The FDA's position on kratom

10,September 2018

Kratom is an opioid that belongs to the coffee family. Native to some South Asian countries such as Thailand, Malaysia, Papua New Guinea and Indonesia; kratom is consumed as a drink in those regions, where it has a cultural and recreational association. It is primarily used as a sedative and stimulant whose effect starts from five to 15 minutes of ingestion and may last from two to 10 hours.

Its botanical name is mitragyna speciosa. Being an opioid, it is used in medicine mainly as a pain reliever, but only when taken in moderate doses. Its alkaline relieves muscle pain to some extent. It is also taken to boost stamina. When taken in high quantities, it can lead to euphoria, mood changes, disorientation and delirium, hostility, aggression, vertigo and loss of motor sensors, the exact feelings many psychedelic drugs induce. Like marijuana, its uses and side effects are a matter of heated debate and conjecture.

The main concerns regarding its uses are:

• Kratom has the same effect on the brain as morphine, which is addictive and leads to abuse and dependence
• It is not scientifically evaluated. Kratom is a substance that is freely available in nature and hence, its use as a medicine in the form in which it is consumed is contested. In the absence of clinical studies, it is not possible for the medical research community to accept its value as a medicine. Evaluating the uses and side effects of kratom is dicey because while small doses of it can relieve pain, higher doses are likely to cause vomiting, nausea, weight and appetite loss, sleeplessness or constipation

In the US

Kratom is not illegal in the US, but since it is sold as an alternative medicine and as a dietary supplement, the FDA does not regulate it. Ironically, it is illegal in a few of its native countries such as Thailand and Malaysia. Kratom is also illegal in places like Australia and a few European Union countries. In the US, it is common to come across packets of paste, capsule or powder or is brewed as tea.

In the US, its production is not regulated. Its dosage is not fixed or scientifically established. This is one of the major causes for concern with the use of kratom and is the likely trigger for addiction to it.

The Centers for Disease Control and Prevention (CDC), in a report published in July 2016 noted with concern the alarmingly increase in the use and availability of kratom in jails in the country. It noted a tenfold increase in the number of calls reporting overuse of the drug it received from jails from 2010 to 2015.

The FDA and kratom

The FDA does not prescribe regulatory procedures for the manufacture and distribution of kratom since it does not regulate it. However, over the past few years, the FDA has been dillydallying in its actions regarding kratom:

• Following the publication of the report by the CDC, the FDA decided to issue a notice of intent classifying two psychoactive substances found in kratom- mitragynine and 7-hydroxymitragynine -as Schedule I drugs. In the FDA’s method of classification, a Schedule I drug is one that has potential for high abuse and for creating high psychological or physical dependence
• However, just two months of this, in October 2016, it was forced to withdraw this proposal for classification following reactions from the public as well as suggestions that the scientific and medical evaluation done till then was not sufficient to warrant this strong classification
• Again, in February 2018, the FDA Commissioner announced that the agency had conducted detailed studies of the substance which showed it that the scientific evidence in it to prove its safety and effectiveness in treating any ailment or condition was weak and that the presence of opioids in kratom underlined its potential for abuse and addiction more clearly than before

Another event of February 2018 precipitated more active action by the FDA about kratom. Several States in the country witnessed the outbreak of salmonellosis that month caused by a strain of salmonella linked directly to the consumption of kratom-containing substances. Following this outbreak, the agency further tightened the grip on kratom, advising people to be careful and avoid consuming products with kratom.

The FDA’s cat and mouse game with kratom

These events underscore the FDA’s tussle with this substance. These advisory actions complement the FDA’s enforcement actions on the ground regarding the substance for the past few years:

In 2012 and 2014, it issued Import Alerts on two separate occasions. In the first of these, the FDA identified kratom as an unidentified drug; in the second, it examined kratom-containing dietary supplements and bulk dietary ingredients. An Import Alert is an action from the FDA by which it informs its field staff and the public that it has sufficient evidence to subject products to a step called Detention Without Physical Examination (DWPE).

Products which the FDA suspects to be violating its laws and regulations are brought under DWPE. In addition to the product, suspicions about the manufacturer or the shipper, as well as other incriminating information could also trigger DWPE. DWPE is usually carried out before a product’s entry into the US.

A series of actions

In September 2014, acting on the FDA’s request, U.S. Marshals seized over 25,000 lbs. of raw kratom material from Rosefield Management, Inc. in Van Nuys, California. The seized consignment’s worth: more than $5 million

In January 2016, close to 90,000 bottles of dietary supplements, whose label showed the presence of kratom, were seized. The value of this seizure, manufactured for and held by Dordoniz Natural Products LLC, in South Beloit, Illinois, and marketed under the brand name RelaKzpro, was close to half a million.

In August 2016, once again requested by the FDA, U.S. Marshals confiscated over a hundred cases of products under the brand name Kratom Therapy with kratom shown as one of its ingredients in its label, valued at over $150,000. The marketing agent for this product was Grover Beach, California-based Nature Therapeutics LLC, doing business as Kratom Therapy.

Despite all these efforts, since this product is outside its regulatory ambit, the FDA can only issue pronouncements and advisories aimed at ensuring public health and safety. For it to take more stringent action, more legislative will and sanction is needed.