You are strongly encouraged to take the time to read this entire document, then submit a polite comment explaining your kratom story and asking the Department of Health and Human Services (HHS) to please keep kratom legal. You have until August 9, 2021. Please select the option to receive a confirmation email and tracking number for your comment, which will not be publicly accessible right away. https://www.federalregister.gov/documents/2021/07/23/2021-15685/international-drug-scheduling-convention-on-psychotropic-substances-single-convention-on-narcotic?fbclid=IwAR1jTz7JSte491H5eTQBwjrivN4Y60s1t-kIPc1iy9UvnjfY2kkwHNFuBvM
On July 23, 2021, the Food and Drug Administration (FDA), as required by law, requested formal comments that will be considered by Health and Human Services (HHS) in a response to a World Health Organization (WHO) request for information on the abuse liability of seven substances including kratom. This comment period will end August 9, 2021. The WHO will convene in Geneva, Switzerland on October 11-15, 2021 with its Expert Committee on Drug Dependence (ECDD) to consider whether to recommend kratom become a scheduled substance to the UN’s Commission on Narcotic Drugs (CND), which makes the final decision.
These comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drug substances.https://www.federalregister.gov/documents/2021/07/23/2021-15685/international-drug-scheduling-convention-on-psychotropic-substances-single-convention-on-narcotic?fbclid=IwAR1jTz7JSte491H5eTQBwjrivN4Y60s1t-kIPc1iy9UvnjfY2kkwHNFuBvM
What are these international restrictions? How are they enforced? Who enforces them? We’ll get to those questions later. For now, let’s try to understand what’s going on with this document and the formal comment period.
The WHO is the international public health agency of the United Nations (UN). The FDA is an agency within HHS. FDA is in place to ensure the safety of food, drugs, medical devices, cosmetics, and other products and to regulate the manufacturing of these products. HHS is within the executive branch and is the main public health agency of the United States.
At this point, WHO is simply requesting information from HHS about the seven substances. When this happens, HHS must prepare a response, but not before reviewing comments in this formal comment period, which ends August 9, 2021.
when WHO notifies the United States under Article 2 of the Psychotropic Convention that it has information that may justify adding a drug or other substances to one of the schedules of the Psychotropic Convention, transferring a drug or substance from one schedule to another, or deleting it from the schedules, the Secretary of State must transmit the notice to the Secretary of Health and Human Services (Secretary of HHS). The Secretary of HHS must then publish the notice in the Federal Register and provide opportunity for interested persons to submit comments that will be considered by HHS in its preparation of the scientific and medical evaluations of the drug or substance.https://www.federalregister.gov/documents/2021/07/23/2021-15685/international-drug-scheduling-convention-on-psychotropic-substances-single-convention-on-narcotic?fbclid=IwAR1jTz7JSte491H5eTQBwjrivN4Y60s1t-kIPc1iy9UvnjfY2kkwHNFuBvM
Though these comments will be made public, nowhere does it state that any or all comments must be presented to WHO by HHS. For this reason, the American Kratom Association is also accepting comments on its website to present directly to WHO.
The Federal Register is the official public journal of the United States. Comments entered directly into the Federal Register will be made public after being reviewed by HHS. With the volume of comments being submitted by kratom advocates, this could take weeks. The comment submission form states, “All comments are considered public and will be posted online once the Health and Human Services Department has reviewed them.” These public comments could then be emailed to WHO by anyone.
It’s important to remember that HHS will not be recommending scheduling any of these substances at this time. From the document:
HHS will not now make any recommendations to WHO regarding whether any of these drugs should be subjected to international controls. Instead, HHS will defer such consideration until WHO has made official recommendations to the Commission on Narcotic Drugs, which are expected to be made in late 2021. Any HHS position regarding international control of these drug substances will be preceded by another Federal Register notice soliciting public commentshttps://www.federalregister.gov/documents/2021/07/23/2021-15685/international-drug-scheduling-convention-on-psychotropic-substances-single-convention-on-narcotic?fbclid=IwAR1jTz7JSte491H5eTQBwjrivN4Y60s1t-kIPc1iy9UvnjfY2kkwHNFuBvM
What are the “international controls” that WHO/UN can place on kratom?
Neither the WHO nor the UN controls its member nations’ internal drug laws. However, international controls can affect the supply of substances like kratom by prohibiting its export or import. As stated in the document:
Such control could limit, among other things, the manufacture and distribution (import/export) of these drug substances and could impose certain recordkeeping requirements on them.https://www.federalregister.gov/documents/2021/07/23/2021-15685/international-drug-scheduling-convention-on-psychotropic-substances-single-convention-on-narcotic?fbclid=IwAR1jTz7JSte491H5eTQBwjrivN4Y60s1t-kIPc1iy9UvnjfY2kkwHNFuBvM
While these controls do not affect US controlled substance law, they could cut off the supply of kratom into the US from countries like Indonesia where most of the kratom consumed in the US is grown.
In 1971, around the time President Richard Nixon launched the “War on Drugs”, the US signed on to the UN’s Convention on Psychotropic Substances. Article 2, Paragraph 4 of this convention lays out the process by which the WHO considers substances and recommends them to the CND who makes the final decision:
If the World Health Organization finds: (a) That the substance has the capacity to produce (i) (1) A state of dependence, and (2) Central nervous system stimulation or depression, resulting in hallucinations or disturbances in motor function or thinking or behaviour or perception or mood, or (ii) Similar abuse and similar ill effects as a substance in Schedule I, II, III or IV, and (b) That there is sufficient evidence that the substance is being or is likely to be abused so as to constitute a public health and social problem warranting the placing of the substance under international control, the World Health Organization shall communicate to the Commission an assessment of the substance, including the extent or likelihood of abuse, the degree of seriousness of the public health and social problem and the degree of usefulness of the substance in medical therapy, together with recommendations on control measures, if any, that would be appropriate in the light of its assessment.– Convention on Psychotropic Substances of 1971, Article 2, Paragraph 4
Notably, alcohol and tobacco should meet these criteria, however the “Commentary on the Convention on Psychotropic Substances”, written in 1976, rationalizes this away.
Alcohol does not ‘warrant’ that type of control because it is not ‘suitable’ for the regime of the Vienna Convention. It appears obvious that the application of the administrative measures for which that treaty provides would not solve or alleviate the alcohol problem.Commentary on the Convention on Psychotropic Substances, 1976
[Tobacco] is not suitable for the kinds of controls for which the Vienna Convention provides, and which if applied would not make any useful impact on the tobacco problem. That problem, however serious, therefore does not ‘warrant’ the placing of tobacco ‘under international’ control, i.e. under the Vienna Convention.Commentary on the Convention on Psychotropic Substances, 1976
In light of the fact that more restrictions on legal access to prescription opioids are directly causing a spike in illicit drug overdose deths, WHO can consider the Commentary on alcohol and tobacco when evaluating whether restricting kratom with be a benefit or detriment to public health.
Articles 12 and 13 of the Convention lay out the rules by which member nations have to follow in terms of the import and export of Schedule I, II, III, or IV substances. Importing and exporting parties must acquire multiple authorizations from the CND and adhere to specific procedures. Each member nation of this convention can also notify the UN Secretary General that it would like to prohibit the import of internationally scheduled substances into its own country. Each member nation is tasked with enforcement of the import/export laws.
Depending on the WHO recommendation and the CND decision to be made in late 2021, international trade in kratom could become very difficult.
Please, at the very least, comment directly into the Federal Register and tell them why you would like to keep kratom legal. You can also use the AKA’s website if you would like to submit a comment that they will deliver to the WHO/UN.