicated to evaluating fragrance ingredient safety.

    • Fragrance ingredients are tested to the same standards that
      apply to consumer goods like food.

    • The composition of perfumes hasn't changed much in hundreds
      of years. They contain primarily water and alcohol 3 -- of the same
      type and purity we drink in beverages -- as well as essential fragrance oils.

    • Fragrance formulations do not contain toxic ingredients such as
      carcinogens or neurotoxins. 4

    • Perfumes and scented personal care products are regulated by
      Health Canada.

    • The safety of an ingredient does not depend on whether it is
      natural or synthetic. For example, almost half of the ingredients
      no longer used in fragrances are naturals that caused skin irritation.


  • Panel Reaffirms Phthalates In Cosmetics are "Safe for Use"
    November 19, 2002
    "...Finding no evidence to suggest that consumer exposure to phthalates in cosmetics and personal care products poses a health risk, the panel of independent toxicologists and dermatologists voted unanimously that phthalates "are safe for use in cosmetic products in present practices of use and concentration."
    (Phthalate Information Center http://www.phthalates.org/mediacenter/pep_2002_11_19.html)

      The statement above was written in response to Not Too Pretty and its report on the harmful effects of phthatlates on developing male fetuses, and now we learn men, too. (See NTP's various releases, including: SPERM DAMAGE LINKED TO PHTHALATE USED IN FRAGRANCES, NEW STUDY BY HARVARD RESEARCHERS FINDS; December 9, 2002 http://www.nottoopretty.org/pa_12_09_02.htm)

  • FRAGRANCES AND FRAGRANCE INGREDIENTS ARE SAFE, WELL TESTED.ÝÝ CONSUMERS SHOULD NOT BE ALARMED.
    http://www.ifraorg.org/Enclosures/News/FMA%20Statement_11%2015%2002.doc.
    "Washington DC, November 19, 2002 --In response to the alarmist campaign by environmental activists, the Fragrance Materials Association (FMA) reinforces that fragrances are safe and perfumers use safe and thoroughly tested ingredients to make fragrances.ÝÝ...

    "... By law, fragrance manufacturers must assure that all ingredients they use to make fragrances are safe. These ingredients are not listed on labels because fragrance formulas are protected under the intellectual property laws,? Roberts continued.Ý Each fragrance is a unique artistic creation, which may consist of hundreds of ingredients, and each final fragrance formula goes through rigorous safety review before its introduction by perfumers.Ý Ý

    "Furthermore, fragrances usually constitute only a small part of ready products ? for instance, the content of fragrance mixture in a strongest possible concentration, perfume, is only 5 to 35 percent, and much less than that in other products.Ý So the quantity of each of the individual ingredient used in a fragrance is practically indiscernible. Ý

    "For decades, the fragrance industry has been committed to providing our customers and the public with safe products.Ý As the government, independent scientists, and our own industry continue research on fragrance ingredients, FMA will continue to consider and evaluate the latest research to ensure only the best and safest ingredients are used in our products.Ý Assuring our clients of the utmost safety and quality is a top priority for FMA and our members.Ý Ý..."

      Excuse me, but WHAT "government and independent scientists"? I haven't found any in the FDA who have researched fragrances thoroughly and other government agencies don't seem anxious to tackle the adverse events associated caused by our modern scents and scented products. The industry tells us that "the individual ingredient used in a fragrance is practically indiscernible," and while that statement may be true, there is no information about the combined effects of many of those ingredients used in a plethora of perfumed products. Nor is there any mention of the effects of those chemicals as they volatilize to become one with the air we all must breathe. Nor is there any study of the effects of multiple sources of fragrance chemicals upon developing embryos and fetuses. ETC.

  • Scents and sensitivities - What to know before buying a Valentine's Day perfume is an informative article by Francesca Lyman; Feb. 6, 2002; MSNBC Contributor.
    Mirrored on EHN with the kind permission of Ms. Lyman and MSNBC. -- barb
    http://ehnca.org/www/FDApetition/flscents.htm

    Had been at: http://www.msnbc.com/news/702445.asp and then it was re-released
    October 2002. and up on http://www.msnbc.com/news/702445.asp?cp1=1

      Some notable quoteables in Ms. Lyman's Scents and sensitivities:
    • "Products are thoroughly tested before being marketed to assure their health and safety, says Glenn Roberts, spokesperson for the Research Institute for Fragrance Materials, an industry-sponsored group that does testing of chemicals. ..."

    • ... "In response to the perceived problems of fragrances in the air, Roberts says that his industry group has begun the first study to examine fragrance inhalation. 'We're spending a lot of money on this,' he says [emphasis added], 'to understand the systemic effects of fragrances on organs and nervous system, what happens when fragrances are inhaled.' "

    • "An FDA spokesperson says it [EHN's petition 99P-1340] is still „under review,¾ but not considered a priority.

      " NO PREMARKET SAFETY TESTS REQUIRED
      " 'As a regulatory agency, we are concerned about the safety of cosmetics,' says an FDA spokesperson. 'But the agency has no authority to require cosmetics to be safety tested before marketing. However, if the ingredients and final product in a product haven't been substantiated, then a warning label can be required on a product stating "the safety of this product has not been determined." '

      "The FDA also noted that even cosmetics that claim to be "fragrance free" can contain perfume to mask other odors: "Fragrance free" only means that a cosmetic "has no perceptible odor." The agency explains: "Fragrance ingredients may be added to a fragrance-free cosmetic to mask any offensive odor originating from the raw materials used, but in a smaller amount than is needed to impart a noticeable scent."

      "INDUSTRY¼S SAFEGUARDS
      "Despite the lack of FDA safety testing, RIFM¼s Roberts provides assurances that safety is insured in a four-step process. 'First, we have a long history of cosmetics ingredients use to go on; additionally, EPA requires safety testing for any new chemicals coming on the market,¾ he says. Additionally, „RIFM does its own safety testing of chemicals ã we¼ve tested about 90 percent to 95 percent in use ã and many fragrance and cosmetics companies do their own testing.'

