My petition to FDA about coumarin in Perfume:
NTEF Petitions the FDA to Have Angel Perfume Declared a Drug
Las Vegas, NV 89126 October 29 2007
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 Weiner
The 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
Angel De Fazio, B.S.A.T (Angel@ntef-usa.org)
President
National Toxic Encephalopathy Foundation (NTEF)
POB 29194
Las Vegas, NV 89126
Phone : 702.598.3382