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November 12, 2007

NTEF Attacks Angel Perfume via FDA

In what could be a major challenge to the American labeling regulations that allow manufacturers to skimp on accurate reporting of cosmetic ingredients, the FDA has accepted a petition from the National Toxic Encephalopathy Foundation (NTEF) to have Angel Perfume declared "Misbranded", and asked that its importation be halted until the issue is resolved. That could take a long time, given a 180 day turnaround process according to the FDA's procedures, and the general slowness of the regulatory process. Or ultimately the FDA could ignore the issue.

NTEF, which is a watchdog organization on perfume toxicity, claims on its website that the Angel perfume contains toxic ingredients that are not listed on the label. The particular ingredient of concern is coumarin, which is similar to a chemical used in rat poison and is definitely considered harmful. NTEF has requested that the FDA declare the perfume a drug, and prohibit its importation.

Angel perfume, which according to Wikipedia is the #1 perfume in France and the #8 seller in the US,  was formulated in France in 1992 by Thierry Mugler and is now distributed by Clarins, mainly through Nordstrom and other department stores.

Angel perfume actual ingredients, as determined by NTEF scientists by chemical analysis, include essential oil chemicals including alpha-pinene, d-limonene, pachouli alcohol, azulene, and many others as well as coumarin [not listed in the MSGC report, however] and diethylphthalate.  Coumarin is a common ingredient of cassia, tonka bean, clary sage, and lavender, and many other aromatic ingredients used in aromatherapy and perfumery, as well as many food items (strawberries, anyone?). Coumarin, according to a French perfumery article has been banned as a food additive in most countries for many years based on animal research that found it can be toxic in doses of 100 mg/kg/day, which are supposedly 100 times the amount that is typically used in perfumery. NTEF claims toxicity at lower level and cites several references. The issue they are most concerned about is harm to the eyes, but they are also listing possible pregnancy problems, and reduced sperm motility as possible problems, among others.

As pointed out in an article in Cosmetics Design Europe, coumarin is used in over 5,000 cosmetic formulations. The article goes on to attack the NTEF in an irresponsible manner.

I've looked over the information on the NTEF web site, and have a number of concerns about the quality of their evidence. They seem to confuse natural and synthetic chemicals, as I mentioned above coumarin didn't seem to be listed on the MSGC, and their claim that an excerpt from the Clarins 2004 Annual Report verifies their claims is questionable (I didn't see much in the way of Financial records there).  The best (highest quality, that is) article linked from their site is this one, which goes into more specific data about stated contents and their changing history, and specifically how these may be toxic. I'm not saying they are wrong; it's probably up to the FDA to determine the truth, but I think the facts may not be completely supported by the evidence they present.

I discussed this with Cropwatch via e-mail, and they pointed out that coumarin is a common perfumery ingredient and question why, if it is actually toxic, that Angel perfume should be singled out. Coumarin in a perfume would pose a very low bodily health threat because it would not migrate through the dermis. Ultimately, there is a question about whether the FDA will take the health claim seriously.

This issue will probably be around for awhile and we encourage your comments and opinions.

Posted by Rob on November 12, 2007 in Perfumery, Politics, Regulatory Issues, Safety/Toxicity | Permalink

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Comments

Clearly you did your homework and I think you blew the bell curve for the rest of us. I agree with you, it is a problem, it is probably not going away quickly and as you pointed out- what of all these other products? When the FDA banned Vanilla Importation because of the coumarin content, they did not just stop one brand. They put a halt to it and forced the manufacturers to reformulate in order to sell to American Consumers. I would love to see the strength, backbone and integrity in our government as they shut down commerce of Coumarin tainted fragrances. It would be a statement to us and the rest of the world that our health matters to the government.

Do you remember when we sold cigarettes and we were led to believe they were good for us? How long did our government let the tobacco firms lobby and pull their strings before the truth came out? How many people have you known with lung cancer or emphysema from smoking?

Most people in modern society are exposed daily to fragrance ingredients from one or more sources. Fragrance ingredients are also one of the most frequent causes of contact allergic reactions. Perfume is absorbed through the skin, mucus membranes and airway.

