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.