Authored by Damian Green
Jan. 14, 2016
This document is presented with the intention of helping to educate and inform the public about Kratom in general, and in particular, about Kratom Powder. The latter sections of the document then present suggested methods of taking Kratom Powder, an objective argument as to the safety of Kratom, and a brief discussion of the options for change that must happen in the United States in order for Kratom to be legally sold for the purpose of consumption.
The structure of this document includes the following sections:
- Current State of Kratom; - A well cited collection of knowledge about kratom, including its current uses and the general understanding of the physiological effects it has on humans. This section is intended to provide an introductory source of knowledge about the nature of kratom in general with substantial references to each claim. Subsections include:
- Identification of Kratom Powder; - A definition of "Kratom Powder".
- Suggested Method of Consumption of Kratom Powder; - Directions for taking "Kratom Powder" with introduction.
- Suggested Directions; - Directions for taking "Kratom Powder".
- As an NDI;
- As a Food Generally Regarded As Safe (GRAS);
- As a Pharmaceutical;
- A Legal Approach;
- Argument that Kratom is "Reasonably Safe";
- Argument Summary;
Mitragyna Speciosa, known as kratom, kratum , or ketum , is a tropical tree native to Southeast Asia , including Thailand, Indonesia, Malaysia, and surrounding areas . Kratom is in the coffee family, or rubiacae family . The trees generally grow to a height of 12-30 feet (3.7–9.1 m) and 15 ft (4.6 m) wide  but some can reach over 15 meters(50 feet) .
The leaves of the tree contain more than 40 compounds , with the indole mitragynine making up more than half of the plant’s alkaloid content. Mitragynine and 7-hydroxymitragynine are believed to be the primary active alkaloids that are responsible for psychoactive components of the plant .
It is well known that there are "vast numbers of online vendors and general information Web sites for kratom" . Google searches and vendor listings on various kratom forums confirm that . More than a hundred independent kratom vendors that have listed kratom for sale on the internet have been identified , and it is estimated that there are hundreds more. It is also estimated that hundreds of thousands of pounds of kratom have been imported into the United States each year for the past several years; an estimate that is based on the size of a number of seizures in recent years made made by U.S. Marshals by request of the FDA, and by the vastly greater number of kratom vendors that can be found on the internet . In Thailand, the National Household Surveys reported a 2007 survey (26 633 respondents aged 12–65 years) that indicated the lifetime, past year, and past 30 days prevalences for kratom as being 2.32 %, 0.81 % and 0.57 %, respectively. In a country of 67 million people , that means that roughly 335,000 people in Thailand alone are likely to use kratom regularly. Kratom has largely been used in South-East Asia for a long time and has more recently been introduced to global markets with it's sale becoming more prevalent in the United States in the early 2000's [14b]
Kratom has long been taken by people in SouthEast Asia as a medicine for many ailments, but most notably as a substitute in cases of opium addiction , as well as for opium withdrawal and pain management . According to some researchers, there has been no clinical studies on humans that support any of the above claims that kratom is safe and effective for any of the medicinal uses mentioned above , however other researchers point out the feasibility and relative safety of kratom for human consumption as well as for medicinal purposes . It's effectiveness for pain management is also supported by a number of animal studies. Additionally, there is an abundance of case studies and anecdotal evidence demonstrating that kratom has been used extensively by humans as an effective means of treating one's self for chronic pain when using it as a substitute for a variety of opioid analgesics, and for self-treating shorter-term residual opioid withdrawal symptoms after quitting from sufficiently low doses of a variety of opiates  .
To a lesser extent, kratom has also been reported to have a number of other uses. Kratom is also commonly used as an ingredient in soaps and detergents, in incense for aromatherapy , and as a pigment in dyes and cosmetics . In Thai folk medicine, it has been reported to be used as an antidiarrheal . Decades of use also suggests that kratom may lower blood pressure and blood sugar , however there are cases cited where blood pressure may in fact rise with kratom . Kratom may also act somewhat as a cough suppressant, and as an intestinal de-worming agent . A study done on mice that suggested that kratom could possibly be used as an antidepressant under certain conditions , however much less information and focus has been dedicated to kratom in these subject areas. Other claims on the internet that kratom can be used to boost metabolism and may be used for weight loss  are not well founded and should be interpreted with a degree of caution.
