FDA warns vs Indonesian herbal tonic sold in unlabeled sachets

MANILA, Philippines — The Food and Drug Administration (FDA) has reiterated its warning against an herbal tonic claiming to treat a wide array of illnesses after discovering that the product from Indonesia is now being peddled in small plastic sachets without labels.

The Sehat Badan herbal drink was the subject of two health warnings by the FDA in 2014 for containing a cocktail of a corticosteroid and non-steroidal anti-inflammatory drugs, posing danger to public health.

When evaluated by the FDA in 2014, the packaging of the herbal drink did not have an English translation of information in violation of the rules and regulations on the labeling of imported food products and prepackaged food items distributed in the country.

According to the latest advisory of the FDA, Sehat Badan is still being sold online and on the streets in various parts of the country despite earlier warnings, this time as “unlabeled powder repacked in small plastic bag with a piece of paper [listing its] therapeutic claims.”

Previous labels on the herbal coffee claimed that it was good for asthma, ulcer, tumor, anemia, goiter, insomnia, stroke, rheumatism, high blood pressure, kidney stones, migraine, skin allergies, gouty arthritis and tonsillitis, among others.

The FDA further stated that its recent laboratory analysis showed that the product also contained the same drugs previously determined in its evaluation. It still found dexamethasone in addition to diclofenac sodium, paracetamol and ibuprofen in the product.

“It must be noted that dexamethasone is a steroid, classified as prescription drug while diclofenac sodium, paracetamol and ibuprofen are non-steroidal anti-inflammatory (NSAID) drugs that are required to be purchased from licensed drugstores,” stated FDA advisory No. 2015-072.

The regulatory agency warned that misuse or chronic use of steroids like dexamethasone may result in serious adverse reactions such as gastrointestinal bleeding and ulcers, osteoporosis, muscle weakness, obesity, dyslipidemia, increased risk for infections and poor wound healing.

Abrupt discontinuation of steroids may cause withdrawal signs and symptoms like hypotension and shock and could lead to coma.

Meanwhile, the chronic use of NSAIDS could worsen heart failure symptoms and might lead to kidney failure, increased cardiovascular risks, and gastrointestinal ulcers and bleeding, said the FDA.

“In the interest of protecting public health and safety and pursuant to Republic Act No. 9711, the officers of the field regulatory operations office are hereby ordered to seize the unregistered drug product found in the market,” it said.

It also ordered all establishments, outlets and individuals against the sale of Sehat Badan, saying that those found peddling the product would be penalized.

The FDA also requested all local government units and law enforcement agencies to ensure that the product was not sold or offered for sale in their areas of jurisdiction.