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Ministry Prosecutes Cosmetic Company

3 February 2000

Ministry Prosecutes Cosmetic Company

A New Zealand Cosmetics company has been fined $13,900 for selling and advertising a medicine without the consent of the Minister of Health.

The medicine, Exoderm, was linked with the death of Leanna Steven who died on 15 March, three weeks after she collapsed while having treatment with Exoderm Facial Peel. The cause of death is still before the Coroner.

The importer of Exoderm facial peel, Farra Cosmetics International Limited pleaded guilty to the charges laid under section 20 of the Medicines Act which related to selling and advertising the availability of Exoderm without the consent of the Minister of Health.

A Christchurch medical practitioner who was jointly charged with the advertising breaches entered a plea of not guilty during his first court appearance today.

Ministry Senior Enforcement Advisor Steve Anthony said Exoderm was not legally allowed to be sold or distributed in New Zealand.

"The Medicines Act 1981 has controls in place to ensure the public are adequately protected from products which have the potential to harm if they do not meet the standards claimed, or if they are used unwisely or inappropriately."

"The Ministry regards any breach of this act as a serious offence and it will investigate and prosecute where it can."

He said a penalty such as this sends a message to others in the industry that a breach of the law is simply not tolerated.

Exoderm is a deep chemical facial skin peeling solution manufactured in Israel. It is used in facial rejuvenation whereby the peel formula melts the top layers of skin removing wrinkles, blemishes and lines on the face. The product is applied to patients under light sedation usually by medical practitioners who have been trained in the process. Exoderm also contains Phenol, a substance known to have toxic effects on the heart.

END

Background Information:

The Ministry of Health launched an investigation following the death of Mrs Steven on 15 March 1999. The investigation confirmed Farra Cosmetics International Limited did not have consent of the Minister of Health to distribute, sell or advertise Exoderm Facial Peel. As soon as the Ministry was informed of Mrs Steven's death and the possible link with Exoderm, the product was immediately withdrawn from sale and is currently unavailable in New Zealand.

Under the Medicines Act 1981, new medicines require the consent of the Minister of Health before they can be distributed in New Zealand. The Act defines the term medicine and contains controls relating to medicines, medical devices, related products and cosmetics. The purpose of these controls is protection of the public. Before consent can be granted, the quality, safety and efficacy of the medicine must be established to ensure the public is adequately protected from products which have the potential to harm if they do not meet the standards claimed for them, or if they are used unwisely or inappropriately.

The maximum penalty for a body corporate breaching section 20 of the Medicines Act 1981 is $100,000.

END

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