US Marshals Seize Dietary Supplements Containing Kratom

Kratom
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FDA seized supplements

In an FDA press release posted on January 6, 2016, the US Food and Drug Administration (FDA) announced that following a request from the FDA, US Marshals had seized up to 90,000 bottles of nutritional supplements that contained kratom, under the Food, Drug, and Cosmetic Act (FD&C Act) and an import alert. The supplements were being marketed and sold under the brand name RelaKzpro, and were worth around $400,000. RelaKzpro was manufactured for Dordoniz Natural Products LLC, a company based out of South Beloit, in Illinois.

What is kratom?

Kratom (Mitragyna speciosa), also known as ketum, is a type of tree native to Southeast Asia. The leaves of the kratom tree contain psychoactive compounds that produce similar effects to opiates when taken, though kratom is not a true opioid.1 Kratom leaves have a variety of effects on the body, and were historically used in traditional Thai medicine. Today, kratom can be easily purchased off the internet and is often used recreationally. The leaves can be chewed, made into a tea, taken in capsules, made into a drink, or taken as a powder.

Kratom has been shown to improve mood, reduce fatigue, act as an aphrodisiac, and decrease pain.2 These effects usually last for a few hours. However, kratom can have many adverse side effects including constipation, loss of appetite, weight loss, skin hyperpigmentation, irritability, anxiety and diarrhea.3 Additionally, long-term usage has been linked to severe muscle spasms, muscle pain, fever, insomnia, and withdrawal. According to the FDA, kratom withdrawal is characterized by aggression, irritability, jerking, and pain in the muscles and bones, though withdrawal symptoms usually do not last for an extended period of time.

The medicinal uses of kratom have not been well-studied. Some chronic opioid users have used kratom to treat the symptoms of opioid addictions, but no formal studies have been conducted on the usage of kratom to treat opioid addiction.2 At this time, no medical uses have been found for kratom, and the FDA has not approved kratom for any medical uses. Though kratom has been involved in few deaths, and no known deaths have resulted from consuming kratom alone, the efficacy and safety of kratom when used for any condition are not well-known.5

Kratom in the US 

Currently, kratom has not been declared illegal on a federal level, though recently, the use and possession of kratom was banned in Alabama in May 2016.6 Additionally, the Drug Enforcement Administration (DEA) has classified kratom as a “Drug and Chemical of Concern”.7 In February 2014, the FDA issued an import alert that gives US officials the jurisdiction to detain dietary supplements and dietary ingredients that contain kratom without physical examination. The import alert was issued since there is “inadequate information to provide reasonable assurance that [kratom] does not present a significant or unreasonable risk of illness or injury”, and because scientific literature has raised some concerns surrounding the toxicity of kratom.

Consequently, the RelaKzpro seizure was a demonstration of the FDA’s willingness to crack down on products containing kratom. On the seizure, Melissa Plaisier, the FDA’s associate commissioner for regulatory affairs, said:

We have identified kratom as a botanical substance that could pose a risk to public health and have the potential for abuse. The FDA will continue to exercise our full authority under law to take action on these new dietary ingredients, especially if they ignore the notification requirements, as part of our commitment to protecting the health of the American people.

As well, the US Department of Justice has filed a complaint with the US District Court for the Northern District of Illinois, stating that kratom falls under the FD&C Act, since there is not enough information to determine if kratom is fully safe for consumption. The FDA has also issued a warning, advising consumers and health professionals not to buy supplements containing kratom, and to report any products containing kratom to the FDA’s MedWatch program.

References

  1. Adkins, Jessica E.; Edward W. Boyer; Christopher R. McCurdy (2011-05-01). Mitragyna speciosa, a psychoactive tree from Southeast Asia with opioid activity”.Current Topics in Medicinal Chemistry 11 (9): 1165–1175.
  2. Ward J, Rosenbaum C, Hernon C, McCurdy CR, Boyer EW; Rosenbaum; Hernon; McCurdy; Boyer (December 2011). “Herbal medicines for the management of opioid addiction: safe and effective alternatives to conventional pharmacotherapy?”.CNS Drugs 25 (12): 999–1007.
  3. Hassan, Zurina; Muzaimi, Mustapha; Navaratnam, Visweswaran; Yusoff, Nurul H.M.; Suhaimi, Farah W.; Vadivelu, Rajakumar; Vicknasingam, Balasingam K.; Amato, Davide; von Hörsten, Stephan; Ismail, Nurul I.W.; Jayabalan, Nanthini; Hazim, Ammar I.; Mansor, Sharif M.; Müller, Christian P. (2013). “From Kratom to mitragynine and its derivatives: Physiological and behavioural effects related to use, abuse, and addiction”. Neuroscience & Biobehavioral Reviews37 (2): 138–51.
  4. Singh D, Müller CP, Vicknasingam BK (2014). “Kratom (Mitragyna speciosa) dependence, withdrawal symptoms and craving in regular users”.Drug Alcohol Depend 139: 132–7.
  5. Kronstrand, R.; Roman, M.; Thelander, G.; Eriksson, A. (2011). “Unintentional Fatal Intoxications with Mitragynine and O-Desmethyltramadol from the Herbal Blend Krypton”.Journal of Analytical Toxicology 35 (4): 242–7.
  6. Hoeger R (13 May 2016).“Mobile Police Department confiscates $30,000 worth of Kratom”Fox10 TV.com. Fox News, Mobile, AL. Retrieved 17 May 2016.
  7. “Drugs of Abuse”. US Drug Enforcement Agency and US Department of Justice. 2015 ed.

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