      "Besides this, says Roberts, FDA collects complaints from consumers, 'and from their records, that¼s less than 1 complaint per million users.'

    I thought I smelled the odor of dissembling.

    Remember above, we've been told the industry "thoroughly tested" and yet the last paragraph in Ms. Lyman's article had the same spokesman, Glenn Roberts, stating that the industry has "begun the first study to examine fragrance inhalation." These products are made to be inhaled! IF the industry has just begun its first study for effects upon inhalation and including systemic effects, how in the world can these products have been "thoroughly tested."

    This is a faith-based industry, as far as I can tell. We must have faith that what they tell us is true. We aren't privy to the ingredients, unless we cough up a lot of money for a lab analysis. The tests and their results are also kept secret . . . except for the fact that fragrances have been tested for dermatological effects upon the PRIMARY user. Even with that testing, consideration is not given the individual who does not wear or use scented products and yet suffers adverse skin reactions to those volatile chemicals released to the ambient air by others. Thorough testing? I think not.

    A query of the EPA, assured me that Roberts comment is confusing and inaccurate. But, that brings to mind another point: The EPA also assured me that it is interested in chemicals that appear on its Toxic Substances Control Act (TSCA) Inventory, yet when I pointed out the number of chemicals found in Calvin Klien's Eternity eau de parfum, I was told my comments would be sent to Air Quality . . . and I've never heard back. Not even further inquiry.

    And then, with all that assurance about "a long history of cosmetics ingredients use to go on," what we really should keep in mind is the change during the past 30 years, from perfumes made largely with plant and animal essences to perfumes now made mostly with petrochemical derivatives. Besides, never before in history had their been such a proliferation of perfumed products. Nor had perfumes been created to last interminably long on the person or in the ambient air or in the fabric laundered with them . . . for that, in part at least, you can thank the addition of hormone
    disrupting PHTHALATES. It's time for a change in FDA paradigm.

    The industry has "begun the first study"

    It's about time!

    Imagine! The fragrance industry has released synthetic chemical products to market, which are made to be inhaled (smelled), and it has not studied them for adverse effects upon inhalation.

    It boggles the mind to realize that back in September 1986 -- [in 2002] 16 very long years ago! -- the National Academy of Sciences targeted fragrances as one of the six categories of chemicals that should be given high priority for neurotoxicity testing. (Neurotoxins affect your brain and nervous systems.) Neurotoxins: At Home and the Workplace (Report by the Committee on Science and Technology. U.S. House of Representatives, Sept. 16, 1986) [Report 99-827] (From Julia Kendall's "Making Sense of Scents." http://ehnca.org/ehnmsofs.htm#National)

    These chemical concoctions have not been tested for systemic and long-term effects. But it is not only the general public who remains clueless about the adverse effects of these products used daily -- too many of our mainstream doctors and our government agencies chraged with protecting public health, remain equally clueless.

    Those who are "in the know" and our doctors have been ignored or stultified. We are viewed as malingerers, chronic complainers, somatizers, ... We should be seen as harbingers, as "Observational Human Studies." Maybe then we wouldn't see "UNEXPLAINED" as the one-word non-explanation explanation given when our experts are asked about the skyrocketing rates in asthma, cancers, ADD, Alzheimer's, low-birthweight babies and other fetal development problems, MCS and other chronic diseases.

    Synthetic scents have been tested for adverse skin reactions suffered by the primary user. And, even with that testing, both the industry and our FDA have not given a thought to all of the skin conditions -- mild to severe -- that are suffered by people who are exposed to scents second- or thirdhand. Furthermore, our mainstream medical doctors are not likely to recognize eczema, acne, rashes, hives, burning and itchiness as being caused by fragrances worn or used by others, although "airborne contact dermatitis" is known. Just because adverse affects haven't been studied officially, doesn't mean that they don't exist. And just because products are not adequately tested before marketing for effects upon inhalation, neurotoxicity, or for long-term, systemic effects, doesn't mean they are proven safe to use. The axiom, "What You Don't Measure, You Can't Manage" comes to mind.


    Making the tobacco industry look like small potatoes

    Let's take another look a that definition of negligence (American Heritage Dictionary):

      "Failure to exercise the degree of care considered reasonable under the circumstances, resulting in an unintended injury to another party.

    Fragrances are made to be smelled, which happens when we inhale, breathe in . . . but the effects don't stop with our olfactory sense. These chemical concoctions are something with which to be reckoned.

    Fragrances are volatile organic compounds (VOCs) so they can adversely affect not only the person who uses the product, but also those who merely come in contact with the noxious fumes left by a user. Severe adverse effects can be suffered from secondary and tertiary levels of exposure. To spell it out: The volatilizing chemicals from scented products include but are not limited to perfumes, scent permeated fragrance ads, fabric softeners wafting on the ambient air, fragrance spritzing devices and other air "fresheners," can cause serious illnesses -- even life-threatening reactions and premature death -- in the body of an already fragrance-sensitized individual. (See EHN's section, Death: http://ehnca.org/www/ehnlinx/d.htm#Death.)

    The other problem is: One never knows when a fragrance reaction will move from one of just annoyance into one with serious consequences. People "get IT!" if you talk about bee stings. They get "IT!" if you talk about peanut allergies. Heavens, even airlines have not served peanuts if a person with a peanut allergy boards. But airline staff and fellow passengers all feel perfectly free to wear and reapply perfume and other scented products, never mind if it puts the fragrance-sensitized people in harm's way. And airlines use recognized air polluters -- misleadingly labeled "freshener" -- in their privies. Of course, just to make sure we are subjected to adverse reactions, planes are also pesticided (and, pesticides are scented so folks don't object too much to the odor of those toxins. There are safer measures one could take to clear the air and control the pests. (Aviation Consumer Protection Division http://www.dot.gov/airconsumer.)