Additionally, in North America and Europe, kratom has largely been marketed as a recreational drug that has often been found for sale in head-shops, and described with terms like "legal high" . Statements of this kind can be justified by anecdotal remarks made by a number of individuals that suggest that kratom can cause a stimulating but mild sense of euphoria, similar to the effect of a large cup of coffee , however, this marketing tactic of describing kratom as a "legal high" is very misleading and is a reasonable cause for concern, and as a result has been the subject of many anti-kratom media reports . And to add to the concern, some individuals who were not predisposed to opiate use have in some cases reported a temporary unpleasant sense of anxiety and internal agitation when using kratom recreationally . It should be noted that these are not very serious concerns, but none-the-less, they are of some concern. A large number of kratom users have posted online their product reviews and their subjective accounts that they have had of their recreational experiences with kratom . These accounts of course vary depending on the kratom dosage and the prior state of the individual , however there are a significant number of reports from recreational users that describe their experiences without incident and with words like "mellow", or "mood lifting", or "energetic", words that are often used to describe other common nutritional supplements. There are also a lot of individuals who use kratom occasionally who report an enhancement in their focus and energy. The general conclusion of reading such accounts is that kratom is not likely to make people act irrationally or destructively. (Further discussion of physiological effects are discussed in the next sub-section.)
A much greater number of individuals have reported their accounts of using kratom products for treating opioid withdrawal symptoms and chronic pain than have for recreational purposes only. It is commonly noted by individuals treating chronic pain that the stimulant effects of kratom are more desirable than the sedative effects of traditional opioids . Individuals treating opioid withdrawal symptoms commonly argue that treating them with kratom is a more reasonable method of treating those symptoms than by traditional methods , but before those arguments are presented, we must briefly discuss those traditional methods of treatment.
Traditional methods of treating people with opiate dependencies largely include prescribing methadone, suboxone, or subutex . These pharmaceuticals are highly regulated and often lead to maintenance programs that require patients to adjust their entire lifestyle to revolve around getting to a treatment center on a daily, or highly regular basis to attain their dose, otherwise they must suffer the consequences of feeling withdrawal symptoms that can be quite severe , and missing an appointment is a situation that unfortunately happens to most patients either accidentally or uncontrollably . Submitting to these treatments can be a huge inconvenience upon the life of an individual and their family  Mortality and morbidity, the risk of new human immunodeficiency virus (HIV) infection, criminal activity, and illicit opioid use all increase under these treatments. More importantly, there is growing evidence that these traditional treatments have a high probability of causing very serious long term health problems such liver damage , and thyroid abnormalities  which often lead to extreme obesity and other serious health issues . With such serious problems associated with traditional treatments, it is clear that kratom may be a better alternative. And although there is evidence that suggests that regular use of kratom may lead to a dependence that can result in withdrawal symptoms of various degrees , there is ample evidence that also suggests that the withdrawal symptoms are typically not nearly as extreme or as painful as the pharmaceuticals of traditional treatments . The convenience and the ease of availability of kratom offers people a greater degree of freedom in their schedules, their range of mobility, and the ability to very accurately adjust their dosage to an amount that is most appropriate to them at any given time  thus greatly improving their level of comfort and their quality of life, especially with respect to the traditional treatments.
At this point, some further discussion about the addictiveness of kratom is warranted. Although there is evidence that a kratom dependency is likely to occur with regular use, the degree and severity of the dependency is arguably about the same as coffee . While there are reports of non-predisposed opiate users experiencing painful withdrawal symptoms , it is unclear from these reports whether these users were pre-dispositioned with some sort of chronic pain, and if so, it would be natural for a person to acquire a dependency simply to avoid the return of such pain, thus kratom in these cases may not be the only factor in creating the dependency. Nevertheless, evidence suggests that dependency is real and noticeable after about five days of regular use . Individuals who had been predisposed to opiate use report that the withdrawal symptoms from kratom are significantly less intense than those from opiates however ; this implies that a kratom addiction is less severe than an opiate addiction. Another way to measure the addictiveness of kratom is to gather evidence from users who were not pre-disposed to pain or opioid use. Occasional users of kratom (recreational users) who were not pre-disposed to chronic pain nor opiate use tend not to report any dependency . Regular users of kratom who were also not pre-disposed to chronic pain nor opiate use have thus far not clearly been identified in studies.
