The US Marshals Service recently seized more than 100 cases of products containing the opioid-like botanical substance.
The US Marshals Service recently seized more than 100 cases of products containing the opioid-like botanical substance, kratom.
Kratom naturally grows in Thailand, Malaysia, Indonesia, and Papua New Guinea. Although it has been used as an herbal drug for centuries, there are serious concerns today regarding its toxicity. Specifically, its consumption can lead to respiratory depression, vomiting, nervousness, weight loss, and constipation.
Kratom also has both narcotic and stimulant-like effects, and it can cause withdrawal symptoms like hostility, aggression, excessive tearing, muscle and bone aches, and jerky limb movements.
Given those health concerns, the FDA issued an import alert in February 2014 regarding imported dietary supplements and bulk dietary ingredients that either are or contain kratom without physical examination.
In January 2016, the FDA found that Nature Therapeutics was marketing kratom products under the brand name Kratom Therapy during an inspection of the company’s facility in Grover Beach, California. The agency also discovered that the company’s website and social media sites included claims that its Kratom Therapy products are drugs because they’re intended for use in the cure, mitigation, or treatment of various diseases.
The FDA hasn’t approved Nature Therapeutics’ products for any use, and the drugs’ labeling fails to provide adequate directions for use. As a result, the US Department of Justice filed a complaint against Nature Therapeutics alleging that the seized kratom products are unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act. The seized products are worth approximately $150,000.
“The FDA will continue to take aggressive enforcement action to safeguard the public from harmful drug products illegally marketed as treatments for which they have not been studied or approved,” said Melinda Plaisier, the FDA’s associate commissioner for regulatory affairs.
In the meantime, health care professionals and consumers are advised to report adverse effects related to kratom to the FDA’s MedWatch Adverse Events Reporting program.