    That sudden jolt from annoyance into extraordinary illness and debilitating disease and disability happened to me. One unfortunate encounter, with a young woman who came in late to a ball game and sat in front of me, put me over the edge, into life with MCS. Anecdotal, but true. I hardly have seen myself as a malingerer . . . but the fragrance industry and its chemical industry sibling the mainstream medical industry, and their government agencies charged with protecting public health, haven't been interested in seeing us as harbingers, as Human Observational Studies. That would be bad for the multibillion dollar industry's economy. But my tale is a commonly shared experience.

    A word to the wise: Following the lowering of one's threshold by daily contact with your own scented products, or as in my case, scented colleagues, just one bad experience with perfume, paint, anesthetics, diesel exhaust, an industry release, pharmaceuticals (yep, they are petroleum products, too), carpet, adhesives, ... and you, too, could go into the new world of MCS. Life is never the same for you. Life is never the same for your family and friends. You, and those willing to travel with you along your life's path, will be developing a "New Normal."

    Also, keep in mind, MCS does not discriminate. It knows no socio-economic, race, age, gender, or national bounderies. Think of our developing embryos and fetuses, our infants and children, our elderly, our already ill, if you don't want to think of yourself or your peers. What if a fragrance-products user is pregnant? How will that baby fair? There is concern for our unborn as some of these chemicals are quite capable of crossing the blood-placental barrier. Some fragrance chemicals, being fat soluble, are stored in mother's breast and then find their way into the suckling infant. Talk about downstream pollution!

    Let's look at a few commonly used fragrance chemicals that you'll not learn about via labeling:

      Coumarin is a common fragrance ingredient . . . and a carcinogen. It is rapidly absorbed through the skin. Pregnant women are not supposed to take coumarins as an anticoagulant because it can lead to Fetal Coumarin Syndrome. Yet, the fragrance industry and our agencies charged with protecting public health do not inform pregnant women of this common fragrance ingredient. Can coumarin in fragrances harm a developing infant? Can coumarin lead to the development of cancer? I don't know, but I believe our experts should be exploring that possibility. See EHN's section on Coumarin http://ehnca.org/www/ehnlinx/c.htm#Coumarin.

      Musks are another common fragrance ingredient. They cross the placental barrier; they store in adipose (fatty) tissue -- they are found in breast tissue and downstream from there, in mother's milk. Musks are also carcinogenic . . . what role do they play in the development of cancers? Musks are also found downstream in our fish and wildlife as they are not washed out in our current wastewater management practices. See EHN's section on Musk http://ehnca.org/www/ehnlinx/m.htm#Musk. Phthalates were found not only in FDA Citizens's Petition 99P-1340, but also by the groups that published the report Not Too Pretty. Phthalates are commonly added to many cosmetics and were found through analysis in all fragrances tested. See EHN's extensive section on Phthalates at http://ehnca.org/www/ehnlinx/p.htm#Phthalates, as well as Not Too Pretty at http://www.nottoopretty.org.

    Synthetic chemical fragrances are acknowledged air pollutants that affect the air for everyone regardless of age or current health status. And these chemicals also adversely affect wildlife, quite literally downstream. I'm put in mind of the line from that old song: Don't drink the water and don't breathe the air. (Sources: NIEHS Common Indoor Air Pollutants at http://www.niehs.nih.gov/external/faq/indoor.htm; EHN's section on POPs (Persistant Organic Pollutants) http://ehnca.org/www/ehnlinx/p.htm#Persistent


    Fragrance chemicals don't adhere to just the user . . . they settle on and are inhaled by non-users, too.

    By now we know that fragrances are volatile, they've been manufactured to be smelled, yet haven't been tested for effects upon inhalation. Thanks to the addition of phthalates (hormone disrupters), they can linger long on the ambient air. So now we come to that bit of a sticky wicket called PERSONAL RIGHTS.

    When I was growing up, I was taught that adage about rights: I could swing my fist all I wanted, however, it had to stop where the next person's nose began.

    I suggest that if you believe you must use fragrances and you feel assured by the industry's claims of safety, please use your fragrances in your own home, among consenting, non-pregnant adults. When dealing with chemical products such as these, a "personal right" or a "personal choice" to wear scents, can become a public issue -- a public nuisance -- in a public venue. This concept was expressed by an astute office manager, who stated: "I know perfume seems like a personal preference but if it affects another's working environment it unfortunately becomes a public issue." (See EHN's Take Heart! http://ehnca.org/www/ehnhompg/mcswkomm.htm.)

    By the way, American Heritage Dictionary defines NUISANCE as: "2. Law. A use of property or course of conduct that interferes with the legal rights of others by causing damage, annoyance, or inconvenience." Perfume and perfumed products, certainly cause damage to health; are damned annoying to those not yet seriously sensitized by those petrochemical pollutants but who simply do not enjoy the perfume emenating from another; and, and I assure one and all that to suddenly experience anaphylactic shock, an asthmatic attack, a migraine, ataxia, "brain fog," rhinitis, sinusitis, ear ache, laryngitis, hives, rashes, acne, burning and itching skin, etc., or several of the above, is deplorably inconvenient.

    Modern fragrances are made to affect all -- to be noticed by all. Some scents last for hours on the ambient air of poorly ventilated elevators, conference rooms, . . . and for weeks in fabric-covered work modules. Modern synthetic fragrances -- petrochemical concoctions -- have been crafted to waft further and last longer on the ambient air. Phthalates, take a bow. Perfumes are made to "announce" your arrival, to "remind" one of your presence. Fragrances in laundry products are created to last for days and weeks in fabrics, which means they volatilize (outgas) for days and weeks. Fabric softener dryer sheets, tucked away in a drawer, continue to outgas for years and years. And, fabric softeners can waft unbidden for blocks throughout your neighborhood to adversely affect those whose astute doctors have told them to avoid the use of fabric softeners and other scented products.

