FDA warns against opioid-like product sold at gas stations

The Food and Drug Administration recommended Tuesday that the substance 7-hydroxymitragynine, or 7-OH, come under federal scheduling due to its opioid-like nature. Officials recognized an elevated risk of abusing 7-OH because of how it binds to opioid receptors in the body, according to a Tuesday news release from the Department of Health and Human Services. The Trump administration is taking action against 7-OH as a critical step to fight the country’s opioid addiction crisis, HHS Secretary Robert F. Kennedy Jr. said.

7-OH is a concentrated byproduct of the kratom plant, a tropical tree native to Southeast Asia. Officials only aim to regulate the 7-OH concentration, not natural kratom leaf products, the FDA noted.

The FDA's report described 7-OH as a potent opioid posing a public health threat because of the compound’s increasing availability and marketing, specifically toward teens and children. Concentrated 7-OH products became popular in recent years and are now sold in gas stations in the form of pills, gummies, and even ice cream cones, according to a letter from FDA Commissioner Martin Makary. He cited a study that found 7-OH to be an opioid much more powerful than morphine. Makary insisted that it must be regulated to prevent another wave of the opioid epidemic.

Why regulate the compound but not the leaf? Officials are not concerned about the impacts of natural kratom plant leaves, which contain trace amounts of 7-OH, Markary noted. Kratom leaves serve as a stimulant in low doses, but as a sedative in high doses, according to a federal fact sheet on the plant. High doses can cause psychotic symptoms and lead to physiological dependence, according to the report. Makary also cited concerns that products containing the 7-OH concentration may be mis-marketed as natural kratom leaf products.

Some Christian counselors also warn that kratom can become addictive.

There are currently no FDA-approved 7-OH drugs or dietary supplements, and the compound may not be legally added to conventional foods, according to the FDA. No federal statutes establish age limits for purchasing 7-OH products, though certain states have individually established purchasing laws.

Dig deeper: Read Lauren Canterberry’s report on all 50 states agreeing to a $7.4 billion settlement with Purdue Pharma, the maker of OxyContin, for its role in the opioid crisis.