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.


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4 Comments

  1. L.A.RamsFan says:

    Wait a minute now! Wasn’t Fen-Phen FDA approved? How ’bout Vioxx? Or Accutane? There are many, many more drugs out there that were FDA approved that proved to be either extremely dangerous or even deadly, some of which they knew to be as they approved its use (look into aspartame if you want a snap-shot of how the FDA truly operates).

    What’s labeled as “FDA Approved” should really read “Big Pharma’ Bought and Paid For”!

    (8) 12 Total Votes - 10 up - 2 down
  2. Rambunctious says:

    What next?

    (1) 3 Total Votes - 2 up - 1 down
  3. mkaney says:

    More criminal behavior by our government.

    “Probably the most important difference between kratom and other opioids, however, is the risk of overdose. While a record-high 28,647 Americans died of opioid-involved (typically multi-drug) overdose in 2014, according to the CDC, even on their own, opioids can kill. In contrast, the few reported kratom-linked deaths have all involved multiple drugs.

    Moreover, even the kratom mixture deaths don’t kill via cessation of breathing, which is a hallmark of opioid overdose. “Direct kratom overdoses from the life-threatening respiratory depression that usually occurs with opioid overdoses have not been reported,” says Oliver Grundmann, clinical associate professor of medicinal chemistry at the University of Florida, who recently reviewed the research on kratom for the International Journal of Legal Medicine.

    That’s probably because kratom tea and powders are both bulky and frequently nausea-inducing, particularly in high doses—so it would be physically difficult for most people to actually keep enough down to be dangerous. And given its lengthy history of medicinal use in Asian countries, if there was a significant risk from acute overdose, it should have been reported by now.”

    (11) 21 Total Votes - 16 up - 5 down
  4. jimmy_me says:

    Another missed opportunity for Grover Beach to slap a tax on something they know nothing about. Just don’t tell the US Marshals that cigarettes also have “serious health effects on users…”

    (32) 56 Total Votes - 44 up - 12 down

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