Drugs, synthetic analogs, and regulation

Earlier today, we posted the #2 post of 2025, which was about the emergence of a synthetic analog to nicotine.

it’s interesting to me that we start with tobacco, move to nicotine vape, then on to the nicotine pouch, and eventually drift to synthetic nicotine analogs. 

And all along we see a consistent theme of:

  • harmful (and unknown) ingredients,
  • marketing to children and youth,
  • avoiding regulation via innovation, and
  • what amounts to a long-term population-sized experiment. 

This brought to mind a podcast episode I’d recently heard about models for regulating kratom.

…there are effectively only two policy choices. One is scheduling kratom, or banning it, which both Louisiana and Connecticut passed this year. The other is the industry-favored KCPA, which was passed by Rhode Island this year. While the KCPA is better than no regulation at all, these customer protection acts are, in my view, insufficient and primarily result in toothless self-regulation.

So why is the KCPA not the solution? 

This is what is included in the Utah KCPA, the first state to pass such a law in 2019:

  • Requires kratom products to be registered with the Utah Department of Agriculture and Food
  • Mandates labeling that discloses alkaloid content
  • Prohibits synthetic kratom alkaloids and synthetic derivatives
  • Caps 7-OH at no more than 2 percent of total alkaloids
  • Prohibits adulteration with controlled substances or harmful additives
  • Bans the sale of kratom to individuals under 18
  • Establishes criminal penalties for violations, including misdemeanors
  • Allows consumers to bring civil lawsuits for damages
  • Authorizes the state to issue fines, seize, and destroy unregistered products
  • Directs the Department to create rules and testing standards, without dedicated enforcement funding

Two things stuck out to me.

First, the industry is trying to design its own regulation model with the Kratom Consumer Protection Act. This is aided by the relative cultural ignorance about the substance. We’re only beginning to hear stories (pro and con) about the impact of kratom on people’s lives. As those narratives take root, they will shape the regulatory environment. It seems like the industry knows this and would like to get its model adopted before the substance enters widespread public consciousness.

Second, the emergence of analogs has created challenges for regulation and the existing business landscape. This blog has previously discussed this issue that “safe supply” models to regulate and reduce harm will inevitably run into issues with innovation (inside or outside the licit industry) changing the risk profile of a drug. This leaves us with the choice between establishing prohibitions on innovation or living with constant updates to the “safe supply” model.

3 thoughts on “Drugs, synthetic analogs, and regulation

    1. Thanks Brian for that link from the archive. I know of Betel Nut but don’t have now insights on any of the details. This is a good start. My first impression reminds me of a core of kratom marketing in the US are appeals to “antiquity, nature and foreign lands”. Alot of ancient plant medicine from southeast Asia glamorization.

      Like this study is very promising and shows the potential of how kratom may help as a harm reduction agent. But they are looking at people in Malaysia, so people there are picking fresh leaves often from their own yard or from their community, which looks nothing like the American marketplace. Plus we don’t have a cultural context for it either in the U.S.

      Kratom (Mitragyna speciosa) as a Replacement for Alcohol Among a Sample of Malaysian Adults with a History of Alcohol Use Problems: Substance Use & Misuse: Vol 0, No 0 https://www.tandfonline.com/doi/abs/10.1080/10826084.2025.2600634

      To be clear, taking kratom is safer than buying drugs off the street, or robbing your neighbor’s medicine cabinet, and in some cases, drinking booze. But it needs real regulation, not industry self-policing and laws written by its lobbyists.

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  1. Thanks for sharing this Jason.

    Yes, the KCPAs are seen by critics as “ban prevention” bills or “industry protection” laws. If they get passed them in enough states, there will be this major perception that kratom is “regulated” plus under their preferred rule set. Just yesterday, the Ohio Pharmacy board voted to ban all kratom 8-0. There is another level and commission it needs to make it through before being finalized in Ohio. But if enough states ban kratom before KCPAs get enacted it could give the FDA and DEA cover to try schedule it again federally.

    I personally think low dose leaf kratom products should be available with a digital pharmacy-like counseling checkout and major warnings not to be sold anywhere candy is available with major curbs on extracts.

    The feds and the industry both appear to agree that 7-oH should be scheduled. While some pain patients report access to this kratom isolate is helpful, there are widespread reports of significant dependency and withdrawals issues related to having it so widely available. The FDA made their 7-oH announcement in July 2025 and nothing appears to be done yet to move it forward yet. Maybe the 7-oH proponents can get a ballot initiative approved in a state to have it available by prescription otherwise it may take years to be available but selling 7oH at every corner doesn’t seem to a good idea public health wise with the American appetite.

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