Kratom is used by many Americans to combat fatigue, relieve pain as well as to decrease their dependence on various types of opiates. Kratom is one of substances on the DEA’s list of Drugs of Concern. This list contains such substances that are not at present controlled by the Controlled Substances Act but as per the DEA pose a risk in terms of their capacity to be abused.

In 2016, the DEA placed kratom as a Schedule I drug but then after much public outcry removed it as well in the same year. Between 1998 and 2017 the CDC’s NORS (National Outbreak Reporting System) showed at least one outbreak due to kratom that caused 199 illnesses, 54 hospitalisation but thankfully, no deaths. The pathogen Salmonella enterica was blamed for it that had entered the kratom products due to proper safety procedures not followed at the vendor level.

People who had fallen ill had consumed kratom in one of its various forms including powders, pills and tea. The North Dakota public health officials tested the leftover kratom powders that these people had taken and found them to contain positive strains of Salmonella. The ill persons had purchased this kratom from online retailers. These tests however failed to find one common source of contamination of the kratom products and both the CDC and the FDA recommended that people should not consume kratom from any manufacturer.

In March 2018, some vendors issued multiple voluntary recalls of kratom products when they identified a supplier in their supply chain as being the source of Salmonella. The companies were alerted by the Department of Health after certain product lots tested positive for Salmonella.

In April 2018, the FDA ordered mandatory recall orders for all food products that contained kratom by a number of vendors and suppliers of raw kratom. They also found that tracing back to the source of the contamination was a challenging thing as kratom enters the market unusual for most other food products. Most kratom enters through packages carried by the person who wants to use them as well as through false declaration at the port of entry.

The FDA thus is unable to confirm if the growers and processors of kratom are actually following good manufacturing practises or not and is unable to take preventative steps to contain salmonella contamination. Due to this lacuna in the industry standards, they are also enable to ensure that the kratom products are of good quality and are salmonella free.

FDA also is concerned that kratom and its psychoactive compounds, mitragynine and 7-hydroxymitragynine which are frequently marketed for treatment of opioid addiction and its withdrawal symptoms, pains and other medical conditions may be misleading. They point out that the sale of such unapproved products that have unsubstantiated and not scientifically proven claims are a violation of the Federal Food, Drug and Cosmetic Act. FDA does not approve any therapeutic uses for kratom.

In the absence of such legal mechanisms, ease of access of the product, marketing and kratom lower costs as compared to the other drugs, its popularity is very high. Consumers use it not just for self treatment of various medical conditions but also use them for recreation purposes.

The DEA has published case reports associated with kratom exposure with seizures, psychosis and deaths. Due to which some jurisdictions are considering legislations to control the use of kratom and provide more controls and measures to the industry in general.