TIGER Balm and Kwan Loong Oil – medicated ointments meant for pain relief – are safe for use, despite
a warning letter issued recently to their maker by the United States drug regulator.
The Health Sciences Authority (HSA) said yesterday that it did not have any major safety concerns about the products, based on its assessment of the available information. Nor has it received reports of anyone reacting adversely to them.
Their safety came into question after the US Food and Drug Administration (FDA) issued a warning letter to their maker, Singapore-based Haw Par Healthcare, following an inspection of its manufacturing facility here in October last year.
In the letter dated July 20, the FDA said it had found that the tests used on Tiger Balm and Kwan Loong Oil were inadequate to detect potential impurities, that laboratory test records were incomplete, and control procedures were not followed.
The Tiger Balm Pain Relieving Patch was also labelled and branded incorrectly, it added.
Noting that countries vary in categorising and regulating health products, the HSA said that the FDA’s letter highlighted technical deficiencies that Haw Par needs to resolve to meet the FDA’s requirements for marketing the products in the US.
The HSA does not require medicated balms and oils to be licensed, because they are considered lower-risk products than medicines. Tiger Balm and Kwan Loong Oil do not contain potent medicinal ingredients
and are applied externally, it said.
But the HSA does require such products to comply with safety and quality requirements, for example, in not containing any toxins.
Haw Par Healthcare said that its manufacturing facility has been inspected and passed by Germany, Japan and Britain. The labelling of its pain relieving patch, which has been sold in the US since 1998, also adheres to the guidelines of the various countries where the patch is sold, it noted. It is working with the FDA to resolve the concerns, it said.