What is 7-OH and why did the FDA seize this potentially life-saving substance?

The U.S. Food and Drug Administration (FDA) enlisted the Justice Department to execute a seizure on Dec. 2 of approximately 73,000 units of 7-OH products, an element of kratom, that were held in three Kansas City-area warehouses. The FDA claims these products are illegal even though they are not controlled substances under federal law, asserting that they violate the Food, Drug, and Cosmetics Act and could be dangerous. However, there’s no real basis to conclude that the products are dangerous. In fact, there’s far more evidence that they may help people overcome opioid addiction.

7-OH is the active alkaloid in kratom—a tree native to Southeast Asia with leaves that have been used for centuries as an herbal remedy, especially as a substitute for opium or morphine. That’s because 7-OH is a partial opioid agonist, meaning it temporarily binds to the body’s opioid receptors, but higher doses do not cause greater opioid-like symptoms. That means key risks from opioids, like respiratory depression and abuse, are minimized.

The most prevalent FDA-approved treatment for opioid addiction—buprenorphine—works similarly to 7-OH. It’s also a partial opioid agonist and accounts for three-quarters of the market for addiction treatments because it’s generally regarded as safer than full-agonist alternatives like methadone.

So why is the FDA seizing these products? According to a warning letter the FDA sent one of the manufacturers prior to the seizure, the agency claims the products are “adulterated dietary supplements” because they contain a “new dietary ingredient”—7-hydroxymitragynine (7-OH) —that the agency hasn’t approved. This invokes the agency’s authority to prevent products from coming to market that haven’t received pre-market approval under the Food, Drug, and Cosmetics Act. The manufacturer, American Shaman, claims they submitted a 100-page response to the agency’s warning letter in August but never received any return response prior to the raid.

The process of registering a new dietary ingredient is normally straightforward. The manufacturer must inform the FDA what the ingredient is, how it will be produced, and any information, such as published journal articles, demonstrating the ingredient is reasonably safe for public consumption. The FDA then has 75 days to dispute the research presented or the ingredient is automatically approved.

Although manufacturers have attempted to comply with this process for 7-OH products, the FDA has argued that the research they’ve presented is unconvincing and denied the applications. The FDA has even gone further by recommending that 7-OH be listed as a controlled substance federally.  But the FDA’s own database of adverse event reporting for consumer products shows there have been zero fatalities and only three serious adverse events from 7-OH use in isolation.

Of course, a handful of deaths have occurred when 7-OH is mixed with more dangerous substances like cocaine, but polysubstance use is always dangerous. The FDA responds to that real-world evidence by saying, “Although FDA’s Adverse Event Reporting System (FAERS) has documented cases reporting adverse events (13 cases, including two deaths) suspected to involve 7-OH, ambiguity about the contributory role of 7-OH from uncharacterized products or concomitant medications and underlying disease limits interpretation.” In other words, the agency acknowledges 7-OH wasn’t the likely cause of these outcomes.

According to a survey of nearly 3,000 kratom users published in a peer-reviewed journal, nearly half of users say they use it to manage the cravings of opioid addiction. Meanwhile, 91% of users say they use it to manage chronic pain, indicating a clear overlap between these subgroups. That’s telling because chronic pain was the key condition for which prescription opioids became prevalent, and users are clearly indicating they see kratom or 7-OH products as a substitute. More than one-third of survey respondents who say they use kratom to manage opioid addiction have been able to continuously abstain from opioids for a full year. That’s higher than the success rate of current FDA-approved treatments for opioid addiction like methadone and buprenorphine. This has led noted pharmacologists in recent years to suggest that 7-OH might play an important role in combating opioid addiction.

One reason it may be easier for users to adhere to a kratom, or 7-OH regimen is precisely because of its availability. Methadone patients, for instance, must go to a clinic each day to receive a single dose, and their course of treatment could last about two years if they can maintain the schedule. Dropout rates are high because it’s difficult for recovering opioid addicts—who may not have reliable transportation—to adhere to this regimen. Moreover, patients may face stigma that discourages them from even entering a treatment program. Kratom and 7-OH products, by contrast, are readily and inexpensively available in many corner stores around the country.

It’s puzzling why the FDA would become so hostile to a class of products that holds such obvious promise as a tool for fighting opioid addiction and for treating chronic pain without opioids. The unprecedented scope of the opioid epidemic cries out for more—not fewer—tools to address the issue.

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