Many of the derivative chemicals used in the manufacture of perfume are allergens and known sensitizing agents. It is known that cosmetics and skin care products can cause adverse skin reactions. When used in formulation together as a fragrance combination this results in a compounding of the health risks with significant p values. Of note in this particular study, Karlburg adds analogues to produce a select molecular structure in an attempt to reduce the sensitizing effect of the fragrance

Cosmetics and skin care products commonly are the cause of adverse skin reactions.
Evaluation of the occurrence of adverse skin reactions to cosmetics among patients referred for standard patch testing owing to suspected contact dermatitis in general, most frequently culminated in hand eczema. Consecutive patients at four patch test clinics in Sweden were invited to participate; 1075 were included. Of these, 47.3% (54.2% women and 30.8% Men) reported current or previous adverse skin reactions to cosmetics and skin care products. This group showed significantly more positive patch test reactions, a higher
Prevalence of atomic dermatitis and the dermatitis was more frequently located in the face and neck region. Our results show that patients referred for standard patch testing have--
or have had--a large proportion of self-reported adverse reactions to cosmetics or skin care products. We conclude that among patients with suspected contact dermatitis, adverse reactions to cosmetics can be a more important etiological and/or complicating factor than is commonly acknowledged and that the reporting of such reactions probably can be improved.

You are right. The FDA should look at them all together. It would make a bold statement that would prompt more ethics when it comes to corporate decision making while drawing up those labels. While we may be clear about avoiding particular substances or mixtures, how are we to know what is in the bottle if it is not listed on the label? The problem and difficulty experienced by consumers attempting to abstract contents from these subject products is a documented problem for those with allergies or atopy. The legislative arm might well be the mechanism we need. Liden urges scientific and legislative coalition mutually supporting each other “It is essential that medical scientific experts support, with their expert knowledge, national and European authorities.”

The complex pathomechanisms underlying skin lesions in atopic dermatitis (AD) result in variations of the clinical picture and frequent diagnostic difficulties. Coumarin for example causes hepatotoxicity in rats in a site- specific manner and is thought to result from the formation of coumarin 3,4-epoxide and its rearrangement product, ohydroxyphenylacetaldehyde (o-HPA). However current studies also indicate that coumarin 3,4-epoxidation also occurs in humans.


Individuals reacting to fragrance preparations with Type 1 and Type 2 Immune responses are increasingly more common and represent a growing problem recognized by experts across the globe. Epidemiological studies indicate environmental pollutants to be involved in the increase in the prevalence of allergic diseases. In human exposure studies, volatile organic compounds (VOCs) have been shown to cause exacerbations of allergic asthma. Additionally, an atopy patch test was applied to the skin after VOC exposure showed a significant increase in transepidermal water loss 48 h after exposure to VOCs. Six out of seven of these patients showed enhanced atopy patch test (APT) reactions.

Perfume contains solvents which are drying by nature as well. Some solvents cause severe defatting of exposed tissues over time. Furthermore, the effects of solvents are cumulative over time. Solvent Neurotoxicity takes place in both dermal and inhalation exposures.

One study looking at these effected individuals documented frequency of positive reactions to specific individual (fragrance) constituents:
hydroxyisohexyl 3-cyclohexene
carboxaldehyde (Lyral) >
citral >
farnesol >
citronellol >
alpha-hexyl-cinnamic aldehyde (AHCA).
Lyral was the dominant offender of the individual constituents, with positive reactions in 36% of the study group. 5/11 patients developed a positive ROAT after a median of 7 days (range 2-10). In other words use of the fragrance mixture sensitized the individual in about a week. The Buckley study from 2000 showed a positive correlation between the isomers isoeugenol and eugenol. Oak moss remained the most common overall allergen throughout the study, positive in 38.3% of females and 35.6% of males who were tested to the constituents of the fragrance mix. During the study period, a 5 % annual increase in the incidence of positive tests to oak moss was documented (P = 0.001, 95% CI 2.2-8.7). The frequency of allergic reactions to eugenol and geraniol remained relatively constant. Isoeugenol and alpha-amyl cinnamic aldehyde sensitivity increased and hydroxycitronellal showed a slow decline. There was a striking reduction in the frequency of sensitivity to cinnamic aldehyde (by 18% yearly; P < 0.001, 95% CI 14.3-21.0). BHA an antioxidant (butylated hydroxyanisole), eugenol (Oil of Cloves) and isoeugenol (Oil of Nutmeg) are esthers as well as phenols. We simply must consider the stability of the mixture and the most likely oxidation states the chemical will undergo until it reaches stability once applied.

Analysis of 24 products obtained from 12 patients in the Frosch study group showed at least 1-5 individual target constituents per product: Lyral (79.2%), citronellol (87.5%), AHCA (58.3%), citral(50%) and coumarin (50%).

