Saturday, 17 October 2015

NAFDAC organises first GMP training for cosmetics, medical devices manufacturers

…Threatens to shut companies caught with banned chemicals

World Health Organisation (WHO) estimation shows that Nigerian women constitutes world’s highest percentage of those that use skin-lightening products, accounting for 77 per cent of the global figure. That compares with 59 per cent in Togo, and 27 percent in Senegal. The reasons for this are varied but most people say they use skin-lighteners because they want ‘white skin.’

It is not only women who are obsessed with bleaching their skins; some men too are involved in the practice.

Skin bleaching comes with hazardous health consequences, according to experts. The dangers associated with the use of toxic compounds for skin bleaching include, blood cancers such as leukemia and cancers of the liver and kidneys as well as severe skin conditions.

Hardcore bleachers use illegal ointments containing toxins like mercury, a metal that blocks production of melanin, which gives the skin its colour, but can also be toxic.

Expressing similar concerns, the National Agency for Food and Drug Administration and Control (NAFDAC), recently raised alarm over increasing use of bleaching creams and skin whitening agents in the country and warned that such chemicals, apart from causing cancer, could lead to psychiatric and kidney problems.

From (L) - Pharm Titilope Owolabi, Director Drug Evaluation & Research, Dr Paul Orhii,
Director General, National Agency for Food and Drug Administration and Control (NAFDAC)
and Dr Monica Eimunjenze, Director Registration and Regulatory Affairs, at the agency’s
Good Manufacturing Practices (GMP)training for Nigerian cosmetics and medical
devices manufacturers in Lagos, recently.
The food and drug agency therefore flayed against continued usage of banned chemicals by unscrupulous manufacturers even as it cautioned users of bleaching cream on its grave implications.

Reading what seemed like a riot act in Lagos during the first NAFDAC’s Good Manufacturing Practice (GMP) training for cosmetics and medical devices manufacturers in Lagos, with the theme: ‘Safeguarding the Health of the Nation,’ the Director-General of the agency, Dr. Paul Orhii, said the use of glutathione intravenous as a skin whitener was unsafe and might result in serious consequences, including cancer.

He expressed concern that the urge to satisfy customers’ ever-increasing demands and the bid to make profits had driven some cosmetics manufacturers into experimenting with raw materials with little or no safety records.

Orhii vowed that the agency would not hesitate to shut down any company, which failed to comply with good manufacturing practice or caught with the banned chemicals.

He said: “Skin bleaching is a cosmetic treatment to reduce the prominence of skin discolourations and even out skin colour.

“Some people apply skin lightener to their entire body to change their complexion, but this can be very risky. The active ingredient in some skin lighteners is mercury and so bleaching can lead to mercury poisoning.”

It is not only women though who are obsessed with bleaching their skins. Some men too are involved in the practice.

In many parts of Africa, lighter-skinned women are considered more beautiful and are believed to be more successful and likely to find marriage partners easily.

The DG regretted that in spite of health implications, “the urge to satisfy customers’ ever-increasing demands has driven some cosmetics manufacturers into experimenting with raw materials with little or no safety records.”

Orhii stated that “the challenge with cosmetics regulation lies mostly in the continued use of banned and toxic chemicals in these products,” adding that “this unethical practice of manufacturers coupled with ignorance on the part of consumers has left many skins permanently damaged and only being concealed by clothing.”

The NAFDAC boss said: “Skin bleaching is a cosmetic treatment to reduce the prominence of skin discolorations and even out the color of the skin. Some people apply skin lightener to their entire body to change their complexion, but this can be very risky. The active ingredient in some skin lighteners is mercury and so bleaching can lead to mercury poisoning. Mercury is a toxic agent that can cause serious psychiatric, neurological, and kidney problems. Pregnant women who use a skin lightener with mercury can pass the mercury to their unborn child. Mercury can accumulate in the body and cause poisoning, which can lead to kidney or liver failure.

“Glutathione, a drug that is used to treat cancer may have the effect (side effect), although also disputed by many, of whitening the skin by inactivating the enzyme tyrosinase, which is necessary in melanin production, the pigment that determines skin colour and converts this pigment to the lighter phaecomelanin. The use of glutathione intravenous, as a skin whitener is not approved. The alarming increase in the unapproved use of glutathione administered intravenously as a skin-whitening agent at very high doses is unsafe and may result in serious consequences,” Orhii stressed.

NAFDAC Director of Drug Evaluation and Research, Mrs.Titilope Owolabi who was also at the occassion explained that manufacturers have the key responsibility of ensuring “the safety of their products by ensuring that adequate facilities and controls are available for the manufacture of their products,” adding that manufacturers “are expected to conscientiously execute their statutory and moral duties of ensuring that only health and non-toxic products are manufactured at all times.”


This story was published in Newswatch Times on October 15, 2015.

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