7-OH needs science-based regulation, not regulatory panic
by Jeff Stier · The Washington TimesOPINION:
The Food and Drug Administration is taking meaningful steps to regulate lower-risk nicotine products based on science, not fear and moral panic. More broadly, the government is still prone to making the same types of errors that led to unscientific de facto product bans.
In August, the Drug Enforcement Administration listed three 7-hydroxymitragynine-related substances — mitragynine pseudoindoxyl, MGM-15 and MGM-16 — in Schedule I of the Controlled Substances Act for up to two years. It has not listed 7-OH — yet.
The developments expose a gap in the legal framework for evaluating and controlling these substances.
The substances were listed less than two months after the DEA announced its intent to do so in July. It had also announced its intent to list a related substance, 7-OH above certain thresholds, in Schedule I alongside substances such as heroin and LSD — a more restrictive classification than fentanyl’s Schedule II placement.
For 7-OH, it opened a docket for public comments, which closed on July 31. Yet in an unusual move, the comment period was reopened on Aug. 25 and extended through Sept. 10, with no decision on whether to list 7-OH. The administration is treating 7-OH differently from the three related compounds: The latter are now Schedule I substances, while the Department of Health and Human Services is still seeking scientific evidence to determine an appropriate concentration threshold for 7-OH.
Foreshadowing this sequence of events, in May, President Trump stated at a White House health-related press conference, “We’re looking very seriously at natural 7-OH and getting that approved.”
Meanwhile, the administration must consider more than 32,000 comments submitted to HHS on the proposed scheduling of 7-OH. Consumers of 7-OH products report using them for pain, psychiatric symptoms and to reduce their reliance on opioids.
These uses are not unique to 7-OH. According to the National Institute on Drug Abuse, kratom leaf, from which 7-OH is derived, is used by consumers “to alleviate pain, to address symptoms of mental health conditions like anxiety and depression, to help stop or reduce opioid or other substance use and to manage withdrawal symptoms and cravings related to opioids and other drugs.”
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If it sounds unnecessarily complicated, that’s because it is. It always is when regulators get ahead of the science. It is even worse when the regulatory tool set available is insufficient.
For starters, the effort to get the feds to ban 7-OH is being driven by the kratom leaf industry, where the more potent 7-OH has cut into its market share. Ironically, kratom leaf companies recently survived efforts to ban their products as well.
The intraindustry battle exposes a question more fundamental than product safety.
On the one hand, we have FDA-approved drugs that undergo rigorous, expensive safety and efficacy trials, which include weighing the risks and benefits for patients. This is the gold standard for medicines, but it is not a good fit for natural products, which lack the same patent protection as synthetic pharmaceuticals.
The dietary supplement pathway does not fit either. The FDA considers 7-OH a new dietary ingredient, but says the existing evidence is insufficient to provide the legally required safety assurance. So products containing 7-OH cannot currently be lawfully marketed as dietary supplements.
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The FDA can therefore keep 7-OH products out of the lawful food and supplement market, while the Controlled Substances Act relies on a criminal approach without even knowing the appropriate thresholds. What is missing is a middle ground: a pathway for regulated sales, enforceable product standards and research to establish appropriate concentration levels.
Many who submitted comments on the Schedule I proposal reported relying on 7-OH for pain, psychiatric symptoms or to avoid more dangerous opioids. Those comments are not proof of safety or efficacy, but they are evidence that regulatory action will have a real-world impact on the lives of some of society’s most vulnerable people. Their real-life experience should be taken into account and translated into science that plays an appropriate role in any regulatory approach.
Clearly, more research, especially regarding appropriate concentration levels, is needed before the feds criminalize a product and place severe barriers to establishing the science by listing it under Schedule I.
This is the type of nuanced, science-based approach we need: neither an unregulated marketplace nor a ban that drives consumers toward far riskier products in an illicit market created when criminalization outruns the evidence.
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• Jeff Stier is a policy adviser to the Heartland Institute.