It is also important to recognize that kratom leaves or powder has self-regulating properties. People are unlikely to regularly consume large amounts of kratom because of the terrible nausea they are likely to feel if they do consume too much . And like the classical conditioning demonstrated by Pavlov's dogs and other experiments , people are not likely to repeat a behaviour that causes a bad experience.
To complicate things somewhat, there are a number of different kratom products available that contain different concentrations of the alkaloids that are believed to be the psychoactive ingredients in kratom. These alkaloid concentrations vary slightly with strain and freshness, but much more so across different types of products. Ultra Enhanced Indo (UEI) for example is a kratom leaf powder that has been enhanced via the addition of a concentrated extract, making it's potency about 12 times greater than without . Having drastic variability across products creates a problem for consumers trying to maintain a consistent amount of active alkaloids when switching from one product to another. Non-enhanced kratom leaves provide greater consistency and may have some additional benefits when compared to more potent extracts, cost for instance . And because there is little to no regulation in extraction methods, irregular extract processes may lead to irregular potencies thereby making it more difficult for an individual to maintain a steady amount of alkaloids throughout a day. An example of such an irregularity can be seen across two products that are both advertised as being a 15x extract, for example. This 15x amount refers to the amount of leaf material (15g) used to make a unit weight (1g) of extract . The extract resulting from one 15x process may end up being only 3-5 times as potent  but the extract from another 15x process may be 5-7 times more potent; thus the amounts of kratom contained in products containing extracts are much less predictable than plain leaf kratom or kratom powder. Additionally, a consumer may find even greater consistency in potency if they source a particular leaf product, that contains no extract additives, from a particular vendor  as that often indicates particular batch or farm from which the leaves came.
Like other medicines, both herbal and pharmaceutical, kratom has some side effects. According to the Drug Enforcement Administration, side effects may include: nausea, itching, sweating, dry mouth, constipation, increased urination, and loss of appetite . The FDA has thus far suggested that the list might include: respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, tremors, loss of libido, constipation, skin hyperpigmentation, nausea, vomiting, and severe withdrawal signs and symptoms . Unfortunately, neither organization has provided citations to these claims, however other studies have been found to reinforce these findings, at least in rare observation . Additionally, at least one case of Bowel Obstruction has been reported (if not a misdiagnosed case of constipation) , and one case of intrahepatic cholestasis in a chronic user of kratom . Additional side effects and withdrawal symptoms are suggested but not cited on Wikipedia  and elsewhere , however many sources suggest that in most cases, the side effects are mild for low to moderate doses  . Nausea and sometimes vomiting and feelings of sedation are the most prominent effects that are likely to occur to people who have ingested large doses . Also, constipation and headaches are fairly common among people who take kratom regularly . Typical amounts taken vary by individual and range between 2 to 8 grams of finely ground kratom powder, but in many cases can be significantly more .
It is important to clarify here that a distinction should be made between the term “side effects” and “withdrawal symptoms”. Most noticeable effects, including side effects, typically last for a 2 to 5 hours  while the active alkaloids are abundantly present in the body. Withdrawal symptoms may follow, and normally last from 3 to 6 hours for occasional users , but for regular users, symptoms typically diminish within a week . It is important to note that the FDA publication of possible side effects, mentioned above, does not differentiate side effects from withdrawal symptoms, and they are likely lumped together; the FDA representation of information about kratom thus far has been extremely limited.
As discussed above, the withdrawals from the cessation of a kratom dependency depend on the individual and their pre-disposition to opioid use. Withdrawal symptoms may include: craving, weakness and lethargy, anxiety, restlessness, rhinorrhea, myalgia, nausea, sweating, muscle pain, jerky movements of the limbs, tremor as well as sleep disturbances and hallucination . A taper is one common method to mitigate the severity of kratom withdrawals (if deemed too severe), where an individual simply reduces their dose by a certain amount over a regular period of time; at some point, the dose will be low enough that the withdrawal symptoms should be insignificant enough, and the individual can then cease using kratom altogether . Other special case treatments have been suggested , but these options have only been used on a limited basis and may require careful consultation and cooperation with a doctor.
