The Justice Ministry is urging the Food and Drug Administration (FDA) to review its regulations on the level of mitragynine allowed in kratom products after potential investors complained the rule is stifling interest.
Kratom (Mitragyna Speciosa) has been taken off the national list of controlled substances. People can cultivate, sell, buy and consume kratom, which is widely used as a mild stimulant, regulated by the FDA.
Business operators say FDA regulations that limit the level of mitragynine in kratom products to 0.2mg per unit are too restrictive to make viable products. They also point out that a single kratom leaf, which is chewed by many people and considered safe, contains 1.2-1.6mg of mitragynine.
Speaking at a recent meeting with the FDA and business operators, Justice Minister Somsak Thepsutin asked the FDA to conduct more studies to see if the level of mitragynine in food and other products can be tweaked.
Warawut Sermsinsiri, director of the FDA's strategy and planning division, said the permitted level is based on trials in animals using extracts from kratom leaves. He said the 0.2mg was found to be safe for animals.
However, he said the FDA is ready to revise the regulation once it has sufficient information.
One operator said the regulation is bad for kratom farmers who want to make a living out of growing the plant.