Unraveling the Kratom Controversy: A Closer Look at the Latest FDA Move

The FDA is intensifying its efforts against a specific chemical found in kratom products. This compound, 7-hydroxymitragynine (7-OH), is appearing in energy drinks, gummies, and supplements sold in convenience stores. Health officials are raising alarms, suggesting a nationwide ban.

What is Kratom?

Kratom, a plant from Southeast Asia, has gained popularity in the U.S. as a remedy for pain, anxiety, and drug dependence, despite not being approved for these uses. The recent focus is on 7-OH, a component that some supplement companies argue is a synthetic and dangerous version of the natural ingredient.

FDA's Stance

The FDA clarifies that their action is not about natural kratom leaf products. Instead, they are releasing a report to highlight the risks of 7-OH and its differences from the kratom plant itself. They are also pushing to add this chemical to the list of illegal drugs, alongside substances like LSD and heroin.

Why the Concern?

7-OH is an opioid that can be more potent than morphine. The FDA is worried about another wave of the opioid epidemic and believes regulation and public education are key to preventing this. The Drug Enforcement Administration (DEA) will review the FDA's recommendation, but a national ban won't happen until new rules are drafted and finalized.

Past and Present Regulations

This isn't the first time kratom has been under scrutiny. For about a decade, federal regulators have been monitoring it due to reports of addiction, injury, and overdose. Users and distributors, however, have opposed regulation, arguing that kratom could be a safer alternative to opioid painkillers.

Recently, the FDA sent warning letters to seven companies selling products infused with 7-OH. These products violate FDA rules because they haven't been evaluated for safety and some claim to treat medical conditions like pain, arthritis, and anxiety. Supplement executives are backing the FDA's move, praising their proactive approach.

Lobbying and Opposition

The American Kratom Association has been lobbying Congress for years against restrictions on the plant. They support legislation that would prevent the FDA from regulating kratom more strictly than food and dietary supplements. On the other hand, a rival group supporting the availability of 7-OH drugs criticized the government's move, pointing to the influence of kratom suppliers.

Previous Attempts at Regulation

In 2016, the federal government nearly banned kratom, planning to add it to the most restrictive drug schedule. But the plan was put on hold after public complaints, including a letter signed by over 60 members of Congress. Since then, the FDA has continued to issue warnings about kratom supplements, which are usually sold in capsules or powders.

Other Unapproved Drugs

In recent months, the FDA has also been warning about other unapproved drugs sold as supplements or energy drinks, including the antidepressant tianeptine. These drugs, sometimes referred to as “gas station heroin”, have been restricted by several states but are not scheduled at the federal level.