Combinations of kratom and other drugs including carisoprodol, modafinil, propylhexedrine or Datura stramonium have been known to cause adverse effects, including seizure. Fatalities involving kratom taken together with other drugs include nine cases of kratom mixed with the synthetic pharmaceutical O-Desmythlytramadol , one case of kratom mixed with proplyhexedrine , and one case involving a particular combination of kratom fentanyl, diphenhydramine, caffeine, and morphine . Others have been reported as well  , however, in our research, we were unable to identify any instances of death in which kratom could be isolated as the only factor, a conclusion that has been recognized in other studies as well .
Admittedly, relatively few scientific studies have been done on the effects of kratom mixtures on the human body, and there is a chance for new potentially harmful cross drug interactions including some that may be toxic. It is also possible that future clinical studies may reveal some un-identified adverse reactions as a result of taking kratom by itself, but the fact that kratom has been widely used for consumption by a large population in the general public for many years  is a strong indicator of the relatively low probability of new and severe health issues to be unveiled at a frequency that would warrant a ban on kratom.
Clearly, kratom for consumption, for nutrition, or the sheer purpose of recreation may not be for everyone. There are some risks associated with using kratom, including the possibility of acquiring a dependence, experiencing withdrawals and/or various side effects, including toxicity or cross-drug interactions, and so for a healthy individual who is not already dependent on opioids, or does not suffer from chronic pain, there is not a very compelling reason to use it, other than to experience a mild euphoric, energetic, or focus enhancing effect. But there may be benefits for others, including individuals who seek to treat chronic pain without opiates, and those who have a predisposed opioid dependency and who have brought themselves down to a sufficiently low opioid dosage; in those cases kratom may provide a beneficial self-treatment allowing individuals to avoid facing the harsh and lingering pain and symptoms of opioid withdrawal. When the individual is ready, the cessation of kratom can then be done with symptoms far less severe than those of opiates and in a number of different ways; hence there exists a compelling reason for kratom to be made available in the United States and around the world.
"Kratom Powder", is defined, for the purpose of this document, as dried and ground leaf material from the particular species of tree having the latin name: Mitragyna Speciosa, first identified with that name by Dutch botanist Pieter Willem Korthals in 1839 . There are however no copies of Korthals journal publications available online and so a more accessible publication by botanist George Darby Haviland in 1897 is often cited as a source that both confirms Korthals as the first to correctly classify the species and includes Korthals' original latin description . Kratom powder does not include any foreign additives nor extracts derived from the plant itself. The reduction of water weight in the drying process of kratom is typically ~4:1 and should be no less than ~2:1 to help prevent mold growth.
Warning: The recommendations provided here have not been approved by the FDA. They are written based on personal and relational experience and the research gathered and presented above, are intended to provide some reasonable instructions for people in the interim until the FDA comes around and allows companies to start sharing information about their products...
First time users are people who have never taken Kratom before, people who haven't taken Kratom in a long time, and people switching Kratom sources or Kratom variety. This section applies to those people.
Warning: Taking too much Kratom will very likely make you feel sick or nauseous. Please follow directions!
Warning: If you are taking other medications or have other health conditions, please use extra caution and check the list of drugs that are known to have cross interactions with Kratom in the Physiological Effects section above before taking Kratom.
Warning: First time users should not drive vehicles or operate heavy machinery. It would also be wise to schedule several hours of free time in preparation of the first use in case adverse effects become noticeable.
It is worth noting that different strains and batches of Kratom Powder may have varying potencies. The following recommendations do account for those variations!
First time users, should start by taking small amounts of Kratom Powder and work up to a dose that is most appropriate for them. Two methods of determining the appropriate initial amount are described here, as well as a method for administering recurring dosages for those that need to take it regularly. Subsections that follow suggest which of these methods are appropriate, according to the special condition for which a person is taking Kratom.
