clarins cosemtic is a drug

[Guest guest]

As you know my foundation has aggressively been going after clarins for a

myriad of federal regulations. In addition to the 2 petitions, we also had

submitted over THREE dozen drug versus cosmetic claims and wanted investigations

initiated and reclassified.

One has already been sent to the agency that over sees drug versus cosmetic

issues.

Here is our press release:

_http://www.prlog.org/10124949-clarins-expertise-3p-is-drug-according-to-fda.htm\

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(http://www.prlog.org/10124949-clarins-expertise-3p-is-drug-according-to-fda.htm\

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Clarins Expertise 3P is a Drug According To FDA.

Clarins Expertise 3P product touting effectiveness against artificial

electro-magnetic radiation is not a cosmetic but is viewed as making drug

claims.

(http://www.prlog.org/10124949-ntef-logo.jpg)

FOR IMMEDIATE RELEASE

_PRLog (Press Release)_ (http://www.prlog.org/) – Oct 06, 2008 – The

National Toxic Encephalopathy Foundation (NTEF) is pleased to announce that the

Food and Drug Administration (FDA) has concurred that Clarins Expertise 3P

(EP3) is a drug, not a cosmetic as advertised.

In February, the NTEF notified the FDA that Clarins EP3 was making drug

versus cosmetics claims and requested an investigation into these allegations.

As previously stated: “We are now requesting that the FDA verify the claims

made by Clarins, in vitro testing versus in vivo testing, along with

compliance, since this product is a new drug under section 201(p) of the FDCA,

21

U.S.C. subsection 321 (p), because it is not generally recognized by qualified

scientific experts as “effectiveâ€As previously stated: “We

On October 1, 2008, the NTEF received the following notification from

A. Hansen, Ph.D. Sr. Advisor for Science and Policy at the FDA:

“The Office of Cosmetics and Colors has reviewed the information at the U.S.

website, where products may also be purchased, and consulted with others in

the Agency. We are of the opinion that the claims made are drug claims. We

have referred the matter to the office that handles these issues, FDA's

Office of Non-Prescription Drug Products in the Center for Drug Evaluation and

Research (CDER). “

“We couldn’t be happier with the FDA’s determination regarding EP3â€,

said

Angel De Fazio, President of the NTEF. “Cosmetic companies have been

skirting the drug versus cosmetics claims for too long. It is hoped that as a

result of this action, cosmetic companies, such as Clarins, will stop their

deceptive advertising. It is expected that in the future they will be forced to

submit new drug applications for their products when making medical claimsâ€.

“I extol the opinion of the FDA’s findings regarding EP3 and am confident

that they will be of the same mind regarding the two dozen plus other drug

versus cosmetic claims that we have submitted. As we will be just as

aggressive

in having those also being re-classifiedâ€As we will be just as aggressive in

having those also being re-classifiedâ€<WBR>, said Dr. Jack D. Thrasher,

Ph.D., Toxicologist, Immuno-toxicologist, Fetal-toxicologist and technical

director for the NTEF. “Clarins has pushed This is not the first time that

the FDA

has taken Clarins to task for drug versus cosmetic claims and we are highly

confident that this will not be the last.â€

# # #

The NTEF is a watchdog environmental group seeking to notify the public of

the hazards inherent in consumer products that have not been fully tested for

safety.

Along with having cosmetics that are making medical claims reclassified as a

drug and requesting FDA regulatory requirements regarding their safety,

effectiveness, etc., be implemented.

The Foundation's main object is to educate the public on the inherent

dangers to the brain associated with the chemicals in fragrances, air

fresheners,

pesticides, various other consumer products that they have been lead to

believe are fully tested for safety. For every chemically based product, there

is

at least one safer alternative that has been proven just as effective.

Angel

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