Authorities in Oklahoma seized $3 million worth of kratom at the behest of the Food and Drug Administration in the latest attempt by the federal agency to pursue an agenda that flies in the face of available research.
On Tuesday, May 2, United States Marshals seized the products from Botanic Tonics of Broken Arrow, Oklahoma due to a complaint filed on behalf of the FDA. The seizure is just the latest action taken under the claim of kratom being a new dietary ingredient and relies on the same reasoning that was dubbed “disappointingly poor evidence,” and will cost an American-owned business millions of dollars for being caught in the crossfire of the FDA’s agenda against the botanical supplement.
United States Attorneys representing the Northern District of Oklahoma filed a civil forfeiture complaint in district court last week, which led to the action taken by the Marshalls. As part of the forfeiture, authorities seized nearly 250,000 bottles of liquid kratom products, a tank containing kratom products, and more than 1000 kilograms of bulk powder kratom.
The questions in the wake of this action comes due to a lack of information provided in the court filings: Is this the case of questionable actions by a vendor, or has Botanic Tonics wound up in the crosshairs of the FDA, which used its leverage in federal courts to seize products that are legal per state law?
Botanic Tonics has come under question in other states, including a class-action lawsuit filed in California. Those claims center on Feel Free, a drink product produced by the company that features a “proprietary blend” of kava extract and kratom. Individual experience with the product echoes concerns that have arisen with adulterated kratom and products that are unclear on potency and dosage.
California has not passed a version of what is known as the Kratom Consumer Protection Act. In other states, KCPAs have set standards for product labels, potency limits and other consumer information. In California, kratom remains unregulated with no standard for labels, product restrictions or penalties for including adulterants and/or synthetic kratom.
At the same time, Oklahoma is one of 10 states who have passed a version of a KCPA, including age restrictions and requirements for labeling and manufacturing standards. The Oklahoma KCPA was signed into law on May 24, 2021. Photos included in news stories surrounding Botanic Tonics products in California do not include proper labels per Oklahoma law, but it is unclear if Botanic Tonics had changed packaging to meet standards, or if the FDA action had anything to do with adherence to state law.
Considering the FDA’s actions, the American Kratom Association, a consumer advocacy group, contends the seizure “undermines states’ authority to protect the health, safety, and welfare of their citizens,“ and the court’s approval of the action goes against the findings of other government bodies.
“Having failed to make the case to ban kratom on statutory criteria set by Congress…the FDA is now unfairly abusing the import alert authority granted by the Congress by using it as a tool to create a de-facto ban on kratom they cannot justify on the evidence and data required by the CSA.”
Beyond simply the effect it has on the businesses who wind up being targeted by the FDA, advocates are worried it could set a dangerous precedent.
“It was never the intent of the Congress for the FDA to use the import alert authority as a self-styled pocket ban on any product, including kratom,” said the AKA.
At the center of the claim is a repeated refrain from the FDA about kratom being a “new dietary ingredient for which there is inadequate information” to ensure safe consumption. In this complaint, as well as in the numerous import alerts that have been issued against kratom, the FDA claims the available research indicates “serious concerns” about the effects of kratom.
The only issue is that those claims fall apart upon further review of that research. Those same claims have also been rebuked upon inspection by other formal governing bodies.
Two attempts to federally schedule kratom have fallen short. In 2016, the petition was rejected as lacking evidence required by the Controlled Substance Act. The next attempt was withdrawn by the Department of Health and Human Services after Dr. Brett Giroir, an assistant Secretary of Health, with a letter that said the attempt presented “disappointingly poor evidence and data and an overall failure to consider public health.”
Giroir vowed to “work expeditiously with colleagues throughout the U.S. government to seek transparent and scientific input.”
As it stands, kratom is still legal at the federal level but has no approved medical use per the FDA’s restrictions on how the plant can be marketed. The FDA has used the concept of faulty medical claims as another reason to target kratom, but even that reasoning doesn’t hold up upon further inspection.
Per a release from the AKA, the group has alerted the FDA to more than 65 kratom vendors for using “illegal marketing claims.” The AKA says that the FDA is yet to initiate a single case, instead opting to use the bad actors as a reason to take action on all kratom consumers and vendors.
It’s an issue that the AKA addressed in its statement: “Consumers using kratom to help with health and wellness issues is vastly different than a kratom vendor using illegal therapeutic claims to sell products, and the FDA sits silently and allows that to occur shows both their complete failure to protect the public health from the real issue: The sale of kratom products that are either adulterated or misbranded to enrich those vendors making illegal health claims.”