Millions of Americans suffer from pain-related conditions. Every day, they face a stark choice — buy safe, legal, regulated products to help with the pain, or resort to opioids like fentanyl, which leave a trail of addiction and ruined lives in their wake. 

If we want America to succeed and be healthy, we must make it as easy as possible to dodge opioids and make safer choices. That includes allowing people to use products like 7-hydroxymitragynine (a concentrated opioid-like chemical [7-OH]) to alleviate pain. Unfortunately, the Food and Drug Administration (FDA) makes that unnecessarily difficult.

7-OH: a pain relief crisis

7-OH, a compound deriving from the kratom plant, is a lifeline for many pain sufferers. It relieves chronic pain, post-traumatic stress disorder (PTSD) and anxiety. It can even alleviate symptoms of opioid withdrawal, helping fight addiction to powerful drugs like fentanyl. 

Unfortunately, it may not be available for purchase much longer. The FDA has recommended designating 7-OH as Schedule I — meaning that the drug has a high potential for abuse, has no currently accepted medical treatment use in the US or has a lack of accepted safety for use under medical supervision — effectively banning its use as a painkiller. This would be an entirely avoidable blow to the fight against opioid addiction.

Ah, says the FDA. But 7-OH products “have not been proven safe.” This is a common problem in the world of regulation — a product being safe is not enough for the FDA to sign off on it. Manufacturers also have to be able to “prove” to the satisfaction of FDA bureaucrats that it is safe. This is absurdly difficult.

Per the FDA’s own data, there have been zero deaths with 7-OH as the sole cause. Still, that doesn’t satisfy the FDA, which requires reams of red tape and paperwork to “prove” a product is safe. The FDA leans hard on the “precautionary principle,” a staple of European-style overregulation that bloats bureaucracy and creates countless hurdles to getting products into the market.

Even after a company has submitted the immense quantities of paperwork the FDA requires, it still has to wait for approval. The FDA drug approval process can often take more than a decade. This is a disaster for innovating new life-saving products. How many lives will have been lost to fentanyl by the time the FDA gets its pants on?

Unwarranted FDA actions on 7-OH

The problems do not end with the approval process. The FDA has a number of aggressive powers at its disposal to use at its discretion, such as designating substances as Schedule I. A responsible regulator would use this extraordinary power in only the most clear-cut of cases.

It is unclear why the FDA feels the need to resort to this extreme measure in the case of 7-OH. Even the basic threshold for considering Schedule I is not met. 7-OH shows minimal real-world misuse, with just a handful of poison control calls nationwide. (For comparison, over-the-counter painkillers like Tylenol account for 11% of calls, and cosmetics for 5%.) There are eight Schedule I criteria. 7-OH fails to meet the FDA’s own thresholds on at least six of them. There is no justification for the FDA’s resolute anti-7-OH position.

Balancing safety and access

The FDA has an important role to play, but it must take care not to overstay its welcome. It is pushing the limits of its powers. Ultimately, the FDA’s job is to protect ordinary Americans from genuinely dangerous products. That matters. Importantly, though, its remit does not extend to making consumption choices on Americans’ behalf.

Many Americans rely on 7-OH for their health needs. Plenty of others could benefit from trying it, lessening the hold their pain has over their everyday lives. It is not the FDA’s place to ban them from accessing it — especially when the primary alternative is often slipping into a crushing opioid addiction.

We live in an age of fragile institutions. Populations are quick to lose trust in those who exert power over them. If the FDA wants to stick around for years to come and enjoy the trust and confidence of Americans, it must keep itself in check. It must rein in its urge to remove legitimate products from the market almost at random. Otherwise, as the fentanyl crisis ruins yet more lives, there will only be one place to direct the blame.

[Kaitlyn Diana edited this piece.]

The views expressed in this article are the author’s own and do not necessarily reflect Fair Observer’s editorial policy.