Is a Kratom Ban Imminent?
by Paul Kemp
The FDA says kratom is harmful, but won’t sit down and discuss the scientific reasons why or produce evidence apart from the computer-generated assertion that kratom is simply another opioid and they present death reports which lack sufficient detail to determine if kratom is at fault. The American Kratom Association (AKA) has asked the FDA for a meeting to discuss their differences but has been kept waiting since August, 2018.
The FDA’s position on kratom is significantly different from the general consensus of the scientific community that has studied the herb in recent years, as seen here
One point of contention that could be causing this impasse may be the fact that herbs that were not actively marketed in the USA prior to 1994 are expected by the FDA to present scientific proof that they are safe in the form of a New Dietary Ingredient notification. While it is very possible that kratom was marketed in ethnic grocery stores prior to 10-15-1994, no proof has been found – nor has an NDI been submitted sufficient to satisfy the FDA.
Michael McGuffin, President of the American Herbal Products Association had this to say about the need for a kratom NDI in April of this year.
A Battle on Many Fronts
Despite the FDA’s weak and unconvincing scientific evidence that kratom is dangerous, states and local police forces tend to follow federal (FDA) pronouncements on which to base their own laws and regulations. For this reason, the AKA is forced to fight battles on multiple fronts, which is an expensive but necessary approach. (It is necessary because, once a state or local jurisdiction passes a kratom ban, it is much harder — and more expensive — to reverse it than it would have been to prevent the ban by providing scientific proof to the governing body that is considering it.)
Nevertheless, the primary goal of the AKA seems to be to correct the FDA’s stated position that kratom is dangerous and addictive, though not all of the federal health agencies seem to be in agreement with the FDA’s position. The National Institutes of Health (NIH) is one that has stepped slightly out of line with the FDA’s position — if only briefly, before moderating its position somewhat.
Ironically, the NIH has stated publicly that there is no inherent danger in natural kratom leaf, per se. This is a positive step, implying that deaths and medical issues are being caused by either the adulteration of products labeled as kratom, undisclosed pre-existing health challenges in the user, or by consumers mixing kratom with multi-drug cocktails — OTC, prescribed and illicit. Nevertheless, the FDA hasn’t been willing to discuss what they know that the consensus of other scientists studying the plant have not found.
Sorting out this key issue appears to be one of the AKA’s primary objectives, but the FDA seems to be stubbornly avoiding dealing with the issues of adulteration and misbranding of kratom, which it could easily eliminate by using its current regulatory enforcement powers.
Since the FDA doesn’t seem inclined to do much to police the issues of misbranding, medical claims, and adulterated or unsanitary kratom, the AKA is assembling a vendor certification program to assure consumer safety and Good Manufacturing Practices among participating vendors.
“… Like a game of Whack-a-Mole!”
Judged by the FDA’s actions on multiple fronts, their preference seems to be a combination of 1) making vocal efforts to persuade the DEA to enact a kratom ban; 2) dissuading the public from using kratom with announcements of salmonella contamination, heavy metals, and recalls of kratom; 3) spreading patently incorrect information to state and local Boards of Pharmacy, police forces, and state legislatures, urging them to ban kratom in their jurisdictions; and finally, 4) the seizure of large and small shipments of kratom at U.S. ports of entry.
The effect of this FDA campaign to ban kratom on multiple fronts seems designed to exhaust the patience, the will, and the finances of vendors and the kratom consumers. At the same time, the FDA refuses to deal with real issues such as rare appearances of adulterated (spiked) kratom on the market. Positive benefits reported by participants in four surveys conducted with participation and funding by the NIH and the more than 22,000 positive comments made by the public and scientists in the Federal Record during the 2016 DEA Emergency Scheduling attempt are ignored.
Despite the lack of cooperation by the FDA, the kratom community (now numbering as many as 7,000,000 consumers), has had some remarkable victories, such as the sound trouncing of the SITSA (Stop Import and Trafficking of Synthetic Analogs) bill, which would have given the Attorney General of the United States the power to ban any substance believed to be similar in effects to opioids or other scheduled drugs, without any scientific review or judicial appeal. This was a major victory for a coalition of anti-drug-war, pro-kratom, and civil rights groups, working together against a bill that would have permitted overreaching federal actions – including a possible kratom ban. This shows the power of coalitions of citizens working together for better government.
In summary, it seems plausible that, though the FDA may be feeling some pressure to enact a kratom ban before the House of Representatives becomes controlled by Democrats in January, 2019 — the ultimate decision is dependent on the public’s willingness to support the fight to keep kratom legal, under the guidance of the expertly advised, best-funded, and most widely recognized non-profit 501(c)(4) organization focused on the task, the American Kratom Association.
As proof that victories against the vast power and resources of the agencies of the U.S. government are possible, we have only to remember the long, hard-fought battles to effectively reverse the historic prohibitions on alcohol and cannabis.
At this stage in the game, it is impossible to predict whether the DEA will once again attempt to schedule kratom along with heroin and LSD, but it is a safe bet that a growing and powerful block of kratom consumers can be counted on to vigorously oppose such a kratom ban.