A good amount to start with would be somewhere in the range of 0.5 grams to 2 grams (about 1 level teaspoon full or less) depending on one's weight and how much they have had to eat. This is your Initial Dose. Most people like to mix the powder in a small amount of water or juice (a shot glass worth) and drink the mixture down fast, because of the unfavorable taste. Any noticeable effects should begin to occur within about 30 minutes of swallowing the powder. The most substantial effects should last for anywhere between about 1 and 4 hours. If no noticeable effects are felt after about 30 minutes, wait 4 to 6 hours and then repeat the procedure but increase the Initial dose by an amount of about .5 grams (and definitely no more than 1g). A slight feeling of nausea is a typical sign that a person has reached the maximum amount that they should be taking (their threshold), and once that point is reached, they should then reduce their dosage each time by at least 0.5 grams for all subsequent takings. If a person's threshold level has been reached, and no beneficial effects are noticeable, then it is questionable whether that person should be taking Kratom. If at any time any adverse reaction occurs, other than nausea or a feeling of needing to throw-up, stop taking Kratom and check with your Doctor. If a person starts feeling nauseous or like vomiting, don't worry, there is probably not reason to see a doctor because the feeling will likely subside in about an hour or two. As a precaution however, if you are feeling nauseous, it might be wise to monitor your heart rate and blood pressure and see a doctor if it is out of the ordinary.
A good amount to start with would be somewhere in the range of 0.5 grams to 2 grams (about 1 level teaspoon full or less) depending on one's weight and how much one has had to eat. Most people like to mix the powder in a small amount of water or juice (a shot glass worth) and drink the mixture down fast, because of the unfavorable taste. Any noticeable effects should begin to occur within about 30 minutes of swallowing the powder. The most substantial effects should last for anywhere between about 1 and 4 hours. If after 30-40 minutes no noticeable effects are felt, repeatedly take another 0.5gram to 1 gram every 30-40 minutes until some noticeable symptom is felt. Add the total amount up that has been taken, and that is your Initial Dose. A slight feeling of nausea is a typical sign that a person has reached the maximum amount that they should be taking (their threshold), and once that point is reached, they should then reduce their dosage each time by at least 0.5 grams for all subsequent takings. If a person's threshold level has been reached, and no beneficial effects are noticeable, then it is questionable whether that person should be taking Kratom. If at any time any adverse reaction occurs, other than nausea or a feeling of needing to throw-up, stop taking Kratom and check with your Doctor. If a person starts feeling nauseous or like vomiting, don't worry, there is probably not reason to see a doctor because the feeling will likely subside in about an hour or two. As a precaution however, if you are feeling nauseous, it might be wise to monitor your heart rate and blood pressure and see a doctor if it is out of the ordinary.
After waiting about 3-6 hours following the Initial Dose, the beneficial effects of the Kratom are expected to dissipate and it is then recommended to take another dose that is less than your Initial Dose (by 1 to 3 grams), because there is likely still some Kratom active in your system from the previous dose. Then, if no effects are noticeable, take a little more (.5-1 gram) every 30-40 minutes until any effects become apparent. The total amount taken during this period is your new dose amount. Each subsequent dose can be based on your previous dose amount and can be adjusted up or down slightly (.5-1grams) depending on how you have been feeling.
People suffering from Opioid Withdrawal are likely to be suffering severely and should start by finding their initial dose using Method 2 above. Because Kratom acts on some of the same receptors in the brain that many opioids do, it is quite common for Opioid Withdrawal sufferers to have a higher initial tolerance to the active alkaloids found in Kratom and those individuals often find themselves requiring initial doses that are significantly higher than someone who is not pre-disposed to opioids. It is not uncommon for someone in this scenario to reach an Initial Dose of 10 grams or more (although that would be considered a high amount). Typical Initial Doses for users in this scenario range between 3 and 8 grams.
A slow taper off of Kratom may be desirable after some time has passed to stabilize the Withdrawal Symptoms. If this is the case, simply reduce the dose amount by a very small amount each day (~.1 gram or whatever amount is tolerable) until the beneficial aspects of Kratom becomes unnoticeable and taking it becomes unnecessary.
People suffering from chronic pain often find that Kratom may provide more manageable relief than prescription pain medicines, and in many cases may be a better, more natural, and possibly safer choice. For those people, if the pain is severe, it is recommended to start taking Kratom by finding your initial dose according to method 2 above. If pain is less severe, then method 1 is recommended. In some cases, Kratom may be used to supplement the effects of other pain relief medicines, but please heed the warnings above and talk to a doctor about any unusual side effects or have any other concerns about particular combinations. Typical Initial Doses for users in this scenario range between 2 and 8 grams.