    The synthetic odor of "clean" and "fresh" are petrochemicals outgassing, 24 hours around the clock. You apply them to your body via your soap, your deodorants, lotions and hair care products. You wear them in your clothing, and you sleep on them in your bedding . . . breathing and absorbing . . . 24 hours a day; day in and day out. So do your infants and children and elderly parents. Every day. Day in. Day out. Think about it. Look at the chemicals used to make scents. Think about it some more. Look at the skyrocketing rates of asthma and other chronic illnesses, which our experts claim are "UNEXPLAINED" without seriously studying the ramifications of perfume pollution. Check the illness timeline along side the rise in use of scented products. Think about it some more . . . then write to the FDA in support of Petition 99P-1340 fdadockets@oc.fda.gov (Numbers of perfumes released: "Chronology of Fragrance Introductions" -- http://www.fragrance.org/news.html.)


    The Fragrance Industry Says the User Has a "Scent Circle"

    Despite the fact that fragrance chemicals cannot respect the industry's defined "scent circle" of an arm's length, that's what the industry states is the area the user is not to pollute beyond. The problem is multileveled. Perfumes contain phthalates. While the industry may be referring only to perfume, they've made sure that there are a wide variety of scented products to use and they all volatilize. It doesn't matter whether these fragrances are in your perfume or your hair care products or your clothes thanks to your use of highly scented laundry detergents and fabric softeners, they all outgas their VOCs to become one with the air we all must breathe. And, trust me on this: Fragrance chemicals don't know a "scent circle" boundary. But, there's an added factor, the hotter the area you are in, the more your scents volatilize. But as they volatilize to become one with the air we ALL breathe, they also have an ability to settle in on the clothes, hair and body of another, and of course, to be inhaled by another. Remember, modern scents are made to waft further and last longer. Oh, yes, "Everyone has a personal 'scent circle' ...!" And I believe in Charlie Brown's Great Pumpkin.

    The Fragrance Foundation, Inc. states in its Fragrance Tips http://www.fragrance.org/feature_tip_content.html

      Everyone has a personal "scent circle": approximately an arm's length from the body. No one should be aware of your fragrance unless he or she steps inside your "circle." Fragrance should be one of the most subtle, personal messages you send to those with whom you come in contact.

      For a long-lasting effect, fragrance should be layered all over the body, starting with toilet water or eau de parfum, next in strength to perfume, to build the fragrance foundation. Because fragrance rises, spray or smooth fragrance onto skin from the feet to the shoulders. If fragrance is applied only behind the ears, it will eventually rise and disappear.

      [...]

    And from Soothing Scents,Perfume Guide, Scents & Sensibility: Dos and Don'ts http://www.eharlequin.com/harl/escapes/escguides/80perg61.htm:

      Do apply fragrance throughout the day because the scent will fade in four to six hours.

    So what's a "scent circle"? And how can a"scent circle" be attained if one is layering for "a long-lasting effect"? Certainly lingering scent in an elevator, which is empty, defies the industry's proclaimed "scent circle." Scent polluting the ambient air indoors or out challenges the industry-defined "scent circle."

    Who is trying to fool whom? The FDA may be convinced, but millions upon millions of scent-sensitized people worldwide know that fragrances know no boundaries -- and that is especially true when one layers and reapplies.

    Through inhalation via one's respiratory system, or on a direct tract to the brain, or absorbed through one's skin and eyes, these chemicals do get into the bodies of people of all ages. And because these synthetic scents are volatile organic compounds, they get into the bodies of people who choose not to use, or whose astute doctors state the impossible: "Avoid fragrances."

    Some of the chemicals are known to cross the blood-brain barrier and the blood-placental barrier. Let's imagine our developing fetuses, our infants and children who are subjected to scented products such as diapers and wipes, laudered items, air "fresheners" and other maintenance products (including pesticides, which in turn include disinfectants). From birth on, in the hospital, at home, at day care and school, our children, our future generations, are inhaling and absorbing fragrance chemicals about which not enough is known. Imagine our already ill. Imagine, too, our elderly who are subjected to highly scented environments in healthcare facilities, hospitals, skilled nursing facilities, retirement residences and then imagine the skyrocketing rates of congestive heart failure. I've lived through episodes with my mother-in-law during her trials with congestive heart failure and I can tell you, her breathing was drastically impaired everytime a scented nurse, doctor or visitor polluted her air. Imagine our fellow employees, students, worshippers -- some already chemically injured, some not yet aware that there insidious diseases could be caused by fragrance chemicals. Imagine!

    Is there any wonder why during the same time frame that synthetic scents became ubiquitous, we've also seen skyrocketing rates of asthma, cancers, and other chronic diseases? (For information on the possible cancer-cosmetic connection see EHN's page http://ehnca.org/www/ehnlinx/c.htm#Connection


    No more industry-hyped "Sound Science" -- Real Science, Real Research Is Long Past Due

    Let's hope RIFM (Research Institute for Fragrance Materials), and our government agencies charged with protecting public health, begin to study the possible carcinogenic (capable of causing cancer), neurotoxic (adversely affecting brain and nervous systems) and tertaogenic (adversely affecting embryonic and fetal development) effects of our modern synthetic fragrance chemical formulations. And while they are at it, they may want to further study the hormone disrupting possibilities provided by the addition of phthalates to fragrances and other cosmetics. Not enough is known about these chemicals used singly, and even less is known about them used in combination to make a single scent. Still less is known about the effects of these chemicals once combined in the air with the many other scented products that are volatilizing -- emanating from one or more people and/or objects.

