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The “Health Risks” of Kratom: Why Is the FDA So Against Kratom?

A US government building in the distance

If you’ve tried to research Kratom, you may have noticed fewer reliable articles on Kratom uses and plenty of alarmist coverage of Kratom’s health risks. Much of that is brought about by a largely antagonistic stance taken by the United States Food and Drug Administration (FDA). The FDA is responsible for ensuring that Americans have access to safe medications, supplements, and foods. Those who have observed the FDA’s relationship with Kratom may have noticed exaggerated aggression toward a Southeast Asian ethnobotanical. Understanding Kratom, its growing popularity, and the realities of a regulatory body under a capitalist economic system are important in understanding the paradoxical stance taken by the FDA.

Kratom’s Uses: The Origins of Kratom

Kratom is not a drug, nor is it a unique chemical compound synthesized in a laboratory environment. Kratom, scientifically known as Mitragyna speciosa, is an evergreen tree in the same family as coffee plants. Native throughout the islands and peninsulas of Southeast Asia, the warm, moist air, plentiful rainfall, and acidic soil packed with mineral deposits from the volcanoes that played a part in the region’s geologic formation combine to create the perfect growing environment for Kratom potency, maximizing the effects of the many uses of Kratom.

The Kratom powder, extracts, and capsules you buy are made from the leaves of this tree. Harvested from both wild growth in the lush jungles and cultivated family garden-farms, these leaves are handpicked from the tree when perfectly ripened to the appropriate vein color. This harvesting process relies not just on the availability of leaves, but the experience of the growers who have learned over generations how to judge what part of its maturation a leaf is in.

As Kratom ages, its active compounds, mitragynine and 7-hydroxymitragynine, shift in their relative concentrations. As this shift occurs, the color of the veins shifts from white through green to red—at the same time, the best uses for that Kratom leaf shifts. This changing nature may account for part of the FDA’s inability to admit Kratom’s potential because unlike a drug, Kratom can vary based on the changing concentration of the leaves alkaline constituents. Rather than taking this nature into account, the FDA simply label Kratom as “inconsistent,” “ineffective,” or immediately decide Kratom poses health risks that are unacceptable. Because they are unable to determine a blanket dosage for Kratom uses or even a blanket set of uses that cover the entirety of the spectrum of products available, Kratom does not fit into the neat package the FDA uses for the regulation of other products, including both drugs and herbs.

To further complicate Kratom’s evaluation, due to FDA restrictions, most companies cannot talk about specific uses of Kratom, although historically it is well known as a popular medicinal plant that was vital to the small, indigenous villages of its native area. This further leaves the public confused and compounds misinformation on Kratom’s health risks by prohibiting information from sources of purchase, forcing people to rely on unverified accounts online and the few peer-reviewed studies available.

A series of green plants in glass beakers

So, Is Kratom Safe?

If the purpose of the FDA is to ensure safe foods, supplements, and drugs, yet they have adopted an aggressive stance toward Kratom, this is a fair question. Any substance when used irresponsibly or without moderation poses a potential health or wellness risk. It also cannot be denied that for generations, the people of Southeast Asia have touted the traditional, centuries-long use of Kratom for stress, improved focus, and promoting alertness. These are all effects reported not just to the earliest Dutch explorers of Kratom’s natural lands but to the American servicemen who learned of it from friendly guides and villagers during the Vietnam war.

As more and more people turn to Kratom as a potential natural way to boost their health and wellness, warnings become dire; however, they don’t tell the entire story. While the FDA’s stance continues to focus on perceived Kratom health risks, the data they use and the way this data is reported has some serious flaws. This began largely under the guidance of former FDA Commissioner Scott Gottlieb but has continued into this year’s latest warnings of alleged potential for heavy metal poisoning in those who choose to explore uses of Kratom as a long-term option.

The Problem With the FDA’s Data

Any of the FDA’s assertions are based on poor science. Due to a hostile regulatory environment, large-scale, high-quality Kratom testing by independent researchers is effectively stifled. Instead, the FDA uses computer modeling as part of their “quality research” to assess Kratom’s potential impact on the body.

This means rather than actual trials, a computer evaluates the chemical shape of an active compound, its hypothesized receptor sites, and attempts to predict how well they will bond and the effect of that bonding and whether it supports the reputed uses of Kratom. It doesn’t take into account the enormous volume of anecdotal reports but relies only on the organic chemistry block collection it is programmed to analyze and only based on the inputted parameters. Without understanding what information was programmed in as data, there is no way to assess the accuracy of the reported results.

Further, when data is released, it is often provided without context, such as in the recent press release about heavy metals in Kratom. This press release alleges that Kratom is a health risk, yet contains no real information that is readily usable by the public to understand what are safe intake levels of these metals. Rather than offering a description of the Kratom uses and patterns that would lead to these high heavy metal levels, the FDA report instead relies on “reported Kratom usage patterns” without specifying where the reports were obtained, what those theoretical usage patterns are, or whether a statistically useful number of people were sampled. The result is a table of numbers on Kratom’s health risks without the context to make an informed decision and a press release that amounts to fear-mongering.

The black silhouettes of people sitting in a room overlooking the DC area

Why Would the FDA Be So Aggressive If Not for Scientifically Sound Safety Reasons?

It’s important to understand that like many of our nation’s regulatory agencies, the FDA can almost be considered two separate bodies. There are the rank-and-file scientists, engineers, and support staff that pursue the day-to-day mission of the FDA, and then there is the leadership, who is not necessarily drawn from these ranks. The post of Commissioner of Food and Drugs is a political appointment made by the President of the United States with the advice and consent of the United States Senate. That places an enormous amount of political pressure on leadership, as their appointment and continued employment in the post relies on keeping elected officials happy.

There are a myriad of Kratom uses, many of which would be competition for large medical and pharmaceutical interests. The Americal medical-industrial complex spends tens of millions of dollars annually on lobbying efforts and campaign contributions to ensure that they have a friendly regulatory environment in Washington. As a political appointee, the FDA commissioner is not immune to pressure from elected officials whose best interests align with ensuring that the interests of donor industries. These realities were undoubtedly well known by former commissioner Gottlieb, who, less than three months after leaving his post, was elected to the board of directors for Pfizer, Inc., one of the nation’s largest pharmaceutical companies, and thus one of the companies that would be most harmed by recognition of Kratom uses as safe and effective.

What You Can Do to Protect Your Access to Kratom

Despite the various initiatives undertaken by the FDA to secure a federal ban or listing as a controlled substance, grassroots efforts have so far been successful in protecting access to Kratom by responsible adults. Through advocacy groups like the American Kratom Association, enthusiasts are taking coordinated action to reach out to their government officials and let them know that their constituents demand legal Kratom. In some states, access is now protected by the Kratom Consumer Protection Act, a model legislative bill put together by the AKA to create a safer Kratom industry and protect the rights of people to make their own determinations about the Kratom uses that are right for their wellness.

Getting involved is easy, and it starts with educating yourself. That way when you are confronted with alarmist reports of Kratom health risks, you can answer with well-reasoned scientific facts. Consider getting involved with the AKA or one of its state chapters, that way you’re ready for the next legislative push. Finally, make sure you are being a responsible Kratom buyer, and share your experiences with others. It’s the only way people will find out about the benefits Kratom’s uses offer.

If you have any questions about our products, contact our Kratom experts. Order your premium Kratom from Kratom Spot today.