The desired effects of taking Kratom for a healthy individual are comparable to those of drinking a strong cup of coffee. For these individuals, it is not recommended to take Kratom more than once a day, nor for multiple consecutive days in a row, because the desirable effects tend to diminish somewhat as your tolerance for the alkaloids builds up with regular use, and there is some evidence that taking it regularly may lead to a mild addiction, much like a coffee addiction. However, in this scenario, either method 1 or 2 may be used to determine your initial dosage amount. It is worth noting that if method 2 is elected, it is not wise to continue taking small amounts beyond the point where you first feel the effects, because for many, there is a very narrow range between the dosage amount where the desirable effects of kratom are first noticeable and the dosage amount where one begins to feel nauseous (a span of about 1 gram or less). Typical Initial Doses for users in this scenario range between 2 and 4 grams.
Although Kratom is legal to have and to sell not for consumption, it is technically not legal to sell in the United States for purposes of consumption. This is described in more detail here, along with other information about the current legal status of Kratom in the US. This section however provides some insight as to what options might exist to make it legal to sell for consumption.
One option to admit Kratom as an unadulterated consumable product would be to submit to the FDA a New Dietary Ingredient (NDI) Notification for Kratom Powder, however, after careful review of the close to 200 Notifications that have been submitted for other NDI products and the corresponding responses by the FDA, it has been determined that the above information, as informative as it is, would probably be considered insufficient and be rejected by the FDA.
In the 1990s and early 2000's, when the FDA was still figuring out how to implement DSHEA, most NDI applications were accepted without much review and no report of FDA concern; that is when the majority of NDI's were admissible. In more recent years, very few NDI's have been allowed by the FDA, and it seems that the only ones that have had at least one clinical trial of the NDI administered at a particular low dose defined in the Notification, and trials showing no signs of adverse events, are the ones that receive a more positive FDA report without concern, and that is as close to an approval as you can get with an NDI.
Hence, it was determined that in order for a notification for Kratom Powder to not be rejected, it is very likely that at least one clinical trial would need to be completed at a very low dose, in order for the FDA to consider it "reasonably safe".
But the problem is: at what dose of Kratom Powder should a clinical trial be performed?
The typical method of determining the low dose for Kratom Powder, or the the No Observed Adverse Effect Level (NOAEL), of course must also be consistent with the method of determining the same for other ingredients, which is something like 1000 times lower than the LD50 level, or 100 times lower than the Lowest Adverse Effect Level (LAEL). Certainly, more research is needed to identify a NOAEL or LAEL for Kratom that would be acceptable by the FDA.
It has been speculated however, that in order for a clinical trial to be performed with Kratom Powder to show no signs of nausea or other adverse events, the dosage would have to be set somewhere below .5g, and probably even between 5mg and 50mg to be on the safe side.
That of course is not optimal for Kratom Vendors as they would prefer to be able to include on their label a more realistic dose starting around 1 to 3 grams, or more depending on weight and various other factors.
Unfortunately, even if Kratom was accepted as a NDI, vendors would never be able to disclose any medical benefits of the plant, nor suggest any other dosage except for what was administered in the clinical trials. Getting it accepted however, would most likely be the fastest path to getting Kratom to the point where it may legally be sold specifically for purpose of consumption, and subsequently, Import Alert 54-15 would then have to be revised.
An initial investigation for how much a clinical trial might cost has it estimated at least $100,000 per 20 subjects, and perhaps 60 or 100 subjects would be needed at a minimum. This amount is not insurmountable, however, most small business entering into the Kratom Industry are not capable of making such an investment, and larger businesses have little incentive because they know that non-investing competition will benefit equally.
Alternative to an NDI, Kratom Powder could be submitted to the FDA as Generally Regarded As Safe (GRAS) by notification, and there would be some pros and cons to doing it that way, but generally speaking, if there are any adverse effects known about a GRAS food, it is likely that the FDA will use that information to quickly remove that food from the GRAS food list.
In order for Kratom Powder to last as a GRAS, it is likely that multiple clinical trials would be necessary, performed at various dosages, in order for the FDA to provide the FDA with sufficient evidence that Kratom Powder would be safe in a broader scope than an NDI. This would be more difficult.
