Ministry of Health Malaysia finally bans ozone therapy beauty treatments once endorsed by local celebrities

Shopping · May 4, 2017, 8:09am

Ozone therapy treatments now banned in Malaysia

PUTRAJAYA: Ozone therapy, which unscrupulous beauty operators have promised could lead to fairer skin and the ability to rejuvenate one’s beauty, is now officially banned in Malaysia.

The Health Ministry, announcing this today, said the decision was made following a thorough assessment made on the treatment, its properties, claims and supposed effects.

Health Minister Datuk Seri Dr S. Subramaniam said the ministry, via its Malaysian Health Technology Assessment Section (MaHTAS) , had completed its study on the treatment.

The assessment, he said, revealed that there was zero scientific evidence to support claims of any benefits from the supposed therapy.

Instead, the assessment showed that ozone therapy treatment could lead to severe medical complications.

"Among others, the therapy potentially exposes users to risks of bleeding from the usage of heparin (blood thinning medicine), embolism (blockage of blood vessel from air bubbles), and infection from non-sterile instruments.

“It could also lead to permanent disability resulting from impairment of organs such as the kidneys,” he told reporters today.

The decision comes after the New Straits Times, in January, had published a series of reports on ‘killer cosmetics.’ The reports, which focused on exposing unscrupulous practices by beauty parlours and so-called health spas.

Among the dubious treatments which came under the microscope were ozone therapy, which had even been endorsed by a number of local celebrities.

The very same celebrities later distanced themselves from being associated with the treatments after being informed by NST of the potential danges of ozone therapy.

Dr Subramaniam, meanwhile, said the ministry viewed seriously the ozone therapy business, especially its claims of being able to rejuvenate one’s skin and beauty, whiten complexion and slow the ageing process.

Dr Subramaniam also noted that the usage of ozone therapy machines has also never been approved.

"Under the Medical Device Act 2012, the machine is defined as a medical device which must be registered with the Medical Device Act (MDA).

"Therefore, any establishment, manufacturer, importer or distributors who import or place the machines in the Malaysian market need to apply for an establishment licence and register the licence under the Act.

“So far, we haven’t received any applications or registrations for such machines in the country,” he said.

Dr Subramaniam said the therapy was similar to dialysis treatment, which involves injection into a person’s vein and running the blood through the machine.

“Because the process falls under the ambit of medical treatment, hence, it is compulsory for the practice to fulfill every aspect of existing medical laws. Action can be taken against the providers should they fail to comply,” he added.

The ministry also found that the therapy was provided in various premises including clinics and beauty salons which are manned by healthcare professionals as well as unqualified personnel.

“These people could be liable to a fine not exceeding RM200,000 or jail time of three years, or both,” he added.

Source: New Straits Times

Shopping · May 4, 2017, 8:52am

Datuk Seri Dr S.Subramaniam:

MINISTRY OF HEALTH’S STERN ACTION AGAINST OZONE THERAPY

Ministry of Health Malaysia would like to inform that all forms of ozone therapy which involves usage of ozone machines, injection into person’s vein and running the blood through the machines, fall under the ambit of medical treatment. Therefore, it is compulsory for the practice to fulfil every aspect of existing medical laws and action can be taken against the providers should they fail to comply. The Ministry noted that ozone therapy are provided by various types of premises including clinics and beauty salon, plus manned by healthcare professionals and unqualified personnel.

Health Technology Assessment done by Malaysian Health Technology Assessment Section (MaHTAS) revealed that there is no scientific evidence to support any therapeutic benefit from the usage of the above mentioned therapies for any illnesses. Moreover, the therapy exposes the users to risks of bleeding from the usage of heparin, embolism (occlusion of blood vessels from air bubble), infection from unsterile instruments and permanent disability resulting from impairment of organs such as the kidneys.

