FDA Issues Kratom Advisory; AKA Calls Upon Agency to Rescind Statement

Popular Posts | Posted by Mia on 11/20/2017
FDA Issues Kratom Advisory; AKA Calls Upon Agency to Rescind Statement

The U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., has issued a kratom advisory on what he calls the “deadly risks associated with kratom.” Although just hours following the release, the American Kratom Association (AKA) formally filed a demand calling upon the FDA to “rescind” the statement.

The AKA has made this demand on the grounds that the advisory is reportedly “misleading and unsubstantiated,” with “discredited, incomplete, and mischaracterized scientific claims,” according to a press release issued by the advocacy group.

What Did the FDA's Kratom Advisory Say?

At its core, the FDA advisory on kratom sought to issue a “public health advisory related to mounting concerns regarding risk associated with the use of kratom,” as the agency cited concerns over “harmful unapproved products that have been crossing our borders in increasing numbers.”

In a move that has been highly criticized by the AKA and other kratom advocacy groups, the FDA Commissioner said that “we must ask ourselves whether the use of kratom – for recreation, pain or other reasons – could expand the opioid epidemic.”

To support this remark, Dr. Gottlieb cited several facts, such as a ten-fold increase in call volume to the U.S. Poison Control Centers concerning kratom. But some are criticizing the Commissioner for his failure to mention the fact that many of these calls involved other substances that could have been responsible for adverse effects.

What's more, kratom proponents have noted that the increased call volume to the Poison Control Center could easily be explained by the medical community's lack of familiarity with kratom, combined with its rise in popularity in the U.S. If a patient presents with symptoms, it's routine to ask about any and all substances they've ingested or been exposed to. In cases where a physician is unfamiliar with a substance and how it could relate to the patient's symptoms or any treatments that may be administered, it's common practice to consult the U.S. Poison Control Center. This agency maintains up-to-date information on thousands of compounds, including new and/or uncommon substances. But advocates argue that a call to the Poison Control Center does not necessarily prove causation; it only suggests that the patient may have contacted a specific substance around the time that a medical situation arose.

One pro-kratom nurse took to social media to write, “The reality is that the U.S. Poison Control Center is simply a resource for accurate information on various drugs, chemicals, substances and compounds. Let's say you arrive in the ER with a broken leg and if you admit you've ingested kratom recently, but the physician does not know how kratom may impact emergency surgery and the medications that will be used during that procedure. That physician is going to call Poison Control to learn more. If we buy into the FDA's advisory, then this is a red mark against kratom, despite the fact that the substance in no way caused the fracture. That feels misleading.”

But the FDA Commissioner presented a unified view on kratom, reiterating that “...the FDA has evidence to show that there are significant safety issues associated with [kratom's] use. Before it can be legally marketed for therapeutic uses in the U.S., kratom’s risks and benefits must be evaluated as part of the regulatory process for drugs that Congress has entrusted the FDA with....We believe using the FDA’s proven drug review process would provide for a much- needed discussion among all stakeholders.”

And on that last point, many kratom proponents agree. Advocates argue that a formal, thorough, and objective review of kratom's properties would almost certainly lead to FDA approval in some capacity. It's a point that the AKA drives home in its formal statement in response to the FDA's kratom advisory: “...several points in the FDA advisory are at odds with the facts and these are facts that FDA staff have at their disposal and should have acknowledged. For example, contrary to the statement that kratom has 'narcotic opioid like' abuse potential and other effects, kratom is primarily used for benefit by millions of Americans and not to get 'high.' In fact, kratom is a poor substitute for opioids for getting high.”

Kratom, Its Legal Status and the FDA

A member of the coffee plant family, kratom (mitragyna speciosa) is derived from the dried leaves of the kratom plant, which is native to southeast Asian nations such as Malaysia, Thailand and Indonesia. Kratom is favored for a number of uses, ranging from incense to aromatherapy and beyond.

Notably, the FDA has not approved kratom for use as a supplement, food product, or medication. But this has not stopped many individuals from brewing kratom tea and filling capsules with kratom powder for ingestion. At one point, the FDA even attempted to implement an emergency kratom ban that would place kratom in the same category as cocaine and heroin, but tremendous public outcry prevailed and the agency ultimately backed off.

The proposed ban did have a couple benefits in the eyes of kratom advocates. That event raised public awareness and it also prompted kratom enthusiasts to share countless anecdotal cases with the media and the world as a whole. Countless individuals have claimed that kratom transformed their life after they used it as a natural alternative to opiate painkillers, while others claimed they've used kratom to ease opiate withdrawal symptoms.

Notably, the FDA advisory indicated that the agency has been involved in numerous recent seizures at the border: “To fulfill our public health obligations, we have identified kratom products on two import alerts and we are working to actively prevent shipments of kratom from entering the U.S. At international mail facilities, the FDA has detained hundreds of shipments of kratom. We’ve used our authority to conduct seizures and to oversee the voluntary destruction of kratom products...”

These seizures could result in an imbalance as demand outpaces supply, although no serious shortages have been reported as of mid-November 2017.

Currently, though, kratom is legal to obtain, sell, and possess in most regions of the United States and beyond. Kratom bans have been enacted in Arkansas, Tennessee, Alabama, Wisconsin, and Indiana. Several nations have also banned kratom, including Australia, Thailand, Germany, Malaysia, and Sweden.

Notably, this recent FDA advisory has not resulted in any changes to kratom’s legal status. The kratom advisory concludes by saying, “To those who believe in the proposed medicinal uses of kratom, I encourage you to conduct the research that will help us better understand kratom’s risk and benefit profile, so that well studied and potentially beneficial products can be considered. In the meantime...the FDA will continue to take action on these products in order to protect public health.”