Furthermore, a GRAS food would still be subject to the same conditions of other foods and Kratom vendors wouldn't ever be able to inform their customers of the health effects of kratom, both positive and negative; and that is still a problem.
These days, countless clinical trials and toxicological studies are necessary before the FDA will approve a new pharmaceutical. Estimations for how much it would cost to approve a new drug range anywhere from $50 million to $5 billion. These costs are simply too high for a company to spend on a natural product for which there is not much control over the source and there are no particular rights of sale granted to that company for doing so.
The third option that could potentially make it legal to sell Kratom as a consumable product would be to change the law. Amending US Code, Title 21, which contains the laws that govern the FDA.
Many individuals will advocate for tighter control, and more regulation on new foods, dietary ingredients, and pharmaceuticals, while others will argue for more freedoms, less regulation, more sharing of information, and more substantial changes. Any changes that are proposed would have to be considered carefully and be passed by congress. This would be a reasonable approach, and most likely the best one, however lobbying would be difficult and would take time. The public opinion will probably need persuasion first.
Besides that, there are many different ways 21CFR could be rewritten, some proposals might just include exceptions for natural products, while others might be more aggressive and restructure the FDA in its entirety. There are a number of changes that could be made that would allow for Kratom to be legally sold as a consumable product, but which proposal would be for the best, and which proposal would most likely get passed by congress are two separate considerations; a topic that would be suited better in another post. Some other qualms with US laws and the FDA and recommendations to improve them are suggested here.
In addition to all the reasons suggested in the Description above, Kratom should be considered "reasonably safe".
Thus far, the FDA has concluded, according to Import Alert 54-15, based on minimal research and with little justification, that there is insufficient evidence that kratom is safe.
Here is the FDA’s conclusion exactly:
"...based on FDA s review of the publicly available information regarding kratom, there does not appear to be a history of use or other evidence of safety establishing that kratom will reasonably be expected to be safe as a dietary ingredient. In fact, the scientific literature disclosed serious concerns regarding the toxicity of kratom in multiple organ systems. Consumption of kratom can lead to a number of health impacts, including respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, tremors, loss of libido, constipation, skin hyper-pigmentation, nausea, vomiting, and severe withdrawal signs and symptoms. In the absence of a history of use or other evidence of safety establishing that kratom will reasonably be expected to be safe as a dietary ingredient, kratom and kratom-containing dietary supplements and bulk dietary ingredients are adulterated under section 402(f)(1)(B) of the Act [21 U.S.C. 342(f)(1)(B)], because they contain a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury."
Despite the fact that very little evidence was presented to substantiate or justify the conclusion, the conclusion is largely incorrect. An abundance of evidence has already been introduced in the Current State of Kratom : Description section above that suggests that there is a long time history of kratom use for consumption, both inside and outside the U.S., by large populations of humans, and that there is sufficient evidence to deduce that kratom is relatively safe and does not present a significant or unreasonable risk of illness or injury.
The strongest piece of evidence included in the FDA’s conclusion was the inclusion of the list of the “health impacts” that were identified during their review. Despite the fact that the source of these “health impacts” are not cited and can not be traced nor verified, the inclusion of these or any other “health impacts” or side effects is simply not relevant to the point unless they can be proven to present a significant or unreasonable risk of illness or injury. In no way has the FDA provided any evidence that any of the listed “health impacts” are either significant nor unreasonable. On the contrary, there is substantial evidence that all known “health impacts”, side effects, and symptoms are neither significant nor unreasonable.
To justify that argument, consider other dietary ingredients:
- Peanuts - People with peanut allergies are noted to experience the following symptoms :
- Itchy skin or hives, which can appear as small spots or large welts
- An itching or tingling sensation in or around the mouth or throat
- A runny or congested nose
- Anaphylaxis (less common), a potentially life-threatening reaction that impairs breathing and can send the body into shock. 
- The simple fact that peanuts pose a risk of a life threatening-reaction and they are still widely accepted as an acceptably safe dietary ingredient is testament to the fact that the risk of even a life threatening reaction is not enough to make the general public consider a dietary ingredient to be significantly or unreasonably unsafe.
- Anaphylaxis instigating foods:
- Strawberries, grapes, cherries, and a number of other fruits .