    No wonder one overhears: sudden attacks of sneezing or severe coughing, or comments such as, "I've got such a headache!," or "My sinuses are killing me!" or some variation on the theme. People are being made ill, but aren't given a clue as to what could be the cause. And sometimes it takes a while to come to grips with the fact that the products advertised as smelling "fresh" and "clean," that are promoted for a sense of self-esteem, that are assumed safe to use because there are no government warnings, ... are the very products that can cause a wide variety of illnesses. It's the chemicals! Tens to hundreds are used to create one scent out of the industry's repertoire of 3,000 to 5,000 inadequately-tested chemicals


    It's The Chemicals AND The Bottom Line

    Glenn Roberts, quoted above in Scents and sensitivities..., stated that fragrance products were thoroughly tested before marketing. Yet he added that the industry has begun the first study for effects upon inhalation. (Doesn't that nullify the "thoroughly tested" comment? I pick up the distinct odor of duplicity.) In that same article, Roberts goes on to lament, "We're spending a lot of money on this [testing] to understand the systemic effects of fragrances on organs and nervous system, what happens when fragrances are inhaled."

    How many billions of dollars has the fragrance industry made at the expense of the unsuspecting public who have been unwittingly using their scented consumer products? How many people have had to leave gainful employment because of synthetic fragrances? How many people have lost their chance for an education? How much money have Jane and John Q. Public had to spend trying to regain their health? What is the amount of money in potential incomes lost due to fragrance sensitization? What price can be placed on a fetus' malformed penis, debilitating diseases, on disability, on premature death? The price the public has been forced to pay is beyond calculation and comprehension. Here, too, our government practices, Never Measure, Never Manage.

    Students could continue to learn, employers could keep their chemically injured staff working, healthcare facilities and public agencies could more safely serve the public, people could travel in safer air, ... by making their air cleaner for all. A start would be to develop Fragrance-Free policies or programs covering personal care products as well as cleaning and maintenance products. Employers set all sorts of standards -- core hours, lunch breaks, dress codes, no smoking policies -- they can set a fragrance-free standard as well. (See JAN -- Job Accommodation Network information's Work-Site Accommodation Ideas for Individuals with Fragrance Sensitivity http://www.jan.wvu.edu/media/fragrance.html)

    Frankly, I beleive that for the people and their family members who have lived with chemical injury, there is no amount of money in the world that can recompense the dignity, health and premature loss of life already suffered.

    It's about time the industry is spending some money on trying to produce safer products. Now, let's cut the whine.


    Barriers: Chemical and attitudinal

    Rest assured that throughout our struggles with our own health and lives, we've all worked hard to inform others. Sometimes we can only manage to work on a person-to-person basis. Others of us take our efforts to the public at large. The goal is always the same: Keep our numbers from growing exponentially. We are the Davids to the fragrance industry's Goliath.

    And during this time, we have certainly been stultified -- as have people living with other disabilities. We can convince ourselves to brush off the musings of the industry flacks -- their poorly researched articles and comments are our best defense! But, it is often difficult to convince employers et al., that just because a well-known TV reporter rants against people who live with MCS, that report isn't necessarily true. Many of us who were making some small gain for access and accommodation in our workplaces, suddenly saw it come crashing down around us following a showing of "Junk Science." (See the response of Albert Donnay, MCS Referrals and Resources http://ehnca.org/ehnmcsrr.htm

    As bad as some of the attitudinal barriers are -- it just seems to be impossible for the not-yet-ill to recognize the fact that fragrances, while invisible, are nonetheless formidable barriers to our access -- it's a devastating blow when doctors dismiss their patients with an, "It's all in your head" statement and a prescription for drugs that make matters worse. (For the record, I've been most fortunate in recent years with my doctors!) I cannot help but wonder just how many people living with MCS have had their brains fried as a result of taking SSRIs (drugs prescribed for anxiety, panic disorder, obsessive compulsive disorder, eating disorders, and social phobia (http://www.medinfo.co.uk/drugs/ssris.html). Sadly, a chemically injured indiviudal's health can be further damaged by inadequately trained doctors. There is a word for doctor-induced illnesses and death: Iatrogenic. (See American Iatrogenic Association at http://www.iatrogenic.org/index.html.)

    Often, our health is also worsened by management and administrations who just don't "get IT" and therefore continue to rely upon high-emitting VOC products such as paints, carpets, adhesives, as well as upon the more commonly used synthetically scented products, including pesticides and cleaners, and of course, their "signature scents" and other fragranced personal care items.

    The already chemically injured have lived a nightmare, that includes not only chemical assaults, but deep attitudinal barriers. And yet, we persevere. Whether it is to remain gainfully employed while trying to inform others of the need for cleaner air for all, or whether we can no longer work and volunteer, exerting energy in an effort to keep others from becoming ill and disabled, we keep plugging along. MCS -- like many cancers -- is largely a preventable disability. It takes a heep of working to overcome some of the stuff we've encountered, but we have to keep our numbers from climbing. See EHN's Stuff Happens http://www.ehnca.org/www/ehnhompg/stufhaps.htm


    Industry's Defense Is Offensive

    Back in 1990, the then Chemical Manufacturers Association, published its call-to-arms, The Environmental Illness Briefing Paper. Lest anyone wonder why it has been such a struggle for the already chemically injured, you'll find it all spelled out in that treatise. The CMA had to know that the commonly used chemical products would take their toll on the health of the individual. They took the offensive with this offensive publication.

    The CMA has gotten to legislatures, to manufacturers, to the media. They've told Human Resource managers what to do. If injured on the job, the worker would naturally think Workers' Compensation was in place to help. (That's another book!) In any case, the common systematic method of dealing with the chemically injured person, as I've come to learn it, has been to at first try to ignore the affected individual and if that doesn't work, the next step is stealth removal from the job. I believe in large part this is due to the damning and damanging EI Briefing Paper. Read it. Judge for yourself. See http://ehnca.org/www/books/cmaeibri.htm

    As I see it, our government agencies haven't issued alerts, much of the media has ignored our letters to the editors and our articles offered for publication, our workplaces continued "business as usual," the medical industry conducted witch hunts against doctors who belived that we were chemically injured and therefore needed alternative treatment, the lawyers and courts played their own game, and the industry continues to manufacture synthetic scents without real testing and without labeling cautions. So, what's the outcome? Our numbers of chemically injured have soared. And so have the numbers associated with a wide variety of other environmentally-caused chronic diseases including asthma and cancers. It is time for a change in paradigm.

