FDA seeks comments on regulation of kratom, 6 other drugs

Regulatory NewsRegulatory News | 26 July 2021 |  By 

Kratom, a popular but unregulated psychotropic herbal extract, is one of seven currently unscheduled psychotropic drugs that will be reviewed by the World Health Organization (WHO) under the provisions of the international psychotropic convention to which the US is a party.
WHO notified the US and other international parties to the 1971 convention that the seven new psychotropic drugs may be added to its list of scheduled drugs. By law, that notification triggers a requirement that the secretary of the US Department of Health and Human Services (HHS) publish a request for comments in the Federal Register.
These substances “have never been formally reviewed by WHO and are not currently under international control,” wrote WHO in notifying the US and other nations of its intent to review the drugs. “Information was brought to WHO's attention that these substances are clandestinely manufactured, of especially serious risk to public health and society, and of no recognized therapeutic use.”
Two novel synthetic opioids, brorphine and metonitazene, are scheduled for review at the October meeting of WHO’s expert committee on drug dependence (ECDD). The synthetic cannabinoid receptor agonist 4F-MDMB-BICA, or 4F-MDMB-BUTICA, is also scheduled for review.
Two “designer drugs” that function as stimulants, eutylone or bk-EBDB, and BMDP, are also up for review by ECDD. BMDP’s chemical name is 3,4-Methylenedioxy-N-benzylcathinone and it is also known as benzilone.
Kratom, along with its two active substances, mitragynine and 7-hydroxymitragynine, are in pre-review status, according to WHO. The pre-review process determines whether sufficient evidence exists to bring the substance before the ECDD for a formal review; “findings at this stage should not determine whether the control status of a substance should be changed,” according to the WHO notification.
One medicine, phenibut (beta-phenyl-gamma-aminobutyric acid HCl), is also in pre-review. Phenibut is currently used in Russia to treat alcohol withdrawal, as well as anxiety, insomnia and vestibular disorders, according to the Federal Register notification. It has no medical use in the US but is available online without a prescription.
The ECDD’s meetings, at which the group “conducts medical, scientific, and public health evaluations of the selected psychoactive substances using the best available information,” are closed to the public, but WHO member states may participate in an ECDD open session slated for 11 October.
Member states are asked to complete a questionnaire about the substances under review, so EDCC can form an assessment on the status and current use patterns of the drugs in each country. Member states can also provide additional relevant information.
According to the 19 July Federal Register notice, the US Food and Drug Administration (FDA) plans to defer any recommendations regarding whether the drugs should be moved to a controlled class until WHO makes official recommendations to its Commission on Narcotic Drugs.
Federal Register


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Tags: FDA, kratom, opioids, US, WHO

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