Kratom: What is That?
Recently, there has been a surge of attention on the effects of kratom. Reports of its deadly risks have been released by many of the major news organizations. The U.S. Food and Drug Administration (FDA) has issued a public health advisory related to their mounting concerns of this product. It is their obligation to act when they see people harmed by unapproved products being passed off as “treatments” and “cures” for serious conditions.
Kratom is a plant that grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. In the U.S., it has gained popularity with some marketers that promote kratom as a safe treatment, as it is plant-based. People are using it to treat a variety of illnesses, such as pain, anxiety, and depression. Kratom is being actively marketed and distributed for these purposes.
Evidence has shown that kratom has similar effects to narcotics like opioids, and carries a similar risk of abuse, addiction, and death. Many patients with opioid addictions are using kratom to treat their withdrawal symptoms. (Opioids, derived from the opium poppy, include heroin and prescription pain pills like morphine, codeine, hydrocodone, oxycodone, and methadone.) The FDA states that there is no reliable evidence to support the use of kratom as treatment for an opioid-use disorder.
The harm associated with kratom is well documented. Between 2010 and 2015, calls to U.S. poison control centers regarding kratom increased 10-fold, with hundreds of calls made each year. The FDA is aware of reports of 36 deaths associated with the use of kratom-containing products. There have been reports of kratom being laced with other opioids, like hydrocodone. The use of kratom is associated with serious side effects like seizures, liver damage, and withdrawal symptoms.
The question remains: Will kratom contribute to the current opioid addiction crises, or can it be used to help it, along with other disorders?
The FDA has a long-established, science-based obligation that relies on evidence.
· It has a well-developed process for evaluating botanical drug products where parties seek to make therapeutic or healing claims
· It is committed to facilitating the development of botanical products that can help improve people’s health
· It has issued guidance on the proper development of botanical drug products
· It has a team of medical reviewers in the FDA’s Center for Drug Evaluation and Research that’s dedicated to the proper development of drug applications for botanicals
· To date, no marketer has sought to properly develop a drug that includes kratom
There are currently no FDA-approved therapeutic uses of kratom. In addition, there is evidence to show that there is significant safety issues associated with its use. Before it can be legally marketed for therapeutic uses in the U.S., kratom’s risks and benefits must be evaluated.
The FDA has exercised jurisdiction over kratom as an unapproved drug, and has also taken action against kratom-containing dietary supplements.
To fulfill their public health obligations, the FDA has identified kratom products on two import alerts, and is actively working to prevent shipments of kratom from entering the U.S.
· At international mail facilities, the FDA has detained hundreds of shipments of kratom
· They’ve used their authority to conduct seizures, and to oversee the voluntary destruction of kratom products
· They’re working with their federal partners to address the risks posed by these imports
In response to a request from the Drug Enforcement Administration (DEA), the FDA has conducted a comprehensive scientific and medical evaluation of two compounds found in kratom.
Kratom is already a controlled substance in 16 countries, including two of its native countries of origin, Thailand and Malaysia, as well as Australia, Sweden and Germany. Kratom is also banned in several states, specifically Alabama, Arkansas, Indiana, Tennessee and Wisconsin and several others have pending legislation to ban it.