    During the past couple of decades we have encountered fragrance assaults, both deliberate and inadvertent. We've been subjected to fragrance chemicals in personal care products; we've breathed them in from household and janitorial cleaning and maintenance products; our air has been polluted by fabric softeners wafting from users in the neighborhood; we've been assaulted in our own homes by scent-permeated pages or leaking scent-strip (I've yet to meet a scent strip that didn't leak!) advertisements in the mail and in newspapers; we have been seriously assaulted by air "fresheners" and especially by spritzing devices used in restroom cubicles; we've been assailed by combo air "freshener" - pesticide devices used in lobby entrances of major public buildings; and we've been blasted with fragrances that are being pumped through heating and ventilating systems.

    Wherever they come from, we are forced to breathe fragrance chemicals that are released to market without adequate testing for effects upon inhalation and/or absorption at primary, secondary and tertiary level of exposures. Air polluted by synthetic scents causes disabilities, which in turn creates the need for access and accommodation. For help in that arena, please visit EHN's access information on Take Heart! http://www.ehnca.org/www/ehnhompg/takheart.htm


    What have we learned?

    Fragrances are made to become one with the air we all must breathe, for how else could we smell them? In addition, they have been created to waft further and last longer on the ambient air (thank phthalates!), plus they have been added to a plethora of products, and thanks to advertising and industry public relations campaigns, more people are wearing and using more scents more places, more times of day and night, than ever before in history.

    Modern synthetic fragrances are petrochemical products and they pollute air, people, water. Quite literally downstream, we are now finding our fish and wildlife are adversely affected. Will we begin to wonder how we may be polluting our unborn? Our infants? Our elderly? Ourselves?

    Synthetic fragrances are far cheaper to make than fragrances from squished flower petals and animal parts, hence, it is a highly profitable industry. Fragrances have become ubiquitous. You'd think some attention would be paid public health under such circumstances, but fragrances, as we learned through Ms. Lyman's article, have have just begun to be tested beyond their standard testing for adverse skin reactions of the primary user.

    It matters not if synthetic fragrances are added to fabric softeners to pollute the ambient air for blocks, or if added to personal care products, or household or janitorial cleaning and maintenance products, or are concocted to be sold as your "signature scent" . . . perfumes pollute. The more perfumed products are used, the more pollution. The more one's air is polluted, the lower one's threshold becomes. The lower one's threshold becomes, the sicker one gets. The sicker one gets, the more the need for access and accommodation. . . . And sooner or later the more of a burden to the financial system.

    Oh, What A Goose . . .

    The unwary consumer of fragrance products is the goose who has been laying the golden eggs for the industry . . . As I see it, like Aesop's Fable, the story is one of greed. The industry has envisioned expanding and expanding, pumping fragrances throughout hotels, stores, workplaces, permeating paper and cloth, ad nauseam, raking in multibillion dollars upon multibillion dollars. Unlike the story in Aesop's Fable, it isn't only the goose who lays the golden eggs who gets done in, as . . .

      . . . We ALL are stakeholders when it comes to breathing!
    -- barb




    Be sure to visit the table of chemicals found in the purchased analysis. (http://www.ehnca.org/www/FDApetition/analysis.htm)

    Spring 2002; update December 2002; January 2003



    Complementary information

    May 22, 2001 -- 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

    Feb. 6, 2002 -- Scents and sensitivities
    What to know before buying a Valentine¼s Day perfume

    By Francesca Lyman; MSNBC Contributor
    Mirrored on EHN with the kind permission of Ms. Lyman and MSNBC. -- barb
    http://ehnca.org/www/FDApetition/flscents.htm

    Had been at: http://www.msnbc.com/news/702445.asp and then it was re-released
    October 2002. and up on http://www.msnbc.com/news/702445.asp?cp1=1

    July 10, 2002 -- Not Too Pretty -- report on phthalates at http://www.NotTooPretty.org

    August 15, 2002 -- Environment News Service (ENS) 2002 and itsLabeling Cosmetics May Help Prevent Cancers http://ens-news.com/ens/aug2002/2002-08-15-01.asp

    August 15, 2002 --Ascribe - Groups Call for Labeling of Cosmetics and Toiletries, Citing Cancer and Other Health Risks http://www.ascribe-news.com/cgi-pub/d?asid=20020815.123311

    Fall 2002 -- Fragrance: Emerging Health and Environmental Concerns by Betty Bridges, RN http://www.fpinva.org/FragranceReview.htm

    Sept. 17, 2002 -- A COMMON FRAGRANCE COMPONENT INCREASES
    AIRWAY RESPONSIVENESS AFTER SKIN SENSITISATION

    "... In summary, the results show that commonly used fragrance components
    can decrease lung function and sensitise the skin on contact and thereby
    also induce increased lung sensitivity.

    " It is important to note that the perfume components of many products that
    act as contact sensitisers of the skin can also cause hyperreactivity of
    the lung. Since multiple chemical sensitivity is an increasing problem in today¼s
    society, the authors hope that the results of their study will help reducing
    use of fragrances in consumer products and thus help people suffering
    from asthma and unspecific reactions. "
    Note the reference to MCS. -- barb
    ABSTRACT NO: 3194
    ORIGINAL ABSTRACT TITLE AND AUTHORS:
    A common fragrance component, 3‚carene, increases airway
    responsiveness after skin sensitisation - a study in isolated
    guinea pig lungs

    L. Lastbom, A. Boman, S. Johnsson, P. Camner, A. Ryrfeldt
    DAY AND TIME OF PRESENTATION
    Tuesday, September 17 / 13:30 ‚ 15:30
    CONTACT PERSON:
    Lena Lastbom
    Division of Inhalation Toxicology, Institute of Environmental Medicine,
    Karolinska Institutet
    Stockholm, Sweden
    Tel: +46 8 728 7570
    Fax: +46 8 30 33 90
    Email: lena.lastbom@imm.ki.se
    http://www.ersnet.org/4/3/4_4_3_5.asp#fragrance

    November 3, 2002 -- The Breathe Easy® / Asthma Digest (email newsletter)
    OCTOBER 2002

      FAIR USE NOTICE. These documents may contain copyrighted material whose use has not been specifically authorized by the copyright owner. We are making these articles available in our efforts to advance understanding of the issues associated with sustainable development, environmental, community and worker health, democracy, public disclosure, corporate accountability, and social justice issues. We believe that this constitutes a `fair use' of the copyrighted material as provided for in section 107 of the US Copyright Law. If you wish to use this copyrighted material for purposes of your own that go beyond `fair use', you must obtain permission from the copyright owner.

