The American Kratom Association (AKA) has come out strongly condemning the recent actions taken by LegitScript and hosting providers to shut down the Internet domains of legitimate businesses who are selling safe Kratom products to consumers in the United States. The association has received reports that a trusted Internet vendor had their domain completely shut down by GoDaddy, the web hosting company, based on the LegitScript report.
Based on AKA’s review of the “Red Flag” alerts by LegitScript relating to kratom, it is clear they relied upon outdated and inaccurate information (a 2014 FDA PressRelease, and a 2015 DEA publication) from the FDA and DEA that materially misrepresents the pharmacological properties of kratom and kratom’s addiction and safety profile.
The DEA published a Notice of Intent for emergency scheduling of kratom as a Schedule I controlled substance on August 31, 2016. On October 13, 2016, the DEA, in an unprecedented regulatory move, withdrew its Notice of Intent and requested the FDA provide a statutorily-mandated Eight-Factor Analysis on the addiction and safety profile of kratom justifying whether any legal basis exists to schedule kratom at all. The DEA requested the FDA response by December 1, 2016. As of this date, the FDA has not made any subsequent recommendation for the scheduling of kratom or provided the requested Eight-Factor Analysis.
On November 28, 2016, the AKA submitted an Eight-Factor Analysis on kratom that was conducted by one of the preeminent scientists in the field of addiction profiles and safety of dietary supplements, Dr. Jack Henningfield of Pinney Associates. This Analysis mirrors the statutorily-mandated criteria for an Eight-Factor Analysis that would be used to support a scheduling recommendation by the FDA for any product they believe should be scheduled as a controlled substance.
Dr. Henningfield’s analysis concluded: (1) scheduling kratom as a controlled substance is not warranted from a public health perspective; (2) kratom has very low toxicity, and thus a favorable safety profile; and (3) there have been no confirmed reports of death that can be causatively due to kratom overdose. This Analysis was submitted to the FDA and the DEA and there has been no attempt to schedule kratom in the following six months, despite the initial view that kratom required “emergency scheduling.”
This updated research is conclusive, and AKA believes LegitScript should immediately rescind their action, just as the DEA did in October 2016.
The AKA fully supports appropriate regulatory actions against any adulterated substance that poses a danger to the public health. The demonization of kratom, which appears to have originated in unjustified accusations that kratom is an “opioid” that has led to deaths of consumers. has proven to be completely false. This outdated and inaccurate information should not be the basis for any regulatory or business decision by any organization.
The actions taken by LegitScript directly interferes with the freedoms of consumers to make individual choices about their health and well-being and raises significant concerns about a nongovernmental agency intervening in commerce causing significant economic harm to American businesses. It also unjustifiably erects barriers to access to the millions of Americans who choose to use kratom as a part of their personal plan for their own health and well-being.
The AKA is working closely with LegitScript, and appropriate regulatory agencies, to correct this egregious decision. They will also seek the assistance of the appropriate regulatory agencies to correct the outdated and inaccurate information they have published that has served as the basis for the unwarranted decisions by LegitScript related to kratom.