Ministry would like to re-emphasise that ozone therapy is not a recognised treatment and could cause severe medical complications including deaths. Hence, Ministry views the practice of ozone therapy seriously and the regulation of this device and practice should be in accordance to existing medical legislations, as follows:

Section 2 and 5, Medical Device Act 2012 [Act 737] defines ozone therapy machine as a medical device which must be registered with Medical Device Authority (MDA). Any establishment, manufacturer, importer or distributor who import or place the ozone therapy machine in the Malaysia market need to apply for establishment licence and registration of the device under this Act with MDA, or recall the distribution/usage of the machine from the market, latest by 1st July 2017.
Anybody who fail to comply or contravene the above requirements could result in legal action and be liable to a fine not exceeding two hundred thousand ringgit or to imprisonment for a term not exceeding three years or to both.
The usage of heparin products is under the purview of Poison Act and Sales of Drug Act 1952, enforced by the Pharmacy Enforcement Division.
Any registered or licensed private healthcare facilities under Private Healthcare Facilities and Services Act 1998 [Act 586], which provide ozone therapy, legal action can be taken under this Act.
The usage of injection needles and injection syringes for intravenous heparin, is regulated under Medical (Instruments) (Exemption) Regulation 1986, whereby the instruments could only be used by registered medical practitioners or registered medical assistants. Legal action can be taken against unregistered or unlicensed facilities providing ozone therapy, if there is evidence that there is usage of injection needles and syringes at the facility.
Complaints towards registered medical practitioner who provides ozone therapy, can be forwarded to Malaysian Medical Council for further action. (phone: 03-26912171, fax: 03-26912937 / 03-26938569, email: admin.mmc@moh.gov.my, http://www.mmc.gov.my/index.php/making-a-complaint)

The Ministry wishes to reiterate that not only ozone therapy does not confer any health benefit, but it could also endanger the life of its users. The collaboration between enforcement agencies under Ministry of Health will be further strengthened to ensure the safety and healthcare quality of the public is continuously improved and upheld.

DATUK SERI DR. S. SUBRAMANIAM
MINISTER OF HEALTH MALAYSIA

3rd May 2017

KENYATAAN AKHBAR MENTERI KESIHATAN MALAYSIA

TINDAKAN TEGAS KEMENTERIAN KESIHATAN TERHADAP ISU TERAPI OZON

Kementerian Kesihatan Malaysia (KKM) ingin memaklumkan bahawa semua bentuk terapi ozon yang melibatkan penggunaan mesin terapi ozon, suntikan ke dalam saluran darah seseorang individu dan darah tersebut diproses menggunakan mesin tersebut, adalah termasuk dalam lingkupan rawatan perubatan. Oleh yang demikian, amalan tersebut perlu mematuhi semua aspek undang-undang perubatan sedia ada dan tindakan boleh diambil ke atas pihak-pihak yang gagal mematuhi ketetapan tersebut. KKM mendapati terapi ozon ini adalah disediakan di pelbagai jenis premis perniagaan termasuk klinik, salun kecantikan dan ianya dikendalikan oleh profesional jagaan kesihatan dan orang yang tidak berkelayakan.

Penilaian Teknologi Kesihatan yang dijalankan oleh Cawangan Penilaian Teknologi Kesihatan KKM (MaHTAS) mendapati tiada bukti saintifik yang menyokong sebarang manfaat terapeutik penggunaan terapi ozon bagi mana-mana penyakit. Malah, terapi tersebut mendedahkan pengguna kepada risiko pendarahan daripada penggunaan heparin, embolism (penyekatan salur darah oleh gelembung udara), jangkitan kuman akibat peralatan yang tidak steril dan kehilangan upaya yang kekal berpunca daripada kegagalan organ seperti buah pinggang.