      This digest is brought to you by the American Lung Association®, engaged in a mission to prevent lung disease and promote lung health for close to 100 years. New on www.lungusa.org (While ALA hints this info is available on their website, several of us were not able to find it, hence I've pasted it in here.)

      PERFUMES MAY BE COMPROMISING LUNG HEALTH, ESPECIALLY FOR PEOPLE WITH ASTHMA-Ý

      The October 28, 2002 MSNBC.com website featured an article that described how perfumes and fragrances present in soaps and other personal hygiene products may trigger allergies and irritation, especially for those who suffer from asthma, rhinitis, and dermatitis. The article cites allergy, dermatology, and pulmonary experts who asset that a growing number of patients are suffering from such sensitivities to fragrances. In light of this, the New York Committee on Occupational Health and Safety (NYCOSH) has stated that wearing perfume at the workplace or in closed in spaces may pose health problems for the wearer and those around them.

      According to the article, the fragrance industry is responding to these concerns by implementing more stringent testing of their products before they are marketed to the public. The article also points out that whereas perfumes were once distilled from flower essences, many of those now being manufactured are complex mixtures of botanical- or animal-derived materials and synthetic chemicals. In addition, about 90% of perfume ingredients are not composed of flower essences or natural products, but are synthesized from petrochemicals, which emit volatile organic compounds or "VOCs." According to the EPA, VOCs may produce eye, nose and throat irritation, headaches, nausea, loss of coordination, damage to the liver, kidneys, and central nervous system, and some are believed to be carcinogen.

      The article points out that the incidence of respiratory sensitivity to fragrances is on the rise, which raises health concerns for people with respiratory illnesses, especially asthma. Although it asserts that most perfumes do not pose immediate danger for people with asthma, some ingredients may trigger asthma attacks since perfumes contain many potentially allergenic ingredients that can add to other irritants, such as tobacco smoke or exhaust fumes. The article reports that the Environmental Health Network, and advocacy group based in California, has petitioned the government to require that products which have not been adequately tested carry warning labels. Since the petition was filed, more than one thousand consumers with health problems associated with exposure to fragrances have written to the FDA in support of the petition; however, to date, the FDA has not put forth a public response. For the entire article: http://www.msnbc.com/news/702445.asp?cp1=1.




    1) Have you ever wondered why the already fragrance-sensitized individual never got anywhere with the FDA . . . L@@K at this! Thanks to Betty Bridges, RN for the heads up . . . she found word about Bailey's move in a document other than CTFA's.
    Return to FDA section, above.


    Former FDA Cosmetics Head Joins CTFA - press release
    " Washington, D.C. - Dr. John Bailey, former Director of FDA's Office of Applied Research and Safety Assessment, is joining the Cosmetic, Toiletry, and Fragrance Association (CTFA) as Director, Cosmetic Chemistry in mid January 2002.

    "CTFA President Ed Kavanaugh, in making the announcement said, 'I am delighted that John will be joining CTFA. He brings to CTFA excellent scientific credentials and
    a great understanding of our industry and its issues based on his many years with FDA.' ... "

    http://web.archive.org/web/20020617152852/http://ctfa.org/viewpage.cfm?id=1543

    Formerly at: http://www.ctfa.org/viewpage.cfm?id=1543

      Take a look back in time to the very early 1990s and Julia Kendall's compilation of information, including two John Bailey statements. Am I surprised to find him with CTFA? Un-un.

      Making Sense of Scents
      Includes John Bailey comments . . .


    But, if all of the above information doesn't outrage you enough for action, how about the following?   Thanks to Betty Bridges, RN for finding this information on http://www.fda.gov/oc/fdama/fdamawebcast/stakeholdersquestions/foods.html.

      "Q. Inhalation of fragranced products is known to trigger asthma and migraine headaches in some individuals. The EPA names "the use of chemically formulated personal care products" along with pesticides and household cleaners as contributors to indoor air pollution. How do you propose to raise public awareness of possible health risks from use of these products?

      A. FDA has little or no information that would support actions to raise public awareness of possible health risks associated with the use of fragranced products. Current regulations do require that products that contain added fragrance ingredients must be labeled in the product ingredient statement as containing "fragrance." FDA is aware of concern about this issue and encourages continued participation by its stakeholders in gathering data to address the possible health risks associated with the use of fragranced products. FDA is committed to fostering such participation by its continued sponsorship of stakeholder outreach initiatives, e.g. public meetings. These public forums not only provide interested persons with an opportunity to comment on the potential health risks associated with fragranced products, but also help identify possible solutions to address these risks." (FDA/Website Management Staff; Web page updated by clb 1999-JUL-16. Note: still present 03/05/03. bw)

    EXCUSE MEEEeeeeee . . . The FDA has WHAT?

    It says it has LITTLE OR NO INFORMATION?!?

    Our FDA actually had the temerity to state -- but buried it at the bottom of a food page -- "FDA has little or no information that would support actions to raise public awareness of possible health risks associated with the use of fragranced products. . . . "

    To put this into perspective, the FDA states that 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," on a page uploaded to their FOODS section, two months after EHN filed its petition, to which the FDA assigned Docket Number 99P-1340. Citizens' Petition 99P-1340 is replete with analyses of six popular scents.

