Legal & Regulatory

The U.S. Food and Drug Administration (FDA) has announced on Wednesday regarding seizure of nearly 90,000 bottles of dietary supplements labeled as containing kratom. The seize drive has been conducted by the U.S. Marshals, at the request of FDA.

The seized products have been manufactured by which was manufactured by Dordoniz Natural Products LLC, in South Beloit, Illinois, and marketed under the brand name RelaKzpro. The consignment worths around $400,000.

A botanical substance, Mitragyna speciosa, growing naturally in Thailand, Malaysia, Indonesia and Papua New Guinea, is commonly known as kratom. The toxicity of kratom may affect multiple human organ systems.

Kratom consumption may lead to a number of health impacts, including respiratory depression, vomiting, nervousness, weight loss and constipation and so on. It has both narcotic and stimulant-like effects and withdrawal symptoms may include hostility, aggression, excessive tearing, aching of muscles and bones and jerky limb movements, reads an FDA statement furnished in its official website.

The drug, RelaKzpro is sold in bars and stores in Florida and other states. Some people are reportedly using it to wean themselves off their heroin addiction. But the drug may be addictive itself and since it is cheaper and more potent, may also lead to relapse with heroin, reports Yahoo Finance quoting The New York Times.

However, The FDA, the agency responsible for ensuring drug safety, doesn't regulate kratom as a drug considering its dietary ingredients. But in 2014, the agency has banned imports of kratom due to its potential health dangers. Withdrawal from the drug may cause hostility, aggression, muscle and bone aches and jerky movements, narrates Business Insider quoting the FDA.

The U.S. Department of Justice, on behalf of the FDA, filed a complaint in the U.S. District Court for the Northern District of Illinois. The complaint accuses kratom containing dietary supplements adulterated under certain clause of the Federal Food, Drug and Cosmetic Act.

The FDA has cautioned consumers not to use any products labeled as containing kratom. It also advices health care professionals and consumers to report any adverse events in line with products containing kratom to the FDA's MedWatch program through www.fda.gov/medwatch/report.htm or fax number 1-800-FDA-0178.

Kratom enriching diet supplements pose unreasonable risk for public health and hence are adulterated as per Federal FD & C Act. Accusing Realkzpro branded supplement diet to be adulterated under this provision, US Marshals, on behalf of FDA have seized 90,000 bottles of diet supplements of a specific brand. Through a statement furnished in its official website, FDA requests healthcare professionals and consumers to report any kratom related adverse event.