Tougher regulations to protect consumers:
The price of beauty
“The Best, Simplest and Most Effective Way
For Smooth Thighs and Hips Within seven days!”
Dr. Hemantha Beneragama
Pic: Thilak Perera
The term “nutraceutical” was
coined from “nutrition” and “pharmaceutical” in 1989 by
Stephen DeFelice, MD, founder and chairman of the Foundation
for Innovation in Medicine (FIM), Cranford, NJ. According to
DeFelice, nutraceutical can be defined as, “a food (or part
of a food) that provides medical or health benefits,
including the prevention and/or treatment of a disease.”
However, the term nutraceutical as commonly used in
marketing has no regulatory definition.
An advertisement for a topical cream that claims to shape your body
starts like that. The product’s manufacturers boast that this is their
invention for 2010 and the luring continues...
Therapeutic drugs and cosmetics have become a modern day craze and a
‘hard to-do-without’ item among not only the fashion conscious, but all
Many women as well as men in our society want to enhance their looks.
So much so, it’s hard to believe that they live for anything else other
than to look attractive.
They dress, eat and sleep with this in mind.
To look young, beautiful and fair-complexioned, they are ready to
gulp down a handful of pills in different colours and shapes everyday.
The impact these pills may have on the system receives no serious
But how safe are these pills and therapeutic cosmetics that are
available in the open market? Can they pose long-term, dangerous health
risks such as skin cancer?
The Sunday Observer met Director of the Cosmetic Devices and Drugs
Regulatory Authority (CDDRA), Dr. Hemantha Beneragama last week to seek
Dr Beneragama says Sri Lanka is relatively safe from such products
than some other countries in the region. However, this certainly does
not mean that we are shielded 100 percent.
There are a host of products in the open market which do not fall
into the regular ‘safe’ category. These include nutraceuticals and
borderline devices, more appropriately termed ‘miracle performers’, that
take desperate consumers for a ride.
Nutraceuticals are neither pharmaceuticals nor food.
The State has a strict monitoring and regulation mechanism in place
for food and pharmaceuticals to ensure that what is in the market is
generally safe for human consumption. Borderline devices are products
that do not fall in to the medical devices category, but essentially
carry health benefit claims.
“The problem is that, under the existing law, we cannot regulate
nutraceuticals, borderline devices and cosmetics that carry herbal,
Ayurvedic or homoeopathy therapeutic claims,” the Director said. This is
a shortcoming in the present law.
“We have had the Cosmetic Devices and Drugs Act from 1980, and there
had been amendments in 1993 and 1994. Under the Act, the CDDRA can
regulate three items - cosmetics, medical devices, and pharmaceuticals”,
Under this law cosmetic products undergo a stringent evaluation
A Cosmetic Evaluation Sub-committee headed by Dr.Beneragama is in
place to evaluate new products and issue certificates before they reach
If the product claims Ayurvedic or homeopathy remedies, it will be
“This expert panel comprises consultant dermatologists,
representatives from the Government Analyst’s Department and the Sri
Lanka Standards Institution and senior pharmacists from the CDDRA,” he
They check whether the particular product is marketed in the country
of origin, the contents are acceptable, any harmful substance is in the
product and whether the product remains stable under Sri Lankan climatic
Without the registration it would be illegal to sell any cosmetic
products in Sri Lanka.
The Fourth Amendment is almost finalised now and is being finetuned
between the CDDRA and the Legal Draftsman’s office.
The CDDRA is in the process of bringing in the amendment to include
nutraceuticals and other goods which carry health claims to prevent the
flow of harmful products into the Sri Lankan market.
The regulation of nutraceuticals is vital to ensure that they are of
acceptable quality, safe for use and have the required efficacy.
Nutraceuticals can be a combination of food and vitamins and
chemicals of herbal origin.
They contain vitamins in small percentages, not essentially the daily
Nutraceuticals are not subject to the same stringent and thorough
testing as pharmaceuticals.
Thus, their presence in our pharmacies and supermarket shelves
without any safety testing by domestic health officials should ring
alarm bells in consumers’ heads no matter how desperate they are to look
good and feel energetic. No authority so far demands proof of their
The law is yet to be ratified.
Thus, it is wise to think twice before falling prey to the latest
product that claims to give you a young look, pimple-free face or make
your baldness a thing of the past, no matter how enticing the
advertisements may seem on TV.
The busy city dwellers who race against time are invariably the
victims of these products.
“Despite the lack of laws, we have warned and stopped the televised
advertising and marketing of cosmetic products and nutraceuticals with
‘false claims’ in the past.
“This tele-marketing has become a big headache for the authorities,”
Dr. Beneragama said.
“One recent incident involved a product promoting hair growth. Their
medium of promotion was the television.
“We intervened and immediately stopped this advertisement which was
utterly misleading,” he said.
However, he said, the CDDRA cannot confirm if these items pose health
risks without proper testing being conducted. However, it does not mean
that the eye-catching bottle of lotion or women’s beauty enhancing pill
is safe for your system.
Under the new laws a Rs. 500,000 fine will be imposed in instances of
violation, if the product sold is substandard or harmful and a tough
jail term up to one year. The punishment could be in either form or
Under the current law, the offenders can be imposed fines up to
Rs.100,000 and/or a six-month jail term.
Once the draft is finalised, the amendments will be submitted for the
Health Minister’s approval and then tabled in Parliament before they are
included in the Legislature. “We are hoping that this process could be
finalised in a few months, certainly before the end of this year,” the
Director said. At present consumers cannot see on the package whether a
particular product has been screened and registered.
This shortcoming is also being looked into. Thus, in future, it may
be compulsory for all registered products to bear the Health Ministry
registration number on the package.
With regard to advertising nutraceuticals, the new law will compel
approval from the CDDRA.
If the product entails a health or any other claim such as diabetes
cure or growth of scalp hair, the dealers or the manufacturers will have
to provide proof of laboratory testing.
If the product is available in other countries with strict domestic
regulations such as the US, UK, Australia, Japan and the EU countries,
the testing process will be less stringent.
The laws may make Sri Lanka a better place to live, but nothing can
beat natural instincts and individual wisdom as far as making a sound
choice for one’s good healthy concerned. This is so, as achieving a 100
degree safety level is absolutely impossible in today’s hi-tech world.