KKM ingin menegaskan semula bahawa terapi ozon merupakan rawatan yang tidak diiktiraf dan boleh menyebabkan komplikasi perubatan yang teruk termasuklah kematian. Maka, KKM mengambil serius perkara ini dan pengawalseliaan terapi ozon ini perlulah mengikut ketetapan perundangan perubatan sedia ada, seperti berikut:

Selaras dengan ketetapan Seksyen 2 dan 5, Akta Peranti Perubatan 2012 [Akta 737], mesin terapi ozon ditafsirkan sebagai suatu peranti perubatan yang perlu didaftarkan dengan Pihak Berkuasa Peranti Perubatan (Medical Device Authority (MDA)). Mana-mana establismen, pembuat, pengimport atau pengedar mesin terapi ozon yang mengimport, mengeksport atau meletakkan dalam pasaran apa-apa mesin terapi ozon perlu memohon lesen establismen dan pendaftaran peranti di bawah Akta 737 dengan MDA, ataupun menarik semula pengedaran/penggunaan mesin tersebut dari pasaran, selewat-lewatnya 1 Julai 2017.
Kegagalan mematuhi ketetapan tersebut atau mereka yang melanggar peraturan ini boleh menyebabkan tindakan perundangan diambil, iaitu apabila disabitkan, didenda tidak melebihi dua ratus ribu ringgit atau dipenjarakan selama tempoh tidak melebihi tiga tahun atau kedua-duanya.
Penggunaan produk heparin bagi rawatan terapi ozon adalah tertakluk kepada Akta Racun dan Akta Jualan Dadah 1952 yang dikuatkuasakan oleh Bahagian Penguatkuasaan Farmasi (BPF).
Bagi kemudahan jagaan kesihatan swasta yang berlesen atau berdaftar bawah Akta Kemudahan Dan Perkhidmatan Jagaan Kesihatan Swasta 1998 [Akta 586] yang menyediakan rawatan terapi ozon, tindakan perundangan bawah Akta 586 boleh diambil.
Penggunaan injection needles dan injection syringes untuk IV heparin tertakluk kepada ketetapan Medical (Instruments) (Exemption) Regulation 1986, di mana radas tersebut hanya boleh digunakan oleh pengamal perubatan berdaftar atau pembantu perubatan berdaftar. Oleh itu, tindakan undang-undang boleh diambil kepada premis yang tidak berdaftar atau tidak berlesen dan menyediakan terapi ozon sekiranya terdapat bukti penggunaan injection needles dan injection syringes di premis berkenaan.
Aduan terhadap pengamal perubatan berdaftar yang menyediakan perkhidmatan terapi ozon boleh dikemukakan kepada Majlis Perubatan Malaysia untuk tindakan selanjutnya (telefon: 03-26912171, faks: 03-26912937 / 03-26938569, email: admin.mmc@moh.gov.my, http://www.mmc.gov.my/index.php/making-a-complaint).

KKM ingin menekankan sekali lagi bahawa terapi ozon bukan sahaja tidak memberikan sebarang manfaat kesihatan, malah rawatan tersebut boleh membahayakan nyawa pengguna. Kerjasama antara agensi penguatkuasa bawah KKM akan diperkukuhkan bagi memastikan keselamatan dan kualiti jagaan kesihatan untuk rakyat sentiasa dipertingkatkan dan dijaga.

DATUK SERI DR. S. SUBRAMANIAM
MENTERI KESIHATAN MALAYSIA

3 Mei 2017

Shopping · May 4, 2017, 9:20am

Medical Mythbusters Malaysia:

