OPINION:
Federal health agencies face a crisis of confidence of their own making. From sweeping COVID-19 lockdowns that kept children out of school to last month’s warning about Tylenol in pregnancy that could discourage acetaminophen use when high fever itself poses a greater risk to the fetus, regulators have too often failed to consider predictable unintended consequences.
Both the political left and right bear blame. The common thread is a failure to consider the trade-offs of a well-intentioned but potentially harmful proposed action.
However, a model for rebuilding trust is already being used to protect the environment. Under the National Environmental Policy Act of 1970, major infrastructure projects must undergo a rigorous environmental assessment or environmental impact statement before ground is broken. These safeguards force regulators to weigh the benefits they tout against risks and other long-term costs.
Congress should extend this exact mechanism to health policy. A health impact policy act would require agencies to conduct thorough assessments before implementing significant initiatives.
Consider the Food and Drug Administration’s recent recommendation that the Drug Enforcement Administration classify kratom-derived 7-hydroxymitragynine (7-OH) as a Schedule 1 substance, the most restrictive classification under the law.
The federal government, local governments and media have all overstated the risks of this yet-to-be-regulated alternative to opioids that is used by addicted patients seeking to avoid street drugs such as fentanyl.
Have we learned nothing from our nation’s long and ugly history of prohibition?
Consider marijuana. Supreme Court Justice Louis D. Brandeis famously wrote in 1932, “that a single courageous state may, if its citizens choose, serve as a laboratory; and try novel social and economic experiments without risk to the rest of the country.” States have been doing just that, as we navigate how to better regulate the drug so grievously classified as a Schedule 1 drug in 1970. There’s more to learn about how to get this right, but one conclusion is obvious: Schedule 1 is a blunt instrument.
The mess that the FDA created by banning the vast majority of e-cigarettes is another example. Adult smokers should have access to a wide range of much lower-risk flavored nicotine products authorized by the FDA. At the same time, we could further reduce youth vaping by establishing an authorized market where sales take place at licensed businesses subject to strict age verification. Doing so would largely snuff out the illicit products coming in from China, further reducing youth nicotine use. Instead, the prohibition of the products preferred by adult smokers has led to too little harm reduction and too much youth uptake.
Instead of scientifically informed regulations that take into account unintended consequences, a federal Schedule 1 classification of 7-OH would harm (and criminalize) the very population the government appropriately seeks to protect by forcing people back to the more dangerous street drugs they are trying to avoid. Equally unwise, Schedule 1 would make it nearly impossible to conduct the type of scientific research necessary to underpin smart regulation.
A congressionally mandated health assessment would require officials to consider known or potential therapeutic benefits, compare the substance with products 7-OH replaces and conduct pharmacology, toxicology and real-world evaluations before instituting a Schedule 1 ban. A more thorough health impact statement would require the government to model changes in misuse, dependence and impact on vulnerable populations. It would also be required to evaluate societal and economic consequences, forcing regulators to consider the impact on black markets, product adulteration, increased policing needs, and the societal harms that stem from it, including arrests, prosecution and a whole new wave of incarcerated populations.
A mandatory public comment period, similar to the one required for environmental regulations, would allow input from addiction specialists, medical professionals, law enforcement, and individuals in the communities who would be affected by the regulation.
Federal health agencies need to rebuild trust, stat. To do so, they must learn the enduring lessons of our nation’s failed experiments with prohibition and the ongoing failure to appropriately regulate e-cigarettes to help adult smokers quit while preventing youth usage.
When health officials resort to calling a lower-risk alternative to street drugs “gas station heroin” without data to back it up, get skeptically curious, quickly.
• Jeff Stier is a senior fellow at the Consumer Choice Center.
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