Coumarin is defined by the FDA:
Chapter IX Subchapter VIII (21`U.S.C. Subchapter VIII Section 381 (a)(3)
"The article appears to bear or contain Coumarin, a poisonous or deleterious substance, which may render it injurious to health"
In throughly reviewing the listed ingredients it is clear that the referenced ingredients carry health warnings associated with the chemicals. A consumer needs a handbook on chemistry to fully understand what they are applying to their skin or shop with a toxicologist.
NTEF Petitions the FDA to Have Angel Perfume Declared a Drug
LAS VEGAS -- The National Toxic Encephalopathy Foundation (NTEF) has submitted a petition to the Food and Drug Administration (FDA) to have Angel Parfum by Thierry Mugler be declared misbranded, reclassified as a drug and have its importation into the United States ceased for numerous federal import violations.
For years, Angel Parfum--manufactured by Clarins of Paris, France--only listed a few ingredients. Now, additional disclosure of ingredients includes Coumarin as a fragrance material.
The FDA previously declared Coumarin to be “a poisonous or deleterious substance, which may render it injurious to health." Furthermore, claims NTEF, Angel fits the criteria of a health hazard by FDA definition: "if it bears or contains any poisonous or deleterious substance which may render it injurious to user under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual," quoting Chapter IX Subchapter VI (`21 U.S.C. Subchapter VI Section 361 (a)) of FDA statutes.
Additionally, the petition submitted to the FDA references over 10 violations of the United States Code and Code of Federal Regulation, said Angel De Fazio, President of the NTEF."
A potential health problem associated with Angel Perfume is that it contains Coumarin. Coumarin is a precursor to the regulated drug Warafin and is used by individuals who have heart disease and other health problems where blood clotting can be fatal. The perfume also contains ethanol and other chemicals that increase the permeability of the skin and can allow Coumarin to enter the blood stream. This increases the potential danger to heart patients as well as individuals scheduled for surgery. This fragrance is a drug that necessitates reclassification and restrictions regarding its use.”, said Jack D. Thrasher, Ph.D., Toxicologist/Immunotoxicologist/Fetaltoxicologist.
"The addition of Coumarin or any other product restricted by the FDA, whenever it began, is disturbing. Coumarin is absorbed through dermal application [1] and this is amplified by co-products used in the manufacture of Angel by Clarins. Coumarins and 1-3-indandiones interact with certain drugs [2] (e.g.: potentiates phenylbutazone [3] and salicylates) while it also antagonizes barbiturates [4] and vitamin K).[5] In fact, Coumarins are competitive inhibitors of Vitamin K, [6,5] in the biosynthesis of prothrombin. Warafin is the sodium salt derivative of Coumarin (otherwise commonly known as rat poison)" [7,8,9] said Nina B. Immers, Medical-Legal Consultant, Vanzer, LLC.
The introduction of Coumarin into a developing fetus in utero from maternal exposure otherwise termed prenatal exposure, has been shown to have an effect on school age children: “…we conclude that behavioural development may be negatively influenced in school-age children after in utero exposure to Coumarins, leading to less favorable task oriented and social-emotional behavioural” [10]“…Coumarins have an influence on the development of the brain which can lead to mild neurological dysfunctions in children of school age.”[11]
It is unconscionable for a major company, such as Clarins, to engage in such substandard and underhanded marketing practices putting their own clients at risk and basically mocking our FDA as well as America’s rules and regulations. I have to believe after the 911 incident and all the political events, which have transpired since that time, that the FDA will enforce our rules and standards swiftly. The FDA simply cannot let foreign entities disobey their guidelines without losing both face and authority” said Immers.
“It is very clear that Clarins numerous intentional omissions (ocular cell necrosis, absorption of Coumarin, lung and skin irritants et al) can be construed as both active concealment (concealment by words or acts of something that one has a duty to reveal) or fraudulent concealment (affirmative suppression or hiding, with the intent to deceive or defraud, of a material fact or circumstance that is legally bound to reveal). This could also be in conjunction with affirmative misconduct (an affirmative act of misrepresentation of a material fact), which warrants immediate action on the part of the FDA,” said De Fazio.
References:
1. Albert RE Allergic contact sensitizing chemicals as environmental carcinogens. Environ Health Perspect. 1997 September; 105(9): 940–948.
2. Gerard Van Den Berg*, Marius L. De Winter†, Wybo A. De Boer and Wijbe Th. Nauta. Inhibition of ß-glucuronidase by 2-diarylmethyl- 1,3-indandiones. Received 23 June 1975; accepted 23 October 1975. Available online 5 November 2002. Biochem Pharmacol. 1976 Jun 15;25(12):1397-403.
3. http://www.usp.org/pdf/EN/veterinary/phenylbutazone.pdf
4. Peter G. Dayton, Yavuz Tarcan, Theodore Chenkin, and Murray WeinerThe Influence of Barbiturates on Coumarin Plasma Levels and Prothrombin Response, J Clin Invest. 1962 February; 41(2): 300.
5. Ren, P, Stark, PY, Johnson, RL, Bell, RG. Mechanism of action of anticoagulants: correlation between the inhibition of prothrombin synthesis and the regeneration of vitamin K1 from vitamin K1 epoxide. J Pharmacol Exp Ther 1977 201: 541-546.
6. Wallin R, Martin L F Vitamin K-dependent carboxylation and vitamin K metabolism in liver. Effects of warfarin. J Clin Invest. 1985 November; 76(5): 1879–1884.
7. Marek LJ, Koskinen WC. Multiresidue analysis of seven anticoagulant rodenticides by high-performance liquid chromatography/electrospray/mass spectrometry. J Agric Food Chem. 2007 Feb 7;55(3):571-6.
8. A Taylor and M G Townsend, Some biochemical studies on warfarin resistance in the rat. Biochem J. 1970 July; 118(3): 56P–57P.
9. http://en.wikipedia.org/wiki/Coumarin
10. Wesseling J, Van Driel D, Heymans HS, Van der Veer E, Sauer PJ, Touwen BC, Smrkovsky M. Behavioural outcome of school-age children after prenatal exposure to coumarins. Early Hum Dev. 2000 Jun;58(3):213-24
11. Wesseling J, Van Driel D, Smrkovsky M, Van der Veer E, Geven-Boere LM, Sauer PJ, Touwen BC. Neurological outcome in school-age children after in utero exposure to coumarins. Early Hum Dev. 2001 Jul;63(2):83-95