ALKISAH RIWAYAT TERAPI OZON

Pembongkaran demi pembongkaran dilakukan secara aktif ke atas perkhidmatan terapi ozon oleh Pseudoscience Watch, Root of Science, Medical Mythbuster Malaysia dan doktor-doktor serta petugas kesihatan yang bertauliah.
Begitu banyak kepincangan dari sudut sains dan aspek perubatan apabila perkhidmatan ini menawarkan keajaiban merawat pelbagai jenis penyakit.
Bagi memberi keyakinan kepada pengguna, perwatakan ahli agama digunakan dengan menggayakan kopiah, janggut dan jubah dalam mempromosikan perkhidmatan ini. Lebih-lebih lagi para artis digunakan sebagai strategi pemasaran mereka.
Hasil pembongkaran didengari pihak kementerian apabila kenyataan Ketua Pengarah Kesihatan bertarikh 2 Januari menjelaskan tiada bukti rawatan ozon mempunyai kelebihan dari aspek terapeutik.
Artis-artis yang sebelum ini memberikan sokongan pada awalnya mula menarik balik sokongan tersebut. Malah mereka menyeru peminat masing-masing untuk menjauhi perkhidmatan terbabit.
Terapi ozon menemui ‘sinar harapan’ apabila pada 27 Februari, sebuah rancangan temubual memaparkan tajuk terapi ozon. Tajuk yang sepatutnya dibincangkan dalam satu episod diterbitkan buat kali kedua atas permintaan ramai penonton, menurut pengacara rancangan tersebut.
Ianya boleh dianggap momen mendukacitakan buat dunia perubatan Malaysia apabila seorang pakar kecemasan di ibu kota dijemput ke dalam rancangan tersebut dan seolah-olah dimanipulasi untuk menyatakan sokongan kepada terapi ozon.
Apatah lagi, lelaki yang dikatakan founder kepada perkhidmatan terapi ozon tanpa segan silu menggunakan gelaran ‘doktor’ di kaca tv padahal gelaran tersebut diperoleh daripada universiti ‘bogus’.
Peperangan demi peperangan. Akhirnya Datuk Seri S. Subramaniam selaku Menteri Kesihatan Malaysia mengisytiharkan pengharaman ke atas rawatan terapi ozon. Beliau mengarahkan semua premis berhenti daripada menawarkan perkhidmatan ini.
Kepada yang degil, mereka boleh didakwa di bawah Akta Peranti Perubatan 2012 yang membawa hukuman denda maksimum RM 200,000 atau penjara tidak lebih tiga tahun, atau kedua-duanya sekali.
Kami berharap hukuman ini dapat dilaksanakan segera kerana pusat terapi ini membiak tanpa rasa malu, memudaratkan masyarakat tanpa silu.

Shopping · May 4, 2017, 9:55am

Found an old report by NST Online published 1 January 2017 regarding local celebrities’ endorsement of ozone therapy and regretted afterwards.

Ozone therapy: Local celebs express regret for endorsing dubious treatment

KUALA LUMPUR: SCORES of celebrities who endorsed dubious and potentially harmful beauty services in clear violation of the law now want their fans to immediately stop undergoing such treatments.

After being made aware of the dangers, the celebrities conceded that they should have known better than to “promote” products and services which may potentially harm their fans. These celebrities, many of them being A-listers in the country, want their fans to forget any “endorsements” that they made for injectable beauty products and the increasingly-popular ozone treatment, which the Health Ministry is highly concerned about.

These celebrities, who have unwittingly promoted these services, are shocked to learn that what they have done is clearly against the law. They expressed regret over their actions and apologised to their fans. These are what some of them said.

Remy Ishak, actor

It (the promotion of dubious services) was a mistake. I am only human. I failed to do enough due diligence before submitting myself to the procedure that I was promoting.

But I did ask the operators about the procedure. They falsely claimed that it had been approved by the Health Ministry.

I should have known better than to take the word of the operators at face value. I actually stay away from such things. I retract my endorsements of such procedures.

In fact, I did not feel any difference in my body after undergoing an ozone treatment.

I feel much better after a session at the gym. I will inform the operators to remove my so-called “promotion” of their business.

Reen Rahim, actress

I did the ozone treatment thinking that it was merely the modern way of doing bekam (skin suction treatment).

I don’t know the risks associated with it or whether the operators are running foul of the law. My advice to the public is not to take testimonials at face value, but carry out your own research so you can make an informed decision.

At the same time, I hope the authorities will make it clear and remove things that consumers seek, which are not supposed to be easily available.

Zizan Razak, comedian, host, actor

To tell you the truth, although the video and images implied that I was undergoing a procedure, I did not have the courage to do it because just a few days earlier, I learned that someone with kidney illness underwent ozone treatment and died soon after.