- Tree nuts (such as walnut, cashew, Brazil nut), shellfish, fish, milk, eggs and preservatives
- Glutens- Wheat, and grains like barley, oats, and rye that contain gluten (ingredients that are found in most breads, pastas, and cereals) - The list of symptoms that are related to gluten is extensive, including a number of intestinal problems, asthma, osteoporosis, and anaphylaxis, symptoms that are considered severe by some accounts , however the risk of being exposed to these symptoms is clearly reasonable and not significant enough for the public to take enact laws to take wheat products off the market.
- Nutmeg - Reported symptoms include: CNS excitation with anxiety/fear, cutaneous flushing, decreased salivation, GI symptoms, and tachycardia. Acute psychosis and anticholinergic-like episodes have been documented; death has rarely been reported following the ingestion of large doses of nutmeg.. Here is a great example of a dietary ingredient that has psychoactive properties, lots of health impacts, very few toxicology or cross drug interaction studies, yet reasonably persists on the market.
- Hydroxycitric acid (HCA) - A new dietary ingredient registered with the FDA that has reported symptoms that include dizziness, dry mouth, upset stomach, and diarrhea but may react with certain medications .
- Nearly every other dietary ingredient known to man - Even water is known to have caused deaths when consumed in abundance; an occurrence that happens quite often .
The point is that nearly all dietary ingredients cause some health risks in certain individuals in certain situations, but that does not mean they are unreasonably unsafe.
If all that was needed for a New Dietary Ingredient (NDI) to be considered adulterated and unsafe and unfit for market was a report of a few health related symptoms, then ultimately all NDIs would be deemed adulterated and unfit for market. Is that reasonable? Is that what legislators intended when they created a system that allowed for NDIs to be established? Absolutely not. There must be room for NDIs to be able to have some health related symptoms and side effects; therefore a list of “health impacts” can not be regarded as conclusive evidence that a product poses “a significant or unreasonable risk of illness or injury.”
The FDA has thus far, simply not been diligent enough in their review to identify enough information that would lead to a conclusion that there is in fact evidence that supports the relative safety of kratom and that it does not pose “a significant or unreasonable risk of illness or injury.” Evidence of this is founded on the fact that for many years, a large population of people have been consuming kratom for a number of useful purposes that greatly outweigh the low risks of illness or injury; this of course is supported in the Description of Kratom section above. The obvious conclusion is that kratom is "relatively safe".
In reflection, the term "relatively safe" is a poor choice of words to have been written into laws as an identifier of what shall be considered a legal food or ingredient, because the term is so subjective and exceptional. Definitions in law should be clear and obvious, not loaded with subjective and exceptional meanings; a legal system that avoids using such terms would be an improvement.
But for now, a legal structure exist that has allowed the FDA to declare that Kratom is not "relatively safe"; a conclusion that is simply wrong!
Health risks are associated with everything that we eat. Those risks only become unreasonable, however, when companies unscrupulously mis-market or mis-inform their customers about the risks of a product that has been advertized with a particular purpose or directions for use. It was the intention of enactments like the Federal Food Drug and Cosmetic Act(FFDC) and the Dietary Supplement Health and Education Act of 1994 (DSHEA) to mitigate these unreasonable risks, however, like most large acts made by Congress, poorly worded subjective definitions have been incorporated into law, and it has been left to judiciary committees and faculty to establish the meaning and legitimacy of those definitions.
Now the FDA is guided by a system of laws that infringe upon the freedoms of Americans to be able to have access to so many important foods and medicines. The system also establishes an unjust environment for companies, and those representing companies from disclosing important information about the products they sell.
The system is old, and it's time to re-evaluate what the role of the FDA should really be. A system should be in place that allows individuals the freedom to make their own decision about whether or not they should have access to something that might make their lives better. Kratom is one of those things, which also happens to have very low risks and can generally be regarded as safe. But just like any other food and medicine, it is important for people to be well informed about the foods and medicines they ingest, and it is important to have a system that ensures companies are providing that information. This is what is important! And that is what the system, or the FDA, should be focusing on: proper labeling and information sharing; not limiting accessibility of products.
So with that knowledge, take action and write to your congressmen; tell them what you think. We have to start somewhere!
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