The scandalous headline-making case of Lyn dietary supplements is not just a wake-up call for consumers in buying suspicious products. It is also a trigger for the Food and Drug Administration (FDA) to actively crack down on manufacturers that break safety regulations.
"A lot of people wonder what the FDA is up to amid this ongoing dietary supplement crisis and if the FDA would do something to send the message to consumers about products available in the market," said Naruemol Chartsanga of the Bureau of Food under the FDA. Last week, Naruemol addressed manufacturers, online sellers and endorsers as well as consumers in a public lecture titled "Understanding Dietary Supplements: For Consumer Safety And Manufacturer Benefits" taking place at Dhurakij Pundit University.
Thailand's dietary supplement industry -- which is worth over 60 billion baht -- has been shaken in the months following the revelation that the weight-loss product Lyn contained the appetite suppressant sibutramine and laxative bisacodyl and has been associated with four deaths. This forced the Ministry of Public Health last month to classify sibutramine as a psychotropic substance to prevent its use as an ingredient in any weight-loss supplement. Sibutramine was banned by the FDA in 2010.
The FDA also revoked Lyn's certification number and production licence in the wake of the scandal and has urged provincial health offices across the country to keep a watchful eye to ensure that the product is no longer on the market.
Besides the legal movements, the FDA has embarked on an education campaign to help the public -- and especially manufacturers -- know the difference between food, dietary supplements and drugs. This is also for producers to fully understand what they should and should not do.
Based on the FDA's definition, dietary supplements are a small subset of food, Naruemol said. Food is something we eat and drink on a daily basis. Though categorised as food, dietary supplements are not something we consume every day; thus the production and sale of it must be accompanied by cautionary notes as to how to take it and so forth. Drugs, on the other hand, are any substance that aims to alleviate, treat or prevent symptoms or diseases.
"This means what is defined as food must not have medicinal properties except for specially formulated patients' diets such as for those suffering cancer and diabetes. However, products labelled as food for patients must have a supportive research paper or clinical tests to back up their efficacy," said Naruemol.
Additives such as flavour enhancers and colours are considered part of food and therefore must not claim as having medicinal properties either, she added.
The FDA's point of concern is when dietary supplements claim to possess medicinal properties, especially when manufacturers promote their products both online and offline. This, said Naruemol, is against FDA regulations.
"Dietary supplements are not medication. And consequently they are not supposed to have properties that are able to relieve or heal sickness. Advertisements that contain such messages are not allowed. Individuals and organisations are also not allowed to claim or certify such medicinal properties."
The marketing strategy of Lyn is unlike their predecessors. They used doctors, nurses and other healthcare personnel instead of celebrities to endorse their products through photos and messages posted on social networks.
"A number of healthcare personnel are involved in the dietary supplement businesses," Naruemol said. "In such cases, the FDA will examine if they really are in a medical profession. But by no means can they through their profession claim medicinal properties for any dietary supplement product."
After the Lyn scandal broke, many dietary supplement brands asked to cancel their products' FDA certification over fears of an investigation.
In the past, the FDA cited a 1979 provision in Thailand's Food Act that required food advertisements to be submitted to authorities for approval. Violations resulted in a maximum fine of 5,000 baht, which is nothing for million-baht businesses. Naruemol said the FDA now cites a more strict statute that prohibits deceptive advertising and false claims that can result in a three-year prison sentence and fine of up to 30,000 baht. Manufacturers' production licences can also be seized, she added.
Setting aside the law, untying all these knots in the country's dietary supplement industry requires awareness, understanding and collaboration from all parties.
"A lot of consumers are not aware of the law so they often make uninformed purchasing decisions. They turn themselves into a victim of illegally-operated dietary supplement products. The FDA encourages all parties involved to be part of the solution where we all should help monitor this market so that manufacturers can sell, the FDA can examine and at the same time consumers are educated. We must together keep an eye on what is happening to make sure things go right and everyone remains safe."
