Tough new laws to battle spurt of bogus ‘health supplements’

Consumers misled with unproven claims of therapeutic effect


by Suresh Perera

Tough new regulations are on the cards to arrest the alarming trend of so-called "health supplements", "supplementary medicines" and "health nutrients" in the market which mislead consumers by making unproven claims of a therapeutic effect on the human body, senior health officials warned last week.

A spurt in these medicines — some locally manufactured but mostly sourced from lesser known manufacturers overseas – has caused widespread concern in health circles as consumers are tricked into using them through advertising gimmicks which portray an entirely different picture, they said.

Under the proposed legislation, health and dietary supplements, herbal and plant based medicines will be amongst the key segments to be compartmentalized to ensure effective supervision and control, the officials noted.

"We need to crack the whip and ensure direct regulation under the proposed new laws", says Dr. Hemantha Beneragama, Director, Cosmetic Devices and Drugs Regulatory Authority (CDDRA).

There are many products which don’t fall into the "pharmaceuticals" category, but what happens is that "adjustments" are done to fit them in, he pointed out. "This should be stopped".

Take Vitamin A as an example. The recommended daily dosage is 5,000 international units, but what many products marketed under ‘pharmaceuticals’ contain only 1,000 international units. It is lower than the daily required intake, but they are sold as ‘health supplements’, he complained.

Dr. Beneragama said there are products which claim to regularize blood pressure in patients, prevent hair loss, promote weight loss and slimming, hair growth, improve eyesight amongst diverse other assertions, but as the CDDRA cannot regulate directly under the law, the therapeutic effects of the products, as claimed, should be proven.

The proof should come not in the form of case studies but as scientific clinical trials, the director explained. "The manufacturers/importers are prosecuted if these claims are found to be bogus".

He said that media institutions have been informed to refrain from accepting for publication, without prior CDDRA approval, any advertisements of products or medical devices which claim a therapeutic effect.

"As much as these guidelines were complied with, there were also instances where they were observed in the breach", he said. "Legal action will be filed under the Cosmetic Devices and Drugs Act regarding such violations".

In the past year, advertisements, particularly in the electronic media, on these products and medical borderline devices had come down drastically. "This is an encouraging development".

Asked whether new restrictions are in place for the sale of sexual stimulants, Dr. Beneragama said these drugs fall within the ambit of Schedule 2B which means they can be sold only a medical doctor’s prescription.

On ayurvedic and homeopathic preparations, it is left to the respective regulatory Councils to decide, he said. "There are, of course, some herbal and plant origin products which fall within the ambit of western drugs".

"I am aware that some pharmacies sell these as OTC (Over-the-Counter) drugs, which is illegal", he noted. "It is difficult to supervise all 3,000 pharmacies in the country at once, but we are using decoys to trap and prosecute offenders".

On unregistered sexual stimulants and aphrodisiacs in the market, he said most of these products are smuggled from India in the personal baggage of passengers. "It is practically impossible to check each piece of luggage, but whatever stocks seized are confiscated".

"Some people buy sexual stimulants off the counter and take a bigger dose to double the effect. This can produce disastrous consequences for people with hypertension and cardiac diseases", he warned. "Legislation alone is not sufficient – it is more important to educate people".

"Sexual stimulants can be fatal for people who take nitrates which are medications used to treat heart conditions such as angina", a senior Colombo-based chemist cautioned. "There have been cases where patients have collapsed and died as the stimulants trigger an increase in blood flow to the penis".

"The lurking danger is for people with hidden heart diseases", he pointed out. "It could be too late when they realize they had a silent cardiac condition".

He said the consumption of alcohol with sexual stimulants could also produce dangerous health consequences. "That is why medical guidance is required before using these drugs".

There were scores of products, both locally made and imported, in the market earlier, but most of them have now disappeared, the chemist explained. "The way some aphrodisiacs are marketed, an impression of ‘instant results’ but the therapeutic effect is long-term".

People should not be allowed to be misled by such advertising gimmicks, he said. "Hopefully, the proposed new laws should halt this unethical trend".

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