    Bear in mind, this FDA statement was posted about a month after they logged a letter from Anderson Laboratories, describing the toxicity of fragrances. (PDF file: http://www.fda.gov/ohrms/dockets/dailys/061199/c000097.pdf.) Also to be considered is the fact that the FDA thinks 100 letters on a topic is a lot, yet two days before they claimed online that they had "little or no information that would support actions to raise public awareness ...," they had logged a total of 166 public comments regarding Eternity eau de parfum and petition 99P-1340. (See "Time to Review Your Cosmetics, Under Bright Light," By JANE E. BRODY, New York Times, May 22, 2001 at http://www.nytimes.com/2001/05/22/health/22BROD.html

    The FDA received four copies of the petition, as required by them. The petition included MSDS (Material Safety Data Sheets) that were available at that time for any given chemical found through laboratory analysis. Since then, I've added links to the chemicals that are also found on the EPA's Toxic Substances Control Act (TSCA) Inventory and on the Registry of Toxic Effects of Chemical Substances (RTECS) -- http://www.ehnca.org/www/FDApetition/analysis.htm. (See "Comments received by the FDA about Docket 99P-1340 during years 1999, 2000, 2001, 2002, 2003" at http://ehnca.org/www/FDApetition/letinfda.htm.)

    The FDA goes on to state: "Current regulations do require that products that contain added fragrance ingredients must be labeled in the product ingredient statement as containing "fragrance."

    Whoopee! How many people read the word "fragrance" and think chemicals that are known or suspected carcinogens teratogens, neurotoxins, hormone disrupters, irritants, and/or sensitizers? How many read "fragrance" and think synthesized from petrochemical derviatives? How many people read "fragrance" and think soaring asthma rates? Yet, marching in lockstep with the skyrocketing "UNEXPLAINED" increase in asthma rates is the increasing prevalence of synthetic fragrances making up perfume, cologne and aftershave, as well as added to a myriad of personal care products and household and janitorial cleaning and maintenance products. The ubiquitousness of fragrances was helped by the addition of phthalates, which give fragrances that lasting power, and further enhanced by industry advertising so more people used and wore more fragrance products more places than ever before. Synthetisizing scents made the universal presence of synthetically scented, air, body and water polluting products possible.

    But there's another troublesome aspect: What the FDA does not state here is that they allow products labeled "fragrance-FREE" or "UNscented" to carry synthetic fragrance chemicals as a masking scent to cover otherwise objectionable chemical odors. How little poison is little enough? Already chemically injured individuala react to products clearly marked "fragrance-free" and then they become the butt of ridicule in public venues. People who mock the harbingers may soon wish they had paid closer attention to their words of wisdom regarding synthetic scents.

    As far as FDA fostering participation, let's swamp the agency with several hundred thousand letters. State that you want your right to know respected. At a minimum the FDA should require its warning message on products released to market without adequate testing. Better yet, the FDA should inform the public regarding synthetically scented products through public service announcements, press releases and via its website. Ask the FDA why the industry can state categorically that it thoroughly tests its products, and yet their focus is on the skin reactions of the primary user. Ask the FDA why a product made to be smelled (inhaled) is not checked for possible adverse events upon inhalation by user and non-user. And while you are writing, you may wish to ask the FDA just why synthetic scents, with their neurotoxin properties, have not been checked for their neurotoxic effects.

    It seems to me that the FDA is showing that it is pervaded with the notion of the rights of industry over the rights of public health and well being, and by extension, the public's right to know.

    What IF the FDA and industry were held fiscally responsible and accountable for all the lives lost and ruined by the pervasiveness of our modern synthetic chemical products? One would assume industry would have been more circumspect in its release of inadequately tested products to market and certainly, the FDA would long ago have issued public health alerts regarding the toxic chemicals used to concoct our modern synthetically scented products.

    I cannot help but feel that because of the FDA's inaction -- despite reports from the harbingers, the activists, and the over 1,000 people who wrote regarding Citizens' Petition 99P-1340 -- millions more people of ALL races, ages and genders have been adversely affected by the toxic chemicals used to concoct synthetic scents. Reprehensibly, the rates of people whose health is in severe decline, and who have become disabled due to chronic diseases, have increased dramatically. But what is really numbingly vile is the fact that too many good people have suffered premature death and too few amongst the POWERS THAT BE seem to give a tinker's damn.

    FDA begin to prove me wrong! Require your warning message on all inadequately-tested fragrances released to market. The public has a right to know. We the people have a right to read on fragrance products, "WARNING: The safety of this product has not been determined." At least with that required warning in place, the public will get a tiny clue that there is more to synthetic scents than meets the eye. Literally.

    See FDA Authority Over Cosmetics at http://vm.cfsan.fda.gov/~dms/cos-206.html.

    Be sure to visit the table of chemicals found in the purchased analysis. Pay close attention to that righthand column. (http://www.ehnca.org/www/FDApetition/analysis.htm)

    -- barb



  • 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

    Printer friendly
    http://www.ewg.org/reports/skindeep/report/executive_summary.php?print_version=1

    EWG's Fragrance/Perfume/Cologne Products
    http://www.ewg.org/reports/skindeep/listproducts.php?ewg_cat=Fragrance/Perfume/Cologne

    EWG's Health concerns for Fragrance/Perfume/Cologne
    http://www.ewg.org/reports/skindeep/healtheffectbycategory.php?ewg_cat=Fragrance/Perfume/Cologne


    Return


Return to EHN's FDA Petition Index
(http://ehnca.org/www/FDApetition/bkgrinfo.htm#Petitioning)

Return to Petition Contact Info so you, too, can write to the FDA
(http://www.ehnca.org/www/FDApetition/bkgrinfo.htm) Last update: 6/04/02


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Installed 6/21/02

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 The URL for EHN is www.ehnca.org