Wednesday, March 16, 2016

Kratom, a High Risk Supplement

Lara Gray, MS, RDN, CSSD
by Lara Gray, MS, RDN, CSSD
National Center for Drug Free Sport, Inc
www.drugfreesport.com

Imagine if a dietary supplement was being sold online as providing its user with a “legal” and “safe” high. Marketers promoting the supplement as a natural way to alleviate fatigue, pain and depression – even to help combat opioid addiction. Sold as powders, capsules, whole leaves, leaf resins or extracts, or bulk liquids and also called thang, kakuam, thom, ketum, biak, or maeng da leaf—this is kratom.

Kratom leaves are closely related to the coffee family and have been used as a stimulant throughout Thailand and other Southeast Asian countries for decades. The leaves are chewed, smoked, brewed into tea, or broken down into powder form. As a botanical, kratom (Mitragyna speciosa) is classified as a dietary ingredient under
the Food, Drug, and Cosmetic Act. This designation allows the product to be sold as a dietary supplement rather than undergoing product and consumer testing as a pharmaceutical drug. Kratom supplements have shown rapid growth and are being sold through online distributors and local smoke shops.

 Example of kratom being sold from an on line
distributor; Photo credit: www.getkratom.com
Ultra enhanced Maneg, Da Kratom Extract  
In December 2015, the FDA issued an “Import Alert” that called for the “detention without physical examination of dietary supplements and bulk dietary ingredients that are or contain mitragyna speciosa or kratom.” The alert detailed that kratom is considered by the FDA as a “new dietary ingredient.” New dietary ingredients are those not marketed prior to the 1994 Dietary Supplement Health and Education Act (DSHEA), and per the legislation require FDA approval before being sold to consumers. FDA approval is dependent on establishing scientific evidence proving that the ingredient is safe for human consumption.

Not only is kratom currently being sold outside established FDA protocol, but research shows considerable issues with toxicity and health concerns associated with consumption. Notably, emergency room visits related to kratom ingestion began putting the substance on the map in 2012. Negative health consequences associated with kratom include hallucinations, paranoia, aggressive behavior, psychotic episodes, respiratory depression, nausea and vomiting. For a full list of adverse effects, please refer to Box 1.1.
The pharmacology of kratom has been described as providing both stimulant and sedative effects, often depending on the strain and dose consumed. The primary chemical constituent, mitragynine, has been identified as having specific opioid-like effects. Another constituent, O-desmethyltramadol, is the main active metabolite of tramadol, a narcotic opioid. Distributors tout kratom as a viable solution to help opioid addicts combat their dependence, yet research and drug rehabilitation programs are finding the substance to be highly addictive with significant withdrawal symptoms. Kratom is not a controlled substance in the United States and is legal in most states, currently appearing on the DEA’s list of “Drugs and Chemicals of Concern.”

 While use among athletes is largely unknown, the Drug Free Sport Resource Exchange Center (REC) has received inquiries about kratom in both 2015 and 2016. The concern is that athletes will consider kratom a recreational alternative to street drugs such as marijuana or K2 spice. Due to the stimulant effects, presence of an active opioid metabolite, documented serious health concerns, significant lack of scientific research and unregulated distribution as a dietary supplement, the REC has categorized kratom as a Risk Level III substance.

One of Drug Free Sport’s labs, the Clinical Reference Laboratory (CRL), has also confirmed that the kratom constituent, 7-hydroxymitragyine, can be screened and confirmed from urine samples should sport organizations choose to include it on a testing panel.

It is advised that sports medicine teams discuss the health implications and lack of regulation associated with dietary ingredients such as kratom. For more information on kratom or education resources, please contact Lara Gray at lgray@drugfreesport.com.

References:
Drug Enforcement Administration Office of Diversion Control, Drug & Chemical Evaluation Section. (2013). KRATOM (Mitragyna speciosa korth). Retrieved from:
U.S. Food and Drug Administration. (2016). Import Alert 54-15. Retrieved from:
Schwarz, Alan. “Kratom, an Addict’s Alternative, is found to Be Addictive Itself.” The New York Times. 2 January 2016. Web. 26 January 2016.
Drug Enforcement Administration. (2013). Drug Fact Sheet: Kratom. Retrieved from:
Natural Medicines Comprehensive Database Professional Monograph. “Kratom.” Therapeutic Research Faculty; ©1995- 2016. Web. Accessed 26 January 2016.
Huus, Kari. “Asian leaf ‘kratom’ making presence felt in US emergency rooms.” NBC News. 16 March 2012. Web. 26 January 2016.
“Effects of Kratom.” Web log post. Narconon. Narconon International, n.d. Web. 26 Jan. 2016.

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