FDA clarifies new rules on products containing kratom

FDA clarifies new rules on products containing kratom

The use of kratom leaves in drinks and food products requires approval and safety clearance from the authorities, the Food and Drug Administration (FDA) has reaffirmed.

While the plant is reclassified as a legal herb, people must seek approval to process and produce kratom products, deputy FDA secretary-general, Withit Saritdeechaikul, told reporters on Friday at a Public Health Ministry press briefing.

The sale of fresh leaves does not require approval though, he added.

Makers of kratom-based beverages, which are classified as herbal drinks, must obtain a production permit under the Herbal Products Act, he said.

Food products with kratom as an ingredient must pass a food safety inspection and their labels must be submitted to the FDA for approval, he said.

Dr Withit said the FDA is also drafting a regulation, in compliance with the Food Act, to allow the use of the plant and extracts in food. To ensure safety, food products containing the plant must be examined by the FDA.

He said while the plant is known for its beneficial properties, people should listen to advice from experts to avoid adverse side effects because misuse is potentially dangerous as consuming too many kratom leaves can cause intestinal obstruction.

Kratom (Mitragyna speciosa) was removed from the narcotics list on Aug 24 and people can now grow, possess, consume and sell the leaves.

The leaves are sometimes chewed fresh or boiled into tea to stimulate energy and reduce fatigue.

Prior to its decriminalisation, kratom was a Class 5 narcotic, which made consuming, cultivating and possessing any part of the plant illegal.

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