What happened was, I did not think it through when helping a friend (to promote her business). I agreed to only have the tubes plastered on my arms.

To my fans, please ignore my so-called “testimonials” on the Vitamin injection and ozone treatment.

Do check on the safety and approval of the products before you even think of using them.

Don’t take things for granted as the repercussions can be dire. Protect your body and life… don’t risk them by using dubious products.

Julia Ziegler, actress and model, who is getting married today

God have mercy… I had no idea of the health risks.

The promoters of these illicit beauty injections, including the one that I went to, had convinced me to sign up for a RM1,000 Vitamin C injection package.

I didn’t know that it was banned.

I even went for the so-called ozone therapy, which they claimed would help with the rashes I was suffering from then. It didn’t do anything for me. That beauty parlour should be reined in.

I have sworn off these procedures and will demand that they take down my pictures, which they are using to promote their products, as I do not want to be associated with encouraging people to put their health at risk.

Ashraf Muslim, actor, host

That so-called endorsement was a one-off thing.

I heard all the concerns and negative stories involving ozone therapy, and I admit that I was an uninformed user. The last thing I want is for the public to suffer health complications.

But at the same time, I am sure there are plenty of people like me, especially when this kind of treatment is being offered at so many outlets. And yet, we have not heard of action being taken against the operators.

This is not like the halal issue, for example, where you see immediate raids being mounted. I thought the fact that these operators are allowed to do it means it has been sanctioned by the authorities.

I apologise for my ignorance, but at the same time, I appeal to the authorities to act accordingly.

Ika Nabila, actress, singer

I became hypoglycaemic in the middle of my ozone therapy.

I remember feeling terrified as my blood was drained and I was shivering. All I could do was ask them to give me something sweet, so they stuffed a piece of chocolate into my mouth. They convinced me that there would be a doctor hooking me up to the machine. But that wasn’t the case. There was no prepping, no checking of my blood sugar or even heart rate.

They just stuck the needle up my arm.

I wouldn’t recommend it to anyone, what more if the Health Ministry does not even endorse it. In fact, later, they arbitrarily used my image for promotion. I apologise if it seemed as if I was encouraging the procedure. I don’t want anything bad to happen to anyone.

Uqasha Senrose, actress

I will never ask my fans to put themselves through any health risks by going for unsanctioned or dubious beauty treatments.

Yes, I had been paid to promote the ozone treatment. It was a one-off thing that I did. Personally, I feel that we should embrace and be grateful for what God has given to us. Nothing beats leading a healthy lifestyle.

‘Be careful when signing deals’

CELEBRITIES endorsing illicit and harmful products and services have been advised to stop doing so and practise caution when sealing deals.

Malaysian Artistes’ Association (Karyawan) president Datuk Freddie Fernandez said they must know not only the consequences of their actions, but also the influence they have on their fans.

“My advice to them is to be careful before agreeing to become a product ambassador or lending publicity.

“They need to carry out due diligence, which includes checking the product’s status with the authorities.

“For example, in the case of beauty and health products, checks should be made with the Health Ministry,” he told the New Sunday Times’ Special Probes Team.

Karyawan, he said, was willing to assist them in the process.

This, Fernandez added, would ensure that the celebrities did not fall into the trap of promoting illicit and hazardous products and services, which could expose them to legal action.

“Artistes should also not expose themselves to health risks by using dubious products and services.

“This is not only about painting a bad image, but also the legal repercussions that they could face.”

Persatuan Seniman Malaysia president Rozaidi Abdul Jamil, fondly known as Zed Zaidi, said artistes should make sure proper agreements were drawn up before allowing themselves to be used in any promotional material.

“They must observe the procedures and make sure the company they are endorsing is legitimate. And, if it involves beauty products, they need to check with the authorities.”

Rozaidi also pointed out that Seniman was aware of cases where images and footage of celebrities were used without their consent.

“There are those who take advantage of artistes visiting their premises and use the images to promote their business. This is not right, more so when the products and services are not sanctioned by the law. It will tarnish the artistes’ reputation.”