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Exoderm, the product was immediately withdrawn from sale and is currently unavailable in New Zealand.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