U.S. Marshals seize drugs from Grover Beach business
August 4, 2016
U.S. Marshals today seized more than 100 cases of products labeled as containing the dangerous and unapproved ingredient Kratom from Kratom Therapy in Grover Beach. The seized products are worth approximately $150,000.
The products were distributed by Nature Therapeutics LLC, which does business as Kratom Therapy. The seized Kratom products are unapproved new and misbranded drugs under the Federal Food, Drug, and Cosmetic Act, according to the U.S. Attorney’s Office.
The FDA is warning consumers not to use any products labeled as containing the botanical substance Kratom. Serious concerns exist regarding the toxicity of Kratom in multiple organ systems.
Kratom is promoted for its psychoactive and opioid-like analgesic effects and for use in the treatment of morphine and heroin addiction, but it is not approved in the United States for any medical use. Mitragyna speciosa, commonly known as Kratom, is a botanical substance that grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea.
Consumption of Kratom can lead to a number of health problems including respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, loss of libido, tremors, skin hyperpigmentation, nausea, vomiting, constipation and severe withdrawal signs and symptoms.
“Kratom is a drug that has very serious health effects on users,” said United States Attorney Eileen Decker. “We will continue to partner with the FDA to protect the public from the distribution of unapproved and mislabeled substances like Kratom.”
According to the complaint, Kratom Therapy products are drugs because they are intended for use in the cure, mitigation, or treatment of various diseases. In addition, the complaint alleges that Nature Therapeutics’ products are also misbranded drugs because their labeling fails to provide adequate directions for use.
“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.