Patients with a problematic history following fragrance exposure may have a negative reaction to the typical patch test but can be identified through retesting with an alternate standardized mixture patch test preparation. 5 Interestingly only 50 % of these individuals would be identified if patch tested with the individual fragrance constituents indicating it is a “MIXTURE ISSUE”.

A recent epidemiologic survey in the UK revealed that 23% of women and 13.8% of men experience some sort of adverse reaction to a personal care product over the course of a year. While most of these reactions may be due to sensory irritation, various studies reveal that up to 10% of dermatologic patients who are patch tested are allergic to cosmetic products or their constituent ingredients. Causative products include deodorants and perfumes, skin care products, hair care products, and nail cosmetics.
Allergic contact dermatitis mainly results from fragrance chemicals and preservatives. Recent work has suggested that additional fragrance chemicals may need to be tested in order to identify those patients 'missed' by the current fragrance mix; in particular, hydroxy-isohexyl-3-cyclohexene carboxaldehyde (HMPPC Lyral) has been singled out as an important sensitizing agent.

Epidemiological studies indicate environmental pollutants are also involved in the increase in the prevalence of allergic diseases. In human exposure studies, volatile organic compounds (VOCs) have been shown to cause exacerbations of allergic asthma. Additionally, an atopy patch test was applied to the skin after VOC exposure showed a significant increase in transepidermal water loss 48 h after exposure to VOCs. Six out of seven patients showed enhanced atopy patch test (APT) reactions after previous exposure to VOCs. The study illustrated exposure to VOCs – at concentrations commonly found in indoor environments -can damage the epidermal barrier and enhance the adverse effect on sensitized subjects with Atopy. 14 As a consequence of this aeroallergen-induced altered epidermal barrier function, further allergens can more easily penetrate the skin, inducing a vicious circle and perpetuating the eczematous
lesions.

The increased usage of natural fragrances and botanic extracts can also cause problems in their own right or through co-reactivity. The preservative methyldibromo glutaronitrile has been identified as an increasingly important sensitizer in Europe, which has led to the recent recommendation that it should be prohibited from 'leave-on' products until information on 'safe' consumer levels becomes available. Clearly this shows Overseas they have made the political statement that their constituents health is an important issue. Moreover, there is no huge controversy because of the apparent trust in the governments motivating factors. Other emerging allergens include UV filters, tosylamide/formaldehyde resin, and nail acrylates. The diagnosis of cosmetic allergy should be confirmed with patch testing, including testing of 'whole' products, when necessary, and repeat open application tests can be used to confirm the relevance of reactions.12
The idea here is that once one knows something is a problem for their health, they can avoid it and avoid the health complications. This is only true if one reads the label and it is listed on the label.

Atopic eczema (AE) is another common skin disorder. Eczematous lesions showing macroscopic, microscopic and immunopathological resemblance to lesional AE can be induced by aeroallergens by epicutaneous testing (atopy patch test, APT). Altered epidermal barrier function, as determined by transepidermal water loss (TEWL), is a typical feature of patients with AE. The present investigation was performed to define the differences in the epidermal barrier function between positive APT reactions to aeroallergens and positive patch test reactions to contact allergens in AE patients. As a consequence of this aeroallergen-induced altered epidermal barrier function, further allergens can more easily penetrate the skin, inducing a vicious circle and perpetuating the eczematous lesions. 16

In the big picture, remember that fragrances are also layered. We also use or wear deodorants, body sprays, hair products, laundry detergents, room fresheners and the list goes on. The rate of asthma is climbing. Autism rates are increasing by exponential factors in some regions. Incidence rates in immune mediated diseases are skyrocketing. Our IQ is falling. We need to wake up and really look at our environment. There is a problem folks!

I just hope we see some muscle from our government that is not spurred by the almighty dollar, rather compassion for our fellow Americans based on sound science with a true sense of personal responsibility.

I keep thinking – It could happen! The day it does, we will have found an ethical politician deserving of their place in office and grossly underpaid. You cannot buy ethics. Thank God for freedom of speech and watchdogs! The American public has been comfortably lured into a false sense of safety.
____________________
Johansen JD. Fragrance contact allergy: a clinical review. Am J Clin Dermatol. 2003;4(11):789-98.

Lindberg M, Tammela M, Boström A, Fischer T, Inerot A, Sundberg K, Berne B. Are adverse skin reactions to cosmetics underestimated in the clinical assessment of contact dermatitis? A prospective study among 1075 patients attending Swedish patch test clinics. Acta Derm Venereol. 2004;84(4):291-5.

Karlberg AT, Nilsson AM, Luthman K, Nilsson JL. Structural analogues inhibit the sensitizing capacity of
carvone. Acta Derm Venereol. 2001 Nov-Dec;81(6):398-402.

Huss-Marp J, Eberlein-König B, Breuer K, Mair S, Ansel A, Darsow U, Krämer U, Mayer E, Ring J, Behrendt H. Influence of short-term exposure to airborne Der p 1 and volatile organic compounds on skin barrier function and dermal blood flow in patients with atopic eczema and
healthy individuals. Clin Exp Allergy. 2006 Mar;36(3):338-45.

Noiesen E, Munk MD, Larsen K, Johansen JD, Agner T. Difficulties in avoiding exposure to allergens in cosmetics. Contact Dermatitis. 2007 Aug; 57 (2): 105-109.

Liden C. Good opportunities to prevent contact eczema through legislation

Samochocki Z, Owczarek W, Zabielski S. Can atopy patch tests with aeroallergens be an additional
diagnostic criterion for atopic dermatitis? Eur J Dermatol. 2006 Mar-Apr;16(2):151-4.

Born SL, Caudill D, Smith BJ, Lehman-McKeeman LD. In vitro kinetics of coumarin 3,4-epoxidation: application to species differences in toxicity and carcinogenicity. Toxicol Sci. 2000 Nov;58(1):23-31.

Buckley DA et al. The frequency of fragrance allergy in a patch-test
population over a 17-year period. Br J Dermatol. 2000 Feb;142(2):279-83.

Huss-Marp J, Eberlein-König B, Breuer K, Mair S, Ansel A, Darsow U, Krämer U, Mayer E, Ring J, Behrendt H. Influence of short-term exposure to airborne Der p 1 and volatile organic compounds on skin barrier function and dermal blood flow in patients with atopic eczema and
healthy individuals. Clin Exp Allergy. 2006 Mar;36(3):338-45.

Soborg P. Solvent Neurotoxicity. CRC Press, 1992 pp. 1 – 382.

Frosch PJ, Rastogi SC, Pirker C, Brinkmeier T, Andersen KE, Bruze M, Svedman C, Goossens A, White
IR, Uter W, Arnau EG, Lepoittevin JP, Johansen JD,Menne T. Patch testing with a new fragrance mix - reactivity to theindividual constituents and chemical detection in relevant
cosmetic products. Contact Dermatitis. 2005 Apr;52(4):216-25.

Wiegand G. Models of Matter: Principles and Perspectives of Chemistry. West Publishing Company 1995, pp. 1-517.

Orton DI, Wilkinson JD. Cosmetic allergy: incidence, diagnosis, and management. Am J Clin Dermatol. 2004;5(5):327-37.

Huss-Marp J, Eberlein-König B, Breuer K, Mair S, Ansel A, Darsow U, Krämer U, Mayer E, Ring J, Behrendt H. Influence of short-term exposure to airborne Der p 1 and volatile organic compounds on skin barrier function and dermal blood flow in patients with atopic eczema and
healthy individuals. Clin Exp Allergy. 2006 Mar;36(3):338-45.

Samochocki Z et al. Can atopy patch tests with aeroallergens be an additional
diagnostic criterion for atopic dermatitis? Eur J Dermatol. 2006 Mar-Apr;16(2):151-4.

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Posted by: parfemy | May 25, 2010 12:57:15 AM

After using Angel Perfume for several months I had several seizures where I would totally black out. I knew they were coming as I had a peculiar sense of smell that is difficult to describe. It was a natural smell, but I've had it only in connection with these seizures!

After discussing this with several people, someone who knew I wore Angel said she had heard that it was toxic! Well, I immediately discontinued using it and haven't had a seizure since!

Do you think this is coincidental? Unless someone gives me some hard evidence that there is no relationship between my seizures the large bottle of Angel I had just purchased (NOT cheap) will remain unopened!

From what I have read online seizures per se were not mentioned as a side effect, so I'm not ready to throw the perfume away until someone who knows what he/she is talking about says there's a very good chance the seizures were caused by Angel. Any response?

Posted by: Martha Eckhart | Jan 19, 2012 7:46:12 PM

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